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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):
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
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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Other | Effectiveness of Luvox CR plus Web-based CBT for OCD |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Luvox CR | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The primary outcome measure (Y-BOCS score) will be obtained by clinician rating | screening, baseline, and end of weeks 4, 8, 12, 16, 20 and 24. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amy Perkins, BA | Contact | 414-328-3702 | aperkins@rogershospital.org |
| Name | Affiliation | Role |
|---|---|---|
| John H Greist, MD | The Rogers Center for Research & Training, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Rogers Center for Research & Training, Inc. | Milwaukee | Wisconsin | 53227-1133 | United States |
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| Behavioral Therapy | 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. |
|
| ID | Term |
|---|---|
| D009771 | Obsessive-Compulsive Disorder |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D016666 | Fluvoxamine |
| D001521 | Behavior Therapy |
| ID | Term |
|---|---|
| D010091 | Oximes |
| D006898 | Hydroxylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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