Pain Reduction Through Empowered Recovery (PRIME) Study

NCT05619510 | Active Not Recruiting DMC

• 2 other identifiers: IRB00341962P30AG022845
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Chronic; Depressive Symptoms; Depression; Disability Physical

Outcome Measures

Primary Outcomes (5)

• Change in Pain Intensity as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain intensity measure

  Pain Intensity will be measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain intensity measure. PROMIS Pain Intensity is a 3 question measure with a range of 3-15 with a higher score indicating increased pain intensity.

  Baseline, 12 weeks, 24 weeks

• Change in Pain Interference as assessed by Patient-Reported Outcomes Measurement Information System (PROMIS)

  Patient-Reported Outcomes Measurement Information System (PROMIS) pain interference is a 6 question measure with a range of 6-30 with a higher score indicating increased pain interference.

  Baseline, 12 weeks, 24 weeks

• Change in Pain Behavior as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS)Pain behavior measure

  Patient-Reported Outcomes Measurement Information System (PROMIS) pain interference is a 20 question measure with a range of 20-100 with a higher score indicating increased pain behaviors

  Baseline, 12 weeks, 24 weeks

• Change in Depression as assessed by the Patient Health Questionnaire 9 (PHQ9)

  The Patient Health Questionnaire 9 (PHQ9) measures depressive symptoms. The score range is 0-27 with a higher score indicating more severe depression.

  Baseline, 12 weeks, 24 weeks

• Change in depression as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) 57

  The Patient Reported Outcomes Measurement System (PROMIS)57 the Patient Reported Outcomes Measurement Information System (PROMIS) 57, which is includes an 8-item instrument that can be used to measure self-reported negative mood, view of self, and somatic symptoms. The score range for PROMIS 57 is 8-40. Higher scores indicate more depressive symptoms

  Baseline, 12 weeks, 24 weeks

Secondary Outcomes (6)

• Change in Psychological Flexibility as assessed by the Psychological Flexibility in Pain Instrument

  Baseline, 12 weeks, 24 weeks

• Change in Interleukin-6 (IL-6), Interleukin-8 (IL-8), and

  Baseline and 12 weeks

• Change in Goal Attainment as assessed by self report

  At baseline and at 12 weeks

• Change in Comorbidities as assessed by the Charlson Comorbidity Index (CCI)

  Baseline and 12 weeks

• Change in Sleep Disturbance as assessed by the 4 item PROMIS sleep disturbance measure

  Baseline and 12 weeks

Study Arms (2)

Wait List Control Group

OTHER

This group will be randomized to wait list control. They will serve as a control for the intervention at time points 1 and 2. However after a 2-3 month period they will receive the intervention.

Behavioral: PRIME Intervention

Intervention Group

EXPERIMENTAL

Individuals randomized to this group will start the intervention immediately and have outcomes measured at three time points.

Behavioral: PRIME Intervention

Interventions

PRIME Intervention BEHAVIORAL

Participants who are randomized to the intervention will participate in five virtual or in person visits with a nurse where the nurse uses self regulation theory as a guide to help them set their own goals surrounding pain and depression and use tailored strategies to address these goals. The second component will include six virtual Acceptance Commitment Therapy (ACT) sessions, led by a clinical psychologist. There will be 3-5 other research participants in the sessions.

Intervention Group; Wait List Control Group

Eligibility Criteria

• Age: 50 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)
• 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.

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute on Aging (NIA): collaborator
• Cornell University: collaborator

Study Sites (1)

Johns Hopkins School of Nursing

Baltimore, Maryland, 21213, United States

Location

Related Publications (3)

• 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.

  PMID: 32475259 RESULT

• 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.

  PMID: 35295801 RESULT

• Taylor JL, Clair CA, Atkins S, Wang C, Booth A, Reid MC, Wethington E, Regier NG. A protocol for a wait list control trial of an intervention to improve pain and depressive symptoms among middle-aged and older women living with disabilities. Contemp Clin Trials. 2025 Mar;150:107826. doi: 10.1016/j.cct.2025.107826. Epub 2025 Jan 28.

  PMID: 39884648 DERIVED

MeSH Terms

Conditions

Chronic Pain; Depression

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Study Officials

• Janiece L Taylor, PhD

  Johns Hopkins School of Nursing

  PRINCIPAL INVESTIGATOR

• Elaine Wethington, PhD

  Cornell Roybal Center (Weill Cornell Medicine)

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The data collectors, interventionists, and investigator will be masked to which group participants belong to.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 9, 2022
• First Posted: November 17, 2022
• Study Start: March 31, 2023
• Primary Completion: March 16, 2025
• Study Completion (Estimated): May 31, 2026
• Last Updated: May 18, 2025

Record last verified: 2025-05

Locations

US (1)