Wellness Program for Trauma

Overseen By Kimberly Hill

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Under 18, Non-English speakers, others

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

Compensation: Varies

Number of Visits: 6

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how group sessions can support the physical and emotional well-being of women living in an emergency shelter. Participants will engage in the Adapted Passport to Freedom program, which includes mindfulness exercises and activities to promote health and healthy relationships. The trial is specifically for women currently residing at the House of Ruth Maryland emergency shelter who can read and write English. As an unphased trial, this study offers participants the opportunity to contribute to innovative research that could enhance support systems for women in similar situations.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this wellness program is safe for participants?

Research shows that most people find the Adapted Passport to Freedom program easy to follow. In earlier studies, about 84% of participants reported doing mindfulness exercises, indicating comfort with the program. Additionally, 63% of participants said these exercises helped them manage daily stress better. This suggests the program is not only safe but also beneficial for emotional health.

No reports of negative side effects from the Adapted Passport to Freedom program appear in the available data. Participants did not experience major problems during the sessions. Since the program focuses on mindfulness and health without involving medication, it is expected to be very safe. It aims to improve well-being through activities that are typically low-risk. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The "Adapted Passport to Freedom" program is unique because it offers a holistic approach to trauma recovery through group sessions that focus on mindfulness and healthy living. Unlike traditional therapy options that may concentrate solely on talk therapy or medication, this program incorporates a wide range of topics, including health, relationships, and family dynamics, in a supportive group setting. Researchers are excited about this approach because it not only addresses the psychological aspects of trauma but also promotes overall wellness and community support, which can be crucial for lasting recovery.

What evidence suggests that the Adapted Passport to Freedom program is effective for promoting well-being in women at emergency shelters?

Research has shown that the Passport to Freedom program can reduce feelings of depression and stress. In one study with 24 participants, 84% reported feeling less stressed and depressed after participating in the program. This trial will test the Adapted Passport to Freedom, which incorporates trauma-informed mindfulness to help participants focus on the present while acknowledging past experiences. Trauma-informed methods have proven beneficial for women who have faced difficult situations. Overall, these findings suggest that the Adapted Passport to Freedom could effectively improve emotional well-being for women in shelters. ^{4 6 7 8 9}

Who Is on the Research Team?

Patty Wilson, PhD, RN

Principal Investigator

Johns Hopkins University School of Nursing

Are You a Good Fit for This Trial?

This trial is for women over 18 who can read and write English, currently living at the House of Ruth Maryland emergency shelter or its transitional housing. It's not suitable for those under 18, non-English speakers, or individuals with health conditions that limit group participation.

Inclusion Criteria

Currently residing at the House of Ruth Maryland emergency shelter or onsite transitional housing

Able to read and write English

Exclusion Criteria

You have physical or mental health problems that would make it difficult for you to participate in the study.

You do not know how to speak or write in English.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants attend 5 weekly group sessions covering mindfulness, health, healthy relationships, family matters, and reflections

5 weeks

5 visits (in-person)

Follow-up

Participants complete follow-up questionnaires to assess changes in stress, emotions, mental health, and physical health

4 weeks

1 visit (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Adapted Passport to Freedom

Trial Overview The study tests an adapted 'Passport to Freedom' wellness program on women in a shelter setting. The program includes group sessions focused on improving physical and emotional well-being through mindfulness exercises and health activities.

How Is the Trial Designed?

Group I: Adapted Passport to Freedom Intervention Arm Experimental Treatment 1 Intervention

The intervention consists of 5 weekly, 90 minute group sessions that cover topics such as mindfulness, health, healthy relationships, family matters, and reflections

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

Published Research Related to This Trial

Current methods for assessing psychotropic drug harms in clinical trials are inadequate, primarily relying on general questions and spontaneous patient reports, leading to inconsistent data.

The authors recommend that social workers play a crucial role in monitoring drug effects by gathering client feedback and using a detailed checklist to track treatment emergent effects, while also advocating for policies that reduce pharmaceutical companies' control over drug testing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Understanding the assessment of psychotropic drug harms in clinical trials to improve social workers' role in medication monitoring. Hughes, S., Cohen, D.[2019]

A 12-week health and wellness group intervention for individuals with moderate to severe traumatic brain injury (TBI) showed no significant efficacy compared to a wait-list control group, based on a study involving 74 participants.

The lack of effectiveness may be attributed to the variability in individual health goals, the structure of the intervention, and the chosen outcome measures, suggesting that a more tailored approach might be necessary for future interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A health and wellness intervention for those with moderate to severe traumatic brain injury: a randomized controlled trial. Brenner, LA., Braden, CA., Bates, M., et al.[2015]

Approximately 70% of military personnel use dietary supplements, which is significantly higher than the 50% usage rate in the general civilian population, potentially increasing their risk of adverse events.

The US Department of Defense has implemented measures like Operation Supplement Safety to educate military personnel about safe supplement use and to monitor and report adverse events associated with dietary supplements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protecting military personnel from high risk dietary supplements. Deuster, PA., Lieberman, HR.[2017]

The Canadian adverse event reporting system for herbal products is severely underreported, leading to a lack of safety data, which poses risks to consumers who often perceive these products as safe.

Health food store personnel in the Greater Toronto Area play a crucial role in reporting adverse reactions by collecting customer information during product returns, suggesting a potential pathway to improve safety monitoring and reporting for herbal products.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse event reporting for herbal medicines: a result of market forces. Walji, R., Boon, H., Barnes, J., et al.[2021]

A culturally tailored health promotion program for Cambodian survivors of torture significantly improved health status, lifestyle activities, sleep, and depression among 126 participants over five sessions from 2007 to 2011.

Participants reported increased confidence in communicating with their healthcare providers, suggesting that culturally relevant education can enhance both health and mental health behaviors in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An innovative model of culturally tailored health promotion groups for Cambodian survivors of torture. Berkson, SY., Tor, S., Mollica, R., et al.[2022]

In a study involving 1,687 substance-abusing participants over 27,198 person-weeks, 12% experienced serious adverse events (SAEs), but none were deemed related to the psychosocial interventions being tested.

There were no significant differences in the incidence rates of SAEs between those receiving standard care and those receiving additional interventions like contingency management or motivational enhancement, suggesting that these psychosocial treatments are safe in terms of serious adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Serious adverse events in randomized psychosocial treatment studies: safety or arbitrary edicts? Petry, NM., Roll, JM., Rounsaville, BJ., et al.[2021]

The Holistic Healing Arts Retreat significantly improved posttraumatic symptoms, depression, and perceived stress in women who experienced trauma, with effects lasting up to 7 months after the intervention.

The retreat also enhanced self-compassion and reduced experiential avoidance, indicating that it may address underlying emotional mechanisms common to various disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The holistic healing arts retreat: An intensive, experiential intervention for survivors of interpersonal trauma. Dutton, MA., Dahlgren, S., Martinez, M., et al.[2023]

Citations

1. researchgate.net researchgate.net/publication/377124744_Passport_to_Freedom_A_Trauma-Informed_Mindfulness_Program_for_Previously_Incarcerated_Women

Passport to Freedom: A Trauma-Informed Mindfulness ... Participants ( N = 24) showed decreased symptoms of depression and concerns of everyday stressors after the intervention. Of participants, 84% ( ...

2. researchgate.net researchgate.net/publication/281541227_Outcomes_of_Trauma-Informed_Interventions_for_Incarcerated_Women_A_Review

Outcomes of Trauma-Informed Interventions for ... In general, SUD treatment approaches for justice-involved women that integrate trauma-informed interventions have demonstrated positive outcomes ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/28678690/

Emotional Freedom Techniques to Treat Posttraumatic ... Some 65% of practitioners found that more than 60% of PTSD clients are fully rehabilitated, and 89% stated that less than 10% of clients make little or no ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10978442/

Feasibility of Emotional Freedom Techniques in Patients ... Of the 30 patients with PTSD, 96.7% showed more than 80% compliance with the EFT sessions, and 86.7% completed the entire study process. In a ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05422612

NCT05422612 | Department of Defense PTSD Adaptive ... ≥30% reduction from Baseline to 12 Weeks in the Clinician-Administered PTSD Scale for DSM-5 Revised (CAPS-5-R), Past Month total score. The range of the scale ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04069754

Study Details | NCT04069754 | Passport to Freedom (P2F): ... A structured online system, such as the ClinicalTrials.gov results database, that provides the public with access to registration and summary results ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38166595/

Passport to Freedom: A Trauma-Informed Mindfulness ... Of participants, 84% (n = 16) reported practicing mindfulness and 63% (n = 8) stated that mindfulness exercises helped with daily stress management. The P2F ...

8. withpower.com withpower.com/trial/phase-9-2019-20645

Wellness Program for Trauma · Info for Participants This N/A medical study run by Johns Hopkins University needs participants to evaluate whether Adapted Passport to Freedom will have tolerable side effects ...

9. reporter.nih.gov reporter.nih.gov/project-details/11083044

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