Back to resultsRandomized Trial of Psychotherapy for Persistently Depressed Primary Care Patients
Primary Purpose
Major Depression
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
behavior therapy
Medication prescribed by PCP
Sponsored by
About this trial
This is an interventional treatment trial for Major Depression focused on measuring Major depression, Primary care
Eligibility 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.
Sites / Locations
- Memorial Hospital of RI
- Butler Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
2
1
Arm Description
Medication prescribed by PCP
Medication prescribed by PCP + behavior therapy
Outcomes
Primary Outcome Measures
Depression symptoms
Secondary Outcome Measures
Psychosocial functioning
Full Information
NCT ID
NCT00541957
First Posted
October 8, 2007
Last Updated
July 6, 2011
Sponsor
Butler Hospital
Collaborators
Memorial Hospital of Rhode Island
1. Study Identification
Unique Protocol Identification Number
NCT00541957
Brief Title
Randomized Trial of Psychotherapy for Persistently Depressed Primary Care Patients
Official Title
Randomized Trial of Psychotherapy for Persistently Depressed Primary Care Patients
Study Type
Interventional
2. Study Status
Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
January 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Butler Hospital
Collaborators
Memorial Hospital of Rhode Island
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depression
Keywords
Major depression, Primary care
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
2
Arm Type
Other
Arm Description
Medication prescribed by PCP
Arm Title
1
Arm Type
Experimental
Arm Description
Medication prescribed by PCP + behavior therapy
Intervention Type
Behavioral
Intervention Name(s)
behavior therapy
Intervention Description
10 sessions over 4 months
Intervention Type
Drug
Intervention Name(s)
Medication prescribed by PCP
Intervention Description
Can include any antidepressant medication
Primary Outcome Measure Information:
Title
Depression symptoms
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Psychosocial functioning
Time Frame
4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa Uebelacker, PhD
Organizational Affiliation
Butler Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Hospital of RI
City
Pawtucket
State/Province
Rhode Island
ZIP/Postal Code
02860
Country
United States
Facility Name
Butler Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
21731830
Citation
Uebelacker LA, German NM, Gaudiano BA, Miller IW. Patient health questionnaire depression scale as a suicide screening instrument in depressed primary care patients: a cross-sectional study. Prim Care Companion CNS Disord. 2011;13(1):PCC.10m01027. doi: 10.4088/PCC.10m01027.
Results Reference
derived
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Randomized Trial of Psychotherapy for Persistently Depressed Primary Care Patients
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