Cost-Effectiveness of Adding Web-Based Cognitive-Behavioral Therapy (CBT) to Luvox CR for Obsessive Compulsive Disorder (OCD)
Recruitment status was Not yet recruiting
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.
Obsessive Compulsive Disorder
Drug: Luvox CR
Behavioral: Behavioral Therapy
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
|Official Title:||Cost-Effectiveness of Adding Web-Based CBT to Luvox CR for OCD|
- The primary outcome measure (Y-BOCS score) will be obtained by clinician rating [ Time Frame: screening, baseline, and end of weeks 4, 8, 12, 16, 20 and 24. ] [ Designated as safety issue: No ]
|Study Start Date:||September 2008|
|Estimated Study Completion Date:||December 2009|
|Estimated Primary Completion Date:||August 2009 (Final data collection date for primary outcome measure)|
Effectiveness of Luvox CR plus Web-based CBT for OCD
Drug: 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 studyBehavioral: 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.
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).
- change in scores on the Work and Social Adjustment Scale, a quality of life measure
change in scores on the Work Productivity and Activity Impairment
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).
- dollar cost per responder
- 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
- dollar cost per 5% decrease in Y-BOCS score at weeks 12 and 24 in the two treatment groups.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00743834
|Contact: Amy Perkins, BAfirstname.lastname@example.org|
|United States, Wisconsin|
|The Rogers Center for Research & Training, Inc.||Not yet recruiting|
|Milwaukee, Wisconsin, United States, 53227-1133|
|Contact: Amy Perkins, BA 414-328-3702 email@example.com|
|Contact: Alex Bruss, BS 414-328-3710 firstname.lastname@example.org|
|Principal Investigator: John H Greist, MD|
|Principal Investigator:||John H Greist, MD||The Rogers Center for Research & Training, Inc.|