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Computer Assisted Cognitive Behavior Therapy for Obsessive Compulsive Disorder: A Comprehensive Stepped-Care Approach

Primary Purpose

Obsessive Compulsive Disorder

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Computer-Assisted Cognitive Behavior Therapy (BT STEPS)
Sponsored by
Center for Psychological Consultation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obsessive Compulsive Disorder focused on measuring Obsessive Compulsive Disorder, Computer Assisted Therapy, Cognitive Behavior Therapy, Cognitive Therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Age 18 or above
  • Have clinically significant OCD
  • YBOCS score of 16-32

Exclusion Criteria:

  • Significant comorbid depression
  • Serious suicide risk
  • Psychosis or psychotic disorder

Sites / Locations

  • Center for Psychological Consultation

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

BT STEPS alone

BT Steps with non-therapist coaching

BT STEPS with therapist coaching

Arm Description

Subjects assigned to BT STEPS without coaching will receive computer assisted Cognitive Behavior Therapy. They will receive a welcome and orientation call from the project manager and up to three automated reminder e-mails if there is no activity in the BT Steps website for 5 days. E-mails will describe most recent "step" the participant used and what to expect in upcoming steps. The focus of reminder messages is on the patient"s progress through BT STEPS.

Subjects randomized to BT STEPS with coaching will receive computer assisted Cognitive Behavior Therapy plus regularly scheduled weekly coaching, encouragement and support via phone. Calls will focus on user's progress in BT STEPS, troubleshoot problems the participant is having with the program, and set progress goals for the next coaching session. Coaches will be supervised by the CBT therapist, and may consult with the CBT clinician as needed.

Subjects randomized to BT STEPS with therapist coaching will receive computer-assisted Cognitive Behavior Therapy plus regularly scheduled weekly coaching and support from a CBT therapist via phone. Calls will focus on user's progress in BT STEPS, troubleshoot problems the participant is having with the program, and set progress goals for the next coaching session.

Outcomes

Primary Outcome Measures

Yale Brown Obsessive Compulsive Scale (YBOCS)
YBOCS measures severity of obsessions and compulsions

Secondary Outcome Measures

PHQ-9
PHQ-9 assesses the 9 core DSM symptoms of depression
Work and Social Adjustment Scale (WSA)
Measures problems at work and social relationships

Full Information

First Posted
January 23, 2012
Last Updated
March 13, 2014
Sponsor
Center for Psychological Consultation
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1. Study Identification

Unique Protocol Identification Number
NCT01522287
Brief Title
Computer Assisted Cognitive Behavior Therapy for Obsessive Compulsive Disorder: A Comprehensive Stepped-Care Approach
Official Title
Computer Assisted CBT for OCD: A Comprehensive Stepped-Care Approach
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Center for Psychological Consultation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The goal of this project is to improve access to effective treatments for obsessive compulsive disorder (OCD) through the use of web-based cognitive behavioral therapy (CBT) treatment. There intervention involves both a computer program (BT Steps) and human interaction via telephone. The investigators will test the efficacy and feasibility of computer therapy alone (n=35), computer plus a non-therapist coach (n=35), and computer plus a CBT therapist coach (n=35
Detailed Description
The need for evidence-based mental health treatments i.e., 'treatment based on the best available science or research evidence"1, has been stressed from scientific, ethical, and marketing perspectives. While empirical evidence supports both the efficacy and effectiveness of cognitive behavior therapy (CBT) for Obsessive-Compulsive Disorder (OCD), demand for clinicians trained in these approaches far exceeds supply. New technologies provide the opportunity to facilitate access to this specialized treatment. A growing body of research has found that web-based self-administered psychotherapy is highly effective, cost-efficient, and can achieve clinical improvements similar to those obtained with clinician administered therapy. The long-term goal of this project is to improve clinical and occupational functioning and decrease disability associated with OCD by improving access to effective treatments through the use of web-based CBT treatment. The intervention involves a computer program (BT STEPS) and human interaction via telephone. The inclusion of human interaction for coaching and encouragement has been found to significantly increase compliance and success rates in computerized self-help. Whether treatment outcomes differ when this coaching is done by a therapist versus when done by a trained non-therapist has not been studied. This is the first program to examine a hybrid model involving different levels of remote clinician coaching in combination with an on-line self-help tutorial. In Phase I the investigators will test the efficacy and feasibility of computer therapy alone (n=35), computer plus nontherapist coach (n=35) and computer plus CBT therapist coach. In phase II the investigators will do a fully powered study comparing our model to traditional face-to-face therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obsessive Compulsive Disorder
Keywords
Obsessive Compulsive Disorder, Computer Assisted Therapy, Cognitive Behavior Therapy, Cognitive Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
88 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BT STEPS alone
Arm Type
Active Comparator
Arm Description
Subjects assigned to BT STEPS without coaching will receive computer assisted Cognitive Behavior Therapy. They will receive a welcome and orientation call from the project manager and up to three automated reminder e-mails if there is no activity in the BT Steps website for 5 days. E-mails will describe most recent "step" the participant used and what to expect in upcoming steps. The focus of reminder messages is on the patient"s progress through BT STEPS.
Arm Title
BT Steps with non-therapist coaching
Arm Type
Active Comparator
Arm Description
Subjects randomized to BT STEPS with coaching will receive computer assisted Cognitive Behavior Therapy plus regularly scheduled weekly coaching, encouragement and support via phone. Calls will focus on user's progress in BT STEPS, troubleshoot problems the participant is having with the program, and set progress goals for the next coaching session. Coaches will be supervised by the CBT therapist, and may consult with the CBT clinician as needed.
Arm Title
BT STEPS with therapist coaching
Arm Type
Active Comparator
Arm Description
Subjects randomized to BT STEPS with therapist coaching will receive computer-assisted Cognitive Behavior Therapy plus regularly scheduled weekly coaching and support from a CBT therapist via phone. Calls will focus on user's progress in BT STEPS, troubleshoot problems the participant is having with the program, and set progress goals for the next coaching session.
Intervention Type
Behavioral
Intervention Name(s)
Computer-Assisted Cognitive Behavior Therapy (BT STEPS)
Other Intervention Name(s)
Cogntive Therapy, Behavior Therapy, Cognitive-Behavior Therapy
Intervention Description
BT STEPS is a computer-assisted self help treatment for OCD. Clients work through the program at their own pace.
Primary Outcome Measure Information:
Title
Yale Brown Obsessive Compulsive Scale (YBOCS)
Description
YBOCS measures severity of obsessions and compulsions
Time Frame
Change from Baseline on YBOCS at 12 weeks
Secondary Outcome Measure Information:
Title
PHQ-9
Description
PHQ-9 assesses the 9 core DSM symptoms of depression
Time Frame
Change from baseline on PHQ9 at 12 weeks
Title
Work and Social Adjustment Scale (WSA)
Description
Measures problems at work and social relationships
Time Frame
Change from baseline on WSA at 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age 18 or above Have clinically significant OCD YBOCS score of 16-32 Exclusion Criteria: Significant comorbid depression Serious suicide risk Psychosis or psychotic disorder
Facility Information:
Facility Name
Center for Psychological Consultation
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53717
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
11874215
Citation
Greist JH, Marks IM, Baer L, Kobak KA, Wenzel KW, Hirsch MJ, Mantle JM, Clary CM. Behavior therapy for obsessive-compulsive disorder guided by a computer or by a clinician compared with relaxation as a control. J Clin Psychiatry. 2002 Feb;63(2):138-45. doi: 10.4088/jcp.v63n0209.
Results Reference
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Computer Assisted Cognitive Behavior Therapy for Obsessive Compulsive Disorder: A Comprehensive Stepped-Care Approach

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