Cost-Effectiveness of Adding Web-Based Cognitive-Behavioral Therapy (CBT) to Luvox CR for Obsessive Compulsive Disorder (OCD)
| Status: | Completed |
|---|---|
| Conditions: | Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/2/2016 |
| Start Date: | September 2008 |
| End Date: | December 2009 |
| Contact: | Amy Perkins, BA |
| Email: | aperkins@rogershospital.org |
| Phone: | 414-328-3702 |
Cost-Effectiveness of Adding Web-Based CBT to Luvox CR for OCD
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.
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.
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.
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:
- Pregnant or nursing women or women of childbearing age not using an effective
contraceptive method
- Organic mental disorder
- Bipolar disorder
- Psychotic disorder
- History of substance abuse or dependence within 3 years of evaluation for study
- Major depression with suicidal risk
- Major depression dominating the clinical picture
- Panic disorder
- Personality disorder severe enough to interfere with cooperation with study
procedures
- Need for antipsychotic medication
- Depot neuroleptic drug within 6 months
- Fluoxetine within 5 weeks
- An MAOI within 2 weeks, any nightly sedative, or taking a medication that may
interact with fluvoxamine
- 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.
- 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.
- 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.
We found this trial at
1
site
Click here to add this to my saved trials
