Clinical trial NCT05619510: Pain Reduction Through Empowered Recovery (PRIME) Study
Official title: Testing an Intervention to Reduce Pain and Depression Among Older Women With Physical Disabilities
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Pain, Chronic
Depressive Symptoms
Depression
Disability Physical
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
name: Cornell University
First posted: 2022-11-17
Enrollment: 30
Sex: FEMALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: A wait list control group will be used for this study. Participants will be randomized to either the intervention group or the wait list control group. Participants in the intervention group will start the intervention immediately. Participants in the wait list control will start after 2-3 months.
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* 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

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 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.

Primary outcomes:
measure: Change in Pain Intensity as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain intensity measure
timeFrame: Baseline, 12 weeks, 24 weeks
measure: Change in Pain Interference as assessed by Patient-Reported Outcomes Measurement Information System (PROMIS)
timeFrame: Baseline, 12 weeks, 24 weeks
measure: Change in Pain Behavior as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS)Pain behavior measure
timeFrame: Baseline, 12 weeks, 24 weeks
measure: Change in Depression as assessed by the Patient Health Questionnaire 9 (PHQ9)
timeFrame: Baseline, 12 weeks, 24 weeks
measure: Change in depression as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) 57
timeFrame: Baseline, 12 weeks, 24 weeks
Secondary outcomes:
measure: Change in Psychological Flexibility as assessed by the Psychological Flexibility in Pain Instrument
timeFrame: Baseline, 12 weeks, 24 weeks
measure: Change in Interleukin-6 (IL-6), Interleukin-8 (IL-8), and
timeFrame: Baseline and 12 weeks
measure: Change in Goal Attainment as assessed by self report
timeFrame: At baseline and at 12 weeks
measure: Change in Comorbidities as assessed by the Charlson Comorbidity Index (CCI)
timeFrame: Baseline and 12 weeks
measure: Change in Sleep Disturbance as assessed by the 4 item PROMIS sleep disturbance measure
timeFrame: Baseline and 12 weeks
measure: Communication with Health Care Providers- Patient Reaction Assessment
timeFrame: Baseline and 12 weeks
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins School of Nursing
state: Maryland
Study officials:
affiliation: Johns Hopkins School of Nursing
name: Janiece L Taylor, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cornell Roybal Center (Weill Cornell Medicine)
name: Elaine Wethington, PhD
role: STUDY_CHAIR
References:
citation: Taylor JL, Drazich BF, Roberts L, Okoye S, Rivers E, Wenzel J, Wright R, Beach MC, Szanton SL. Pain in low-income older women with disabilities: a qualitative descriptive study. J Women Aging. 2020 Jul-Aug;32(4):402-423. doi: 10.1080/08952841.2020.1763895. Epub 2020 May 31.
citation: Drazich BF, Jenkins E, Nkimbeng M, Abshire Saylor M, Szanton SL, Wright R, Beach MC, Taylor JL. Exploring the Experiences of Co-morbid Pain and Depression in Older African American Women and Their Preferred Management Strategies. Front Pain Res (Lausanne). 2022 Feb 28;3:845513. doi: 10.3389/fpain.2022.845513. eCollection 2022.