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Randomized Trial of Psychotherapy for Persistently Depressed Primary Care Patients

Randomized Trial of Psychotherapy for Persistently Depressed Primary Care Patients

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00541957
Enrollment
40
Registered
2007-10-10
Start date
2007-04-30
Completion date
2010-01-31
Last updated
2011-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Depression

Keywords

Major depression, Primary care

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.

Interventions

BEHAVIORALbehavior therapy

10 sessions over 4 months

DRUGMedication prescribed by PCP

Can include any antidepressant medication

Sponsors

Memorial Hospital of Rhode Island
CollaboratorOTHER
Butler Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Depression symptoms4 months

Secondary

MeasureTime frame
Psychosocial functioning4 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 30, 2026