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

July 30, 2012 updated by: Christian Rück, Karolinska Institutet

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

98

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden
        • Psykiatri Sydväst

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
No offer of booster program.
Experimental: Booster
3 week booster program + 2 additional weeks two months later for follow-up.
Behavioral: Booster
3 week booster program + 2 additional weeks two months later for follow-up.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline of obsessions and compulsions after 3, 8 and 20 months after baseline.
Time Frame: 3 months before treatment, 3 weeks after treatment starts, 6 and 18 months after treatment has ended
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline of obsessions and compulsions after 8 and 20 months.
Time Frame: 3 months before treatment, 6 and 18 months after treatment has ended
Obsessive Compulsive Scale - Revised (OCI-R)
3 months before treatment, 6 and 18 months after treatment has ended
Change from Baseline of obsessions and compulsions after 8 and 20 months.
Time Frame: 3 months before treatment, 6 and 18 months after treatment has ended
Trimbos Institute Cost-assessment for Psychiatry (TIC-P)
3 months before treatment, 6 and 18 months after treatment has ended
Change from Baseline of obsessions and compulsions after 8 and 20 months.
Time Frame: 3 months before treatment, 6 and 18 months after treatment has ended
Montgomery Asberg Depression Rating Scale
3 months before treatment, 6 and 18 months after treatment has ended
Change from Baseline of obsessions and compulsions after 8 and 20 months.
Time Frame: 3 months before treatment, 6 and 18 months after treatment has ended
Euroqol
3 months before treatment, 6 and 18 months after treatment has ended

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska Institutet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

July 1, 2012

Study Registration Dates

First Submitted

February 1, 2012

First Submitted That Met QC Criteria

February 2, 2012

First Posted (Estimate)

February 3, 2012

Study Record Updates

Last Update Posted (Estimate)

July 31, 2012

Last Update Submitted That Met QC Criteria

July 30, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OCD_B

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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