Cost-Effectiveness of Adding Web-Based Cognitive-Behavioral Therapy (CBT) to Luvox CR for Obsessive Compulsive Disorder (OCD)

NCT ID: NCT00743834

Last Updated: 2008-09-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2009-12-31

Brief Summary

This study will test the hypotheses that: 1. 12 weeks of Luvox-CR plus web-based Cognitive-Behavioral Therapy (CBT) [CT-STEPS] will produce greater symptom relief of OCD than treatment with Luvox-CR alone; and, 2. subjects receiving 12 weeks of CT-STEPS added to Luvox-CR treatment after 12-weeks of Luvox-CR monotherapy will experience greater OCD symptom relief (from weeks 12-24) than those continuing Luvox-CR treatment and having access to CT-STEPS from week one. 3. subjects who begin CT-STEPS at week 12 will be more likely to complete it than those who begin CT-STEPS at baseline.

Detailed Description

Primary Endpoint(s): Change in Y-BOCS score from baseline to endpoint at weeks 12 and 24; and, number (and percent) "responders" at weeks 12 and 24, defined as subjects with a 35% decrease in Y-BOCS score at endpoint and a Clinical Global Impressions score of 1 or 2 (very much or much improved).

Secondary Endpoint(s):

1. change in scores on the Work and Social Adjustment Scale, a quality of life measure

2. change in scores on the Work Productivity and Activity Impairment

Questionnaire:

Specific Health Problem scale; in particular, we will analyze change in work hours/week lost because of OCD, and change in effect of OCD on work productivity (0-10 scale).

3. dollar cost per responder

4. dollar cost per total number of patients needed to produce one additional responder in the Luvox-CR plus web-based CBT group over the number produced by Luvox-CR alone, i.e., dollar cost per number needed to treat

5. dollar cost per 5% decrease in Y-BOCS score at weeks 12 and 24 in the two treatment groups.

Conditions

Obsessive Compulsive Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

A

Effectiveness of Luvox CR plus Web-based CBT for OCD

Group Type: OTHER

Luvox CR

Intervention Type: DRUG

In light of the Luvox-CR dosing procedure of Hollander et al (2003) (50 mg increments weekly) and the available dose capsules of Luvox-CR (100 mg and 150 mg), the Luvox-CR dose will be increased over the first 6 weeks of treatment as tolerated in 50 mg to 100-mg increments every week, as tolerated and clinically indicated, to a bedtime dose between 100 and 300 mg/day. The dose will then be held constant for the duration of the study

Behavioral Therapy

Intervention Type: BEHAVIORAL

The web-based CBT (CT STEPS) includes an introductory session explaining the treatment, with videotapes of OCD patients who used an earlier version, along with 9 subsequent treatment modules. The CBT will include weekly email feedback from a psychologist in response to questions asked about the CBT by the subjects assigned to this treatment arm.

Interventions

Luvox CR

In light of the Luvox-CR dosing procedure of Hollander et al (2003) (50 mg increments weekly) and the available dose capsules of Luvox-CR (100 mg and 150 mg), the Luvox-CR dose will be increased over the first 6 weeks of treatment as tolerated in 50 mg to 100-mg increments every week, as tolerated and clinically indicated, to a bedtime dose between 100 and 300 mg/day. The dose will then be held constant for the duration of the study

Intervention Type: DRUG

Behavioral Therapy

The web-based CBT (CT STEPS) includes an introductory session explaining the treatment, with videotapes of OCD patients who used an earlier version, along with 9 subsequent treatment modules. The CBT will include weekly email feedback from a psychologist in response to questions asked about the CBT by the subjects assigned to this treatment arm.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Men and women aged 18 years, with OCD of at least 1 year's duration, meeting DSM-IV diagnostic criteria, and having a baseline Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) score of 18.

Exclusion Criteria

• Pregnant or nursing women or women of childbearing age not using an effective contraceptive method
• Organic mental disorder
• Bipolar disorder
• Psychotic disorder
• History of substance abuse or dependence within 3 years of evaluation for study
• Major depression with suicidal risk
• Major depression dominating the clinical picture
• Panic disorder
• Personality disorder severe enough to interfere with cooperation with study procedures
• Need for antipsychotic medication
• Depot neuroleptic drug within 6 months
• Fluoxetine within 5 weeks
• An MAOI within 2 weeks, any nightly sedative, or taking a medication that may interact with fluvoxamine
• Serious or unstable medical condition (hematological, endocrine, cardiovascular, renal or gastrointestinal), a history of malignancy (other than excised basal cell carcinoma), history of brain disease, including more than one childhood febrile convulsion and all forms of epilepsy; or, are receiving behavior therapy for OCD.
• Subjects who qualify for the study while taking an SSRI must have been taking their current dose or a higher dose for at least 12 weeks prior to study baseline.
• Subjects who qualify for the study while taking fluvoxamine must be taking no more than 150 mg/day and never had a trial at a higher dose, must be believed by the investigator to be able to tolerate an increase to 250 mg/day starting at baseline, and must have been taking their pre-study dose or a higher dose (up to 150 mg/day) for at least 12 weeks prior to study baseline.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Rogers Center for Research & Training, Inc.

OTHER

Sponsor Role: lead

Responsible Party

Rogers Center for Research & Training, Inc.

Principal Investigators

John H Greist, MD

Role: PRINCIPAL_INVESTIGATOR

The Rogers Center for Research & Training, Inc.

Locations

The Rogers Center for Research & Training, Inc.

Milwaukee, Wisconsin, United States

Countries

United States

Central Contacts

Amy Perkins, BA

Role: CONTACT

Phone: 414-328-3702

Email: aperkins@rogershospital.org

Facility Contacts

Amy Perkins, BA

Role: primary

Alex Bruss, BS

Role: backup

Other Identifiers

JIIT-07-LCR001a

Identifier Type: -

Identifier Source: org_study_id