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OpenTrials
Completed

NCT Number: NCT00895999

Psychosocial Treatment for Women With Depression and Pain

Patients with depression and pain have poorer outcomes in response to depression treatments than depressed patients without pain. While psychotherapy treatment studies have demonstrated improvement in pain and depression, no psychosocial interventions have been developed and tested prospectively specifically for patients with both conditions. Interpersonal psychotherapy (IPT), an effective treatment for depression, has been adapted successfully for physically ill patients and demonstrates good adherence, treatment satisfaction, and depression outcomes. The investigators propose to test a modified form of IPT-P for depressed patients with co-morbid pain.

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Key information

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • major depression
  • chronic pelvic pain

Exclusion criteria

  • current or past psychosis
  • moderate mental retardation or greater
  • active suicidal intent
  • active abuse of non-prescribed substances (< 3 months)
  • current individual psychotherapy
  • current pregnancy
  • terminal illness
  • inability to communicate in English
  • men

Treatment and study plan

Interpersonal Therapy for Pain (IPT-P)

Behavioral

IPT-P focuses on improving relationships as a way to improve depression and pain. The patient and therapist work together to improve communication and enhance relationships and social support. Patients choose a problem focus and goal related to both their pain and depression. Up to 8 IPT-P sessions are provided regardless of ability to pay.

Enhanced Support and Connection to Counseling

Behavioral

Research staff connect patients with the Strong Family Therapy Services, Women's Behavioral Health Service, or other appropriate mental health care and reduce potential barriers from making it to the initial appointment. This support includes navigating insurance issues, addressing issues of childcare and transportation, helping to schedule the initial appointment, reminder calls, and follow-up after the scheduled intake. Research staff will also check-in monthly to see if the patients require any additional support to remain in mental health treatment. Up to 8 therapy sessions are covered regardless of ability to pay.

Primary outcomes

  1. A self-report measure BDI and a clinician measure HRSD will evaluate depression severity. These measures are standards in primary care depression trials and in pain studies and have demonstrated sensitivity to detect changes in depress

    Time frame: 0, 12 wks, 24 wks, 36 wks

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Psychosocial Treatment for Gynecology Patients With Comorbid Depression and Pain

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
May 11, 2009
Registry last updated
Mar 14, 2014

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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