DAPPER Intervention for Depression and Pain

(DAPPER Trial)

Overseen By Sarah Szanton, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Frequent hospitalization, Physical therapy, Terminal diagnosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assist African American women over 50 who experience depression, pain, and mobility issues. The research evaluates the effectiveness of the DAPPER intervention, which includes 8 nurse visits at home to help manage pain and mood. Participants will either receive the intervention immediately or join a waitlist to receive it later. This trial suits African American women with long-term pain that limits daily activities and who have symptoms of depression. As an unphased trial, it offers participants the chance to contribute to research that could enhance care for others facing similar challenges.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the DAPPER intervention is safe for African American women aged 50 and older?

Research shows that the DAPPER program is generally safe for participants. This program helps manage depression and pain and has proven practical and acceptable for those involved. Studies have not reported any serious side effects, with most being mild to moderate. Participants typically handle it well. For those considering joining a trial with DAPPER, these findings can offer reassurance about its safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the DAPPER intervention for depression and pain because it offers a fresh approach to tackling these conditions simultaneously. Unlike conventional treatments that often rely on separate medications or therapies for each condition, DAPPER integrates strategies to address both depression and pain together. This holistic approach not only aims to improve mental health but also targets the physical discomfort that often accompanies depression, potentially leading to more comprehensive and quicker relief for patients. By focusing on the interconnected nature of these issues, DAPPER could redefine how we manage depression and pain.

What evidence suggests that the DAPPER intervention could be effective for depression and pain?

Research has shown that the DAPPER program, which stands for Depression and Pain Perseverance through Empowered Recovery, is under study for its potential to alleviate depression and pain. In this trial, participants in the intervention arm will undergo a 12-week course to receive support for managing mood and pain. Early results suggest that participants find the program doable and worthwhile. While detailed results on its effectiveness are still being gathered, the program helps participants set personal goals, an important step in improving mood and reducing pain. Meanwhile, participants in the waitlist control arm will have outcomes measured but will not receive the intervention until the intervention group completes it. ^{1 2 6 7 8}

Who Is on the Research Team?

Janiece L Taylor, PhD

Principal Investigator

Johns Hopkins School of Nursing

Catherine Clair, MHS

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I need help with at least one daily activity.

Live in a community dwelling

You have signs of being physically weak or frail, such as difficulty walking or exhaustion.

Exclusion Criteria

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.

> moderate intellectual impairment (5-7 errors) based on the Short Portable Mental Status Questionnaire (SPMSQ)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the DAPPER intervention, including 8 nurse visits in participants' homes to help with pain and mood

12 weeks

8 visits (in-person)

Follow-up

Participants are monitored for changes in depressive symptoms, pain, and other health measures

12 weeks

Wait List Control

Wait list control group receives the intervention after the initial treatment group completes their phase

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• DAPPER

Trial Overview 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.

How Is the Trial Designed?

Group I: Intervention Arm Experimental Treatment 1 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 Arm Active Control 1 Intervention

Once the intervention group has completed the intervention the wait list control group will complete the intervention.

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

Robert Wood Johnson Foundation

Collaborator

Trials

161

Recruited

697,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Published Research Related to This Trial

The dialectical pain management (DPM) intervention, involving 17 adults with chronic pain over 8 weeks, was found to be feasible and well-accepted, with 70% of participants attending six or more sessions.

Preliminary results indicated significant improvements in pain acceptance and reductions in depressive symptoms, with some participants even reducing their opioid dosage, suggesting potential effectiveness in managing chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dialectical Pain Management: Feasibility of a Hybrid Third-Wave Cognitive Behavioral Therapy Approach for Adults Receiving Opioids for Chronic Pain. Barrett, D., Brintz, CE., Zaski, AM., et al.[2021]

A web-based cognitive behavioral therapy (CBT) intervention significantly reduced pain catastrophizing in chronic pain patients, which led to decreased pain interference and severity, demonstrating its efficacy in managing chronic pain.

The intervention was particularly effective for younger patients (≤ 50 years) and those with a history of substance use disorder, indicating that web-CBT may be especially beneficial for these groups in reducing both pain and aberrant drug-related behavior.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Web-based cognitive behavior therapy for chronic pain patients with aberrant drug-related behavior: How did it work and for whom? Xie, H., Guarino, H., Moore, SK., et al.[2021]

A study involving 431 individuals with chronic non-cancer pain found that using a standardized herbal cannabis product for one year did not increase the risk of serious adverse events compared to non-users, suggesting a reasonable safety profile for medical cannabis.

However, cannabis users experienced a higher rate of non-serious adverse events, mostly mild to moderate, indicating that while cannabis may be safe for serious complications, it can still lead to some side effects that need to be monitored.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cannabis for the Management of Pain: Assessment of Safety Study (COMPASS). Ware, MA., Wang, T., Shapiro, S., et al.[2022]

A systematic review of 18 randomized controlled trials found that cannabinoids, including smoked cannabis and extracts, significantly relieve chronic non-cancer pain, particularly in conditions like neuropathic pain, fibromyalgia, and rheumatoid arthritis.

Cannabinoids were generally safe, with no serious adverse effects reported, and most side effects were mild to moderate, indicating they could be a viable option for patients seeking pain relief.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cannabinoids for treatment of chronic non-cancer pain; a systematic review of randomized trials. Lynch, ME., Campbell, F.[2022]

This study will evaluate the effectiveness of cannabis in reducing opioid use and managing chronic non-cancer pain in 250 adults currently taking prescription opioids, as part of a comprehensive behavioral pain management program.

Participants will be randomly assigned to either use cannabis or abstain for 6 months, with primary outcomes focusing on changes in opioid dosage and pain interference, while also monitoring for any adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomised, pragmatic, waitlist controlled trial of cannabis added to prescription opioid support on opioid dose reduction and pain in adults with chronic non-cancer pain: study protocol. Jashinski, J., Grossman, E., Quaye, A., et al.[2023]

Citations

1. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2831134

Prevalence of Depression and Anxiety Among Adults With ... This study suggests that the prevalences of depression and anxiety among adults with chronic pain are approximately 40%.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10527967/

A protocol for a wait list control trial of an intervention to ... The purpose of this study is to test the feasibility and acceptability of a 12-week behavioral activation intervention called DAPPER (Depression and Pain ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04091347

Depression and Pain Perseverance Through Empowered ... The aims of this pilot project are to 1) test the Depression and Pain Perseverance through Empowered Recovery (DAPPER) program for feasibility and acceptability ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714423002227

A protocol for a wait list control trial of an intervention to ... The purpose of this study is to test the feasibility and acceptability of a 12-week behavioral activation intervention called DAPPER (Depression and Pain ...

5. academic.oup.com academic.oup.com/innovateage/article/7/10/igad096/7264883

Acceptability and Feasibility of a Pain and Depressive ... In this study, we are testing the feasibility of the DAPPER intervention and working with participants who will set their goals based on their experiences and ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11376547/

“The peace that I wanted, I got”: Qualitative insights from ... SMART DAPPER provides data to inform evidence-based scale up of non-specialist delivery of treatment for depression and trauma-disorder, a much ...

7. withpower.com withpower.com/trial/phase-depression-2020-07321

DAPPER Intervention for Depression and Pain Cannabinoids were generally safe, with no serious adverse effects reported, and most side effects were mild to moderate, indicating they could be a viable ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT03466346

SMART-DAPPER: Leveraging the Depression And Primary ... Compared to placebo, fluoxetine is more likely to produce symptom response for MDD. Despite the interim development of many other antidepressants since the ...