Clinical trial NCT00316355: Stepped Care for Treating Obsessive-Compulsive Disorder
Official title: Stepped Care for Obsessive-Compulsive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obsessive-compulsive Disorder
Keywords: Anxiety
Behavior therapy
Cognitive-behavioral therapy
Stepped care
Cost-effectiveness
Lead sponsor: Hartford Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2006-04-20
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) Total Score
timeFrame: Pretreatment, Posttreatment, and 3-month follow-up
measure: Treatment-related Total Cost Estimates
timeFrame: Posttreatment
Secondary outcomes:
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Institute of Living/Hartford Hospital
state: Connecticut
Study officials:
affiliation: Institute of Living/Hartford Hospital
name: David F. Tolin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.