Clinical trial NCT02191631: Internet-delivered CBT for Adolescents With OCD: A Randomized Controlled Study
Official title: Internet-delivered Cognitive Behavior Therapy for Adolescents With Obsessive-Compulsive Disorder: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obsessive-Compulsive Disorder
Keywords: OCD
adolescents
pediatric
internet
online
CBT
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2014-07-16
Enrollment: 67
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Children's Yale Brown Obsessive Compulsive Scale, CY-BOCS
timeFrame: Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended
Secondary outcomes:
measure: Clinical Global Impression - Severity, CGI-S
timeFrame: Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended
measure: Clinical Global Impression - Improvement, CGI-I
timeFrame: Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended
measure: Parent Adherence EX/RP Scale, PEAS
timeFrame: Baseline, 6 and 12 weeks after treatment starts
measure: Children's Obsessional Compulsive Inventory Revised, (CHOCI-R, Shafran et al., 2003)
timeFrame: Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended
measure: Education, Work and Social Adjustment Scale - child and parent version (EWSAS)
timeFrame: Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended
measure: Spence Child Anxiety Scale - Child and Parent version (SCAS-C/P, Spence, 1998
timeFrame: Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended
measure: Child Depression Inventory - Short version (CDI-S, Kovacs, 1985)
timeFrame: Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended
measure: Family Accommodation Scale, Parent-Report (FAS-PR, Flessner et al., 2009)
timeFrame: Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended
measure: Technology acceptance scale
timeFrame: Baseline, 6 and 12 weeks after treatment starts,
measure: Trimbos/iMTA questionnaire for Costs associated with Psychiatric Illness - Child version (TiC-P)
timeFrame: Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended
measure: EQ-5D - quality of life
timeFrame: Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended
Other outcomes:
measure: Measurement of homework adherence
timeFrame: Baseline, daily measurements until 12 weeks after baseline
measure: Number of Participants with Adverse Events
timeFrame: 12 weeks after baseline
measure: DNA samples (from blood and/or saliva)
timeFrame: Baseline
Locations:
city: Stockholm
country: Sweden
facility: Karolinska Institutet
Study officials:
affiliation: Karolinska Institutet
name: Eva Serlachius, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lenhard F, Ssegonja R, Andersson E, Feldman I, Ruck C, Mataix-Cols D, Serlachius E. Cost-effectiveness of therapist-guided internet-delivered cognitive behaviour therapy for paediatric obsessive-compulsive disorder: results from a randomised controlled trial. BMJ Open. 2017 May 17;7(5):e015246. doi: 10.1136/bmjopen-2016-015246.
citation: Lenhard F, Andersson E, Mataix-Cols D, Ruck C, Vigerland S, Hogstrom J, Hillborg M, Brander G, Ljungstrom M, Ljotsson B, Serlachius E. Therapist-Guided, Internet-Delivered Cognitive-Behavioral Therapy for Adolescents With Obsessive-Compulsive Disorder: A Randomized Controlled Trial. J Am Acad Child Adolesc Psychiatry. 2017 Jan;56(1):10-19.e2. doi: 10.1016/j.jaac.2016.09.515. Epub 2016 Oct 25.