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

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.

Study Overview

• Status: Unknown
• Conditions: Obsessive Compulsive Disorder
• Intervention / Treatment: Drug: Luvox CR; Behavioral: Behavioral Therapy

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):

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
• Enrollment (Anticipated): 50
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Amy Perkins, BA; Phone Number: 414-328-3702; Email: aperkins@rogershospital.org

Study Locations

• United States
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53227-1133
      • The Rogers Center for Research & Training, Inc.
      • Contact: Amy Perkins, BA; Phone Number: 414-328-3702; Email: aperkins@rogershospital.org
      • Contact: Alex Bruss, BS; Phone Number: 414-328-3710; Email: abruss@rogershospital.org
      • Principal Investigator: John H Greist, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Collaborators and Investigators

• Sponsor: Rogers Center for Research & Training, Inc.
• Investigators: Principal Investigator: John H Greist, MD, The Rogers Center for Research & Training, Inc.

Study record dates

Study Major Dates

• Study Start: September 1, 2008
• Primary Completion (Anticipated): August 1, 2009
• Study Completion (Anticipated): December 1, 2009

Study Registration Dates

• First Submitted: August 28, 2008
• First Submitted That Met QC Criteria: August 28, 2008
• First Posted (Estimate): August 29, 2008

Study Record Updates

• Last Update Posted (Estimate): September 4, 2008
• Last Update Submitted That Met QC Criteria: September 3, 2008
• Last Verified: September 1, 2008

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Personality Disorders; Anxiety Disorders; Compulsive Personality Disorder; Obsessive-Compulsive Disorder; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Enzyme Inhibitors; Tranquilizing Agents; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Anti-Anxiety Agents; Cytochrome P-450 Enzyme Inhibitors; Antidepressive Agents, Second-Generation; Cytochrome P-450 CYP1A2 Inhibitors; Cytochrome P-450 CYP2C19 Inhibitors; Fluvoxamine
• Other Study ID Numbers: JIIT-07-LCR001a