NCT00316355

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 18, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 20, 2006

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2006

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
6.4 years until next milestone

Results Posted

Study results publicly available

June 6, 2016

Completed
Last Updated

February 22, 2018

Status Verified

January 1, 2018

Enrollment Period

3.6 years

First QC Date

April 18, 2006

Results QC Date

March 29, 2016

Last Update Submit

January 24, 2018

Conditions

Obsessive-compulsive Disorder

Keywords

AnxietyBehavior therapyCognitive-behavioral therapyStepped careCost-effectiveness

Outcome Measures

Primary Outcomes (2)

  • Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) Total Score

    The Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) total score was used as the outcome measure. The Y-BOCS is a clinician-rated scale assessing obsession (5 items) and compulsion (5 items) symptom severity on a 0 to 4 scale. All 10 items are added for the total score, with total scores ranging from 0 to 40, and higher numbers indicating more severe symptoms.

    Pretreatment, Posttreatment, and 3-month follow-up

  • Treatment-related Total Cost Estimates

    total estimated costs calculated based upon the fixed-dose schedule

    Posttreatment

Study Arms (2)

Traditional CBT

ACTIVE COMPARATOR

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

Behavioral: Traditional CBT

Stepped-Care CBT

EXPERIMENTAL

Stepped-care CBT

Behavioral: Stepped-Care CBT

Interventions

Traditional CBTBEHAVIORAL

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

Traditional CBT
Stepped-Care CBTBEHAVIORAL

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).

Stepped-Care CBT

Eligibility Criteria

Age18 Years - 69 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Living/Hartford Hospital

Hartford, Connecticut, 06106, United States

Location

Related Publications (1)

  • 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.

    BACKGROUND

MeSH Terms

Conditions

Obsessive-Compulsive DisorderAnxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Results Point of Contact

Title
David Tolin
Organization
Hartford Hospital
david.tolin@hhchealth.org
860-545-7685

Study Officials

  • David F. Tolin, PhD

    Institute of Living/Hartford Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 18, 2006

First Posted

April 20, 2006

Study Start

June 1, 2006

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

February 22, 2018

Results First Posted

June 6, 2016

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)