Pain Reduction Through Empowered Recovery (PRIME) Study

Completed · Not applicable

Conditions studied: Pain, Chronic, Depressive Symptoms, Depression, Disability Physical

In brief

Chronic pain and depression or low mood are often experience by women who age with or into disabilities. Due to various factors women with disabilities often experience this cycle of pain and depression. Both of these conditions can be debilitating and lead to declines in health. Treating these conditions simultaneously, particularly , in older adults can be complicated due to side effects, risks of poor access to pain management and mental health care , and complications from other co occuring conditions. In order to address this cycle in older women with disabilities the investigators are testing the Women in Pain Reduction through Improved Mood and Empowerment (PRIME) study. The PRIME intervention includes four in person visits by a nurse to the women's homes where the participants set goals regarding pain and depression and the nurse helps the participants strategize ways to meet these goals. The second component of the study will be eight group sessions virtually with other participants in the study. The group sessions will be led by a clinical psychologist who will engage in Acceptance Commitment Therapy with the women.

Key facts

Study ID

NCT05619510

Run by

Johns Hopkins University

People needed

9

Starts

2023-03-31

Expected to finish

2026-06-01

Last updated by the study team

2026-06-05

Who can join

Age: 50 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• self-reported pain >4 out of a 0-10 scale that has lasted longer than 3 months and prohibits at least one valued or daily activity,
• physical disability based on the 2008 American Community Survey. The survey includes one question about disability in the following categories: sensory, physical, self-care, ability to go outside of the home, and independent living difficulty. Candidates who report having mobility disabilities will be considered for the study,
• non-institutionalized and living in Maryland, and
• score a 5 or higher on the PHQ9 (depression measure) at least two times during a two week period (screening call and then at first data collection visit via video)
• 50 years of age and older, 6) female

You may not qualify if…

• hospitalized > 3 times in the last year,
• participating in physical therapy,
• have a terminal diagnosis (<1 year expected survival),
• > moderate intellectual impairment (5-7 errors) based on the Short Portable Mental Status Questionnaire (SPMSQ), 81 and
• unable to understand or speak English. We will exclude anyone with more than three hospitalizations and/or have a terminal diagnosis because of the acuity of their conditions which may limit the effectiveness of the intervention. Physical therapy may impact the outcomes of the intervention and having impaired cognition may make it difficult for participants to engage in the nurse visits, set goals and participate in the ACT sessions.

Where it is running

• Johns Hopkins School of Nursing — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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