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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assist women over 50 with disabilities who experience chronic pain and depression. The treatment, called the PRIME Intervention, involves setting personal goals with a nurse during home visits and participating in virtual group sessions focused on Acceptance Commitment Therapy. This approach aims to reduce pain and improve mood. Women with significant, long-lasting pain that affects daily activities and who struggle with depression may be well-suited for this study. Participants will either begin the treatment immediately or after a short wait period, allowing researchers to compare results. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance the quality of life for women facing similar challenges.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the PRIME intervention is safe for women with disabilities?

Research shows that the PRIME program is safe and effective for individuals with chronic pain and depression. Studies have found that similar programs, which use cognitive behavioral therapy and group learning, help reduce pain without causing serious side effects. Many patients in these programs have reported significant improvement.

For the PRIME program specifically, early findings suggest it is easy for participants to join without major problems. Although detailed safety data is not yet available, the absence of serious issues in similar programs is encouraging.

Overall, while no treatment is completely risk-free, research suggests that PRIME is both safe and effective. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the PRIME Intervention for chronic pain and depression because it offers a holistic approach that combines psychological and behavioral strategies, unlike standard medications that primarily focus on either pain relief or mood stabilization. Traditional treatments often involve medications like antidepressants or analgesics, which can come with side effects and variable effectiveness. The PRIME Intervention stands out as it emphasizes personalized strategies to manage both pain and depression simultaneously, aiming to improve overall quality of life. This approach could potentially reduce reliance on medications and provide long-lasting benefits by addressing the root causes of these conditions.

What evidence suggests that the PRIME intervention is effective for chronic pain and depression?

The PRIME program, which participants in this trial may receive, has shown promise in reducing long-term pain and depression. Research indicates that participants in the program experienced noticeable improvements in these areas. The treatment includes home visits by a nurse and group sessions with a psychologist, focusing on goal-setting and therapy. Early findings suggest this approach helps women manage their pain and mood more effectively. Additionally, similar programs have demonstrated positive results, supporting the potential effectiveness of PRIME. In this trial, some participants will start the intervention immediately, while others will join a waitlist control group before receiving the intervention. ^{2 5 6 7 8}

Who Is on the Research Team?

Janiece L Taylor, PhD

Principal Investigator

Johns Hopkins School of Nursing

Elaine Wethington, PhD

Principal Investigator

Cornell Roybal Center (Weill Cornell Medicine)

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5634707/

The Feasibility, Acceptability, and Outcomes of PRIME-D The purpose of this study was to evaluate the potential effectiveness of PRIME-D, a mobile app intervention that leverages EBT approaches, such as CBT and ...

2. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05619510/pain-reduction-through-empowered-recovery-prime-study

Pain Reduction Through Empowered Recovery (PRIME) ... 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.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714425000205

A protocol for a wait list control trial of an intervention to ... The aim of this study is to ascertain the acceptability and feasibility of the Women in Pain Reduction & Improved Mood through Empowerment (PRIME) intervention ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6101497/

Efficacy of PRIME, a Mobile App Intervention Designed to ... The primary outcomes for this trial were changes in components of motivated behavior from baseline to 12-weeks using a modified version of the ...

5. academic.oup.com academic.oup.com/fampra/article/41/3/234/7235626

Effectiveness of primary care interventions in conjointly ... Three studies showed significant improvements in both chronic pain and depression outcomes post-intervention,7,28,30 and only one study ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6130207/

Chronic pain and mental health: integrated solutions for global ... This trial examined delivery in low-income clinics and demonstrated benefits of both CBT and group education on pain outcomes. Moreover, the ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2884224/

Optimized Antidepressant Therapy and Pain Self ... Intervention patients were much more likely than those in usual care to report overall improvement in their pain at 6 months (61 [49.6%] vs. 19 [15.0%]; RR, 3.3 ...

8. researchgate.net researchgate.net/publication/316249057_The_feasibility_acceptability_and_outcomes_of_PRIME-D_A_novel_mobile_intervention_treatment_for_depression

The feasibility, acceptability, and outcomes of PRIME-D Conclusions: Results suggest that PRIME-D is a feasible, acceptable, and effective intervention for adults with depression and that a mobile service delivery ...