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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Christian Rück, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT01525576
First received: February 1, 2012
Last updated: July 30, 2012
Last verified: July 2012
History of Changes
  Purpose

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).


Condition Intervention Phase
Obsessive-compulsive Disorder
 Behavioral: Booster
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of an Internet-based Booster Program for Obsessive-compulsive Disorder: A Randomized Controlled Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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. [ Time Frame: 3 months before treatment, 6 and 18 months after treatment has ended ] [ Designated as safety issue: No ]
    Obsessive Compulsive Scale - Revised (OCI-R)

  • 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 ] [ Designated as safety issue: No ]
    Trimbos Institute Cost-assessment for Psychiatry (TIC-P)

  • 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 ] [ Designated as safety issue: No ]
    Montgomery Asberg Depression Rating Scale

  • 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 ] [ Designated as safety issue: No ]
    Euroqol


Enrollment: 98
Study Start Date: February 2012
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01525576

Locations
Sweden
Psykiatri sydväst
Stockholm, Sweden
Sponsors and Collaborators
Karolinska Institutet
  More Information

Additional Information:
This is an amendment to NCT01347099  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Christian Rück, Dr Christian Ruck, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT01525576     History of Changes
Other Study ID Numbers: OCD_B
Study First Received: February 1, 2012
Last Updated: July 30, 2012
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Karolinska Institutet:
booster program
internet
cbt
Study the specific effects of adding a booster program

Additional relevant MeSH terms:
Obsessive-Compulsive Disorder
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 19, 2013