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

34 Participants Needed

Trial Summary

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 data supports the effectiveness of the DAPPER treatment for depression and pain?

The DAPPER treatment is a behavioral activation intervention aimed at improving pain and mood symptoms without medication. Similar approaches, like The Lighten Your Life Program, have shown significant improvements in managing depressive symptoms and chronic pain through educational support and self-management tools, suggesting that non-drug interventions can be effective for these conditions. ^{1 2 3 4 5}

Is the DAPPER intervention for depression and pain safe for humans?

The DAPPER intervention is a behavioral activation program that uses non-drug strategies, and while specific safety data for DAPPER itself isn't provided, similar behavioral interventions are generally considered safe. The study aims to test its feasibility and acceptability, which suggests a focus on ensuring it is safe and manageable for participants. ^{1 6 7 8 9}

How is the DAPPER treatment different from other treatments for depression and pain?

The DAPPER treatment is unique because it is a 12-week behavioral activation program specifically designed for older African American women, using non-drug strategies to address both pain and depression. It focuses on empowerment and recovery, making it different from traditional medication-based approaches. ^{1 5 10 11 12}

What is the purpose of this trial?

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.

Research Team

Janiece L Taylor, PhD

Principal Investigator

Johns Hopkins School of Nursing

Catherine Clair, MHS

Principal Investigator

Johns Hopkins University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

A protocol for a wait list control trial of an intervention to improve pain and depressive symptoms among middle-aged and older African American women. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Patients' Experiences with Telecare for Chronic Pain and Mood Symptoms: A Qualitative Study. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Interpersonal Psychotherapy for Co-occurring Depression and Chronic Pain. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Pain limits the effectiveness of collaborative care for depression. [2007]

5. United States pubmed.ncbi.nlm.nih.gov

The Lighten Your Life Program: An Educational Support Group Intervention That Used a Mobile App for Managing Depressive Symptoms and Chronic Pain. [2020]

6. England 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. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Cannabinoids for treatment of chronic non-cancer pain; a systematic review of randomized trials. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Cannabis for the Management of Pain: Assessment of Safety Study (COMPASS). [2022]

9. England pubmed.ncbi.nlm.nih.gov

Development, evaluation and implementation of a digital behavioural health treatment for chronic pain: study protocol of the multiphase DAHLIA project. [2022]

10. Germany pubmed.ncbi.nlm.nih.gov

Applying dialectical behavior therapy to chronic pain: A case study. [2019]

11. England 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. [2021]

12. United States 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? [2021]