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

Obsessive Compulsive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01522287
• Other study ID #: R43MH090612
• Status: Completed
• Phase: Phase 1
• First received: January 23, 2012
• Last updated: March 13, 2014
• Start date: January 2012
• Est. completion date: December 2013

Study information

• Verified date: March 2014
• Source: Center for Psychological Consultation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Compulsive Behavior
• Obsessive Compulsive Disorder
• Obsessive-Compulsive Disorder

Intervention

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.

Locations

Country	Name	City	State
United States	Center for Psychological Consultation	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Center for Psychological Consultation

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Yale Brown Obsessive Compulsive Scale (YBOCS)	YBOCS measures severity of obsessions and compulsions	Change from Baseline on YBOCS at 12 weeks	No
Secondary	PHQ-9	PHQ-9 assesses the 9 core DSM symptoms of depression	Change from baseline on PHQ9 at 12 weeks	Yes
Secondary	Work and Social Adjustment Scale (WSA)	Measures problems at work and social relationships	Change from baseline on WSA at 12 weeks	No