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New program aims to break the Pain-Depression cycle in older women

NCT ID NCT05619510

Symptom relief Sponsor: Johns Hopkins University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 12, 2026 · Updated 3 times

Summary

This study tested a program called PRIME for older women with chronic pain and depression who also have physical disabilities. Nine women took part in nurse-led goal-setting visits and group therapy sessions focused on acceptance and commitment. The goal was to see if this combined approach could reduce pain and improve mood without medication.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
PRIME Intervention (behavioral: nurse goal-setting visits and Acceptance Commitment Therapy group sessions)
What this could lead to
If it works, this could offer a non-drug way to help older women with disabilities manage both chronic pain and depression together.
What could go wrong
This was a very small pilot study with only 9 participants, so results may not apply to everyone. The program is time-intensive and may not work for all.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

9 people

The number who actually took part.

Started

Mar 2023

Finished

Jun 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

50 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Chronic Pain chronic pain syndrome Depression depressive disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Depression Depressive symptoms Disability physical Pain, chronic

Contacts and locations

Locations

  • Johns Hopkins School of Nursing

    Baltimore, Maryland, 21213, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.