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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 9 weeks

Awards & highlights

Study Summary

This trial will help women at an emergency shelter who participate in group sessions that cover topics promoting physical and emotional well-being through mindfulness exercises and health promotion activities.

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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Mental Health as assessed by the Patient Health Questionnaire

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

Secondary outcome measures

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

Change in Stress as assessed by Everyday Stressor Index

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 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor

2,263 Previous Clinical Trials

14,823,125 Total Patients Enrolled

Phyllis Sharps, PhD, RN, FAANPrincipal InvestigatorJohns Hopkins University School of Nursing

Patty Wilson, PhD, RNPrincipal InvestigatorJohns Hopkins University School of Nursing

Media Library

Adapted Passport to Freedom (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04069754 — N/A

Trauma Research Study Groups: Adapted Passport to Freedom Intervention Arm

Trauma Clinical Trial 2023: Adapted Passport to Freedom Highlights & Side Effects. Trial Name: NCT04069754 — N/A

Adapted Passport to Freedom (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04069754 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are currently engaged in the experiment?

"Affirmative. Clinical trials data hosted online suggests that this medical trial is on-going and currently recruiting patients. This clinical experiment was first posted on the 28th of October 2019, with an most recent update being made 28 July 2022; 40 participants are needed from 1 location."

Answered by AI

Are there still participation opportunities available in this research program?

"Affirmative. Clinicaltrials.gov's data confirms that this clinical trial is presently recruiting, with a first posting on October 28th 2019 and most recent update on July 28th 2022. The study needs to recruit 40 patients from 1 medical centre."

Answered by AI