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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Center for Psychological Consultation
ClinicalTrials.gov Identifier:
NCT01522287
First received: January 23, 2012
Last updated: March 13, 2014
Last verified: March 2014
  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

Resource links provided by NLM:


Further study details as provided by Center for Psychological Consultation:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 88
Study Start Date: January 2012
Study Completion Date: December 2013
Primary Completion Date: December 2013 (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:
  • Cogntive Therapy
  • Behavior 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:
  • Cogntive Therapy
  • Behavior 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:
  • Cogntive Therapy
  • Behavior Therapy
  • Cognitive-Behavior Therapy

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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01522287

Locations
United States, Wisconsin
Center for Psychological Consultation
Madison, Wisconsin, United States, 53717
Sponsors and Collaborators
Center for Psychological Consultation
  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: March 13, 2014
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
Compulsive Personality Disorder
Anxiety Disorders
Mental Disorders
Personality Disorders

ClinicalTrials.gov processed this record on July 20, 2014