Treatment Effects of Family Based Cognitive Therapy in Children and Adolescents With Obsessive Compulsive Disorder

NCT03595098 | Active Not Recruiting

• 1 other identifier: TECTO
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

Obsessive-Compulsive Disorder in Children; Obsessive-Compulsive Disorder in Adolescence

Keywords

OCD

Outcome Measures

Primary Outcomes (1)

• Change in Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS) score

  Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS) is a 10-item questionnaire assessing the severity of obsessive compulsive disorder (OCD). Severity of compulsions and obsessions are rated on a scale from 0 (none) to 4 (extreme). The total score is calculated by summing the 10 individual scores and ranges from 0 to 40, where higher scores indicate more extreme symptoms.

  Week 0, 4, 8, 16 and 40

Secondary Outcomes (2)

• health-related quality of life assesses with KIDSCREEN-52

  Week 0, 4, 8, 16 and 40

• Occurrence of negative adverse events

  Week 4, 8, 16 and 40

Other Outcomes (19)

• Magnetic resonance imaging

  Week 0 and 16

• Family Accommodation Scale

  Week 4, 8, 16 and 40

• Family Environment Scale

  Week 0

Study Arms (2)

FCBT

EXPERIMENTAL

The Family Based Cognitive Behavioural Therapy (FCBT)

Behavioral: Family Based Cognitive Behavioural Therapy

FPRT

ACTIVE COMPARATOR

Family-based Psychoeducation /Relaxation Training (FPRT)

Behavioral: Family Based Psychoeducation/Relaxation Training

Interventions

Family Based Cognitive Behavioural Therapy BEHAVIORAL

Family Based Cognitive Behavioural Therapy (FCBT) focuses on the interrelation between thought, emotion, and behaviour, Exposure and Response Prevention, family involvement, homework assignments, and formulating of specific goals for the child. The important, active components is Exposure and Response Prevention. It involves exposing the child to a feared object, situation or thought, and preventing the child from carrying out compulsions to show the child that distress/anxiety can decrease or disappear without performing rituals.

FCBT

Family Based Psychoeducation/Relaxation Training BEHAVIORAL

Family-based Psychoeducation/Relaxation Training (FPRT) as an active control matches the experimental intervention as closely as possible, many elements of the control intervention are similar to FCBT. The main and intended difference between the two approaches is the absence of the Exposure and Response Prevention component, which is deemed the most effective treatment for OCD.

FPRT

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Anne Katrine Pagsberg: lead
• Danish Research Centre for Magnetic Resonance: collaborator
• Copenhagen Trial Unit, Center for Clinical Intervention Research: collaborator

Study Sites (1)

Child and Adolescent Mental Health Centre, Bispebjerg

Copenhagen, 2100, Denmark

Location

Related Publications (3)

• Pretzmann L, Christensen SH, Bryde Christensen A, Funch Uhre C, Uhre V, Thoustrup CL, Clemmesen IT, Gudmandsen TA, Korsbjerg NLJ, Mora-Jensen AC, Ritter M, Olsen MH, Clemmensen LKH, Lindschou J, Gluud C, Thomsen PH, Vangkilde S, Hagstrom J, Rozental A, Jeppesen P, Verhulst F, Hybel KA, Lonfeldt NN, Plessen KJ, Poulsen S, Pagsberg AK. Adverse events in cognitive behavioral therapy and relaxation training for children and adolescents with obsessive-compulsive disorder: A mixed methods study and analysis plan for the TECTO trial. Contemp Clin Trials Commun. 2023 Jun 20;34:101173. doi: 10.1016/j.conctc.2023.101173. eCollection 2023 Aug.

  PMID: 37497354 DERIVED

• 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.

  PMID: 36203215 DERIVED

• 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.

  PMID: 35305587 DERIVED

Related Links

• Updated systematic review of cognitive behavioural therapy for children and adolescents with obsessive-compulsive disorder

MeSH Terms

Interventions

Relaxation Therapy

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Anne Katrine Pagsberg, Professor

  Child and Adolescent Mental Health Centre, Copenhagen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Due to the nature of the interventions, it is not possible to blind the participants, the investigators administrating the interventions (therapists, i.e. medical doctors and clinical psychologists, and other caregivers), or parents. Blinding will be applied in all possible aspects of the trial such as: outcome assessment and MRI-scanning and neuropsychological testing. Additionally data managers, statisticians, and investigators drawing conclusions, will be fully blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate professor at Child and Adolescent Mental Health Centre, Copenhagen

Model Details: single-centre, parallel group superiority randomised clinical trial with blinded outcome assessment

Study Record Dates

• First Submitted: May 3, 2018
• First Posted: July 23, 2018
• Study Start: August 28, 2018
• Primary Completion: April 7, 2022
• Study Completion (Estimated): December 31, 2027
• Last Updated: July 5, 2024

Record last verified: 2024-07

Locations

DK (1)