Randomized Trial of Psychotherapy for Persistently Depressed Primary Care Patients

Phase 1

Completed

• Conditions: Major Depression
• Interventions: Drug: Medication prescribed by PCP; Behavioral: behavior therapy

• Registration Number: NCT00541957
• Lead Sponsor: Butler Hospital

Brief Summary

This is a pilot study. The purpose of this study is to determine whether adding 4 months of behavioral therapy to primary care physician medication treatment(relative to medication treatment alone) improves outcomes for persistently depressed primary care patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-04
• Study First Submitted: 2007-10-08
• Study First Submitted QC: 2007-10-08
• Study First Posted: 2007-10-10
• Primary Completion: 2009-09
• Study Completion: 2010-01
• Status Verified: 2011-07
• Last Update Submitted: 2011-07-06
• Last Update Posted: 2011-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Current MDD or MDD within the past year or current dysthymia
• PHQ-9 > 10
• have been prescribed an antidepressant medication (by their PCP) at least 8 weeks before pre-treatment timepoint
• are able to speak, read, and understand English sufficiently well to complete study procedures
• are between the ages of 18 and 70

Exclusion Criteria

• presence of significant suicidal ideation or risk
• history of bipolar disorder, schizophrenia, psychotic symptoms, or severe alcohol or drug problems within the past year;
• history of antisocial personality disorder or borderline personality disorder;
• currently in psychotherapy or have received counseling more frequently than once per month in the past year.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Medication prescribed by PCP	Medication prescribed by PCP
1	behavior therapy	Medication prescribed by PCP + behavior therapy
1	Medication prescribed by PCP	Medication prescribed by PCP + behavior therapy

Primary Outcome Measures

Name	Time	Method
Depression symptoms	4 months

Secondary Outcome Measures

Name	Time	Method
Psychosocial functioning	4 months

Trial Locations

Locations (2)

Memorial Hospital of RI; 🇺🇸 Pawtucket, Rhode Island, United States

Butler Hospital; 🇺🇸 Providence, Rhode Island, United States