Booster as an Adjunct to Internet-based Cognitive Behavior Therapy (CBT)

Obsessive-compulsive Disorder Clinical Trial

Official title:

Efficacy of an Internet-based Booster Program for Obsessive-compulsive Disorder: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01525576
• Other study ID #: OCD_B
• Status: Completed
• Phase: Phase 2
• First received: February 1, 2012
• Last updated: July 30, 2012
• Start date: February 2012
• Est. completion date: July 2012

Study information

• Verified date: July 2012
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial Summary

In this trial, we test if adding an Internet-based booster program to regular Internet-based cognitive behavior therapy (ICBT) is effective for patients with obsessive-compulsive disorder (OCD).

Description:

Written consent form. Completing ICBT in our previous study: Please see NCT01347099 for more details.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Signed consent

• Previously enrolled in our randomized controlled trial testing ICBT for OCD:

NCT01347099

Exclusion Criteria:

• Suicidal ideation that could jeopardize participation

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:
• Booster
3 week booster program + 2 additional weeks two months later for follow-up.

Locations

Country	Name	City	State
Sweden	Psykiatri sydväst	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline of obsessions and compulsions after 3, 8 and 20 months after baseline.	Yale Brown Obsessive Compulsive Scale (Y-BOCS). Analysis will examine the frequency of relapse from remission between the groups. Furthermore, frequency of incremental cases of remission will be compared between the groups.	3 months before treatment, 3 weeks after treatment starts, 6 and 18 months after treatment has ended	No
Secondary	Change from Baseline of obsessions and compulsions after 8 and 20 months.	Obsessive Compulsive Scale - Revised (OCI-R)	3 months before treatment, 6 and 18 months after treatment has ended	No
Secondary	Change from Baseline of obsessions and compulsions after 8 and 20 months.	Trimbos Institute Cost-assessment for Psychiatry (TIC-P)	3 months before treatment, 6 and 18 months after treatment has ended	No
Secondary	Change from Baseline of obsessions and compulsions after 8 and 20 months.	Montgomery Asberg Depression Rating Scale	3 months before treatment, 6 and 18 months after treatment has ended	No
Secondary	Change from Baseline of obsessions and compulsions after 8 and 20 months.	Euroqol	3 months before treatment, 6 and 18 months after treatment has ended	No

External Links

•   This is an amendment to NCT01347099