Frances Thorndike - Academia.edu (original) (raw)

Papers by Frances Thorndike

Research paper thumbnail of Manual Transmission Enhances Attention and Driving Performance of ADHD Adolescent Males

Journal of Attention Disorders, 2006

Objective: Inattention is a major contributor to driving mishaps and is especially problematic am... more Objective: Inattention is a major contributor to driving mishaps and is especially problematic among adolescent drivers with ADHD, possibly contributing to their 2 to 4 times higher incidence of collisions. Manual transmission has been demonstrated to be associated with greater arousal. This study tests the hypotheses that manual transmission, compared to automatic transmission, would be associated with better attention and performance on a driving simulator. Method: Ten adolescent drivers with ADHD practice driving on the simulator in the manual and automatic mode. Employing a single-blind, cross-over design, participants drive the simulator at 19:30 and 22:30 hr for 30 min in both transmissions and rate their attention to driving. Results: Subjectively, participants report being more attentive while driving in manual transmission mode. Objectively, participants drive safer in the manual transmission mode. Conclusion: Although in need of replication, this pilot study suggests a beh...

Research paper thumbnail of Moderators of the Effects of mySmartSkin, a Web-Based Intervention to Promote Skin Self-examination and Sun Protection Among Individuals Diagnosed With Melanoma

Annals of Behavioral Medicine

Background Identifying the characteristics of persons who benefit more from behavioral interventi... more Background Identifying the characteristics of persons who benefit more from behavioral interventions can help health care providers decide which individuals should be offered particular interventions because this is the subgroup of persons who are more likely to derive greater benefit from the intervention and refine the underlying constructs of the model guiding the intervention. Purpose This study evaluated possible demographic, medical, knowledge and attitudinal, and psychosocial variables that may moderate the impact of an online intervention, called mySmartSkin (MSS), on engagement in skin self-examination (SSE) and sun protection behaviors among melanoma survivors. Methods Participants completed a baseline survey and were then randomized to the MSS condition or usual care. Follow-up surveys were completed by participants at 8-, 24-, and 48-week postrandomization. Results A greater impact of MSS on SSE was illustrated among participants with more phenotypic skin cancer risk fac...

Research paper thumbnail of PreScription DigitaL ThErapEutic for Patients with Insomnia (SLEEP-I): a protocol for a pragmatic randomised controlled trial

BMJ Open

IntroductionCognitive behavioural therapy for insomnia (CBT-I) is effective at treating chronic i... more IntroductionCognitive behavioural therapy for insomnia (CBT-I) is effective at treating chronic insomnia, yet in-person CBT-I can often be challenging to access. Prior studies have used technology to bridge barriers but have been unable to extensively assess the impact of the digital therapeutic on real-world patient experience and multidimensional outcomes. Among patients with insomnia, our aim is to determine the impact of a prescription digital therapeutic (PDT) (PEAR-003b, FDA-authorised as Somryst; herein called PDT) that provides mobile-delivered CBT-I on patient-reported outcomes (PROs) and healthcare utilisation.Methods and analysisWe are conducting a pragmatically designed, prospective, multicentre randomised controlled trial that leverages Hugo, a unique patient-centred health data-aggregating platform for data collection and patient follow-up from Hugo Health. A total of 100 participants with insomnia from two health centres will be enrolled onto the Hugo Health platform,...

Research paper thumbnail of PreScription DigitaL ThErapEutic for Patients with Insomnia (SLEEP-I): A Protocol for a Pragmatic Randomized Controlled Trial

ABSTRACTIntroductionCognitive behavioral therapy for insomnia (CBT-I) is effective at treating ch... more ABSTRACTIntroductionCognitive behavioral therapy for insomnia (CBT-I) is effective at treating chronic insomnia, yet in-person CBT-I can often be challenging to access. Prior studies have used technology to bridge barriers but have been unable to extensively assess the impact of the digital therapeutic on real-world patient experience and multi-dimensional outcomes. Among patients with insomnia, our aim is to determine the impact of a Prescription Digital Therapeutic (PDT) (PEAR-003b, FDA-authorized as Somryst; herein called PDT) that provides mobile-delivered CBT-I on patient-reported outcomes (PROs) and healthcare utilization.Methods and AnalysisWe are conducting a pragmatically designed, prospective, multi-center randomized controlled trial that leverages Hugo, a unique patient-centered health data-aggregating platform for data collection and patient follow-up from Hugo Health. A total of 100 participants with insomnia from two health centers will be enrolled onto the Hugo Health...

Research paper thumbnail of Supplementary_Table_1 – Supplemental material for Adjunctive Internet-delivered cognitive behavioural therapy for insomnia in men with depression: A randomised controlled trial

Supplemental material, Supplementary_Table_1 for Adjunctive Internet-delivered cognitive behaviou... more Supplemental material, Supplementary_Table_1 for Adjunctive Internet-delivered cognitive behavioural therapy for insomnia in men with depression: A randomised controlled trial by Nick Glozier, Helen Christensen, Kathleen M Griffiths, Ian B Hickie, Sharon L Naismith, Daniel Biddle, Simon Overland, Frances Thorndike and Lee Ritterband in Australian & New Zealand Journal of Psychiatry

Research paper thumbnail of Additional file 1: of Online cognitive behavioral therapy for insomnia (CBT-I) for the treatment of insomnia among individuals with alcohol use disorder: study protocol for a randomized controlled trial

Study Schema and Timing of Assessments. Timing of assessment of outcome measures. (DOCX 19 kb)

Research paper thumbnail of Protocol for Digital Real-world Evidence trial for Adults with insomnia treated via Mobile (DREAM): an open-label trial of a prescription digital therapeutic for treating patients with chronic insomnia

Journal of Comparative Effectiveness Research, 2021

Background: Cognitive behavioral therapy for insomnia (CBT-I) is underused in healthcare settings... more Background: Cognitive behavioral therapy for insomnia (CBT-I) is underused in healthcare settings and is challenging for people with insomnia to access because of uneven geographical distribution of behavioral sleep medicine providers. Prescription digital therapeutics can overcome these barriers. This study evaluates the effectiveness of a specific digital CBT-I therapeutic. Materials & methods: Digital Real-world Evidence trial for Adults with insomnia treated via Mobile (DREAM) is a 9-week, open-label, decentralized clinical trial to collect real-world evidence for a digital therapeutic (Somryst™) delivering CBT-I to patients with chronic insomnia. The primary objective is to examine the effectiveness of Somryst to reduce self-reported insomnia symptoms and severity in a real-world population (n = 350). Conclusion: This pragmatic study seeks to assess the potential benefits of treating insomnia with an asynchronous, mobile, tailored prescription digital therapeutic. Clinical tria...

Research paper thumbnail of Effects of an Internet-Based Cognitive Behavioral Therapy for Insomnia Program on Work Productivity: A Secondary Analysis

Annals of Behavioral Medicine, 2020

Background Cognitive-behavioral therapy for insomnia (CBT-I) may improve productivity along with ... more Background Cognitive-behavioral therapy for insomnia (CBT-I) may improve productivity along with insomnia symptoms, but the long-term duration of productivity gains is unknown. Purpose In this secondary analysis, effects of Internet-delivered CBT-I on work-related and daily activity productivity were examined through 1 year post-treatment. Methods Adults with chronic insomnia (N = 303) were randomized to Internet-delivered CBT-I (Sleep Healthy Using the Internet [SHUTi]) or to patient education (PE). Participants reported interference with attendance (absenteeism) and productivity (presenteeism) at paid employment and in daily activities outside work on the Work Productivity Activity Impairment scale at baseline, 9 weeks later for postintervention assessment (post-assessment), and 6- and 12-month follow-ups. Results Participants randomized to SHUTi were about 50% less likely than those in the PE condition to report any absenteeism (logistic regression odds ratio [OR] = 0.48 [95% con...

Research paper thumbnail of Adjunctive Internet-delivered cognitive behavioural therapy for insomnia in men with depression: A randomised controlled trial

Australian & New Zealand Journal of Psychiatry, 2018

Objective: Internet-delivered cognitive behavioural therapy for insomnia is efficacious for insom... more Objective: Internet-delivered cognitive behavioural therapy for insomnia is efficacious for insomnia, and post hoc analyses suggest mood improvements. We undertook the first clinical trial evaluating the efficacy of Internet-delivered cognitive behavioural therapy for insomnia on depressive symptoms as an adjunct to guideline-based treatment of depressive disorders. Methods: Older men undergoing psychiatrist-coordinated treatment for major depressive disorder or dysthymia and who had significant insomnia symptoms were randomised to either adjunctive Internet-delivered cognitive behavioural therapy for insomnia (Sleep Healthy Using The Internet) or online sleep psychoeducation. The primary outcome was change in depressive symptoms (Centre for Epidemiological Studies Depression scale) from baseline to week 12 (post intervention). Secondary outcomes were insomnia and anxiety symptoms. Results: In all, 87 men were randomised (Internet-delivered cognitive behavioural therapy for insomnia...

Research paper thumbnail of Online insomnia treatment and the reduction of anxiety symptoms as a secondary outcome in a randomised controlled trial: The role of cognitive-behavioural factors

Australian & New Zealand Journal of Psychiatry, 2018

Objective: Insomnia and anxiety commonly co-occur, yet the mechanisms underlying this remain uncl... more Objective: Insomnia and anxiety commonly co-occur, yet the mechanisms underlying this remain unclear. The current paper describes the impact of an Internet-based intervention for insomnia on anxiety, and explores the influence of two cognitive-behavioural constructs – dysfunctional beliefs about sleep and sleep-threat monitoring. Methods: A large-scale, 9-week, two-arm randomised controlled trial ( N = 1149) of community-dwelling Australian adults with insomnia and elevated yet subclinical depression symptoms was conducted, comparing a cognitive behavioural therapy–based online intervention for insomnia (Sleep Healthy Using The Internet) with an attention-matched online control intervention (HealthWatch). Symptoms of anxiety were assessed at pretest, posttest, and 6-month follow-up. Dysfunctional beliefs about sleep and sleep threat monitoring were assessed only at pretest. Results: Sleep Healthy Using The Internet led to a greater reduction in anxiety symptoms at both posttest ( t7...

Research paper thumbnail of Web-Delivered Cognitive Behavioral Therapy for Distressed Cancer Patients: Randomized Controlled Trial

Journal of Medical Internet Research, 2018

Research paper thumbnail of Overcoming insomnia: protocol for a large-scale randomised controlled trial of online cognitive behaviour therapy for insomnia compared with online patient education about sleep

BMJ open, Jan 30, 2018

Insomnia is a major public health concern. While cognitive behaviour therapy for insomnia (CBT-I)... more Insomnia is a major public health concern. While cognitive behaviour therapy for insomnia (CBT-I) is acknowledged as the best available intervention, there are unanswered questions about its wider dissemination, socioeconomic benefits and its impact on health resource utilisation. The aim of this randomised controlled trial (RCT) is to investigate the effectiveness of a fully automated online version of CBT-I compared with online patient education about sleep (PE). Outcome measures comprise changes in symptoms of insomnia, time off work due to sick leave as well as medication and health resource utilisation. Also, we will examine (i) putative mediators of the effects of CBT-I on insomnia severity and (ii) selected potential psycho-bio-social moderators of the effects of the interventions. A parallel-group RCT will be conducted in a target sample of about 1500 adults recruited across Norway. Participants will complete an online screening and consent process. Those who meet eligibilit...

Research paper thumbnail of Effect of a Web-Based Cognitive Behavior Therapy for Insomnia Intervention With 1-Year Follow-up: A Randomized Clinical Trial

JAMA psychiatry, 2017

Although cognitive behavior therapy for insomnia (CBT-I) has been established as the first-line r... more Although cognitive behavior therapy for insomnia (CBT-I) has been established as the first-line recommendation for the millions of adults with chronic insomnia, there is a paucity of trained clinicians to deliver this much needed treatment. Internet-delivered CBT-I has shown promise as a method to overcome this obstacle; however, the long-term effectiveness has not been proven in a representative sample with chronic insomnia. To evaluate a web-based, automated CBT-I intervention to improve insomnia in the short term (9 weeks) and long term (1 year). A randomized clinical trial comparing the internet CBT-I with internet patient education at baseline, 9 weeks, 6 months, and 1 year. Altogether, 303 adults with chronic insomnia self-referred to participate, of whom 151 (49.8%) reported at least 1 medical or psychiatric comorbidity. The internet CBT-I (Sleep Healthy Using the Internet [SHUTi]) was a 6-week fully automated, interactive, and tailored web-based program that incorporated the...

Research paper thumbnail of The Sleep Or Mood Novel Adjunctive therapy (SOMNA) trial: a study protocol for a randomised controlled trial evaluating an internet-delivered cognitive behavioural therapy program for insomnia on outcomes of standard treatment for depression in men

BMC Psychiatry, 2015

Background: Insomnia is a significant risk factor for depression onset, can result in more disabl... more Background: Insomnia is a significant risk factor for depression onset, can result in more disabling depressive illness, and is a common residual symptom following treatment cessation that can increase the risk of relapse. Internet-based cognitive behavioural therapy for insomnia has demonstrated efficacy and acceptability to men who are less likely than women to seek help in standard care. We aim to evaluate whether internet delivered cognitive behavioural therapy for insomnia as an adjunct to a standard depression therapeutic plan can lead to improved mood outcomes. Methods/Design: Male participants aged 50 years or more, meeting Diagnostic and Statistical Manual of Mental Disorders criteria for current Major Depressive Episode and/or Dysthymia and self-reported insomnia symptoms, will be screened to participate in a single-centre double-blind randomised controlled trial with two parallel groups involving adjunctive internet-delivered cognitive behavioural therapy for insomnia and an internet-based control program. The trial will consist of a nine-week insomnia intervention period with a six-month follow-up period. During the insomnia intervention period participants will have their depression management coordinated by a psychiatrist using standard guideline-based depression treatments. The study will be conducted in urban New South Wales, Australia, where 80 participants from primary and secondary care and direct from the local community will be recruited. The primary outcome is change in the severity of depressive symptoms from baseline to week 12. Discussion: This study will provide evidence on whether a widely accessible, evidence-based, internet-delivered cognitive behavioural therapy for insomnia intervention can lead to greater improvements than standard treatment for depression alone, in a group who traditionally do not readily access psychotherapy. The study is designed to establish effect size, feasibility and processes associated with implementing e-health solutions alongside standard clinical care, to warrant undertaking a larger more definitive clinical trial. Trial registration: Australian and New Zealand Clinical Trials Registry ACTRN12612000985886.

Research paper thumbnail of Sleep disturbance in cancer patients and caregivers who contact telephone-based help services

Supportive Care in Cancer, 2014

Purpose Insomnia is highly prevalent in people who are affected by cancer. However, options avail... more Purpose Insomnia is highly prevalent in people who are affected by cancer. However, options available to receive support for insomnia are limited. Telephone-based help services, such as cancer helplines, may be ideally placed to meet unmet needs regarding insomnia after cancer. The present study describes the prevalence and predictors of insomnia in patients and caregivers who call cancer helplines seeking support. Methods Participants (N=500 patients, N=234 caregivers) were recruited through an Australian state-based telephonedelivered cancer helpline. In addition to routine screening with the Distress Thermometer, participants were administered the Insomnia Severity Index. Results Most participants were female, older than 50 years of age, and were three (caregivers) to four (patients) months post-diagnosis. Insomnia symptoms were reported by 59.4 % of patients and 62.9 % of caregivers, with moderate to severe levels of insomnia reported by 27 % of patients and 30 % of caregivers. Insomnia was predicted by distress level for both patients (β=.31, p<.001) and caregivers (β=.32, p<.001) and age for patients only (β=−.13, p<.01). Conclusions Insomnia symptoms are common in patients and caregivers who call cancer helplines and appear to be related to distress. Telephone-based helplines have the potential to act as the first line of support in a stepped care approach addressing insomnia.

Research paper thumbnail of The Further Rise of Internet Interventions

SLEEP, 2012

The Further Rise of Internet Interventions Commentary on Espie et al. A randomized, placebo-contr... more The Further Rise of Internet Interventions Commentary on Espie et al. A randomized, placebo-controlled trial of online cognitive behavioral therapy for chronic insomnia disorder delivered via an automated media-rich web application. SLEEP 2012;35:769-781.

Research paper thumbnail of Initial evaluation of an Internet intervention to improve the sleep of cancer survivors with insomnia

Psycho-Oncology, 2011

Objective-Insomnia is a common complaint among cancer survivors. Fortunately, cognitivebehavioral... more Objective-Insomnia is a common complaint among cancer survivors. Fortunately, cognitivebehavioral therapy for insomnia (CBT-I) has been shown to be an effective treatment in this population. However, it is rarely implemented given its limited availability. To address this barrier, we examined the ability of an easily-accessible online CBT-I program to improve insomnia symptoms in cancer survivors. Methods-Twenty-eight cancer survivors with insomnia were randomly assigned to either an Internet insomnia intervention (n=14) or to a waitlist control group (n=14). The online program, Sleep Healthy Using the Internet, delivers the primary components of CBT-I (sleep restriction, stimulus control, cognitive restructuring, sleep hygiene, and relapse prevention). Pre-and postassessment data were collected via online questionnaires and daily sleep diaries. Results-Participants in the Internet group showed significant improvements at post-assessment compared to those in the control group in overall insomnia severity (F 1,26 =22.8; P<.001), sleep efficiency (F 1,24 =11.45; P=.002), sleep onset latency (F 1,24 =5.18; P=.03), soundness of sleep (F 1,24 =9.34; P=.005), restored feeling upon awakening (F 1,24 =11.95; P=.002), and general fatigue (F 1,26 =13.88; P=.001). Although other group x time interactions were not significant, overall adjusted effect sizes for all sleep variables as well as for fatigue, depression, anxiety, and quality of life ranged from small to large. Conclusions-CBT-I delivered through an interactive, individually-tailored Internet intervention may be a viable treatment option for cancer survivors experiencing insomnia.

Research paper thumbnail of Relative Benefits of Stimulant Therapy With OROS Methylphenidate Versus Mixed Amphetamine Salts Extended Release in Improving the Driving Performance of Adolescent Drivers With Attention-Deficit/Hyperactivity Disorder

Pediatrics, 2006

OBJECTIVE. Automobile accidents are the leading cause of death among adolescents, and collisions ... more OBJECTIVE. Automobile accidents are the leading cause of death among adolescents, and collisions are 2 to 4 times more likely to occur among adolescents with attention-deficit/hyperactivity disorder. Studies have demonstrated that stimulants improve driving performance. This study compared 2 long-acting stimulant medications during daytime and evening driving evaluations. METHODS. Adolescent drivers with attention-deficit/hyperactivity disorder were compared on a driving simulator after taking 72 mg of OROS methylphenidate, 30 mg of mixed amphetamine salts extended release, or placebo in a randomized, double-blind, placebo-controlled, crossover study design. During laboratory testing, adolescents drove a driving simulator at 5:00 pm, 8:00 pm, and 11:00 pm. Driving performance was rated by adolescents and investigators. RESULTS. The study included 35 adolescent drivers with attention-deficit/hyperactivity disorder (19 boys/16 girls). The mean age was 17.8 years. The overall Impaired ...

Research paper thumbnail of Stages of Change in Smoking Cessation: A Comparison of Expectancies Among Precontemplators and Contemplators

Journal of Rational-Emotive & Cognitive-Behavior Therapy, 2004

Previous research has shown that smokers progress through a series of stages of change as they at... more Previous research has shown that smokers progress through a series of stages of change as they attempt to quit their habit. This study evaluated smokers in the precontemplation and contemplation stages in order to explore how we can effectively facilitate positive stage transition. Precontemplators (n = 71) and contemplators (n = 30) were compared in terms of two types of expectancies: self-efficacy beliefs and response outcome expectancies. Stage of change was defined according to both categorical and continuous dimensions, each of which led to different results. The findings are discussed in terms of their potential applications to smoking cessation programs and their implications regarding the stage model of change.

Research paper thumbnail of Depression Proneness and Reactions to a Depressive Stimulus

The Journal of Psychology, 2006

In the context of a project examining depression vulnerability and cigarette smoking, this study ... more In the context of a project examining depression vulnerability and cigarette smoking, this study tested whether depression-vulnerable people differed from less vulnerable people in their reactions to a depressive stimulus. Regular smokers with a history of depression, but not currently depressed (n = 63) and never-depressed smokers (n = 64) listened to audiotapes of confederates reading depressive and non-depressive scripts, and reported their reactions. Neither history of depression nor selfreported depression proneness predicted reactions to depression. However, depression proneness positively correlated with beliefs about depression contagion. Likewise, stronger depression-related contagion beliefs and lower levels of empathic responding predicted behavioral rejection of the depressive stimulus. Depression Proneness and Reactions to a Depressive Stimulus Extensive research shows that depression elicits rejection from others (see Segrin & Dillard, 1992, for review), but of course not everyone who comes in contact with depressed people rejects them. To understand the interpersonal environment confronted by depressed people, and its possible role in maintenance of depression, it would be helpful to know more about individual differences in the tendency to reject those who are depressed. In the research reported in this article we explored whether being prone to depression oneself would be one such individual difference. If depression-prone people have more empathy for those suffering from depression, because they understand how debilitating it can be, then they might be less rejecting of the currently depressed. This result would be consistent with findings that prior experience with a particular need facilitates empathy for others with that need (Batson et al., 1996) and with research linking higher trait empathy in one person with less rejection of another (Joiner, Alfano, & Metalsky, 1992).

Research paper thumbnail of Manual Transmission Enhances Attention and Driving Performance of ADHD Adolescent Males

Journal of Attention Disorders, 2006

Objective: Inattention is a major contributor to driving mishaps and is especially problematic am... more Objective: Inattention is a major contributor to driving mishaps and is especially problematic among adolescent drivers with ADHD, possibly contributing to their 2 to 4 times higher incidence of collisions. Manual transmission has been demonstrated to be associated with greater arousal. This study tests the hypotheses that manual transmission, compared to automatic transmission, would be associated with better attention and performance on a driving simulator. Method: Ten adolescent drivers with ADHD practice driving on the simulator in the manual and automatic mode. Employing a single-blind, cross-over design, participants drive the simulator at 19:30 and 22:30 hr for 30 min in both transmissions and rate their attention to driving. Results: Subjectively, participants report being more attentive while driving in manual transmission mode. Objectively, participants drive safer in the manual transmission mode. Conclusion: Although in need of replication, this pilot study suggests a beh...

Research paper thumbnail of Moderators of the Effects of mySmartSkin, a Web-Based Intervention to Promote Skin Self-examination and Sun Protection Among Individuals Diagnosed With Melanoma

Annals of Behavioral Medicine

Background Identifying the characteristics of persons who benefit more from behavioral interventi... more Background Identifying the characteristics of persons who benefit more from behavioral interventions can help health care providers decide which individuals should be offered particular interventions because this is the subgroup of persons who are more likely to derive greater benefit from the intervention and refine the underlying constructs of the model guiding the intervention. Purpose This study evaluated possible demographic, medical, knowledge and attitudinal, and psychosocial variables that may moderate the impact of an online intervention, called mySmartSkin (MSS), on engagement in skin self-examination (SSE) and sun protection behaviors among melanoma survivors. Methods Participants completed a baseline survey and were then randomized to the MSS condition or usual care. Follow-up surveys were completed by participants at 8-, 24-, and 48-week postrandomization. Results A greater impact of MSS on SSE was illustrated among participants with more phenotypic skin cancer risk fac...

Research paper thumbnail of PreScription DigitaL ThErapEutic for Patients with Insomnia (SLEEP-I): a protocol for a pragmatic randomised controlled trial

BMJ Open

IntroductionCognitive behavioural therapy for insomnia (CBT-I) is effective at treating chronic i... more IntroductionCognitive behavioural therapy for insomnia (CBT-I) is effective at treating chronic insomnia, yet in-person CBT-I can often be challenging to access. Prior studies have used technology to bridge barriers but have been unable to extensively assess the impact of the digital therapeutic on real-world patient experience and multidimensional outcomes. Among patients with insomnia, our aim is to determine the impact of a prescription digital therapeutic (PDT) (PEAR-003b, FDA-authorised as Somryst; herein called PDT) that provides mobile-delivered CBT-I on patient-reported outcomes (PROs) and healthcare utilisation.Methods and analysisWe are conducting a pragmatically designed, prospective, multicentre randomised controlled trial that leverages Hugo, a unique patient-centred health data-aggregating platform for data collection and patient follow-up from Hugo Health. A total of 100 participants with insomnia from two health centres will be enrolled onto the Hugo Health platform,...

Research paper thumbnail of PreScription DigitaL ThErapEutic for Patients with Insomnia (SLEEP-I): A Protocol for a Pragmatic Randomized Controlled Trial

ABSTRACTIntroductionCognitive behavioral therapy for insomnia (CBT-I) is effective at treating ch... more ABSTRACTIntroductionCognitive behavioral therapy for insomnia (CBT-I) is effective at treating chronic insomnia, yet in-person CBT-I can often be challenging to access. Prior studies have used technology to bridge barriers but have been unable to extensively assess the impact of the digital therapeutic on real-world patient experience and multi-dimensional outcomes. Among patients with insomnia, our aim is to determine the impact of a Prescription Digital Therapeutic (PDT) (PEAR-003b, FDA-authorized as Somryst; herein called PDT) that provides mobile-delivered CBT-I on patient-reported outcomes (PROs) and healthcare utilization.Methods and AnalysisWe are conducting a pragmatically designed, prospective, multi-center randomized controlled trial that leverages Hugo, a unique patient-centered health data-aggregating platform for data collection and patient follow-up from Hugo Health. A total of 100 participants with insomnia from two health centers will be enrolled onto the Hugo Health...

Research paper thumbnail of Supplementary_Table_1 – Supplemental material for Adjunctive Internet-delivered cognitive behavioural therapy for insomnia in men with depression: A randomised controlled trial

Supplemental material, Supplementary_Table_1 for Adjunctive Internet-delivered cognitive behaviou... more Supplemental material, Supplementary_Table_1 for Adjunctive Internet-delivered cognitive behavioural therapy for insomnia in men with depression: A randomised controlled trial by Nick Glozier, Helen Christensen, Kathleen M Griffiths, Ian B Hickie, Sharon L Naismith, Daniel Biddle, Simon Overland, Frances Thorndike and Lee Ritterband in Australian & New Zealand Journal of Psychiatry

Research paper thumbnail of Additional file 1: of Online cognitive behavioral therapy for insomnia (CBT-I) for the treatment of insomnia among individuals with alcohol use disorder: study protocol for a randomized controlled trial

Study Schema and Timing of Assessments. Timing of assessment of outcome measures. (DOCX 19 kb)

Research paper thumbnail of Protocol for Digital Real-world Evidence trial for Adults with insomnia treated via Mobile (DREAM): an open-label trial of a prescription digital therapeutic for treating patients with chronic insomnia

Journal of Comparative Effectiveness Research, 2021

Background: Cognitive behavioral therapy for insomnia (CBT-I) is underused in healthcare settings... more Background: Cognitive behavioral therapy for insomnia (CBT-I) is underused in healthcare settings and is challenging for people with insomnia to access because of uneven geographical distribution of behavioral sleep medicine providers. Prescription digital therapeutics can overcome these barriers. This study evaluates the effectiveness of a specific digital CBT-I therapeutic. Materials & methods: Digital Real-world Evidence trial for Adults with insomnia treated via Mobile (DREAM) is a 9-week, open-label, decentralized clinical trial to collect real-world evidence for a digital therapeutic (Somryst™) delivering CBT-I to patients with chronic insomnia. The primary objective is to examine the effectiveness of Somryst to reduce self-reported insomnia symptoms and severity in a real-world population (n = 350). Conclusion: This pragmatic study seeks to assess the potential benefits of treating insomnia with an asynchronous, mobile, tailored prescription digital therapeutic. Clinical tria...

Research paper thumbnail of Effects of an Internet-Based Cognitive Behavioral Therapy for Insomnia Program on Work Productivity: A Secondary Analysis

Annals of Behavioral Medicine, 2020

Background Cognitive-behavioral therapy for insomnia (CBT-I) may improve productivity along with ... more Background Cognitive-behavioral therapy for insomnia (CBT-I) may improve productivity along with insomnia symptoms, but the long-term duration of productivity gains is unknown. Purpose In this secondary analysis, effects of Internet-delivered CBT-I on work-related and daily activity productivity were examined through 1 year post-treatment. Methods Adults with chronic insomnia (N = 303) were randomized to Internet-delivered CBT-I (Sleep Healthy Using the Internet [SHUTi]) or to patient education (PE). Participants reported interference with attendance (absenteeism) and productivity (presenteeism) at paid employment and in daily activities outside work on the Work Productivity Activity Impairment scale at baseline, 9 weeks later for postintervention assessment (post-assessment), and 6- and 12-month follow-ups. Results Participants randomized to SHUTi were about 50% less likely than those in the PE condition to report any absenteeism (logistic regression odds ratio [OR] = 0.48 [95% con...

Research paper thumbnail of Adjunctive Internet-delivered cognitive behavioural therapy for insomnia in men with depression: A randomised controlled trial

Australian & New Zealand Journal of Psychiatry, 2018

Objective: Internet-delivered cognitive behavioural therapy for insomnia is efficacious for insom... more Objective: Internet-delivered cognitive behavioural therapy for insomnia is efficacious for insomnia, and post hoc analyses suggest mood improvements. We undertook the first clinical trial evaluating the efficacy of Internet-delivered cognitive behavioural therapy for insomnia on depressive symptoms as an adjunct to guideline-based treatment of depressive disorders. Methods: Older men undergoing psychiatrist-coordinated treatment for major depressive disorder or dysthymia and who had significant insomnia symptoms were randomised to either adjunctive Internet-delivered cognitive behavioural therapy for insomnia (Sleep Healthy Using The Internet) or online sleep psychoeducation. The primary outcome was change in depressive symptoms (Centre for Epidemiological Studies Depression scale) from baseline to week 12 (post intervention). Secondary outcomes were insomnia and anxiety symptoms. Results: In all, 87 men were randomised (Internet-delivered cognitive behavioural therapy for insomnia...

Research paper thumbnail of Online insomnia treatment and the reduction of anxiety symptoms as a secondary outcome in a randomised controlled trial: The role of cognitive-behavioural factors

Australian & New Zealand Journal of Psychiatry, 2018

Objective: Insomnia and anxiety commonly co-occur, yet the mechanisms underlying this remain uncl... more Objective: Insomnia and anxiety commonly co-occur, yet the mechanisms underlying this remain unclear. The current paper describes the impact of an Internet-based intervention for insomnia on anxiety, and explores the influence of two cognitive-behavioural constructs – dysfunctional beliefs about sleep and sleep-threat monitoring. Methods: A large-scale, 9-week, two-arm randomised controlled trial ( N = 1149) of community-dwelling Australian adults with insomnia and elevated yet subclinical depression symptoms was conducted, comparing a cognitive behavioural therapy–based online intervention for insomnia (Sleep Healthy Using The Internet) with an attention-matched online control intervention (HealthWatch). Symptoms of anxiety were assessed at pretest, posttest, and 6-month follow-up. Dysfunctional beliefs about sleep and sleep threat monitoring were assessed only at pretest. Results: Sleep Healthy Using The Internet led to a greater reduction in anxiety symptoms at both posttest ( t7...

Research paper thumbnail of Web-Delivered Cognitive Behavioral Therapy for Distressed Cancer Patients: Randomized Controlled Trial

Journal of Medical Internet Research, 2018

Research paper thumbnail of Overcoming insomnia: protocol for a large-scale randomised controlled trial of online cognitive behaviour therapy for insomnia compared with online patient education about sleep

BMJ open, Jan 30, 2018

Insomnia is a major public health concern. While cognitive behaviour therapy for insomnia (CBT-I)... more Insomnia is a major public health concern. While cognitive behaviour therapy for insomnia (CBT-I) is acknowledged as the best available intervention, there are unanswered questions about its wider dissemination, socioeconomic benefits and its impact on health resource utilisation. The aim of this randomised controlled trial (RCT) is to investigate the effectiveness of a fully automated online version of CBT-I compared with online patient education about sleep (PE). Outcome measures comprise changes in symptoms of insomnia, time off work due to sick leave as well as medication and health resource utilisation. Also, we will examine (i) putative mediators of the effects of CBT-I on insomnia severity and (ii) selected potential psycho-bio-social moderators of the effects of the interventions. A parallel-group RCT will be conducted in a target sample of about 1500 adults recruited across Norway. Participants will complete an online screening and consent process. Those who meet eligibilit...

Research paper thumbnail of Effect of a Web-Based Cognitive Behavior Therapy for Insomnia Intervention With 1-Year Follow-up: A Randomized Clinical Trial

JAMA psychiatry, 2017

Although cognitive behavior therapy for insomnia (CBT-I) has been established as the first-line r... more Although cognitive behavior therapy for insomnia (CBT-I) has been established as the first-line recommendation for the millions of adults with chronic insomnia, there is a paucity of trained clinicians to deliver this much needed treatment. Internet-delivered CBT-I has shown promise as a method to overcome this obstacle; however, the long-term effectiveness has not been proven in a representative sample with chronic insomnia. To evaluate a web-based, automated CBT-I intervention to improve insomnia in the short term (9 weeks) and long term (1 year). A randomized clinical trial comparing the internet CBT-I with internet patient education at baseline, 9 weeks, 6 months, and 1 year. Altogether, 303 adults with chronic insomnia self-referred to participate, of whom 151 (49.8%) reported at least 1 medical or psychiatric comorbidity. The internet CBT-I (Sleep Healthy Using the Internet [SHUTi]) was a 6-week fully automated, interactive, and tailored web-based program that incorporated the...

Research paper thumbnail of The Sleep Or Mood Novel Adjunctive therapy (SOMNA) trial: a study protocol for a randomised controlled trial evaluating an internet-delivered cognitive behavioural therapy program for insomnia on outcomes of standard treatment for depression in men

BMC Psychiatry, 2015

Background: Insomnia is a significant risk factor for depression onset, can result in more disabl... more Background: Insomnia is a significant risk factor for depression onset, can result in more disabling depressive illness, and is a common residual symptom following treatment cessation that can increase the risk of relapse. Internet-based cognitive behavioural therapy for insomnia has demonstrated efficacy and acceptability to men who are less likely than women to seek help in standard care. We aim to evaluate whether internet delivered cognitive behavioural therapy for insomnia as an adjunct to a standard depression therapeutic plan can lead to improved mood outcomes. Methods/Design: Male participants aged 50 years or more, meeting Diagnostic and Statistical Manual of Mental Disorders criteria for current Major Depressive Episode and/or Dysthymia and self-reported insomnia symptoms, will be screened to participate in a single-centre double-blind randomised controlled trial with two parallel groups involving adjunctive internet-delivered cognitive behavioural therapy for insomnia and an internet-based control program. The trial will consist of a nine-week insomnia intervention period with a six-month follow-up period. During the insomnia intervention period participants will have their depression management coordinated by a psychiatrist using standard guideline-based depression treatments. The study will be conducted in urban New South Wales, Australia, where 80 participants from primary and secondary care and direct from the local community will be recruited. The primary outcome is change in the severity of depressive symptoms from baseline to week 12. Discussion: This study will provide evidence on whether a widely accessible, evidence-based, internet-delivered cognitive behavioural therapy for insomnia intervention can lead to greater improvements than standard treatment for depression alone, in a group who traditionally do not readily access psychotherapy. The study is designed to establish effect size, feasibility and processes associated with implementing e-health solutions alongside standard clinical care, to warrant undertaking a larger more definitive clinical trial. Trial registration: Australian and New Zealand Clinical Trials Registry ACTRN12612000985886.

Research paper thumbnail of Sleep disturbance in cancer patients and caregivers who contact telephone-based help services

Supportive Care in Cancer, 2014

Purpose Insomnia is highly prevalent in people who are affected by cancer. However, options avail... more Purpose Insomnia is highly prevalent in people who are affected by cancer. However, options available to receive support for insomnia are limited. Telephone-based help services, such as cancer helplines, may be ideally placed to meet unmet needs regarding insomnia after cancer. The present study describes the prevalence and predictors of insomnia in patients and caregivers who call cancer helplines seeking support. Methods Participants (N=500 patients, N=234 caregivers) were recruited through an Australian state-based telephonedelivered cancer helpline. In addition to routine screening with the Distress Thermometer, participants were administered the Insomnia Severity Index. Results Most participants were female, older than 50 years of age, and were three (caregivers) to four (patients) months post-diagnosis. Insomnia symptoms were reported by 59.4 % of patients and 62.9 % of caregivers, with moderate to severe levels of insomnia reported by 27 % of patients and 30 % of caregivers. Insomnia was predicted by distress level for both patients (β=.31, p<.001) and caregivers (β=.32, p<.001) and age for patients only (β=−.13, p<.01). Conclusions Insomnia symptoms are common in patients and caregivers who call cancer helplines and appear to be related to distress. Telephone-based helplines have the potential to act as the first line of support in a stepped care approach addressing insomnia.

Research paper thumbnail of The Further Rise of Internet Interventions

SLEEP, 2012

The Further Rise of Internet Interventions Commentary on Espie et al. A randomized, placebo-contr... more The Further Rise of Internet Interventions Commentary on Espie et al. A randomized, placebo-controlled trial of online cognitive behavioral therapy for chronic insomnia disorder delivered via an automated media-rich web application. SLEEP 2012;35:769-781.

Research paper thumbnail of Initial evaluation of an Internet intervention to improve the sleep of cancer survivors with insomnia

Psycho-Oncology, 2011

Objective-Insomnia is a common complaint among cancer survivors. Fortunately, cognitivebehavioral... more Objective-Insomnia is a common complaint among cancer survivors. Fortunately, cognitivebehavioral therapy for insomnia (CBT-I) has been shown to be an effective treatment in this population. However, it is rarely implemented given its limited availability. To address this barrier, we examined the ability of an easily-accessible online CBT-I program to improve insomnia symptoms in cancer survivors. Methods-Twenty-eight cancer survivors with insomnia were randomly assigned to either an Internet insomnia intervention (n=14) or to a waitlist control group (n=14). The online program, Sleep Healthy Using the Internet, delivers the primary components of CBT-I (sleep restriction, stimulus control, cognitive restructuring, sleep hygiene, and relapse prevention). Pre-and postassessment data were collected via online questionnaires and daily sleep diaries. Results-Participants in the Internet group showed significant improvements at post-assessment compared to those in the control group in overall insomnia severity (F 1,26 =22.8; P<.001), sleep efficiency (F 1,24 =11.45; P=.002), sleep onset latency (F 1,24 =5.18; P=.03), soundness of sleep (F 1,24 =9.34; P=.005), restored feeling upon awakening (F 1,24 =11.95; P=.002), and general fatigue (F 1,26 =13.88; P=.001). Although other group x time interactions were not significant, overall adjusted effect sizes for all sleep variables as well as for fatigue, depression, anxiety, and quality of life ranged from small to large. Conclusions-CBT-I delivered through an interactive, individually-tailored Internet intervention may be a viable treatment option for cancer survivors experiencing insomnia.

Research paper thumbnail of Relative Benefits of Stimulant Therapy With OROS Methylphenidate Versus Mixed Amphetamine Salts Extended Release in Improving the Driving Performance of Adolescent Drivers With Attention-Deficit/Hyperactivity Disorder

Pediatrics, 2006

OBJECTIVE. Automobile accidents are the leading cause of death among adolescents, and collisions ... more OBJECTIVE. Automobile accidents are the leading cause of death among adolescents, and collisions are 2 to 4 times more likely to occur among adolescents with attention-deficit/hyperactivity disorder. Studies have demonstrated that stimulants improve driving performance. This study compared 2 long-acting stimulant medications during daytime and evening driving evaluations. METHODS. Adolescent drivers with attention-deficit/hyperactivity disorder were compared on a driving simulator after taking 72 mg of OROS methylphenidate, 30 mg of mixed amphetamine salts extended release, or placebo in a randomized, double-blind, placebo-controlled, crossover study design. During laboratory testing, adolescents drove a driving simulator at 5:00 pm, 8:00 pm, and 11:00 pm. Driving performance was rated by adolescents and investigators. RESULTS. The study included 35 adolescent drivers with attention-deficit/hyperactivity disorder (19 boys/16 girls). The mean age was 17.8 years. The overall Impaired ...

Research paper thumbnail of Stages of Change in Smoking Cessation: A Comparison of Expectancies Among Precontemplators and Contemplators

Journal of Rational-Emotive & Cognitive-Behavior Therapy, 2004

Previous research has shown that smokers progress through a series of stages of change as they at... more Previous research has shown that smokers progress through a series of stages of change as they attempt to quit their habit. This study evaluated smokers in the precontemplation and contemplation stages in order to explore how we can effectively facilitate positive stage transition. Precontemplators (n = 71) and contemplators (n = 30) were compared in terms of two types of expectancies: self-efficacy beliefs and response outcome expectancies. Stage of change was defined according to both categorical and continuous dimensions, each of which led to different results. The findings are discussed in terms of their potential applications to smoking cessation programs and their implications regarding the stage model of change.

Research paper thumbnail of Depression Proneness and Reactions to a Depressive Stimulus

The Journal of Psychology, 2006

In the context of a project examining depression vulnerability and cigarette smoking, this study ... more In the context of a project examining depression vulnerability and cigarette smoking, this study tested whether depression-vulnerable people differed from less vulnerable people in their reactions to a depressive stimulus. Regular smokers with a history of depression, but not currently depressed (n = 63) and never-depressed smokers (n = 64) listened to audiotapes of confederates reading depressive and non-depressive scripts, and reported their reactions. Neither history of depression nor selfreported depression proneness predicted reactions to depression. However, depression proneness positively correlated with beliefs about depression contagion. Likewise, stronger depression-related contagion beliefs and lower levels of empathic responding predicted behavioral rejection of the depressive stimulus. Depression Proneness and Reactions to a Depressive Stimulus Extensive research shows that depression elicits rejection from others (see Segrin & Dillard, 1992, for review), but of course not everyone who comes in contact with depressed people rejects them. To understand the interpersonal environment confronted by depressed people, and its possible role in maintenance of depression, it would be helpful to know more about individual differences in the tendency to reject those who are depressed. In the research reported in this article we explored whether being prone to depression oneself would be one such individual difference. If depression-prone people have more empathy for those suffering from depression, because they understand how debilitating it can be, then they might be less rejecting of the currently depressed. This result would be consistent with findings that prior experience with a particular need facilitates empathy for others with that need (Batson et al., 1996) and with research linking higher trait empathy in one person with less rejection of another (Joiner, Alfano, & Metalsky, 1992).