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Behavioral Intervention
DAPPER Intervention for Depression and Pain (DAPPER Trial)
N/A
Waitlist Available
Led By Janiece L Taylor, PhD
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
One ADL or IADL limitation
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
Must not have
Hospitalized > 3 times in the last year
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 12 weeks and 24 weeks
Awards & highlights
Summary
This trial tests a program called DAPPER, where nurses visit African American women aged 50+ at home to help them manage pain and depression. The nurses provide personalized support to improve the participants' physical and emotional well-being.
Who is the study for?
This trial is for African American women over 50 who live at home, have some difficulty with daily activities due to frailty, experience persistent pain that interferes with their activities, and show signs of depression. They should not be in physical therapy or have severe mental impairment.
What is being tested?
The DAPPER intervention involves eight home visits by a nurse to assist participants with managing pain and improving mood. It's designed specifically for older African American women struggling with mobility due to pain and depression.
What are the potential side effects?
Since the DAPPER intervention is non-pharmaceutical, focusing on nursing support rather than medication, specific side effects are not anticipated as commonly seen in drug trials.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I need help with at least one daily activity.
Select...
I have pain over 3/10 that stops me from doing activities and it's lasted more than 3 months.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have been hospitalized more than three times in the past year.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 12 weeks and 24 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 12 weeks and 24 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Depressive Symptoms as assessed by the PROMIS 57
Change in Depressive Symptoms as assessed by the Patient Health Questionnaire 9 (PHQ-9)
Change in Pain Intensity as assessed by the Patient Reported Outcomes Measurement Information System (PROMIS)
+1 moreSecondary study objectives
Change in Frailty as assessed by the Frail Scale
Change in Frailty as assessed by the Frailty Phenotype measure
Change in Physical Function as assessed by the Katz Activities of daily living (ADL)
+1 moreOther study objectives
Change in Communication with Health Care Providers as assessed by the Patients' Reaction Assessment
Change in Comorbid Conditions as assessed by the Charlson Comorbidity Index
Change in Self Efficacy as assessed by the Coping and Self-Efficacy Scale
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention ArmExperimental Treatment1 Intervention
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.
Group II: Wait List Control ArmActive Control1 Intervention
Once the intervention group has completed the intervention the wait list control group will complete the intervention.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
DAPPER
2020
N/A
~40
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for depression include pharmacological approaches like SSRIs, SNRIs, and tricyclic antidepressants, which work by adjusting neurotransmitter levels in the brain to improve mood. Non-pharmacological treatments such as Cognitive Behavioral Therapy (CBT) and Behavioral Activation (BA) focus on changing negative thought patterns and increasing engagement in positive activities.
Personalized interventions, like the DAPPER study involving nurse visits, address both pain and mood, offering a holistic approach that can be particularly effective for patients with co-occurring physical and mental health issues. Understanding these mechanisms is crucial for tailoring treatments to individual needs, thereby enhancing the overall effectiveness of depression management.
A Feasibility Study of Behavioral Activation for Major Depressive Disorder in a Community Mental Health Setting.A randomized controlled trial of a senior centre group programme for increasing social support and preventing depression in elderly people living at home in Norway.Delineating mechanisms of change in child and adolescent therapy: methodological issues and research recommendations.
A Feasibility Study of Behavioral Activation for Major Depressive Disorder in a Community Mental Health Setting.A randomized controlled trial of a senior centre group programme for increasing social support and preventing depression in elderly people living at home in Norway.Delineating mechanisms of change in child and adolescent therapy: methodological issues and research recommendations.
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Who is running the clinical trial?
Johns Hopkins UniversityLead Sponsor
2,315 Previous Clinical Trials
14,872,689 Total Patients Enrolled
57 Trials studying Depression
29,508 Patients Enrolled for Depression
Robert Wood Johnson FoundationOTHER
158 Previous Clinical Trials
695,866 Total Patients Enrolled
15 Trials studying Depression
7,096 Patients Enrolled for Depression
National Institute on Aging (NIA)NIH
1,751 Previous Clinical Trials
28,123,781 Total Patients Enrolled
37 Trials studying Depression
28,781 Patients Enrolled for Depression
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I need help with at least one daily activity.You have signs of being physically weak or frail, such as difficulty walking or exhaustion.I have pain over 3/10 that stops me from doing activities and it's lasted more than 3 months.I have been hospitalized more than three times in the past year.You have been diagnosed with a condition that is not expected to allow you to live for more than one year.I am an African American/Black female.You are currently undergoing physical therapy.
Research Study Groups:
This trial has the following groups:- Group 1: Wait List Control Arm
- Group 2: Intervention Arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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