Depression and Pain Perseverance Through Empowered Recovery Intervention
- Conditions
- AgingPainDepressive SymptomsFrailty
- Interventions
- Behavioral: DAPPER
- 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
- Arm && Interventions
Group Intervention Description Intervention Arm DAPPER The intervention group will receive the intervention for 12 weeks. The wait list control group will have outcomes measured but will not receive the intervention at this time. Wait List Control Arm DAPPER Once the intervention group has completed the intervention the wait list control group will complete the intervention.
- Primary Outcome Measures
Name Time Method Change in Depressive Symptoms as assessed by the Patient Health Questionnaire 9 (PHQ-9) Baseline, 12 weeks and 24 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.
Change in Pain Intensity as assessed by the Patient Reported Outcomes Measurement Information System (PROMIS) Baseline, 12 weeks and 24 weeks The PROMIS Intensity is used to measure pain intensity on a scale of 0-10. Higher scores indicate more pain intensity.
Change in Depressive Symptoms as assessed by the PROMIS 57 Baseline, 12 weeks and 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.
Change in Pain Interference as assessed by the PROMIS Pain Interference Baseline, 12 weeks and 24 weeks The Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference is a six item scale used to measure how much pain interferes with activities. The scores can range from 6-30. Higher scores indicate more pain interference with activities.
- Secondary Outcome Measures
Name Time Method Change in Frailty as assessed by the Frail Scale Baseline, 12 weeks and 24 weeks The Frail Scale is used to measure frailty. The scores range from 0-17 with higher scores indicating more frailty.
Change in Physical Function as assessed by the Lawton's Instrumental Activities of Daily Living (IADL) Baseline, 12 weeks and 24 weeks Lawton's Instrumental Activities of Daily Living (IADL) measures instrumental activities of daily living as a measure of physical function. The scores range from 0-8 with higher scores indicating better physical function.
Change in Frailty as assessed by the Frailty Phenotype measure Baseline, 12 weeks and 24 weeks The Frailty Phenotype measure is used to determine if a person is robust (score of 0), pre-frail (score of 1 or 2), or frail (score of 3-5).
Change in Physical Function as assessed by the Katz Activities of daily living (ADL) Baseline, 12 weeks and 24 weeks The Katz Activities of daily living (ADL) is used measure physical function through ability to perform activities of daily living. Score ranges are from 0-6 with 6 indicating full function and a score of 2 or less indicating severe functional impairment.
Trial Locations
- Locations (1)
Johns Hopkins School of Nursing
🇺🇸Baltimore, Maryland, United States