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

Computer Assisted CBT for OCD: A Comprehensive Stepped-Care Approach

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

Study Overview

• Status: Completed
• Conditions: Obsessive Compulsive Disorder
• Intervention / Treatment: Behavioral: Computer-Assisted Cognitive Behavior Therapy (BT STEPS)

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.

• Study Type: Interventional
• Enrollment (Actual): 88
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53717
      • Center for Psychological Consultation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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: Behavior Therapy; Cogntive Therapy; Cognitive-Behavior Therapy
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: Behavior Therapy; Cogntive Therapy; Cognitive-Behavior Therapy
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: Behavior Therapy; Cogntive Therapy; Cognitive-Behavior Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Yale Brown Obsessive Compulsive Scale (YBOCS)	YBOCS measures severity of obsessions and compulsions	Change from Baseline on YBOCS at 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PHQ-9	PHQ-9 assesses the 9 core DSM symptoms of depression	Change from baseline on PHQ9 at 12 weeks
Work and Social Adjustment Scale (WSA)	Measures problems at work and social relationships	Change from baseline on WSA at 12 weeks

Collaborators and Investigators

• Sponsor: Center for Psychological Consultation

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: January 23, 2012
• First Submitted That Met QC Criteria: January 27, 2012
• First Posted (Estimate): January 31, 2012

Study Record Updates

• Last Update Posted (Estimate): March 14, 2014
• Last Update Submitted That Met QC Criteria: March 13, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Keywords: Obsessive Compulsive Disorder; Cognitive Therapy; Cognitive Behavior Therapy; Computer Assisted Therapy
• Additional Relevant MeSH Terms: Mental Disorders; Personality Disorders; Anxiety Disorders; Compulsive Personality Disorder; Obsessive-Compulsive Disorder
• Other Study ID Numbers: R43MH090612 (U.S. NIH Grant/Contract)