Stepped Care for Treating Obsessive-Compulsive Disorder

NCT ID: NCT00316355

Last Updated: 2018-02-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-06-30
• Study Completion Date: 2010-01-31

Brief Summary

This study will determine the effectiveness and cost-effectiveness of a stepped-care treatment program for people with obsessive-compulsive disorder.

Detailed Description

Obsessive-Compulsive Disorder (OCD) is a chronic and debilitating anxiety disorder. People with OCD often experience recurrent unwanted thoughts, called obsessions, and repetitive behaviors, called compulsions. These thoughts and behaviors interfere with everyday life to a great extent. Currently, the most frequently used psychosocial treatment for OCD is cognitive-behavioral therapy (CBT) that incorporates exposure with ritual prevention (EX/RP). However, although effective, this treatment approach is largely inaccessible, time-consuming, labor-intensive, and expensive. A stepped-care approach to treating OCD may be more cost-effective and therefore more accessible for many individuals. Stepped-care CBT begins with the least expensive, least intrusive, most accessible option, and works up to the most expensive option if the less intrusive treatments do not work. This study will determine the benefits and cost-effectiveness of a stepped care treatment program for OCD.

Participants in this open label study will be randomly assigned to receive CBT for 6 to 14 weeks either through the stepped-care approach or immediately upon study entry. Participants will report to the study site for treatments and assessments on a regular basis, ranging from every 2 weeks to twice a week, depending on the stage of the study and the assigned treatment group. Stepped-care CBT will begin with self-administered EX/RP combined with counseling to address medication issues, life stress, and motivational enhancement. If ineffective, this treatment will be followed by therapist-administered EX/RP. OCD symptoms will be assessed at Week 6. Participants who have responded to treatment after 6 weeks will not receive further treatment. All others will continue for an additional 8 weeks. These participants' OCD symptoms will be assessed again at Week 14. Participants assigned to the stepped-care approach whose OCD symptoms improved initially, but relapsed without further treatment by the Week 14 evaluation will receive full-scale CBT. Outcomes will be assessed again at 1- and 3-month follow-up visits.

Conditions

Obsessive-compulsive Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Traditional CBT

Cognitive-behavioral therapy (CBT) that incorporates exposure with ritual prevention (EX/RP)

Group Type: ACTIVE_COMPARATOR

Traditional CBT

Intervention Type: BEHAVIORAL

CBT with EX/RP is a psychosocial treatment that incorporates exposure with ritual prevention.

Stepped-Care CBT

Stepped-care CBT

Group Type: EXPERIMENTAL

Stepped-Care CBT

Intervention Type: BEHAVIORAL

In the CBT stepped-care program, patients are first provided with a less expensive, less intrusive, and more accessible option that resembles quality community care (e.g., self-administered EX/RP combined with counseling to address medication issues, life stress, and motivational enhancement). Patients who fail to respond to this initial treatment progress to a more intensive treatment (e.g., therapist-administered EX/RP).

Interventions

Traditional CBT

CBT with EX/RP is a psychosocial treatment that incorporates exposure with ritual prevention.

Intervention Type: BEHAVIORAL

Stepped-Care CBT

In the CBT stepped-care program, patients are first provided with a less expensive, less intrusive, and more accessible option that resembles quality community care (e.g., self-administered EX/RP combined with counseling to address medication issues, life stress, and motivational enhancement). Patients who fail to respond to this initial treatment progress to a more intensive treatment (e.g., therapist-administered EX/RP).

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Primary diagnosis of OCD of moderate or greater severity
• Presence of OCD symptoms for at least 1 year

Exclusion Criteria

• History of psychotic or developmental disorder
• Uncontrolled bipolar disorder
• Serious suicide risk
• Prior history of adequate CBT, including exposure and response prevention

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 69 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Hartford Hospital

OTHER

Sponsor Role: lead

Responsible Party

David Tolin

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David F. Tolin, PhD

Role: PRINCIPAL_INVESTIGATOR

Institute of Living/Hartford Hospital

Locations

Institute of Living/Hartford Hospital

Hartford, Connecticut, United States

Countries

United States

References

Tolin, D.F., Diefenbach, G.J., Maltby, N., & Hannan, S. (2005). Stepped care for obsessive-compulsive disorder: A pilot study. Cognitive and Behavioral Practice, 12, 403-414.

Reference Type: BACKGROUND

Other Identifiers

R34MH071464

Identifier Type: NIH

Identifier Source: secondary_id

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R34MH071464

Identifier Type: NIH

Identifier Source: org_study_id

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