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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
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obsessive Compulsive Disorder focused on measuring CBT, OCD, Internet, Reduce symptom burden

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
May 2, 2011
Last Updated
March 19, 2018
Sponsor
Karolinska Institutet
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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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