Clinical trial NCT04091347: Depression and Pain Perseverance Through Empowered Recovery Intervention
Official title: Pilot Study of Depression and Pain Perseverance Through Empowered Recovery (DAPPER) Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Depressive Symptoms
Frailty
Aging
Keywords: African American
Women's Health
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Robert Wood Johnson Foundation
name: National Institute on Aging (NIA)
First posted: 2019-09-16
Enrollment: 34
Sex: FEMALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The investigator will conduct subsequent single blind wait list control design to test the preliminary effects of DAPPER and the feasibility of older African American women integrating strategies to address pain, depression, and frailty that are tailored to the individual into the individual's daily routines.
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Change in Pain Intensity as assessed by the Patient Reported Outcomes Measurement Information System (PROMIS)
timeFrame: Baseline, 12 weeks and 24 weeks
measure: Change in Pain Interference as assessed by the PROMIS Pain Interference
timeFrame: Baseline, 12 weeks and 24 weeks
measure: Change in Depressive Symptoms as assessed by the Patient Health Questionnaire 9 (PHQ-9)
timeFrame: Baseline, 12 weeks and 24 weeks
measure: Change in Depressive Symptoms as assessed by the PROMIS 57
timeFrame: Baseline, 12 weeks and 24 weeks
Secondary outcomes:
measure: Change in Frailty as assessed by the Frailty Phenotype measure
timeFrame: Baseline, 12 weeks and 24 weeks
measure: Change in Frailty as assessed by the Frail Scale
timeFrame: Baseline, 12 weeks and 24 weeks
measure: Change in Physical Function as assessed by the Katz Activities of daily living (ADL)
timeFrame: Baseline, 12 weeks and 24 weeks
measure: Change in Physical Function as assessed by the Lawton's Instrumental Activities of Daily Living (IADL)
timeFrame: Baseline, 12 weeks and 24 weeks
Other outcomes:
measure: Change in Communication with Health Care Providers as assessed by the Patients' Reaction Assessment
timeFrame: Baseline, 12 weeks and 24 weeks
measure: Change in Stress as assessed by the Perceived Stress Scale
timeFrame: Baseline, 12 weeks and 24 weeks
measure: Change in Social engagement as assessed by the Social Network Scale
timeFrame: Baseline, 12 weeks and 24 weeks
measure: Change in Self Efficacy as assessed by the Coping and Self-Efficacy Scale
timeFrame: Baseline, 12 weeks and 24 weeks
measure: Change in Comorbid Conditions as assessed by the Charlson Comorbidity Index
timeFrame: Baseline, 12 weeks and 24 weeks
measure: Change in interleukin (IL)-6 in saliva (pg/ml)
timeFrame: Baseline, 12 weeks and 24 weeks
measure: Change in interleukin (IL)-8 in saliva (pg/ml)
timeFrame: Baseline, 12 weeks and 24 weeks
measure: Change in interleukin (IL)-1 beta in saliva (pg/ml)
timeFrame: Baseline, 12 weeks and 24 weeks
measure: Change in tumor necrosis factor (TNF)-alpha in saliva (pg/ml)
timeFrame: Baseline, 12 weeks and 24 weeks
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins School of Nursing
state: Maryland
Study officials:
affiliation: Johns Hopkins School of Nursing
name: Janiece L Taylor, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Johns Hopkins University
name: Catherine Clair, MHS
role: STUDY_DIRECTOR
References: