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

NCT01522287 | Completed Phase 1 DMC

• 1 other identifier: R43MH090612
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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

Conditions

Obsessive Compulsive Disorder

Keywords

Obsessive Compulsive Disorder; Computer Assisted Therapy; Cognitive Behavior Therapy; Cognitive Therapy

Outcome Measures

Primary Outcomes (1)

• Yale Brown Obsessive Compulsive Scale (YBOCS)

  YBOCS measures severity of obsessions and compulsions

  Change from Baseline on YBOCS at 12 weeks

Secondary Outcomes (2)

• PHQ-9

  Change from baseline on PHQ9 at 12 weeks

• Work and Social Adjustment Scale (WSA)

  Change from baseline on WSA at 12 weeks

Study Arms (3)

BT STEPS alone

ACTIVE COMPARATOR

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 with non-therapist coaching

ACTIVE COMPARATOR

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 with therapist coaching

ACTIVE COMPARATOR

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)

Interventions

Computer-Assisted Cognitive Behavior Therapy (BT STEPS) BEHAVIORAL

BT STEPS is a computer-assisted self help treatment for OCD. Clients work through the program at their own pace.

Also known as: Cogntive Therapy, Behavior Therapy, Cognitive-Behavior Therapy

BT STEPS alone; BT STEPS with therapist coaching; BT Steps with non-therapist coaching

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Center for Psychological Consultation: lead

Study Sites (1)

Center for Psychological Consultation

Madison, Wisconsin, 53717, United States

Location

Related 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. doi: 10.4088/jcp.v63n0209.

  PMID: 11874215 BACKGROUND

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

Behavior Therapy; Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2012
• First Posted: January 31, 2012
• Study Start: January 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: March 14, 2014

Record last verified: 2014-03

Locations

US (1)