Psychosocial Treatment for Women With Depression and Pain

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Ellen Poleshuck, University of Rochester
ClinicalTrials.gov Identifier:
NCT00895999
First received: May 8, 2009
Last updated: March 12, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Pelvic Pain
Depression
Behavioral: Interpersonal Therapy for Pain (IPT-P)
Behavioral: Enhanced Support and Connection to Counseling

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Psychosocial Treatment for Gynecology Patients With Comorbid Depression and Pain

Resource links provided by NLM:


Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: March 2007
Study Completion Date: December 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Female patients (n=30) who meet criteria for major depression and chronic pelvic pain will be randomly assigned to 8 individual sessions of IPT adapted for depression and pain.
Behavioral: Interpersonal Therapy for Pain (IPT-P)
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.
2
Female patients (n=30) who meet criteria for major depression and chronic pelvic pain will be randomly assigned to Enhanced Support and Connection to Counseling (ESCC).
Behavioral: Enhanced Support and Connection to Counseling
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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00895999

Locations
United States, New York
University of Rochester Medical Center
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
Investigators
Principal Investigator: Ellen Poleshuck, PhD University of Rochester
  More Information

No publications provided

Responsible Party: Ellen Poleshuck, Assistant Professor, Department of Psychiatry, University of Rochester
ClinicalTrials.gov Identifier: NCT00895999     History of Changes
Other Study ID Numbers: Poleshuck K23, 5K23MH079347
Study First Received: May 8, 2009
Last Updated: March 12, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Depression
Depressive Disorder
Pelvic Pain
Behavioral Symptoms
Mood Disorders
Mental Disorders
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on July 29, 2014