Internet-delivered CBT for Adolescents With OCD: A Randomized Controlled Study

Obsessive-Compulsive Disorder Clinical Trial

— BiPOCD  

Official title:

Internet-delivered Cognitive Behavior Therapy for Adolescents With Obsessive-Compulsive Disorder: A Randomized Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02191631
• Other study ID #: BiPOCD RCT
• Status: Completed
• Phase: N/A
• First received: July 3, 2014
• Last updated: December 21, 2016
• Start date: August 2014
• Est. completion date: December 2016

Study information

• Verified date: December 2016
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: December 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 17 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Compulsive Behavior
• Obsessive-Compulsive Disorder

Intervention

Behavioral:
• Internet-delivered Cognitive Behavior Therapy
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.

Locations

Country	Name	City	State
Sweden	Karolinska Institutet	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Measurement of homework adherence		Baseline, daily measurements until 12 weeks after baseline	No
Other	Number of Participants with Adverse Events		12 weeks after baseline	No
Other	DNA samples (from blood and/or saliva)		Baseline	No
Primary	Children's Yale Brown Obsessive Compulsive Scale, CY-BOCS	Change from Baseline of obsessions and compulsions after 12 weeks and at 3- and 12 months after treatment	Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended	No
Secondary	Clinical Global Impression - Severity, CGI-S		Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended	No
Secondary	Clinical Global Impression - Improvement, CGI-I		Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended	No
Secondary	Parent Adherence EX/RP Scale, PEAS		Baseline, 6 and 12 weeks after treatment starts	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Child Depression Inventory - Short version (CDI-S, Kovacs, 1985)		Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended	No
Secondary	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	No
Secondary	Technology acceptance scale		Baseline, 6 and 12 weeks after treatment starts,	No
Secondary	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	No
Secondary	EQ-5D - quality of life		Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended	No