Internet-based Cognitive Behavior Therapy (CBT) for Obsessive Compulsive Disorder (OCD)
Primary Purpose
Obsessive Compulsive Disorder
Status
Completed
Phase
Phase 2
Locations
Sweden
Study Type
Interventional
Intervention
Internet-based cognitive behavior therapy
Support therapy on Internet
Sponsored by
About this trial
This is an interventional treatment trial for Obsessive Compulsive Disorder focused on measuring CBT, OCD, Internet, Reduce symptom burden
Eligibility Criteria
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
Sites / Locations
- Psykiatri Sydväst
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Internet CBT
Support therapy
Arm Description
Internet-delivered CBT. Contact with therapist thru an e-mail system. 10 weeks.
10 weeks. Therapist support contact through e-mail.
Outcomes
Primary Outcome Measures
Change from Baseline of obsessions and compulsions after 10 weeks and at 3- and 12 months after treatment.
Yale Brown Obsessive Compulsive Scale (Y-BOCS)
Secondary Outcome Measures
Change from Baseline of obsessions and compulsions after 10 weeks and at 3- and 12 months after treatment.
Obsessive Compulsive Scale - Revised (OCI-R)
Change from Baseline of obsessions and compulsions after 10 weeks and at 3- and 12 months after treatment.
Dimensional Obsessive Compulsive Scale (DOCS)
Change from Baseline of depressive symptoms after 10 weeks and at 3- and 12 months after treatment.
Montgomery Asberg Depression Rating Scale
Change from Baseline of meta cognitions after 10 weeks and at 3- and 12 months after treatment.
Obsessive Beliefs Scale
Change from Baseline of quality of life after 10 weeks and at 3- and 12 months after treatment.
Euroqol
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01347099
Brief Title
Internet-based Cognitive Behavior Therapy (CBT) for Obsessive Compulsive Disorder (OCD)
Official Title
Internet-based Cognitive Behavior Therapy for Obsessive Compulsive Disorder: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
February 2011 (Actual)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Karolinska Institutet
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
This is a randomized controlled trial with 101 participants. The control group receives support therapy on demand on the Internet.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obsessive Compulsive Disorder
Keywords
CBT, OCD, Internet, Reduce symptom burden
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
101 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Internet CBT
Arm Type
Experimental
Arm Description
Internet-delivered CBT. Contact with therapist thru an e-mail system. 10 weeks.
Arm Title
Support therapy
Arm Type
Placebo Comparator
Arm Description
10 weeks. Therapist support contact through e-mail.
Intervention Type
Behavioral
Intervention Name(s)
Internet-based cognitive behavior therapy
Intervention Description
Internet-delivered CBT. Contact with therapist thru an e-mail system. 10 weeks
Intervention Type
Behavioral
Intervention Name(s)
Support therapy on Internet
Intervention Description
Internet-delivered support therapy. Contact with therapist thru an e-mail system. 10 weeks
Primary Outcome Measure Information:
Title
Change from Baseline of obsessions and compulsions after 10 weeks and at 3- and 12 months after treatment.
Description
Yale Brown Obsessive Compulsive Scale (Y-BOCS)
Time Frame
Two weeks before treatment, 10 weeks after treatment starts, 3 and 12 months after treatment has ended
Secondary Outcome Measure Information:
Title
Change from Baseline of obsessions and compulsions after 10 weeks and at 3- and 12 months after treatment.
Description
Obsessive Compulsive Scale - Revised (OCI-R)
Time Frame
Two days before treatment, once per week for 10 weeks after treatment starts, 3 and 12 months after treatment has ended
Title
Change from Baseline of obsessions and compulsions after 10 weeks and at 3- and 12 months after treatment.
Description
Dimensional Obsessive Compulsive Scale (DOCS)
Time Frame
Two weeks before treatment, 10 weeks after treatment starts, 3 and 12 months after the treatment has ended
Title
Change from Baseline of depressive symptoms after 10 weeks and at 3- and 12 months after treatment.
Description
Montgomery Asberg Depression Rating Scale
Time Frame
Two weeks before treatment, 10 weeks after treatment starts, 3 and 12 months after treatment has ended
Title
Change from Baseline of meta cognitions after 10 weeks and at 3- and 12 months after treatment.
Description
Obsessive Beliefs Scale
Time Frame
Two weeks before treatment, 10 weeks after treatment starts, 3 and 12 months after treatment has ended
Title
Change from Baseline of quality of life after 10 weeks and at 3- and 12 months after treatment.
Description
Euroqol
Time Frame
Two weeks before treatment, 10 weeks after treatment starts, 3 and 12 months after treatment has ended
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian Rück, MD, PhD
Organizational Affiliation
Department of Clinical Neuroscience, KI
Official's Role
Principal Investigator
Facility Information:
Facility Name
Psykiatri Sydväst
City
Stockholm
Country
Sweden
12. IPD Sharing Statement
Citations:
PubMed Identifier
22348650
Citation
Andersson E, Enander J, Andren P, Hedman E, Ljotsson B, Hursti T, Bergstrom J, Kaldo V, Lindefors N, Andersson G, Ruck C. Internet-based cognitive behaviour therapy for obsessive-compulsive disorder: a randomized controlled trial. Psychol Med. 2012 Oct;42(10):2193-203. doi: 10.1017/S0033291712000244. Epub 2012 Feb 21.
Results Reference
result
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Internet-based Cognitive Behavior Therapy (CBT) for Obsessive Compulsive Disorder (OCD)
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