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

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ClinicalTrials.gov Identifier: NCT01525576
Recruitment Status : Completed
First Posted : February 3, 2012
Last Update Posted : July 31, 2012
Sponsor:
Information provided by (Responsible Party):
Christian Rück, Karolinska Institutet

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).

Condition or disease Intervention/treatment Phase
Obsessive-compulsive Disorder Behavioral: Booster Phase 2

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 98 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of an Internet-based Booster Program for Obsessive-compulsive Disorder: A Randomized Controlled Trial
Study Start Date : February 2012
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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)

  2. 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. 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

  4. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01525576


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

Additional Information:
Responsible Party: Christian Rück, Dr Christian Ruck, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT01525576     History of Changes
Other Study ID Numbers: OCD_B
First Posted: February 3, 2012    Key Record Dates
Last Update Posted: July 31, 2012
Last Verified: July 2012

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

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