Randomized Trial of Psychotherapy for Persistently Depressed Primary Care Patients
1 other identifier
interventional
40
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Apr 2007
Typical duration for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2007
CompletedFirst Submitted
Initial submission to the registry
October 8, 2007
CompletedFirst Posted
Study publicly available on registry
October 10, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2010
CompletedJuly 8, 2011
July 1, 2011
2.4 years
October 8, 2007
July 6, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Depression symptoms
4 months
Secondary Outcomes (1)
Psychosocial functioning
4 months
Study Arms (2)
2
OTHERMedication prescribed by PCP
1
EXPERIMENTALMedication prescribed by PCP + behavior therapy
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Butler Hospitallead
- Memorial Hospital of Rhode Islandcollaborator
Study Sites (2)
Memorial Hospital of RI
Pawtucket, Rhode Island, 02860, United States
Butler Hospital
Providence, Rhode Island, 02906, United States
Related Publications (1)
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.
PMID: 21731830DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lisa Uebelacker, PhD
Butler Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
October 8, 2007
First Posted
October 10, 2007
Study Start
April 1, 2007
Primary Completion
September 1, 2009
Study Completion
January 1, 2010
Last Updated
July 8, 2011
Record last verified: 2011-07