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

Condition(s) targeted: Obsessive Compulsive Disorder

Intervention: Luvox CR (Drug); Behavioral Therapy (Behavioral)

Phase: Phase 4

Status: Not yet recruiting

Sponsored by: Rogers Center for Research & Training, Inc.

Official(s) and/or principal investigator(s):
John H Greist, MD, Principal Investigator, Affiliation: The Rogers Center for Research & Training, Inc.

Overall contact:
Amy Perkins, BA, Phone: 414-328-3702, Email: aperkins@rogershospital.org

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.

Official title: Cost-Effectiveness of Adding Web-Based CBT to Luvox CR for OCD

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Primary outcome: The primary outcome measure (Y-BOCS score) will be obtained by clinician rating

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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Amy Perkins, BA, Phone: 414-328-3702, Email: aperkins@rogershospital.org

The Rogers Center for Research & Training, Inc., Milwaukee, Wisconsin 53227-1133, United States; Not yet recruiting
Amy Perkins, BA, Phone: 414-328-3702, Email: aperkins@rogershospital.org
Alex Bruss, BS, Phone: 414-328-3710, Email: abruss@rogershospital.org
John H Greist, MD, Principal Investigator

Starting date: September 2008
Last updated: September 3, 2008