Treatment for Depression in the Primary Care Setting
Primary Purpose
Depression
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Problem-Solving Treatment for Primary Care
Sponsored by
About this trial
This is an interventional treatment trial for Depression
Eligibility Criteria
Inclusion Criteria: Primary care patient at Dartmouth-Hitchcock Medical Center (DHMC) Hamilton Depression Score >= 10 and minor depression at time of entry and after 4 weeks of observation Exclusion Criteria: Psychosis, Obsessive Compulsive Disorder (OCD), or Post Traumatic Stress Disorder (PTSD) Active substance abuse Receiving treatment for depression
Sites / Locations
- Dartmouth-Hitchcock Medical Center
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00055328
First Posted
February 25, 2003
Last Updated
September 6, 2013
Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT00055328
Brief Title
Treatment for Depression in the Primary Care Setting
Official Title
Problem-Solving Treatment for Primary Care Depression
Study Type
Interventional
2. Study Status
Record Verification Date
August 2008
Overall Recruitment Status
Completed
Study Start Date
December 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
5. Study Description
Brief Summary
This study will compare a brief form of counseling to usual care for the treatment of minor depression in the primary care setting.
Detailed Description
Minor depression is one of the most common types of depressive disorders seen in primary care. The effectiveness and tolerability of antidepressants in patients with minor depression is unclear, and the development of alternative treatments is necessary.
In the first phase of this study, participants are observed for 4 weeks to identify those most in need of depression-specific treatment. Participants are then exposed to the Problem-Solving Treatment for Primary Care (PST-PC), a six-session behavioral treatment for depression. After 4 weeks, patients who do not respond adequately to the treatment are randomly assigned to either continued PST-PC or to usual care for 9 weeks. Participants are followed for 6 months after the study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (false)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Problem-Solving Treatment for Primary Care
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Primary care patient at Dartmouth-Hitchcock Medical Center (DHMC)
Hamilton Depression Score >= 10 and minor depression at time of entry and after 4 weeks of observation
Exclusion Criteria:
Psychosis, Obsessive Compulsive Disorder (OCD), or Post Traumatic Stress Disorder (PTSD)
Active substance abuse
Receiving treatment for depression
Facility Information:
Facility Name
Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
12. IPD Sharing Statement
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Treatment for Depression in the Primary Care Setting
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