Randomized Trial of Psychotherapy for Persistently Depressed Primary Care Patients

Butler Hospital

Status and phase: Completed; Phase 1

Conditions: Major Depression

Treatments: Drug: Medication prescribed by PCP; Behavioral: behavior therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT00541957

K23MH067779

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

2

Other group

Description:

Medication prescribed by PCP

Treatment:

Drug: Medication prescribed by PCP

1

Experimental group

Description:

Medication prescribed by PCP + behavior therapy

Treatment:

Behavioral: behavior therapy

Drug: Medication prescribed by PCP