Cost-Effectiveness of Adding Web-Based Cognitive-Behavioral Therapy (CBT) to Luvox CR for Obsessive Compulsive Disorder (OCD)
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|ClinicalTrials.gov Identifier: NCT00743834|
Recruitment Status : Unknown
Verified September 2008 by Rogers Center for Research & Training, Inc..
Recruitment status was: Not yet recruiting
First Posted : August 29, 2008
Last Update Posted : September 4, 2008
|Condition or disease||Intervention/treatment||Phase|
|Obsessive Compulsive Disorder||Drug: Luvox CR Behavioral: Behavioral Therapy||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Factorial Assignment|
|Official Title:||Cost-Effectiveness of Adding Web-Based CBT to Luvox CR for OCD|
|Study Start Date :||September 2008|
|Estimated Primary Completion Date :||August 2009|
|Estimated Study Completion Date :||December 2009|
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 study
Behavioral: 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.
- 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. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00743834
|Contact: Amy Perkins, BAfirstname.lastname@example.org|
|United States, Wisconsin|
|The Rogers Center for Research & Training, Inc.|
|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.|