PRIME Program for Chronic Pain and Depression

(PRIME Trial)

Overseen By Janiece L Taylor, PhD, RN

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Hospitalized, Physical therapy, Terminal diagnosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

30 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Janiece L Taylor, PhD

Principal Investigator

Johns Hopkins School of Nursing

Elaine Wethington, PhD

Principal Investigator

Cornell Roybal Center (Weill Cornell Medicine)

Eligibility Criteria

The PRIME study is for women over 50 living in Maryland with disabilities, experiencing chronic pain that affects daily activities and have depression. They must be able to communicate in English and not be hospitalized frequently, undergoing physical therapy, or have a terminal illness or moderate intellectual impairment.

Inclusion Criteria

I have scored 5 or higher for depression twice in two weeks.

I am female.

Non-institutionalized and living in Maryland

Exclusion Criteria

Currently undergoing physical therapy

I have been hospitalized more than three times in the past year.

You have been diagnosed with a condition that is expected to be fatal within a year.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive the PRIME intervention, including four in-person visits by a nurse and eight virtual group sessions led by a clinical psychologist.

12 weeks

4 visits (in-person), 8 sessions (virtual)

Follow-up

Participants are monitored for changes in pain and depression using various assessment tools.

12 weeks

Wait List Control

Participants in the wait list control group receive the intervention after a 2-3 month period.

2-3 months

Treatment Details

Interventions

• PRIME Intervention

Trial Overview The PRIME intervention aims to help older women with disabilities manage chronic pain and depression. It includes home visits from a nurse for goal setting and virtual group sessions led by a psychologist using Acceptance Commitment Therapy.

Participant Groups

Group I: Wait List Control Group Experimental Treatment 1 Intervention

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.

Group II: Intervention Group Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Cornell University

Collaborator

Trials

179

Recruited

14,090,000+