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Completed

NCT Number: NCT00541957

Randomized Trial of Psychotherapy for Persistently Depressed Primary Care Patients

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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Key information

Conditions

Major Depression Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Memorial Hospital of RI, Pawtucket, Rhode Island, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Behavior Therapy

Behavioral

10 sessions over 4 months

Medication prescribed by PCP

Drug

Can include any antidepressant medication

Primary outcomes

  1. Depression symptoms

    Time frame: 4 months

Secondary outcomes

  1. Psychosocial functioning

    Time frame: 4 months

Sponsors and collaborators

Lead sponsor

Butler Hospital

Other

Collaborators

  • Memorial Hospital of Rhode Island

Registry information

Important dates

Study start
2007
Primary completion
2009
Study completion
2010
First posted
Oct 10, 2007
Registry last updated
Jul 8, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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