Psychosocial Treatment for Women With Depression and Pain
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|ClinicalTrials.gov Identifier: NCT00895999|
Recruitment Status : Completed
First Posted : May 11, 2009
Last Update Posted : March 14, 2014
|Condition or disease||Intervention/treatment||Phase|
|Pelvic Pain Depression||Behavioral: Interpersonal Therapy for Pain (IPT-P) Behavioral: Enhanced Support and Connection to Counseling||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Psychosocial Treatment for Gynecology Patients With Comorbid Depression and Pain|
|Study Start Date :||March 2007|
|Actual Primary Completion Date :||September 2011|
|Actual Study Completion Date :||December 2011|
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.
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.
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00895999
|United States, New York|
|University of Rochester Medical Center|
|Rochester, New York, United States, 14642|
|Principal Investigator:||Ellen Poleshuck, PhD||University of Rochester|