- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05619510
Pain Reduction Through Empowered Recovery (PRIME) Study (PRIME)
Testing an Intervention to Reduce Pain and Depression Among Older Women With Physical Disabilities
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Janiece L Taylor, PhD, RN
- Phone Number: 443-287-4581
- Email: jwalke90@jhu.edu
Study Contact Backup
- Name: Catherine Clair, MHS
- Email: cclair1@jhu.edu
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21213
- Recruiting
- Johns Hopkins School of Nursing
-
Contact:
- Janiece L Taylor, PhD, RN
- Phone Number: 443-287-4503
- Email: jwalke90@jhu.edu
-
Contact:
- Natalie Regier, PhD
- Email: nregier1@jhu.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Wait List Control Group
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.
|
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.
|
Experimental: Intervention Group
Individuals randomized to this group will start the intervention immediately and have outcomes measured at three time points.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Pain Intensity as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain intensity measure
Time Frame: Baseline, 12 weeks, 24 weeks
|
Pain Intensity will be measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain intensity measure.
PROMIS Pain Intensity is a 3 question measure with a range of 3-15 with a higher score indicating increased pain intensity.
|
Baseline, 12 weeks, 24 weeks
|
Change in Pain Interference as assessed by Patient-Reported Outcomes Measurement Information System (PROMIS)
Time Frame: Baseline, 12 weeks, 24 weeks
|
Patient-Reported Outcomes Measurement Information System (PROMIS) pain interference is a 6 question measure with a range of 6-30 with a higher score indicating increased pain interference.
|
Baseline, 12 weeks, 24 weeks
|
Change in Pain Behavior as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS)Pain behavior measure
Time Frame: Baseline, 12 weeks, 24 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
|
Baseline, 12 weeks, 24 weeks
|
Change in Depression as assessed by the Patient Health Questionnaire 9 (PHQ9)
Time Frame: Baseline, 12 weeks, 24 weeks
|
The Patient Health Questionnaire 9 (PHQ9) measures depressive symptoms.
The score range is 0-27 with a higher score indicating more severe depression.
|
Baseline, 12 weeks, 24 weeks
|
Change in depression as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) 57
Time Frame: Baseline, 12 weeks, 24 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
|
Baseline, 12 weeks, 24 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Psychological Flexibility as assessed by the Psychological Flexibility in Pain Instrument
Time Frame: Baseline, 12 weeks, 24 weeks
|
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.
|
Baseline, 12 weeks, 24 weeks
|
Change in Interleukin-6 (IL-6), Interleukin-8 (IL-8), and
Time Frame: Baseline and 12 weeks
|
All three IL-6, IL-8, TNF and will be on a cytokine panel that will be measured using sweat patches.
The unit of measurement used will be picograms per millimeter (pg/ml) .
|
Baseline and 12 weeks
|
Change in Goal Attainment as assessed by self report
Time Frame: At baseline and at 12 weeks
|
Self-report if goals were achieved fully, partially or not at all
|
At baseline and at 12 weeks
|
Change in Comorbidities as assessed by the Charlson Comorbidity Index
Time Frame: Baseline and 12 weeks
|
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.
|
Baseline and 12 weeks
|
Change in Sleep Disturbance as assessed by the 4 item PROMIS sleep disturbance measure
Time Frame: Baseline and 12 weeks
|
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.
|
Baseline and 12 weeks
|
Communication with Health Care Providers- Patient Reaction Assessment
Time Frame: Baseline and 12 weeks
|
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.
|
Baseline and 12 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Janiece L Taylor, PhD, Johns Hopkins School of Nursing
- Study Chair: Elaine Wethington, PhD, Cornell Roybal Center (Weill Cornell Medicine)
Publications and helpful links
General 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.
- Drazich 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00341962
- P30AG022845 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Depression
-
ProgenaBiomeRecruitingDepression | Depression, Postpartum | Depression, Anxiety | Depression Moderate | Depression Severe | Clinical Depression | Depression in Remission | Depression, Endogenous | Depression ChronicUnited States
-
Washington University School of MedicineCompletedTreatment Resistant Depression | Late Life Depression | Geriatric Depression | Refractory Depression | Therapy-Resistant DepressionUnited States, Canada
-
Kintsugi Mindful Wellness, Inc.Sonar Strategies; Vituity PsychiatryRecruitingDepression | Depression Moderate | Depression Severe | Depression MildUnited States
-
University of California, San FranciscoRecruitingDepression Moderate | Depression Mild | Depression, TeenUnited States
-
University GhentUniversiteit Antwerpen; Janssen-Cilag Ltd.RecruitingDepression Moderate | Depression Severe | Depression MildBelgium
-
Baylor College of MedicineUniversity of TexasRecruitingDepression | Depression Moderate | Depression Severe | Suicide and Self-harm | Depression in Adolescence | Depression MildUnited States
-
University of Cape TownNational Institute of Mental Health (NIMH)CompletedPostpartum Depression | Clinical Depression | Moderate DepressionSouth Africa
-
Northern Illinois UniversityUniversity Autonoma de Santo DomingoTerminatedDepression Moderate | Depression MildUnited States, Dominican Republic
-
Washington University School of MedicinePatient-Centered Outcomes Research Institute; National Institute of Mental...CompletedMajor Depressive Disorder | Treatment Resistant Depression | Treatment-Refractory Depression | Late Life Depression | Geriatric DepressionUnited States, Canada
-
Lawson Health Research InstituteTerminated
Clinical Trials on PRIME Intervention
-
Biotronik AGUnknownCoronary Artery DiseaseLatvia, Germany, Spain, Switzerland, Austria, France, Hungary, Netherlands
-
Yale-NUS CollegeCompleted
-
University of California, San FranciscoWithdrawnDepressionUnited States
-
University of UtahCompletedBasic Motor Learning ProblemUnited States
-
Ajou University School of MedicineCompletedIntravenous Drug UsageKorea, Republic of
-
University of MinnesotaUniversity of California, San FranciscoCompletedPsychotic Disorders | Schizophrenia | Schizoaffective Disorder | Cognitive Impairment | Psychosis | Treatment | Psychotic Depression | Psychotic Episode | Active Control | Psychotic Mood DisordersUnited States
-
University Hospital TuebingenRecruitingFunctional Magnetic Resonance Imaging | Eating Behavior | HabitsGermany
-
Maastricht University Medical CenterCompletedCigarette Smoking | Cigarette Smoking Toxicity | Smoking BehaviorNetherlands
-
Israel Institute for Biological Research (IIBR)Completed
-
University Hospitals, LeicesterNovartis; Medical Research Council; Public Health England; National Institute of...CompletedImmunogenicity of Adjuvanted or Non-adjuvanted H5N1 Booster Vaccine in Adults Primed to A/VN/1194/04InfluenzaUnited Kingdom