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| Name | Class |
|---|---|
| Region Stockholm | OTHER_GOV |
| Vastra Gotaland Region | OTHER_GOV |
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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).
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stepped care | Experimental | Internet-delivered cognitive behavioral therapy (ICBT) |
|
| Gold standard treatment | Active Comparator | Cognitive behavioral therapy (CBT) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Internet-delivered cognitive behavioral therapy (ICBT) | Behavioral | Participants will receive internet-delivered CBT with therapist support for 16 weeks. The treatment consists of 14 online chapters with interactive features as videos and illustrations. The treatment has the main focus on exposure with ritual prevention. The children and parents have regular contact with a personal assigned therapist via written text messages in the platform. Participants that are classified as non-responders at 3 months follow-up will receive face-to-face CBT of up to 12 sessions over 12 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Children's Yale Brown Obsessive-Compulsive Scale (CY-BOCS) | Change in OCD symptom severity from baseline to week 16 and 3 and 6 months after treatment has ended, and at 1, 2 and 5 years follow-up. Primary endpoint is 6 months follow-up. | week 0, week 16, at 3 and 6 months follow-up, at 1, 2 and 5 years follow-up. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical global impression severity (CGI-S) | Change in global severity from baseline to week 16 and 3 and 6 months after treatment has ended, and at 1, 2 and 5 years follow-up. | week 0, week 16, at 3 and 6 months follow-up, at 1, 2 and 5 years follow-up |
| Clinical global impression improvement (CGI-I) |
| Measure | Description | Time Frame |
|---|---|---|
| Autism Spectrum Quotient (AQ-10) | Measure of autistic symptoms at baseline | week 0 |
| Treatment credibility and expectancy scale | Child and parent version. Investigate if both conditions have equal credibility in order to rule out placebo. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eva Serlachius, MD, PhD | Karolinska Institutet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BUP Specialmottagning | Gothenburg | Sweden | ||||
| Child and Adolescent Psychiatry (CAP) research center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33974020 | Derived | 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. | |
| 31642928 |
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| ID | Term |
|---|---|
| D009771 | Obsessive-Compulsive Disorder |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| Cognitive behavioral therapy (CBT) | Behavioral | Participants in the gold standard group will receive 14 individual face-to-face CBT sessions over 16 weeks. The treatment is based on current evidence based recommendations for OCD, and focuses on exposure with ritual prevention. Participants that are classified as non-responders at 3 months follow-up will receive additional face-to-face CBT of up to 12 sessions over 12 weeks. |
|
Change in global improvement from week 16 to 3 and 6 months after treatment has ended, and at 1, 2 and 5 years follow-up. |
| week 16, at 3 and 6 months follow-up, at 1, 2 and 5 years follow-up |
| Children's global assessment scale (C-GAS) | Change in global functioning from baseline to week 16 and 3 and 6 months after treatment has ended, and at 1 year follow-up. | week 0, week 16, at 3 and 6 months follow-up, at 1 year follow-up |
| Obsessive-compulsive inventory - child version (OCI-CV) | Change in child-rated OCD symptoms from baseline to week 16 and 3 and 6 months after treatment has ended, at 1 year follow-up, and weekly during treatment. | week 0, week 16, at 3 and 6 months follow-up, at 1 year follow-up, and weekly during treatment |
| The Child Health Utility 9D (CHU9D) | Change in general health from baseline to week 16 and 3 and 6 months after treatment has ended, and at 1 year follow-up. | week 0, week 16, at 3 and 6 months follow-up, at 1 year follow-up |
| Insomnia Severity Index (ISI) | Change in sleep problems from baseline to week 16 and 3 and 6 months after treatment has ended, and at 1 year follow-up | week 0, week 16, at 3 and 6 months follow-up, at 1 year follow-up |
| Children's Obsessional Compulsive Inventory Revised - parent version (ChOCI-R) | Change in parent-rated OCD symptoms from baseline to week 16 and 3 and 6 months after treatment has ended, at 1 year follow-up, and weekly during treatment. | week 0, week 16, at 3 and 6 months follow-up, at 1 year follow-up, and weekly during treatment |
| Family accommodation scale for obsessive-compulsive disorder - self-rated version (FAS-SR) | Change in parent-rated family accommodation from baseline to week 16 and 3 and 6 months after treatment has ended, and at 1 year follow-up | week 0, week 16, at 3 and 6 months follow-up, at 1 year follow-up |
| Trimbos/iMTA questionnaire for Costs associated with Psychiatric Illness (TiC-P) | Change in economic costs from baseline to week 16 and 3 and 6 months after treatment has ended, and at 1, 2 and 5 years follow-up. | week 0, week 16, at 3 and 6 months follow-up, at 1, 2 and 5 years follow-up. |
| Mood and Feeling Questionnaire (MFQ) | Change in child and parent rated depressive symptoms from baseline to week 16 and 3 and 6 months after treatment has ended, and at 1 year follow-up | week 0, week 16, at 3 and 6 months follow-up, at 1 year follow-up |
| Education, work and social adjustment scale (EWSAS) | Change in child and parent rated impairment and functioning from baseline to week 16 and 3 and 6 months after treatment has ended, and at 1 year follow-up | week 0, week 16, at 3 and 6 months follow-up, at 1 year follow-up |
| week 2 |
| Working alliance inventory (WAI) | Child and parent version. Investigate if both conditions have equal working alliance in order to rule out non-specific factors. | week 2 |
| Client Satisfaction Questionnaire (CSQ-8) | Child and parent version. Investigate if both conditions have equal satisfaction. | week 16 and at 6 months follow-up |
| Patient EX/RP Adherence Scale (PEAS) | Clinician-rated version during face-to-face CBT. Self-rated version during both ICBT and face-to-face CBT. Investigate treatment adherence in both conditions. | 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 |
| internet intervention Patient Adherence Scale (iiPAS) | Investigate treatment adherence in the ICBT condition. | week 8 and 16 |
| Parental strategy scale | Investigate the use of parental strategies weekly during treatment. | 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 |
| Stockholm |
| 11330 |
| Sweden |
| Derived |
| 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. |