Depression and Pain Perseverance Through Empowered Recovery Intervention
- Conditions
- AgingPainDepressive SymptomsFrailty
- Registration Number
- NCT04091347
- Lead Sponsor
- Johns Hopkins University
- Brief Summary
African American women who are 50 years of age and older with depressive symptoms, pain and difficulty with mobility will participate in the DAPPER intervention study that includes 8 nurse visits in participants' homes to help participants with participants' pain and mood.
- Detailed Description
The proposed intervention is called Depression and Pain Perseverance through Empowered Recovery (DAPPER). The investigators are adapting the Get Busy Get Better intervention by adding components (e.g. nurse visits and person directed goals) from the CAPABLE study for this intervention. The investigator will further develop the intervention through this two-phase pilot test. The aims of this pilot project are to 1) test the Depression and Pain Perseverance through Empowered Recovery (DAPPER) program for feasibility and acceptability. Specifically, the investigators will test the effect size of DAPPER on pain and depressive symptoms from baseline to 12 weeks (compare intervention to wait list control group) and then at 24 weeks to compare the intervention group to wait list control group once again. 2) estimate preliminary effect sizes for DAPPER in reduction pain and depressive symptoms, 3) measure effect sizes and feasibility of measuring cytokines and heart rate variability (HRV).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 34
- Self-report pain >3 out of a 0 -10 scale that has lasted longer than 3 months and keeps subjects from doing at least one activity that subjects would like to do
- Self-Identify as African American/Black female
- Live in a community dwelling
- Score a 5 or higher on the PHQ-9 (depression measure) at least two times during a two week period (screening call and then at first data collection visit)
- Must be pre-frail (one or two criteria on frailty phenotype) or frail (three or more of the criteria on frailty phenotype)
- One ADL or IADL limitation
- 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)
- Unable to speak or understand English
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Pain Intensity as Assessed by the Patient Reported Outcomes Measurement Information System (PROMIS) Baseline and 12 weeks The PROMIS Intensity is used to measure pain intensity on a scale of 0-10. Higher scores indicate more pain intensity.
Depressive Symptoms as Assessed by the Patient Health Questionnaire 9 (PHQ-9) Baseline and 12 weeks The Patient Health Questionnaire 9 (PHQ-9) includes 9 questions related to the Diagnostic and Statistical Manual of Mental Disorders (DSM) diagnostic criteria for major depression. The PHQ-9 scores range from 0-27. Higher scores indicate more depressive symptoms.
- Secondary Outcome Measures
Name Time Method Interleukin (IL)-6 in Saliva (pg/ml) Baseline and 12 weeks An decrease in IL 6 indicates a decrease in this inflammatory marker.
Interleukin (IL)-8 in Saliva (pg/ml) Pre intervention , Post intervention 12 weeks for Intervention arm A decrease indicates a decrease IL8 , which is an inflammatory marker.
Interleukin (IL)-1 Beta in Saliva (pg/ml) Baseline and Post intervention 12 weeks for intervention arm. Baseline for wait list control. A change in IL-1beta indicates a change in this cytokine or protein.
Tumor Necrosis Factor (TNF)-Alpha in Saliva (pg/ml) Baseline and post intervention (12 weeks ) for intervention arm. Baseline only (wait list control arm) Tumor necrosis factor (TNF)-alpha in saliva (pg/ml). TNF-alpha is a cytokine that signals inflammation in the body. Higher levels indicate there may be more inflammation.
Related Research Topics
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Trial Locations
- Locations (1)
Johns Hopkins School of Nursing
🇺🇸Baltimore, Maryland, United States
Johns Hopkins School of Nursing🇺🇸Baltimore, Maryland, United States