- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01347099
Internet-based Cognitive Behavior Therapy (CBT) for Obsessive Compulsive Disorder (OCD)
March 19, 2018 updated by: Karolinska Institutet
Internet-based Cognitive Behavior Therapy for Obsessive Compulsive Disorder: A Randomized Controlled Trial
Cognitive behavior therapy (CBT) is an effective treatment for obsessive compulsive disorder (OCD) but there is a lack of properly trained CBT therapists.
One possible treatment alternative is Internet-based CBT (ICBT) with minimal therapist input.
The aim of this study was therefore to evaluate ICBT for OCD.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This is a randomized controlled trial with 101 participants.
The control group receives support therapy on demand on the Internet.
Study Type
Interventional
Enrollment (Actual)
101
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
-
-
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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:
- Primary diagnosis of obsessive compulsive disorder (OCD)
- At least 18 years old
- Able to read and write in swedish
- Computer access
Exclusion Criteria:
- other primary diagnosis
- substance abuse,
- psychosis,
- bipolar disorder,
- suicidal ideation,
- adjusted pharmacological treatment the last two months
- current psychological treatment for OCD,
- been treated with CBT the last two years,
- serious somatic disease,
- Y---BOCS>31
- hoarding as primary OCD subtype
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
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Internet CBT
Internet-delivered CBT.
Contact with therapist thru an e-mail system.
10 weeks.
|
Internet-delivered CBT.
Contact with therapist thru an e-mail system.
10 weeks
|
PLACEBO_COMPARATOR: Support therapy
10 weeks.
Therapist support contact through e-mail.
|
Internet-delivered support therapy.
Contact with therapist thru an e-mail system.
10 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Baseline of obsessions and compulsions after 10 weeks and at 3- and 12 months after treatment.
Time Frame: Two weeks before treatment, 10 weeks after treatment starts, 3 and 12 months after treatment has ended
|
Yale Brown Obsessive Compulsive Scale (Y-BOCS)
|
Two weeks before treatment, 10 weeks after treatment starts, 3 and 12 months after treatment has ended
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Baseline of obsessions and compulsions after 10 weeks and at 3- and 12 months after treatment.
Time Frame: Two days before treatment, once per week for 10 weeks after treatment starts, 3 and 12 months after treatment has ended
|
Obsessive Compulsive Scale - Revised (OCI-R)
|
Two days before treatment, once per week for 10 weeks after treatment starts, 3 and 12 months after treatment has ended
|
Change from Baseline of obsessions and compulsions after 10 weeks and at 3- and 12 months after treatment.
Time Frame: Two weeks before treatment, 10 weeks after treatment starts, 3 and 12 months after the treatment has ended
|
Dimensional Obsessive Compulsive Scale (DOCS)
|
Two weeks before treatment, 10 weeks after treatment starts, 3 and 12 months after the treatment has ended
|
Change from Baseline of depressive symptoms after 10 weeks and at 3- and 12 months after treatment.
Time Frame: Two weeks before treatment, 10 weeks after treatment starts, 3 and 12 months after treatment has ended
|
Montgomery Asberg Depression Rating Scale
|
Two weeks before treatment, 10 weeks after treatment starts, 3 and 12 months after treatment has ended
|
Change from Baseline of meta cognitions after 10 weeks and at 3- and 12 months after treatment.
Time Frame: Two weeks before treatment, 10 weeks after treatment starts, 3 and 12 months after treatment has ended
|
Obsessive Beliefs Scale
|
Two weeks before treatment, 10 weeks after treatment starts, 3 and 12 months after treatment has ended
|
Change from Baseline of quality of life after 10 weeks and at 3- and 12 months after treatment.
Time Frame: Two weeks before treatment, 10 weeks after treatment starts, 3 and 12 months after treatment has ended
|
Euroqol
|
Two weeks before treatment, 10 weeks after treatment starts, 3 and 12 months after treatment has ended
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Christian Rück, MD, PhD, Department of Clinical Neuroscience, KI
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.
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 (ACTUAL)
February 1, 2011
Primary Completion (ACTUAL)
June 1, 2011
Study Completion
June 1, 2011
Study Registration Dates
First Submitted
May 2, 2011
First Submitted That Met QC Criteria
May 3, 2011
First Posted (ESTIMATE)
May 4, 2011
Study Record Updates
Last Update Posted (ACTUAL)
March 21, 2018
Last Update Submitted That Met QC Criteria
March 19, 2018
Last Verified
May 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- OCD-S
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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