Obsessive-Compulsive Disorder
Conditions
Keywords
OCD, adolescents, pediatric, internet, online, CBT
Brief summary
The effect of Internet-delivered Cognitive Behavior Therapy (ICBT) on adolescents (12 to 17 years) with Obsessive-Compulsive Disorder is studied. Participants are randomized to either ICBT or a no-treatment condition. We expect ICBT to be superior over the no-treatment condition.
Detailed description
The primary objective of this study is to test the efficacy of Internet-delivered cognitive behavior therapy (ICBT) for adolescents (12 - 17 years) with OCD. We aim to conduct a randomized controlled study with N = 66 participants. Participants will be randomly assigned to ICBT or a wait list condition, either lasting 12 weeks. The primary outcome measure is the Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS). Study participants will be followed up 3 and 12 months after treatment. ICBT is expected to yield significantly better symptom reduction than the wait list condition.
Interventions
The treatment consists of standard cognitive behavior therapy for obsessive-compulsive disorder and is delivered via an internet plattform and regular therapist contact several times per week via email and telephone. The treatment is 12 weeks.
Sponsors
Karolinska Institutet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* a primary diagnosis of OCD as defined by DSM-5 * a total score of ≥ 16 on the Children's Yale-Brown Obsessive-Compulsive Scale, CY-BOCS * age between 12 and 17 years * ability to read and write Swedish * daily access to the internet * a parent that is able to co-participate in the treatment * Participants on psychotropic medication must have been on a stable dose for the last 6 weeks prior to baseline assessment
Exclusion criteria
* diagnosed autism spectrum disorder, psychosis or bipolar disorder, severe eating disorder * suicidal ideation * ongoing substance dependence * subject not able to read or understand the basics of the ICBT material * completed CBT for OCD within last 12 months (defined as at least 5 sessions of CBT including exposure and response prevention) * ongoing psychological treatment for OCD or another anxiety disorder
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Children's Yale Brown Obsessive Compulsive Scale, CY-BOCS | Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended | Change from Baseline of obsessions and compulsions after 12 weeks and at 3- and 12 months after treatment |
Secondary
| Measure | Time frame |
|---|---|
| Parent Adherence EX/RP Scale, PEAS | Baseline, 6 and 12 weeks after treatment starts |
| Child Depression Inventory - Short version (CDI-S, Kovacs, 1985) | Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended |
| Family Accommodation Scale, Parent-Report (FAS-PR, Flessner et al., 2009) | Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended |
| Technology acceptance scale | Baseline, 6 and 12 weeks after treatment starts, |
| Trimbos/iMTA questionnaire for Costs associated with Psychiatric Illness - Child version (TiC-P) | Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended |
| EQ-5D - quality of life | Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended |
| Clinical Global Impression - Severity, CGI-S | Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended |
| Clinical Global Impression - Improvement, CGI-I | Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended |
| Children's Obsessional Compulsive Inventory Revised, (CHOCI-R, Shafran et al., 2003) | Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended |
| Education, Work and Social Adjustment Scale - child and parent version (EWSAS) | Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended |
| Spence Child Anxiety Scale - Child and Parent version (SCAS-C/P, Spence, 1998 | Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended |
Other
| Measure | Time frame |
|---|---|
| DNA samples (from blood and/or saliva) | Baseline |
| Measurement of homework adherence | Baseline, daily measurements until 12 weeks after baseline |
| Number of Participants with Adverse Events | 12 weeks after baseline |
Countries
Sweden
Outcome results
None listed