Randomized Trial of Psychotherapy for Persistently Depressed Primary Care Patients

This study has been completed.
Sponsor:
Collaborator:
Memorial Hospital of Rhode Island
Information provided by:
Butler Hospital
ClinicalTrials.gov Identifier:
NCT00541957
First received: October 8, 2007
Last updated: July 6, 2011
Last verified: July 2011
  Purpose

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
Endpoint Classification: Efficacy Study
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Psychosocial functioning [ Time Frame: 4 months ] [ Designated as safety issue: No ]

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
2
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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00541957

Locations
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
Investigators
Principal Investigator: Lisa Uebelacker, PhD Butler Hospital
  More Information

No publications provided

Responsible Party: Lisa Uebelacker, Ph.D., PI, Butler Hospital
ClinicalTrials.gov Identifier: NCT00541957     History of Changes
Other Study ID Numbers: k23MH067779
Study First Received: October 8, 2007
Last Updated: July 6, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Butler Hospital:
Major depression
Primary care

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mental Disorders
Mood Disorders

ClinicalTrials.gov processed this record on October 21, 2014