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NCT Number: NCT04091347

Depression and Pain Perseverance Through Empowered Recovery Intervention

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.

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Key information

Conditions

Pain Aging Behavior Behavioral Symptoms Depression Depressive Symptoms Frailty Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

50 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins School of Nursing

Baltimore, Maryland, 21205, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DAPPER

Behavioral

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.

Primary outcomes

  1. Pain Intensity as Assessed by the Patient Reported Outcomes Measurement Information System (PROMIS)

    Time frame: 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.

  2. Depressive Symptoms as Assessed by the Patient Health Questionnaire 9 (PHQ-9)

    Time frame: 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 outcomes

  1. Interleukin (IL)-6 in Saliva (pg/ml)

    Time frame: Baseline and 12 weeks

    An decrease in IL 6 indicates a decrease in this inflammatory marker.

  2. Interleukin (IL)-8 in Saliva (pg/ml)

    Time frame: Pre intervention , Post intervention 12 weeks for Intervention arm

    A decrease indicates a decrease IL8 , which is an inflammatory marker.

  3. Interleukin (IL)-1 Beta in Saliva (pg/ml)

    Time frame: 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.

  4. Tumor Necrosis Factor (TNF)-Alpha in Saliva (pg/ml)

    Time frame: 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.

Other outcomes

  1. Physical Function as Assessed by the Katz Activities of Daily Living (ADL)

    Time frame: Baseline

    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.

  2. Physical Function as Assessed by the Lawton's Instrumental Activities of Daily Living (IADL)

    Time frame: Baseline

    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.

  3. Frailty as Assessed by the Frail Scale

    Time frame: Baseline

    The Frail Scale is used to measure frailty. The scores range from 0-17 with higher scores indicating more frailty.

  4. Change in Depressive Symptoms as Assessed by the PROMIS 57

    Time frame: Nurse Visit 1 and Nurse Visit 8

    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.

  5. Stress as Assessed by the Perceived Stress Scale (Intervention Group)

    Time frame: Pre intervention, Post intervention 12 weeks

    The Perceived Stress Scale assesses a person's perceived stress levels. The scores can range from 0 to 40 with higher scores indicating higher perceived stress.

  6. Comorbid Conditions as Assessed by the Charlson Comorbidity Index

    Time frame: Baseline

    The Charlson Comorbidity Index consists of 17 categories of chronic conditions and two subcategories for diabetes and liver disease. Each comorbidity category has an associated weight (from 1 to 6), based on the adjusted risk of mortality or resource use, and the sum of all the weights results in a single comorbidity score for a patient. A score of zero indicates that no comorbidities were found. The higher the score, the more likely the predicted outcome will result in mortality or higher resource use. Up to 12 comorbidities with various weightings can result in a maximum score of 24. Score range 0-24.

  7. Change in Social Engagement as Assessed by the Social Network Scale

    Time frame: Baseline, 12 weeks and 24 weeks

    The Lubben Social Network Scale -6 is used to measure social engagement including family and friends. The scores range from 0 to 60 with higher scores indicating more social engagement.

  8. Change in Self Efficacy as Assessed by the Coping and Self-Efficacy Scale

    Time frame: Baseline and 12 weeks

    The Coping and Self-Efficacy Scale is a 26 item scale used to measure coping and self efficacy. The scores on this instrument range from 0-260 with higher scores indicating more self efficacy.

  9. Change in Frailty as Assessed by the Frailty Phenotype Measure

    Time frame: Baseline and 12 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). total score range of 0-5.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • National Institute on Aging (NIA)
  • Robert Wood Johnson Foundation

Registry information

Official study title

Pilot Study of Depression and Pain Perseverance Through Empowered Recovery (DAPPER) Intervention

Acronym: DAPPER

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Sep 16, 2019
Registry last updated
Nov 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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