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Randomized Trial of Psychotherapy for Persistently Depressed Primary Care Patients

This study has been completed.
Memorial Hospital of Rhode Island
Information provided by:
Butler Hospital Identifier:
First received: October 8, 2007
Last updated: July 6, 2011
Last verified: July 2011
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.

Condition Intervention Phase
Major Depression
Behavioral: behavior therapy
Drug: Medication prescribed by PCP
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Trial of Psychotherapy for Persistently Depressed Primary Care Patients

Further study details as provided by Butler Hospital:

Primary Outcome Measures:
  • Depression symptoms [ Time Frame: 4 months ]

Secondary Outcome Measures:
  • Psychosocial functioning [ Time Frame: 4 months ]

Estimated Enrollment: 40
Study Start Date: April 2007
Study Completion Date: January 2010
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Medication prescribed by PCP
Drug: Medication prescribed by PCP
Can include any antidepressant medication
Experimental: 1
Medication prescribed by PCP + behavior therapy
Behavioral: behavior therapy
10 sessions over 4 months
Drug: Medication prescribed by PCP
Can include any antidepressant medication


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00541957

United States, Rhode Island
Memorial Hospital of RI
Pawtucket, Rhode Island, United States, 02860
Butler Hospital
Providence, Rhode Island, United States, 02906
Sponsors and Collaborators
Butler Hospital
Memorial Hospital of Rhode Island
Principal Investigator: Lisa Uebelacker, PhD Butler Hospital
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Lisa Uebelacker, Ph.D., PI, Butler Hospital Identifier: NCT00541957     History of Changes
Other Study ID Numbers: K23MH067779 ( US NIH Grant/Contract Award Number )
Study First Received: October 8, 2007
Last Updated: July 6, 2011

Keywords provided by Butler Hospital:
Major depression
Primary care

Additional relevant MeSH terms:
Depressive Disorder, Major
Behavioral Symptoms
Depressive Disorder
Mood Disorders
Mental Disorders processed this record on April 28, 2017