Cost-Effectiveness of Adding Web-Based Cognitive-Behavioral Therapy (CBT) to Luvox CR for Obsessive Compulsive Disorder (OCD)
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
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):
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change in scores on the Work and Social Adjustment Scale, a quality of life measure
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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).
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dollar cost per responder
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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
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dollar cost per 5% decrease in Y-BOCS score at weeks 12 and 24 in the two treatment groups.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: A 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.
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Outcome Measures
Primary Outcome Measures
- 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.]
Eligibility Criteria
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:
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Pregnant or nursing women or women of childbearing age not using an effective contraceptive method
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Organic mental disorder
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Bipolar disorder
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Psychotic disorder
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History of substance abuse or dependence within 3 years of evaluation for study
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Major depression with suicidal risk
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Major depression dominating the clinical picture
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Panic disorder
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Personality disorder severe enough to interfere with cooperation with study procedures
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Need for antipsychotic medication
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Depot neuroleptic drug within 6 months
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Fluoxetine within 5 weeks
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An MAOI within 2 weeks, any nightly sedative, or taking a medication that may interact with fluvoxamine
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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.
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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.
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The Rogers Center for Research & Training, Inc. | Milwaukee | Wisconsin | United States | 53227-1133 |
Sponsors and Collaborators
- Rogers Center for Research & Training, Inc.
Investigators
- Principal Investigator: John H Greist, MD, The Rogers Center for Research & Training, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- JIIT-07-LCR001a