Back to resultsBooster as an Adjunct to Internet-based Cognitive Behavior Therapy (CBT)
Primary Purpose
Obsessive-compulsive Disorder
Status
Completed
Phase
Phase 2
Locations
Sweden
Study Type
Interventional
Intervention
Booster
Sponsored by
About this trial
This is an interventional treatment trial for Obsessive-compulsive Disorder focused on measuring booster program, internet, cbt, Study the specific effects of adding a booster program
Eligibility Criteria
Inclusion Criteria:
- Signed consent
- Previously enrolled in our randomized controlled trial testing ICBT for OCD: NCT01347099
Exclusion Criteria:
- Suicidal ideation that could jeopardize participation
Sites / Locations
- Psykiatri sydväst
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control group
Booster
Arm Description
No offer of booster program.
3 week booster program + 2 additional weeks two months later for follow-up.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Change from Baseline of obsessions and compulsions after 8 and 20 months.
Obsessive Compulsive Scale - Revised (OCI-R)
Change from Baseline of obsessions and compulsions after 8 and 20 months.
Trimbos Institute Cost-assessment for Psychiatry (TIC-P)
Change from Baseline of obsessions and compulsions after 8 and 20 months.
Montgomery Asberg Depression Rating Scale
Change from Baseline of obsessions and compulsions after 8 and 20 months.
Euroqol
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01525576
Brief Title
Booster as an Adjunct to Internet-based Cognitive Behavior Therapy (CBT)
Official Title
Efficacy of an Internet-based Booster Program for Obsessive-compulsive Disorder: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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).
Detailed Description
Written consent form. Completing ICBT in our previous study: Please see NCT01347099 for more details.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obsessive-compulsive Disorder
Keywords
booster program, internet, cbt, Study the specific effects of adding a booster program
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
98 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
No Intervention
Arm Description
No offer of booster program.
Arm Title
Booster
Arm Type
Experimental
Arm Description
3 week booster program + 2 additional weeks two months later for follow-up.
Intervention Type
Behavioral
Intervention Name(s)
Booster
Intervention Description
3 week booster program + 2 additional weeks two months later for follow-up.
Primary Outcome Measure Information:
Title
Change from Baseline of obsessions and compulsions after 3, 8 and 20 months after baseline.
Description
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.
Time Frame
3 months before treatment, 3 weeks after treatment starts, 6 and 18 months after treatment has ended
Secondary Outcome Measure Information:
Title
Change from Baseline of obsessions and compulsions after 8 and 20 months.
Description
Obsessive Compulsive Scale - Revised (OCI-R)
Time Frame
3 months before treatment, 6 and 18 months after treatment has ended
Title
Change from Baseline of obsessions and compulsions after 8 and 20 months.
Description
Trimbos Institute Cost-assessment for Psychiatry (TIC-P)
Time Frame
3 months before treatment, 6 and 18 months after treatment has ended
Title
Change from Baseline of obsessions and compulsions after 8 and 20 months.
Description
Montgomery Asberg Depression Rating Scale
Time Frame
3 months before treatment, 6 and 18 months after treatment has ended
Title
Change from Baseline of obsessions and compulsions after 8 and 20 months.
Description
Euroqol
Time Frame
3 months before treatment, 6 and 18 months after treatment has ended
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Signed consent
Previously enrolled in our randomized controlled trial testing ICBT for OCD: NCT01347099
Exclusion Criteria:
Suicidal ideation that could jeopardize participation
Facility Information:
Facility Name
Psykiatri sydväst
City
Stockholm
Country
Sweden
12. IPD Sharing Statement
Links:
URL
http://clinicaltrials.gov
Description
This is an amendment to NCT01347099
Learn more about this trial
Booster as an Adjunct to Internet-based Cognitive Behavior Therapy (CBT)
We'll reach out to this number within 24 hrs