Clinical trial NCT03263546: Internet-delivered CBT for Paediatric OCD
Official title: Implementation of Internet-delivered Cognitive-behavior Therapy for Paediatric Obsessive-compulsive Disorder in the Clinic: a Randomized Stepped Care Non-inferiority Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obsessive-Compulsive Disorder
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Region Stockholm
name: Vastra Gotaland Region
First posted: 2017-08-28
Enrollment: 152
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate if therapist-guided internet-delivered cognitive behavioral therapy (ICBT) in a stepped-care approach is an effective and cost-effective treatment in reducing OCD symptoms for children and adolescents compared to gold standard treatment (face-to-face CBT).

Detailed description: A randomized controlled non-inferiority trial comparing therapist-guided internet-delivered cognitive behavioral therapy (ICBT) in a stepped care model with face-to-face CBT for children and adolescents with obsessive-compulsive disorder (OCD).

Participants will be randomized to either stepped care ICBT or to gold standard face-to-face CBT. One group (stepped care) will be first offered ICBT for 16 weeks. Non-responders at the 3-month follow-up will receive additional face-to-face CBT. The other group (gold standard treatment) will be randomized directly to receive face-to-face CBT for 16 weeks. Non-responders will, as in the other group, receive additional face-to-face treatment after the 3-month follow-up. The primary endpoint will be at 6-month follow-up. Long-term effects are also investigated (1 year, 2 years and 5 years after treatment completion).

The primary objective is to evaluate whether ICBT in a stepped care approach will be non-inferior to gold standard treatment (face-to-face CBT) in reducing OCD symptoms, depression, impairment, sleep problems, health and functioning. The secondary objective is to a) carry out a full health economic evaluation and b) investigate if self-referred and referred participants differ regarding outcome in the two treatment groups.

The hypotheses are:

1. An ICBT stepped care approach will be non-inferior to gold standard treatment (face-to-face CBT) in reducing OCD symptoms.
2. The stepped care approach will be associated with lower costs, such as reduced therapist and administration times, service utilization, minimized work and school absence for families etc., compared to gold standard treatment.
3. Self-referred patients will benefit significantly better than referred patients regarding outcome in the ICBT group, but there will not be any difference in the face-to-face CBT group.

Eligibility criteria: Inclusion Criteria:

* Primary DSM-5 diagnosis of OCD
* Total score of ≥16 on the Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS)
* Age between 7 and 17 years
* Ability to read and write Swedish and with access to a computer and use of internet.
* Participants on psychotropic medication must had been on a stable dose for the last 6 weeks prior to baseline assessment. If the child is on medication for OCD, they will be requested to stay on stable doses for the duration of the trial.

Exclusion Criteria:

* Organic brain disorders, global learning disabilities, autism spectrum disorder, psychosis, bipolar disorder and severe eating disorder.
* Suicidal ideation
* Not able to understand the basics of the ICBT self-help material, patient being housebound or in need of intensive- or in-patient treatment.
* Having completed a course of CBT for OCD within the last 12 months (defined as at least 5 sessions CBT including exposure and response prevention).
* Children with ongoing psychological treatment for OCD or another anxiety disorder will not be included in the study.

Primary outcomes:
measure: Children's Yale Brown Obsessive-Compulsive Scale (CY-BOCS)
timeFrame: week 0, week 16, at 3 and 6 months follow-up, at 1, 2 and 5 years follow-up.
Secondary outcomes:
measure: Clinical global impression severity (CGI-S)
timeFrame: week 0, week 16, at 3 and 6 months follow-up, at 1, 2 and 5 years follow-up
measure: Clinical global impression improvement (CGI-I)
timeFrame: week 16, at 3 and 6 months follow-up, at 1, 2 and 5 years follow-up
measure: Children's global assessment scale (C-GAS)
timeFrame: week 0, week 16, at 3 and 6 months follow-up, at 1 year follow-up
measure: Obsessive-compulsive inventory - child version (OCI-CV)
timeFrame: week 0, week 16, at 3 and 6 months follow-up, at 1 year follow-up, and weekly during treatment
measure: The Child Health Utility 9D (CHU9D)
timeFrame: week 0, week 16, at 3 and 6 months follow-up, at 1 year follow-up
measure: Insomnia Severity Index (ISI)
timeFrame: week 0, week 16, at 3 and 6 months follow-up, at 1 year follow-up
measure: Children's Obsessional Compulsive Inventory Revised - parent version (ChOCI-R)
timeFrame: week 0, week 16, at 3 and 6 months follow-up, at 1 year follow-up, and weekly during treatment
measure: Family accommodation scale for obsessive-compulsive disorder - self-rated version (FAS-SR)
timeFrame: week 0, week 16, at 3 and 6 months follow-up, at 1 year follow-up
measure: Trimbos/iMTA questionnaire for Costs associated with Psychiatric Illness (TiC-P)
timeFrame: week 0, week 16, at 3 and 6 months follow-up, at 1, 2 and 5 years follow-up.
measure: Mood and Feeling Questionnaire (MFQ)
timeFrame: week 0, week 16, at 3 and 6 months follow-up, at 1 year follow-up
measure: Education, work and social adjustment scale (EWSAS)
timeFrame: week 0, week 16, at 3 and 6 months follow-up, at 1 year follow-up
Other outcomes:
measure: Autism Spectrum Quotient (AQ-10)
timeFrame: week 0
measure: Treatment credibility and expectancy scale
timeFrame: week 2
measure: Working alliance inventory (WAI)
timeFrame: week 2
measure: Client Satisfaction Questionnaire (CSQ-8)
timeFrame: week 16 and at 6 months follow-up
measure: Patient EX/RP Adherence Scale (PEAS)
timeFrame: week 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8, week 9, week 10, week 11, week 12, week 13, week 14, week 15, week 16
measure: internet intervention Patient Adherence Scale (iiPAS)
timeFrame: week 8 and 16
measure: Parental strategy scale
timeFrame: week 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8, week 9, week 10, week 11, week 12, week 13, week 14, week 15, week 16
Locations:
city: Göteborg
country: Sweden
facility: BUP Specialmottagning
city: Stockholm
country: Sweden
facility: Child and Adolescent Psychiatry (CAP) research center
Study officials:
affiliation: Karolinska Institutet
name: Eva Serlachius, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Aspvall K, Andersson E, Melin K, Norlin L, Eriksson V, Vigerland S, Jolstedt M, Silverberg-Morse M, Wallin L, Sampaio F, Feldman I, Bottai M, Lenhard F, Mataix-Cols D, Serlachius E. Effect of an Internet-Delivered Stepped-Care Program vs In-Person Cognitive Behavioral Therapy on Obsessive-Compulsive Disorder Symptoms in Children and Adolescents: A Randomized Clinical Trial. JAMA. 2021 May 11;325(18):1863-1873. doi: 10.1001/jama.2021.3839.
citation: Aspvall K, Andersson E, Lenhard F, Melin K, Norlin L, Wallin L, Silverberg-Morse M, Feldman I, Bottai M, Mataix-Cols D, Serlachius E. Stepped Care Internet-Delivered vs Face-to-Face Cognitive-Behavior Therapy for Pediatric Obsessive-Compulsive Disorder: A Trial Protocol for a Randomized Noninferiority Trial. JAMA Netw Open. 2019 Oct 2;2(10):e1913810. doi: 10.1001/jamanetworkopen.2019.13810.