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

NCT00743834 | Unknown Phase 4

• 1 other identifier: JIIT-07-LCR001a
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Obsessive Compulsive Disorder

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (1)

A

OTHER

Effectiveness of Luvox CR plus Web-based CBT for OCD

Drug: Luvox CR; Behavioral: Behavioral Therapy

Interventions

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

A

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.

A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rogers Center for Research & Training, Inc.: lead

Study Sites (1)

The Rogers Center for Research & Training, Inc.

Milwaukee, Wisconsin, 53227-1133, United States

Location

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

Fluvoxamine; Behavior Therapy

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Oximes; Hydroxylamines; Amines; Organic Chemicals; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• John H Greist, MD

  The Rogers Center for Research & Training, Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amy Perkins, BA

CONTACT

414-328-3702; aperkins@rogershospital.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 28, 2008
• First Posted: August 29, 2008
• Study Start: September 1, 2008
• Primary Completion: August 1, 2009
• Study Completion: December 1, 2009
• Last Updated: September 4, 2008

Record last verified: 2008-09

Locations

US (1)