CClinicalTrials.gg
CompletedNCT00895999Updated Mar 14, 2014

Psychosocial Treatment for Women With Depression and Pain

An interventional study of Interpersonal Therapy for Pain (IPT-P) and Enhanced Support and Connection to Counseling in Pelvic Pain and Depression, sponsored by University of Rochester. Completed at 1 site in United States. Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-03-14.

Sponsored by University of Rochester · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
Female
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Study 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.

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Conditions studied

  • Pelvic Pain
  • Depression
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In context

Pelvic Pain

375 studies on the registry are indexed under Pelvic Pain; 83 are open to participants now.

This study's enrollment of 60 is above the median of 54 across 273 interventional studies indexed under Pelvic Pain.

Browse Pelvic Pain studies →

Lead sponsor

University of Rochester is the lead sponsor of 715 studies on the registry; 116 are open to participants now.

Of its 56 completed or terminated interventional studies of FDA-regulated products, 44 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • major depression
  • chronic pelvic pain

Exclusion criteria

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
60 participants (actual)

Study arms

  • 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)

  • 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

Interventions

  • BehavioralInterpersonal 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.

  • BehavioralEnhanced 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.

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What researchers measure

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

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Study locations

1 site
  • University of Rochester Medical Center
    Rochester, New York 14642, United States
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References and documents

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. PubMed 25937505 ↗
  • 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. PubMed 25280823 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 14, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00895999
Lead sponsor
University of Rochester
Collaborators
National Institute of Mental Health (NIMH)
Responsible party
Ellen Poleshuck (Assistant Professor, Department of Psychiatry, University of Rochester) — Principal investigator
First posted
May 11, 2009
Start date
Mar 2007
Primary completion
Sep 2011
Completion
Dec 2011
Last update
Mar 14, 2014

Study contacts

Ellen Poleshuck, PhD
principal investigator · University of Rochester

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2014. You cannot join it, but the record below documents what was studied.

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