Cost-Effectiveness of Adding Web-Based Cognitive-Behavioral Therapy (CBT) to Luvox CR for Obsessive Compulsive Disorder (OCD)

Obsessive Compulsive Disorder Clinical Trial

Official title:

Cost-Effectiveness of Adding Web-Based CBT to Luvox CR for OCD

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00743834
• Other study ID #: JIIT-07-LCR001a
• Status: Not yet recruiting
• Phase: Phase 4
• First received: August 28, 2008
• Last updated: September 3, 2008
• Start date: September 2008
• Est. completion date: December 2009

Study information

• Verified date: September 2008
• Source: Rogers Center for Research & Training, Inc.
• Contact: Amy Perkins, BA
• Phone: 414-328-3702
• Email: aperkins[@]rogershospital.org
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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):

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: December 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Compulsive Behavior
• Obsessive Compulsive Disorder
• Obsessive-Compulsive Disorder

Intervention

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.

Locations

Country	Name	City	State
United States	The Rogers Center for Research & Training, Inc.	Milwaukee	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Rogers Center for Research & Training, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No