Clinical trial NCT03595098: Treatment Effects of Family Based Cognitive Therapy in Children and Adolescents With Obsessive Compulsive Disorder
Official title: Treatment Effects of Family Based Cognitive Therapy in Children and Adolescents With Obsessive Compulsive Disorder
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Obsessive-Compulsive Disorder in Children
Obsessive-Compulsive Disorder in Adolescence
Keywords: OCD
Lead sponsor: Copenhagen Trial Unit, Center for Clinical Intervention Research
Sponsor class: OTHER
Collaborators: name: Danish Research Centre for Magnetic Resonance
name: Copenhagen Trial Unit, Center for Clinical Intervention Research
First posted: 2018-07-23
Enrollment: 128
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: single-centre, parallel group superiority randomised clinical trial with blinded outcome assessment
Primary purpose: TREATMENT

Brief summary: To investigate the benefits and harms, and the neural and neurocognitive mediators of treatment response, in family-based cognitive behavioural therapy versus family-based psychoeducation and relaxation training in children and adolescents with obsessive compulsive disorder. The aim is to conduct this investigation in an optimal trial design with the lowest possible risk of bias.

Detailed description: Obsessive-compulsive disorder is the fourth most common psychiatric disorder, affecting 1-3% of children and adolescents globally. The recommended first-line treatment is cognitive behavioral therapy with exposure and response prevention. Yet, more than 40% of patients do not, or only partially, benefit from therapy. A better understanding of the mechanisms underlying response to cognitive behavioral therapy is needed to improve treatment. In the TECTO study, we will conduct a combined randomized clinical trial and longitudinal case-control study to elucidate how neural, cognitive, emotional, and neuroendocrine factors moderate and mediate treatment response. At baseline, 128 children and adolescents with obsessive-compulsive disorder will be compared to 128 healthy control participants to map neurobiological, cognitive, and emotional markers of obsessive-compulsive disorder. After baseline assessment, patients are randomly assigned to 16 weeks of either cognitive behavioral therapy with exposure and response prevention or an active control treatment with psychoeducation and relaxation training. This design allows us to test how factors that are specific to cognitive behavioral therapy (e.g. exposure and response prevention) contribute to observed treatment effects. Our primary outcome is OCD symptom severity measured with the Children's Yale-Brown Obessive-Compulsive Scale. Secondary outcomes are health-related quality of life and negative treatment effects. To detect neural and cognitive mediators of treatment, we will measure brain structure and function, and cognitive performance, at baseline and end-of-treatment. Furthermore, we will monitor a range of therapeutic, emotional, family, and neuroendocrine factors before, during, and after treatment. We expect that findings from TECTO will have important theoretical implications and will help refine our understanding of OCD as a heterogeneous and multidimensional disorder. Finally, we expect that our findings will contribute significantly to the improvement of psychotherapy and development of more targeted interventions for pediatric obsessive-compulsive disorder, which can minimize the use of medication, prevent chronicity, and reduce the substantial socioeconomic burden of the disorder.

Eligibility criteria: Inclusion Criteria:

* OCD diagnosis as primary diagnosis, meeting the criteria for International Classification of Diseases 10 (ICD-10) F42, verified with a semi-structured psychopathological interview using Schedule for Affective Disorders and Schizophrenia for school-aged children, Present and Lifetime version (K-SADS-PL).
* Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS) entry score ≥16, a cut-off score used in previous studies.
* Age 8 through 17 years (both inclusive).
* Signed informed consent.

Exclusion Criteria:

* Comorbid illness that contraindicates trial participation: pervasive developmental disorder not including Asperger's syndrome (ICD-10 F84.0-84.4 + F84.8-84.9), schizophrenia/paranoid psychosis (ICD-10 F20-25 + F28-29), mania or bipolar disorder (ICD-10 F30 and F31), depressive psychotic disorders (F32.3 + F33.3), substance dependence syndrome (ICD-10 F1x.2).
* Intelligence Quotient \<70.
* Treatment with Cognitive Behavioural Therapy (CBT), Serotonin Reuptake Inhibitors, or other antidepressant medication or antipsychotic medication within the last 6 months prior to trial entry.
* For MRI-scanning:

  * metal braces on teeth or metal implants;
  * any known brain pathology;
  * history of severe head-trauma (ICD-10 S6-S9);
  * pregnancy.

Primary outcomes:
measure: Change in Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS) score
timeFrame: Week 0, 4, 8, 16 and 40
Secondary outcomes:
measure: health-related quality of life assesses with KIDSCREEN-52
timeFrame: Week 0, 4, 8, 16 and 40
measure: Occurrence of negative adverse events
timeFrame: Week 4, 8, 16 and 40
Other outcomes:
measure: Magnetic resonance imaging
timeFrame: Week 0 and 16
measure: Family Accommodation Scale
timeFrame: Week 4, 8, 16 and 40
measure: Family Environment Scale
timeFrame: Week 0
measure: Parental Stress Scale
timeFrame: Week 4, 8, 16 and 40
measure: Child Obsessive-Compulsive Impact Scale
timeFrame: Week 4, 8, 16 and 40
measure: Clinical Global Impression Severity and Clinical Global Impression Improvement Scale
timeFrame: Week 4, 8, 16 and 40
measure: Occurrence of Serious Adverse Events
timeFrame: Week 0-Week 40
measure: Children's Global Assessment Scale
timeFrame: Week 4, 8, 16 and 40
measure: Remission
timeFrame: Week 16
measure: OCD symptoms remission
timeFrame: Week 16
measure: Toronto Obsessive-Compulsive Rating Scale
timeFrame: Week 0 and week 16
measure: Risk taking and decision-making ability
timeFrame: Week 0 and week 16th
measure: Planning ability
timeFrame: Week 0 and week 16th
measure: Working memory capacity
timeFrame: Week 0 and week 16th
measure: Motor skills
timeFrame: Week 0 and week 16th
measure: Habit formation
timeFrame: Week 0 and week 16th
measure: Change in Delis-Kaplan Executive Function System (D-KEFS)
timeFrame: Week 0 and week 16th
measure: Change in Thought-Action Fusion Questionnaire for Adolescents
timeFrame: Week 0, 4, 8, 16 and 40
measure: Executive function
timeFrame: Week 0 and week 16
Locations:
city: Copenhagen
country: Denmark
facility: Child and Adolescent Mental Health Centre, Bispebjerg
Study officials:
affiliation: Child and Adolescent Mental Health Centre, Copenhagen
name: Anne Katrine Pagsberg, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Olsen MH, Hagstrom J, Lonfeldt NN, Uhre C, Uhre V, Pretzmann L, Christensen SH, Thoustrup C, Korsbjerg NLJ, Mora-Jensen AC, Ritter M, Engstrom J, Lindschou J, Siebner HR, Verhulst F, Jeppesen P, Jepsen JRM, Vangkilde S, Thomsen PH, Hybel K, Clemmesen LKH, Gluud C, Plessen KJ, Pagsberg AK, Jakobsen JC. Family-based cognitive behavioural therapy versus family-based relaxation therapy for obsessive-compulsive disorder in children and adolescents (the TECTO trial): a statistical analysis plan for the randomised clinical trial. Trials. 2022 Oct 6;23(1):854. doi: 10.1186/s13063-022-06799-4.
citation: Pagsberg AK, Uhre C, Uhre V, Pretzmann L, Christensen SH, Thoustrup C, Clemmesen I, Gudmandsen AA, Korsbjerg NLJ, Mora-Jensen AC, Ritter M, Thorsen ED, Halberg KSV, Bugge B, Staal N, Ingstrup HK, Moltke BB, Kloster AM, Zoega PJ, Mikkelsen MS, Harboe GS, Larsen KF, Clemmensen LKH, Lindschou J, Jakobsen JC, Engstrom J, Gluud C, Siebner HR, Thomsen PH, Hybel K, Verhulst F, Jeppesen P, Jepsen JRM, Vangkilde S, Olsen MH, Hagstrom J, Lonfeldt NN, Plessen KJ. 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). BMC Psychiatry. 2022 Mar 19;22(1):204. doi: 10.1186/s12888-021-03669-2.