Randomized Trial of Psychotherapy for Persistently Depressed Primary Care Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2010-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Major Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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2

Medication prescribed by PCP

Group Type OTHER

Medication prescribed by PCP

Intervention Type DRUG

Can include any antidepressant medication

1

Medication prescribed by PCP + behavior therapy

Group Type EXPERIMENTAL

behavior therapy

Intervention Type BEHAVIORAL

10 sessions over 4 months

Medication prescribed by PCP

Intervention Type DRUG

Can include any antidepressant medication

Interventions

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behavior therapy

10 sessions over 4 months

Intervention Type BEHAVIORAL

Medication prescribed by PCP

Can include any antidepressant medication

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No