Randomized Trial of Psychotherapy for Persistently Depressed Primary Care Patients

July 6, 2011 updated by: Butler Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Rhode Island
      • Pawtucket, Rhode Island, United States, 02860
        • Memorial Hospital of RI
      • Providence, Rhode Island, United States, 02906
        • Butler Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 2
Medication prescribed by PCP
Drug: Medication prescribed by PCP
Can include any antidepressant medication
Experimental: 1
Medication prescribed by PCP + behavior therapy
Drug: Medication prescribed by PCP
Can include any antidepressant medication
Behavioral: behavior therapy
10 sessions over 4 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Depression symptoms
Time Frame: 4 months
4 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Psychosocial functioning
Time Frame: 4 months
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Butler Hospital

Collaborators

Memorial Hospital of Rhode Island

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Primary Completion (Actual)

September 1, 2009

Study Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

October 8, 2007

First Submitted That Met QC Criteria

October 8, 2007

First Posted (Estimate)

October 10, 2007

Study Record Updates

Last Update Posted (Estimate)

July 8, 2011

Last Update Submitted That Met QC Criteria

July 6, 2011

Last Verified

July 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K23MH067779 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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