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Behavioral Intervention

PRIME Program for Chronic Pain and Depression (PRIME Trial)

N/A

Recruiting

Led By Janiece L Taylor, PhD

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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)

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 12 weeks, 24 weeks

Awards & highlights

PRIME Trial Summary

This trial aims to help older women with disabilities who experience chronic pain and depression. The intervention includes home visits and virtual group sessions to help participants reduce pain and improve mood.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Since the PRIME study involves non-pharmaceutical interventions like therapy sessions and goal-setting exercises, there are no direct medical side effects; however, discussing sensitive topics may cause emotional discomfort.

PRIME Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I have pain over 4/10 that stops me from doing daily tasks and it's been more than 3 months.

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I have a physical disability that affects my senses, mobility, self-care, or independence.

Select...

I am 50 years old or older.

PRIME Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 12 weeks, 24 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 12 weeks, 24 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 12 weeks, 24 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Mental Depression

Pain

+2 more

Secondary outcome measures

Comorbidity

Change in Goal Attainment as assessed by self report

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

+3 more

PRIME Trial Design

2Treatment groups

Experimental Treatment

Group I: Wait List Control GroupExperimental Treatment1 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 GroupExperimental Treatment1 Intervention

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

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor

2,266 Previous Clinical Trials

14,837,467 Total Patients Enrolled

57 Trials studying Depression

29,585 Patients Enrolled for Depression

National Institute on Aging (NIA)NIH

1,675 Previous Clinical Trials

28,020,855 Total Patients Enrolled

36 Trials studying Depression

28,323 Patients Enrolled for Depression

Cornell UniversityOTHER

166 Previous Clinical Trials

14,089,830 Total Patients Enrolled

4 Trials studying Depression

1,106 Patients Enrolled for Depression

Media Library

PRIME Intervention (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05619510 — N/A

Depression Research Study Groups: Wait List Control Group, Intervention Group

Depression Clinical Trial 2023: PRIME Intervention Highlights & Side Effects. Trial Name: NCT05619510 — N/A

PRIME Intervention (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05619510 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies remaining for this clinical experiment?

"According to clinicaltrials.gov, this research is no longer accepting participants as it was posted on March 31st 2023 and last edited April 5th of the same year. Nevertheless, there are 1,583 other medical trials actively seeking new candidates at present."

Answered by AI

What are the key goals of this medical experiment?

"This medical trial, evaluated across a Baseline, 12 week and 24 weeks duration, will focus on assessing Change in Pain Intensity as reported by PROMIS. Secondary outcomes include the observation of cytokine concentrations through sweat samples with measurements taken in picograms per millimeter (pg/ml), Goal Attainment assessed via self-report, and Psychological Flexibility as measured using the PIPS scale ranging from 7-84; higher scores indicating increased psychological inflexibility associated with pain."

Answered by AI