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.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
34
The DAPPER program is person directed and will consist of 8 nurse visits during which the nurse assesses each participant for pain, depression and frailty and then implements a manualized individually tailored intervention. Participants will be randomized into either the intervention or the wait list control group. Once the intervention group has completed the intervention group's visits, the wait list control group will begin the waitlist control group's visits. All participants will all be offered the same information and format of nurse visits. The nurses will systematically tailor the content of the visits to the participants' risk profile and goals based on protocols. All participants will be assessed at the start of the study, at 12 weeks and 24 weeks.
Johns Hopkins School of Nursing
Baltimore, Maryland, United States
Pain Intensity as Assessed by the Patient Reported Outcomes Measurement Information System (PROMIS)
The PROMIS Intensity is used to measure pain intensity on a scale of 0-10. Higher scores indicate more pain intensity.
Time frame: Baseline and 12 weeks
Depressive Symptoms as Assessed by the Patient Health Questionnaire 9 (PHQ-9)
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.
Time frame: Baseline and 12 weeks
Interleukin (IL)-6 in Saliva (pg/ml)
An decrease in IL 6 indicates a decrease in this inflammatory marker.
Time frame: Baseline and 12 weeks
Interleukin (IL)-8 in Saliva (pg/ml)
A decrease indicates a decrease IL8 , which is an inflammatory marker.
Time frame: Pre intervention , Post intervention 12 weeks for Intervention arm
Interleukin (IL)-1 Beta in Saliva (pg/ml)
A change in IL-1beta indicates a change in this cytokine or protein.
Time frame: Baseline and Post intervention 12 weeks for intervention arm. Baseline for wait list control.
Tumor Necrosis Factor (TNF)-Alpha in Saliva (pg/ml)
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.
Time frame: Baseline and post intervention (12 weeks ) for intervention arm. Baseline only (wait list control arm)
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