Pain Reduction Through Empowered Recovery (PRIME) Study

Phase

N/A

Condition

Chronic Pain

Depression

Pain

Treatment

PRIME Intervention

Clinical Study ID

NCT05619510

IRB00341962

P30AG022845

Ages > 50
Female

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

self-reported pain >4 out of a 0-10 scale that has lasted longer than 3 months andprohibits at least one valued or daily activity,
physical disability based on the 2008 American Community Survey. The survey includesone 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 twoweek period (screening call and then at first data collection visit via video)
50 years of age and older, 6) female

Exclusion

Exclusion Criteria:

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 MentalStatus Questionnaire (SPMSQ), 81 and
unable to understand or speak English. We will exclude anyone with more than threehospitalizations and/or have a terminal diagnosis because of the acuity of theirconditions which may limit the effectiveness of the intervention. Physical therapymay impact the outcomes of the intervention and having impaired cognition may makeit difficult for participants to engage in the nurse visits, set goals andparticipate in the ACT sessions.

Study Design

PRIME Intervention

March 31, 2023

March 30, 2025

Study Description

Chronic pain and depression frequently co-occur among older women with disabilities, and each can exacerbate the other in a worsening cycle. This co-occurrence may be due, in part, to pain and depression sharing biologic etiologies such as inflammation. Beyond each individual category of risk, the intersection of age, sex, and disability place older women with disabilities at even higher risk of having co-occurring pain and depression.There are several effective multi-component behavioral interventions for either pain or depression, but not both outcomes in combination, and none were designed to integrate social determinants of health to address the inequities inherent in being an older woman with disabilities. Addressing these two conditions in this population warrants multicomponent interventions that are appropriate for and inclusive of all older women with disabilities. The proposed study is to apply self-regulation theory to refine and further test the feasibility of a tailored behavioral activation intervention, older women with disabilities in Pain Reduction through Improved Mood and Empowerment (PRIME) Study Aim 1: Leveraging the investigators previous research, the investigators will enroll 15-30 community dwelling women , ages 50 and over, with physical disabilities , living in Maryland who have pain and depression in the Women in PRIME clinical trial.

Aim 2: The investigators will determine a) feasibility and acceptability of the intervention and b) if strategies and evaluation techniques are appropriate.

Connect with a study center

Johns Hopkins School of Nursing
Baltimore, Maryland 21213
United States
Site Not Available

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