Psychosocial Treatment for Women With Depression and Pain

Psychosocial Treatment for Gynecology Patients With Comorbid 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.

Study Overview

• Status: Completed
• Conditions: Depression; Pelvic Pain
• Intervention / Treatment: Behavioral: Interpersonal Therapy for Pain (IPT-P); Behavioral: Enhanced Support and Connection to Counseling

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14642
      • University of Rochester Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.
OTHER: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	0, 12 wks, 24 wks, 36 wks

Collaborators and Investigators

• Sponsor: University of Rochester
• Collaborators: National Institute of Mental Health (NIMH)

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2007
• Primary Completion (ACTUAL): September 1, 2011
• Study Completion (ACTUAL): December 1, 2011

Study Registration Dates

• First Submitted: May 8, 2009
• First Submitted That Met QC Criteria: May 8, 2009
• First Posted (ESTIMATE): May 11, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): March 14, 2014
• Last Update Submitted That Met QC Criteria: March 12, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Pain; Neurologic Manifestations; Depression; Depressive Disorder; Pelvic Pain
• Other Study ID Numbers: Poleshuck K23; 5K23MH079347 (NIH)