Computer Assisted Cognitive Behavior Therapy for Obsessive Compulsive Disorder: A Comprehensive Stepped-Care Approach
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Obsessive Compulsive Disorder |
Behavioral: Computer-Assisted Cognitive Behavior Therapy (BT STEPS) |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Computer Assisted CBT for OCD: A Comprehensive Stepped-Care Approach |
- Yale Brown Obsessive Compulsive Scale (YBOCS) [ Time Frame: Change from Baseline on YBOCS at 12 weeks ] [ Designated as safety issue: No ]YBOCS measures severity of obsessions and compulsions
- PHQ-9 [ Time Frame: Change from baseline on PHQ9 at 12 weeks ] [ Designated as safety issue: Yes ]PHQ-9 assesses the 9 core DSM symptoms of depression
- Work and Social Adjustment Scale (WSA) [ Time Frame: Change from baseline on WSA at 12 weeks ] [ Designated as safety issue: No ]Measures problems at work and social relationships
| Estimated Enrollment: | 105 |
| Study Start Date: | January 2012 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: BT STEPS alone
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.
|
Behavioral: Computer-Assisted Cognitive Behavior Therapy (BT STEPS)
BT STEPS is a computer-assisted self help treatment for OCD. Clients work through the program at their own pace.
Other Names:
|
|
Active Comparator: BT Steps with non-therapist coaching
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.
|
Behavioral: Computer-Assisted Cognitive Behavior Therapy (BT STEPS)
BT STEPS is a computer-assisted self help treatment for OCD. Clients work through the program at their own pace.
Other Names:
|
|
Active Comparator: BT STEPS with therapist coaching
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.
|
Behavioral: Computer-Assisted Cognitive Behavior Therapy (BT STEPS)
BT STEPS is a computer-assisted self help treatment for OCD. Clients work through the program at their own pace.
Other Names:
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations| Contact: Revere Greist, BS | 608-556-0766 | rgreist@centerforpsychconsulting.com |
| Contact: Kenneth Kobak, PhD | 608-239-3919 | kobak@charter.net |
| United States, Wisconsin | |
| Center for Psychological Consultation | Recruiting |
| Madison, Wisconsin, United States, 53717 | |
| Contact: Kenneth Kobak, Ph.D. 608-239-3919 kobak@charter.net | |
More Information
Publications:
| Responsible Party: | Center for Psychological Consultation |
| ClinicalTrials.gov Identifier: | NCT01522287 History of Changes |
| Other Study ID Numbers: | R43MH090612 |
| Study First Received: | January 23, 2012 |
| Last Updated: | January 27, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Center for Psychological Consultation:
|
Obsessive Compulsive Disorder Computer Assisted Therapy Cognitive Behavior Therapy Cognitive Therapy |
Additional relevant MeSH terms:
|
Obsessive-Compulsive Disorder Anxiety Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 19, 2013