Randomized Trial of Psychotherapy for Persistently Depressed Primary Care Patients

Major Depression Clinical Trial

Official title:

Randomized Trial of Psychotherapy for Persistently Depressed Primary Care Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00541957
• Other study ID #: K23MH067779
• Status: Completed
• Phase: Phase 1
• First received: October 8, 2007
• Last updated: July 6, 2011
• Start date: April 2007
• Est. completion date: January 2010

Study information

• Verified date: July 2011
• Source: Butler Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 2010
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depressive Disorder, Major
• Major Depression

Intervention

Behavioral:
• behavior therapy
10 sessions over 4 months

Drug:
• Medication prescribed by PCP
Can include any antidepressant medication

Locations

Country	Name	City	State
United States	Memorial Hospital of RI	Pawtucket	Rhode Island
United States	Butler Hospital	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
Butler Hospital	Memorial Hospital of Rhode Island

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Depression symptoms		4 months	No
Secondary	Psychosocial functioning		4 months	No