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Depression and Pain Perseverance Through Empowered Recovery Intervention

Not Applicable
Completed
Conditions
Aging
Pain
Depressive Symptoms
Frailty
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
Inclusion Criteria
  • 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
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)
  • Unable to speak or understand English

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
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
NameTimeMethod
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.

Trial Locations

Locations (1)

Johns Hopkins School of Nursing

🇺🇸

Baltimore, Maryland, United States

Johns Hopkins School of Nursing
🇺🇸Baltimore, Maryland, United States

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