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Psychosocial Treatment for Women With Depression and Pain

Primary Purpose

Pelvic Pain, Depression

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Interpersonal Therapy for Pain (IPT-P)
Enhanced Support and Connection to Counseling
Sponsored by
University of Rochester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pelvic Pain

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • University of Rochester Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

1

2

Arm Description

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.

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).

Outcomes

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

Secondary Outcome Measures

Full Information

First Posted
May 8, 2009
Last Updated
March 12, 2014
Sponsor
University of Rochester
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00895999
Brief Title
Psychosocial Treatment for Women With Depression and Pain
Official Title
Psychosocial Treatment for Gynecology Patients With Comorbid Depression and Pain
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Pain, Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
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.
Arm Title
2
Arm Type
Other
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Interpersonal Therapy for Pain (IPT-P)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Enhanced Support and Connection to Counseling
Intervention Description
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 Outcome Measure Information:
Title
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ellen Poleshuck, PhD
Organizational Affiliation
University of Rochester
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25937505
Citation
Poleshuck E, Wittink M, Crean H, Gellasch T, Sandler M, Bell E, Juskiewicz I, Cerulli C. Using patient engagement in the design and rationale of a trial for women with depression in obstetrics and gynecology practices. Contemp Clin Trials. 2015 Jul;43:83-92. doi: 10.1016/j.cct.2015.04.010. Epub 2015 Apr 30.
Results Reference
derived
PubMed Identifier
25280823
Citation
Poleshuck EL, Gamble SA, Bellenger K, Lu N, Tu X, Sorensen S, Giles DE, Talbot NL. Randomized controlled trial of interpersonal psychotherapy versus enhanced treatment as usual for women with co-occurring depression and pelvic pain. J Psychosom Res. 2014 Oct;77(4):264-72. doi: 10.1016/j.jpsychores.2014.07.016. Epub 2014 Jul 26.
Results Reference
derived

Learn more about this trial

Psychosocial Treatment for Women With Depression and Pain

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