What side effects are associated with this type of intervention?

Mindfulness-based interventions, like mindfulness meditation and MBSR, are typically well-tolerated but can sometimes cause increased anxiety or emotional discomfort initially. Health promotion activities, such as aerobic exercise, may result in muscle soreness, fatigue, or injury if not done properly. Combining these methods generally aims to improve well-being with minimal side effects.

What prior FDA approvals exist?

The FDA has approved several treatments for trauma-related conditions, including medications like SSRIs (e.g., sertraline and paroxetine) for PTSD. While mindfulness and health promotion activities are not FDA-approved treatments per se, they are recognized as beneficial complementary therapies. These approaches, such as Mindfulness-Based Stress Reduction (MBSR) and Mindfulness-Based Cognitive Therapy (MBCT), have shown efficacy in improving emotional and physical well-being in trauma survivors. These therapies focus on enhancing mindfulness, reducing stress, and promoting overall health, aligning with the goals of the Mindfulness and Health Promotion Activities trial.

What other types of research exist?

Promising, novel alternatives to mindfulness and health promotion activities for trauma patients in 2024 include biofeedback, guided imagery, progressive muscle relaxation, cognitive-behavioral therapy (CBT), acceptance and commitment therapy (ACT), and physical exercise. These interventions have shown efficacy in improving physical and emotional well-being in various patient populations.

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Behavioral Intervention

Wellness Program for Trauma

N/A

Recruiting

Led By Phyllis Sharps, PhD, RN, FAAN

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

18 years of age or older

Be older than 18 years old

Must not have

Under 18 years of age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 9 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial involves women in emergency shelters attending group sessions to practice mindfulness and learn about health. The goal is to reduce their stress and help them manage long-term health issues.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this intervention involves mindfulness exercises and health promotion activities rather than medication, typical medical side effects are not expected. However, participants may experience emotional discomfort when discussing personal topics.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am younger than 18 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 9 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 9 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 9 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Mental Health as assessed by the Patient Health Questionnaire

Change in Physical Health as assessed by the Perceived Health Competence Scale

Secondary study objectives

Change in Emotions as assessed by Difficulties in Emotion Regulation Scale-Short Form

Change in Stress as assessed by Everyday Stressor Index

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Adapted Passport to Freedom Intervention ArmExperimental Treatment1 Intervention

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

0 / 2Eligibility criteria met

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 trauma, such as mindfulness-based interventions and health education, work by promoting awareness and acceptance of the present moment, reducing stress, and improving emotional regulation. Mindfulness helps patients manage their symptoms by fostering a non-judgmental awareness of their thoughts and feelings, which can reduce the impact of traumatic memories. Health education provides patients with knowledge about their condition and effective coping strategies, enhancing their sense of control and self-efficacy. These mechanisms are vital as they address both the psychological and physiological aspects of trauma, supporting a holistic approach to recovery.

Implementing mindfulness meditation in hand surgery training: a feasibility study.Cognitive behavioural group therapy versus mindfulness-based stress reduction group therapy for intimate partner violence: a randomized controlled trial.