Pain, ChronicPRIMENCT05619510
Pain Reduction Through Empowered Recovery (PRIME) Study
A study testing PRIME Intervention in people with Pain, Chronic and Depressive Symptoms, run by Johns Hopkins University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older, women only
- Conditions the study is for
- Pain, Chronic, Depressive Symptoms, Depression
- What is being tested?
- PRIME Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Mar 2023to 1 Jun 2026
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins School of Nursing
Baltimore, Maryland, 21213
About this study
Official title: Testing an Intervention to Reduce Pain and Depression Among Older Women With Physical Disabilities
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.
Read the detailed description
Chronic pain and depression frequently co-occur among older women with disabilities, and each can exacerbate the other in a worsening cycle. This co-occurrence may be due, in part, to pain and depression sharing biologic etiologies such as inflammation. Beyond each individual category of risk, the intersection of age, sex, and disability place older women with disabilities at even higher risk of having co-occurring pain and depression.There are several effective multi-component behavioral interventions for either pain or depression, but not both outcomes in combination, and none were designed to integrate social determinants of health to address the inequities inherent in being an older woman with disabilities. Addressing these two conditions in this population warrants multicomponent interventions that are appropriate for and inclusive of all older women with disabilities. The proposed study is to apply self-regulation theory to refine and further test the feasibility of a tailored behavioral activation intervention, older women with disabilities in Pain Reduction through Improved Mood and Empowerment (PRIME) Study Aim 1: Leveraging the investigators previous research, the investigators will enroll 15-30 community dwelling women , ages 50 and over, with physical disabilities , living in Maryland who have pain and depression in the Women in PRIME clinical trial.
Aim 2: The investigators will determine a) feasibility and acceptability of the intervention and b) if strategies and evaluation techniques are appropriate.
- Conditions
- Pain, Chronic, Depressive Symptoms, Depression, Disability Physical
- Being tested
- PRIME Intervention
- Medical subject headings
- Chronic Pain, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRIME InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: PRIME Intervention |
| Intervention Group | Experimental | Individuals randomized to this group will start the intervention immediately and have outcomes measured at three time points. Receives: Behavioral: PRIME Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity as Assessed by the Patient-Reported Outcomes Measurement Information System Pain Intensity Measure
Pain Intensity was measured by the Patient-Reported Outcomes Measurement Information System . Pain intensity measure. Patient-Reported Outcomes Measurement Information System . Survey uses a standardized T-score metric based on a mean of 50 and a standard deviation of 10. Higher score worse pain.
Measured: Baseline and 12 weeks
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 0-100 with a higher score indicating increased pain interference.
Measured: Baseline and 12 weeks.
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
Measured: Baseline and 12 weeks.
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.
Measured: Baseline and 12 weeks.
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, which is a worse outcome.
Measured: Baseline and 12 weeks
Secondary outcomes (5)
Psychological Flexibility as Assessed by the Psychological Flexibility in Pain Instrument
The Psychological Flexibility in Pain Instrument will be used. The ability to act in alignment of goals, values and in acceptance while living with pain and distress.The Psychological Inflexibility in Pain Scale (PIPS) is a 12-item scale measuring avoidance of pain, and fusion with pain thoughts. Scores range from 7-84 with a higher score indicating increased psychological inflexibility in pain.
Measured: Baseline and 12 weeks. Baseline are pre intervention scores and 12 weeks are post intervention scores.
Percentage of Goals Attained as Assessed by Self Report
Self-report if goals were achieved fully, partially or not at all. 23 goals were set.
Measured: 12 weeks
Comorbidities as Assessed by the Charlson Comorbidity Index (CCI)
The Charlson Comorbidity Index will be used to obtain a score for number of chronic conditions from 19 categories.The CCI consists of 19 selected conditions that are weighted and summed to an index on a 0-33 scale. Higher scores indicate more comorbidities.
Measured: Baseline
Change in Sleep Disturbance as Assessed by the 4 Item PROMIS Sleep Disturbance Measure
Sleep disturbance will be measured using the 4 item PROMIS sleep disturbance measure. This six item scale is used to measure sleep disturbances in the past 7 days and the range is 6 -30 with higher scores indicating more sleep disturbances.
Measured: Baseline and 12 weeks
Communication With Health Care Providers- Patient Reaction Assessment
The Patients' Reaction Assessment has a 5-item subscale used to measure perceived ability to communicate with providers. The sub scale on perceived ability to communicate with providers can have scores ranging from 0-35 with higher scores indicating higher perceived ability to communicate.
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2022
- Study start31 Mar 2023
- Primary completion16 Mar 2025
- Study completion1 Jun 2026
Why it stopped: Recruitment halted prematurely due to recruitment timing and resources for the study not aligning.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pain, ChronicStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA), Cornell University
- Responsible party
- Sponsor
- Investigators
- Janiece L Taylor, PhD, Principal investigator, Johns Hopkins School of NursingElaine Wethington, PhD, Study chair, Cornell Roybal Center (Weill Cornell Medicine)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05619510
- Sponsor's protocol ID
- IRB00341962
- Other IDs
- P30AG022845
- Acronym
- PRIME
- Status last verified
- Aug 2026
- First submitted
- 9 Nov 2022
- Last updated
- 11 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 32475259Drazich 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.
PubMed 35295801Taylor 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.
PubMed 39884648
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing an Intervention to Reduce Pain and Depression Among Older Women With Physical Disabilities
- ClinicalTrials.gov ID
- NCT05619510
- Acronym / sponsor ID
- PRIME / IRB00341962
- Conditions
- Pain, Chronic, Depressive Symptoms, Depression, Disability Physical
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment halted prematurely due to recruitment timing and resources for the study not aligning.
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA), Cornell University
- Study start
- 31 Mar 2023 (actual)
- Primary completion
- 16 Mar 2025 (actual)
- Study completion
- 1 Jun 2026 (actual)
- First posted
- 17 Nov 2022 (actual)
- Results
- Posted 10 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Chronic pain and depression frequently co-occur among older women with disabilities, and each can exacerbate the other in a worsening cycle. This co-occurrence may be due, in part, to pain and depression sharing biologic etiologies such as inflammation. Beyond each individual category of risk, the intersection of age, sex, and disability place older women with disabilities at even higher risk of having co-occurring pain and depression.There are several effective multi-component behavioral interventions for either pain or depression, but not both outcomes in combination, and none were designed to integrate social determinants of health to address the inequities inherent in being an older woman with disabilities. Addressing these two conditions in this population warrants multicomponent interventions that are appropriate for and inclusive of all older women with disabilities. The proposed study is to apply self-regulation theory to refine and further test the feasibility of a tailored behavioral activation intervention, older women with disabilities in Pain Reduction through Improved Mood and Empowerment (PRIME) Study Aim 1: Leveraging the investigators previous research, the investigators will enroll 15-30 community dwelling women , ages 50 and over, with physical disabilities , living in Maryland who have pain and depression in the Women in PRIME clinical trial.
Aim 2: The investigators will determine a) feasibility and acceptability of the intervention and b) if strategies and evaluation techniques are appropriate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Wait List Control Group | Other | Behavioral: PRIME InterventionThis 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. |
| Intervention Group | Experimental | Behavioral: PRIME InterventionIndividuals randomized to this group will start the intervention immediately and have outcomes measured at three time points. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRIME InterventionParticipants 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. | Behavioural | Intervention Group, Wait List Control Group |
Primary outcome
Pain Intensity as Assessed by the Patient-Reported Outcomes Measurement Information System Pain Intensity Measure
Time frame: Baseline and 12 weeks
Pain Intensity was measured by the Patient-Reported Outcomes Measurement Information System . Pain intensity measure. Patient-Reported Outcomes Measurement Information System . Survey uses a standardized T-score metric based on a mean of 50 and a standard deviation of 10. Higher score worse pain.
Pain Interference as Assessed by Patient-Reported Outcomes Measurement Information System (PROMIS)
Time frame: Baseline and 12 weeks.
Patient-Reported Outcomes Measurement Information System (PROMIS) pain interference is a 6 question measure with a range of 0-100 with a higher score indicating increased pain interference.
Pain Behavior as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS)Pain Behavior Measure
Time frame: Baseline and 12 weeks.
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
Depression as Assessed by the Patient Health Questionnaire 9 (PHQ9)
Time frame: Baseline and 12 weeks.
The Patient Health Questionnaire 9 (PHQ9) measures depressive symptoms. The score range is 0-27 with a higher score indicating more severe depression.
Depression as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) 57
Time frame: Baseline and 12 weeks
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, which is a worse outcome.
5 secondary outcomes
Psychological Flexibility as Assessed by the Psychological Flexibility in Pain Instrument
Time frame: Baseline and 12 weeks. Baseline are pre intervention scores and 12 weeks are post intervention scores.
Percentage of Goals Attained as Assessed by Self Report
Time frame: 12 weeks
Comorbidities as Assessed by the Charlson Comorbidity Index (CCI)
Time frame: Baseline
Change in Sleep Disturbance as Assessed by the 4 Item PROMIS Sleep Disturbance Measure
Time frame: Baseline and 12 weeks
Communication With Health Care Providers- Patient Reaction Assessment
Time frame: Baseline and 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 32475259Taylor 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.
- Results publication: PubMed 35295801Drazich 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.
- Derived from this study: PubMed 39884648Taylor 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janiece L Taylor, PhD principal investigator
Johns Hopkins School of Nursing
Elaine Wethington, PhD study chair
Cornell Roybal Center (Weill Cornell Medicine)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PRIME Intervention in people with Pain, Chronic and Depressive Symptoms, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity as Assessed by the Patient-Reported Outcomes Measurement Information System Pain Intensity Measure (time frame: Baseline and 12 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05619510, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.