Family-based cognitive behavioural therapy versus family-based relaxation therapy for obsessive-compulsive disorder in children and adolescents: protocol for a randomised clinical trial (the TECTO trial) (original) (raw)
Related papers
Trials, 2022
Background: Obsessive-compulsive disorder (OCD) is a debilitating psychiatric disorder which affects up to 3% of children and adolescents. OCD in children and adolescents is generally treated with cognitive behavioural therapy (CBT), which, in more severely affected patients, can be combined with antidepressant medication. The TECTO trial aims to compare the benefits and harms of family-based CBT (FCBT) versus family-based psychoeducation/relaxation training (FPRT) in children and adolescents aged 8 to 17 years. This statistical analysis plan outlines the planned statistical analyses for the TECTO trial. Methods: The TECTO trial is an investigator-initiated, independently funded, single-centre, parallel-group, superiority randomised clinical trial. Both groups undergo 14 sessions of 75 min each during a period of 16 weeks with either FCBT or FPRT depending on the allocation. Participants are randomised stratified by age and baseline Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS) score. The primary outcome is the CY-BOCS score. Secondary outcomes are health-related quality of life assessed using KIDSCREEN-10 and adverse events assessed by the Negative Effects Questionnaire (NEQ). Primary and secondary outcomes are assessed at the end of the intervention. Continuous outcomes will be analysed using linear regression adjusted for the stratification variables and baseline value of the continuous outcome. Dichotomous outcomes will be analysed using logistic regression adjusted for the stratification variables. The statistical analyses will be carried out by two independent blinded statisticians.
Journal of the American Academy of Child & Adolescent Psychiatry, 2011
To examine the efficacy of exposure-based cognitive-behavioral therapy (CBT) plus a structured family intervention (FCBT) versus psychoeducation plus relaxation training (PRT) for reducing symptom severity, functional impairment, and family accommodation in youths with obsessive-compulsive disorder (OCD). Method: A total of 71 youngsters 8 to 17 years of age (mean 12.2 years; range, 8 -17 years, 37% male, 78% Caucasian) with primary OCD were randomized (70:30) to 12 sessions over 14 weeks of FCBT or PRT. Blind raters assessed outcomes with responders followed for 6 months to assess treatment durability. Results: FCBT led to significantly higher response rates than PRT in ITT (57.1% vs 27.3%) and completer analyses (68.3% vs. 35.3%). Using HLM, FCBT was associated with significantly greater change in OCD severity and child-reported functional impairment than PRT and marginally greater change in parent-reported accommodation of symptoms. These findings were confirmed in some, but not all, secondary analyses. Clinical remission rates were 42.5% for FCBT versus 17.6% for PRT. Reduction in family accommodation temporally preceded improvement in OCD for both groups and child functional status for FCBT only. Treatment gains were maintained at 6 months. Conclusions: FCBT is effective for reducing OCD severity and impairment.
Family-Based Cognitive-Behavioral Therapy for Pediatric Obsessive-Compulsive Disorder
Journal of the American Academy of Child & Adolescent Psychiatry, 2007
Objective: To examine the relative efficacy of intensive versus weekly cognitive-behavioral therapy (CBT) for children and adolescents with obsessive-compulsive disorder (OCD). Method: Forty children and adolescents with OCD (range 7-17 years) were randomized to receive 14 sessions of weekly or int6nsive (daily psychotherapy sessions) family-based CBT. Assessments were conducted at three time points: pretreatment, posttreatment, and 3-month follow-up. Raters were initially blind to randomization. Primary outcomes included scores on the Children's Yale-Brown Obsessive-Compulsive Scale, remission status, and ratings on the Clinical Global Impression-Severity and Clinical Global Improvement scales. Secondary outcomes included the Child Obsessive Compulsive Impact Scale-Parent Rated, Children's Depression Inventory, Multidimensional Anxiety Scale for Children, and Family Accommodation Scale. Adjunctive pharmacotherapy was not an exclusion criterion. Results: Intensive CBT was as effective as weekly treatment with some advantages present immediately after treatment. No group differences were found at follow-up, with gains being largely maintained over time. Although no group x time interaction was found for the Children's Yale-Brown Obsessive-Compulsive Scale (F 1 , 38 = 2.2, p = .15), the intensive group was rated on the Clinical Global Impression-Severity as less ill relative to the weekly group (F 1 , 38 = 9.4, p< .005). At posttreatment, 75% (15/20) of youths in the intensive group and 50% (10/20) in the weekly group met remission status criteria. Ninety percent (18/20) of youths in the intensive group and 65% (13/20) in the weekly group were considered treatment responders on the Clinical Global Improvement (X2 = 3.6, p = .06). Conclusions: Both intensive and weekly CBT are efficacious treatments for pediatric OCD. Intensive treatment may have slight immediate advantages over weekly CBT, although both modalities have similar outcomes at 3-month follow-up.
Journal of the American Academy of Child & Adolescent Psychiatry
Objective: To assess benefits and harms of cognitive-behavioral therapy (CBT) versus no intervention or versus other interventions for pediatric obsessive-compulsive disorder (OCD). Method: We searched for randomized clinical trials of CBT for pediatric OCD. Primary outcomes were OCD severity, serious adverse events, and level of functioning. Secondary outcomes were quality of life and adverse events. Remission from OCD was included as an exploratory outcome. We assessed risk of bias and evaluated the certainty of the evidence with the Grading of Recommendations Assessment, Development and Evaluation (GRADE). Results: Nine trials (N ¼ 645) were included comparing CBT with no intervention and 3 trials (N ¼ 146) comparing CBT with selective serotonin reuptake inhibitors (SSRIs). Compared with no intervention, CBT decreased OCD severity (mean difference [MD] ¼ À8.51, 95% CI ¼ À10.84 to À6.18, p < .00001, low certainty), improved level of functioning (patient-rated: standardized MD [SMD] ¼ À0.90, 95% CI ¼ À1.19 to À0.62, p < .00001, very low certainty; parent-rated: SMD ¼ À0.68, 95% CI ¼ À1.12 to À0.23, p ¼ .003, very low certainty), had similar proportions of participants with adverse events (risk ratio ¼ 1.06, 95% CI ¼ 0.93À1.22, p ¼ .39, GRADE: low certainty), and was associated with reduced risk of still having OCD (risk ratio ¼ 0.50, 95% CI ¼ 0.37À0.67, p < .00001, very low certainty). We had insufficient data to assess the effect of CBT versus no intervention on serious adverse events and quality of life. Compared with SSRIs, CBT led to similar decreases in OCD severity (MD ¼ À0.75, 95% CI ¼ À3.79 to 2.29, p ¼ .63, GRADE: very low certainty), and was associated with similar risk of still having OCD (risk ratio ¼ 0.85, 95% CI ¼ 0.66À1.09, p ¼ .20, very low certainty). We had insufficient data to assess the effect of CBT versus SSRIs on serious adverse events, level of functioning, quality of life, and adverse events. Conclusion: CBT may be more effective than no intervention and comparable to SSRIs for pediatric OCD, but we are very uncertain about the effect estimates.
2021
Cognitive behaviour therapy (CBT) for young people with obsessive compulsive disorder (OCD) has become the treatment of first choice. However, the literature is largely based on studies emphasising exposure and response prevention. In this study, we report on a randomised controlled trial of CBT for young people carried out in typical outpatient clinic conditions which focused on cognitions. A randomised controlled trial compares 10 sessions of manualised cognitive behavioural treatment with a 12-week waiting list for adolescents and children with OCD. Assessors were blind to treatment allocation. 21 consecutive patients with OCD aged between 9 and 18 years were recruited. The group who received treatment improved more than a comparison group who waited for 3 months. The second group was treated subsequently using the same protocol and made similar gains. In conclusion, CBT can be delivered effectively to young people with OCD in typical outpatient settings.
The Cochrane library, 2006
BackgroundThis is an update of a Cochrane Review first published in The Cochrane Library in Issue 4, 2006.Obsessive‐compulsive disorder (OCD) in children and adolescents is characterised by persistent intrusive thoughts, inappropriate impulses or images which cause marked anxiety, and/or by persistent repetitive behaviours such as hand washing, checking and ordering. Along with antidepressant medication, behavioural or cognitive‐behavioural therapy (BT/CBT) is recommended as the treatment of choice for paediatric obsessive‐compulsive disorder (OCD).ObjectivesThis review examines the overall efficacy of BT/CBT for paediatric OCD, its relative efficacy against medication and whether there are benefits in using BT/CBT combined with medication.Search methodsWe searched CCDANCTR‐Studies,CCDANCTR‐References (16/3/2009), MEDLINE, EMBASE, PsycINFO, national trials registers, reference lists of all selected studies and handsearched journals related to cognitive behavioural treatment of OCD.Selection criteriaIncluded studies were randomised or quasi‐randomised controlled trials trials with participants 18 years of age or younger with a diagnosis of OCD, established by clinical assessment or standardised diagnostic interview. Reviewed studies included standard behavioural or cognitive‐behavioural techniques, either alone or in combination, compared with wait‐list, attention placebo, pill placebo or medication.Data collection and analysisThe quality of selected studies was assessed independently by two review authors. Using Review Manager software, weighted mean differences were calculated for the total severity of OCD symptoms at post treatment and relative risks for having OCD at post treatment.Main resultsEight studies with 343 participants were included. The review found evidence for lower post‐treatment OCD severity and reduced risk of continuing with OCD for the BT/CBT group compared to pill placebo or wait‐list comparisons. There was no evidence found that the efficacy of BT/CBT alone and medication alone differ in terms of post treatment symptom severity or in the risk of having OCD. There was some evidence of a benefit for combined BT/CBT and medication compared to medication alone but not relative to BT/CBT alone. The low rates of drop out suggested BT/CBT is an acceptable treatment to child and adolescent patients and their families.Authors' conclusionsAlthough only based on a small number of studies which vary in quality, behavioural or cognitive‐behaviour therapy alone appears to be an effective treatment for OCD in children and adolescents. It is as effective as medication alone and may lead to better outcomes when combined with medication compared to medication alone. Additional higher quality trials are needed to confirm these findings.
Journal of Child Psychology and Psychiatry, 2011
Background: Reviews and practice guidelines for paediatric obsessive-compulsive disorder (OCD) recommend cognitive-behaviour therapy (CBT) as the psychological treatment of choice, but note that it has not been sufficiently evaluated for children and adolescents and that more randomized controlled trials are needed. The aim of this trial was to evaluate effectiveness and optimal delivery of CBT, emphasizing cognitive interventions. Methods: A total of 96 children and adolescents with OCD were randomly allocated to the three conditions each of approximately 12 weeks duration: full CBT (average therapist contact: 12 sessions) and brief CBT (average contact: 5 sessions, with use of therapist-guided workbooks), and wait-list/delayed treatment. The primary outcome measure was the child version of the semi-structured interviewer-based Yale-Brown Obsessive Compulsive Scale. Clinical Trial registration: http://www.controlled-trials.com/ISRCTN/; unique identifier: ISRCTN29092580. Results: There was statistically significant symptomatic improvement in both treatment groups compared with the wait-list group, with no significant differences in outcomes between the two treatment groups. Controlled treatment effect sizes in intention-to-treat analyses were 2.2 for full CBT and 1.6 for brief CBT. Improvements were maintained at follow-up an average of 14 weeks later. Conclusions: The findings demonstrate the benefits of CBT emphasizing cognitive interventions for children and adolescents with OCD and suggest that relatively lower therapist intensity delivery with use of therapist-guided workbooks is an efficient mode of delivery.
Journal of the American …, 2007
Objective: To examine the relative efficacy of intensive versus weekly cognitive-behavioral therapy (CBT) for children and adolescents with obsessive-compulsive disorder (OCD). Method: Forty children and adolescents with OCD (range 7-17 years) were randomized to receive 14 sessions of weekly or int6nsive (daily psychotherapy sessions) family-based CBT. Assessments were conducted at three time points: pretreatment, posttreatment, and 3-month follow-up. Raters were initially blind to randomization. Primary outcomes included scores on the Children's Yale-Brown Obsessive-Compulsive Scale, remission status, and ratings on the Clinical Global Impression-Severity and Clinical Global Improvement scales. Secondary outcomes included the Child Obsessive Compulsive Impact Scale-Parent Rated, Children's Depression Inventory, Multidimensional Anxiety Scale for Children, and Family Accommodation Scale. Adjunctive pharmacotherapy was not an exclusion criterion. Results: Intensive CBT was as effective as weekly treatment with some advantages present immediately after treatment. No group differences were found at follow-up, with gains being largely maintained over time. Although no group x time interaction was found for the Children's Yale-Brown Obsessive-Compulsive Scale (F 1 , 38 = 2.2, p = .15), the intensive group was rated on the Clinical Global Impression-Severity as less ill relative to the weekly group (F 1 , 38 = 9.4, p< .005). At posttreatment, 75% (15/20) of youths in the intensive group and 50% (10/20) in the weekly group met remission status criteria. Ninety percent (18/20) of youths in the intensive group and 65% (13/20) in the weekly group were considered treatment responders on the Clinical Global Improvement (X2 = 3.6, p = .06). Conclusions: Both intensive and weekly CBT are efficacious treatments for pediatric OCD. Intensive treatment may have slight immediate advantages over weekly CBT, although both modalities have similar outcomes at 3-month follow-up.
Journal of the American Academy of Child & Adolescent Psychiatry, 2005
Objective: To evaluate the relative efficacy of (1) individual cognitive-behavioral family-based therapy (CBFT); (2) group CBFT; and (3) a waitlist control group in the treatment of childhood obsessive-compulsive disorder (OCD). Method: This study, conducted at a university clinic in Brisbane, Australia, involved 77 children and adolescents with OCD who were randomized to individual CBFT, group CBFT, or a 4-to 6-week waitlist control condition. Children were assessed before and after treatment and at 3 months and 6 months following the completion of treatment using diagnostic interviews, symptom severity interviews, and self-report measures. Parental distress, family functioning, sibling distress, and levels of accommodation to OCD demands were also assessed. Active treatment involved a manualized 14-week cognitivebehavioral protocol, with parental and sibling components. Results: By an evaluable patient analysis, statistically and clinically significant pretreatment-to-posttreatment change occurred in OCD diagnostic status and severity across both individual and group CBFT, with no significant differences in improvement ratings between these conditions. There were no significant changes across measures for the waitlist condition. Treatment gains were maintained up to 6 months of follow-up. Conclusions: Contrary to previous findings and expectations, group CBFT is as effective in reducing OCD symptoms for children and adolescents as individual treatment. Findings support the efficacy and durability of CBFT in treating childhood OCD.
Early Childhood OCD: Preliminary Findings From a Family-Based Cognitive-Behavioral Approach
Journal of the American Academy of Child & Adolescent Psychiatry, 2008
Objective: To examine the relative efficacy of family-based cognitive-behavioral therapy (CBT) versus family-based relaxation treatment (RT) for young children ages 5 to 8 years with obsessive-compulsive disorder (OCD). Method: Fortytwo young children with primary OCD were randomized to receive 12 sessions of family-based CBT or family-based RT.