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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
50
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
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 Rogers Center for Research & Training, Inc.
Milwaukee, Wisconsin, United States
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.
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