Passport to Freedom (P2F): Adaptation and Implementation of a Wellness Program

NCT04069754 | Terminated

• 1 other identifier: IRB00203504
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Women currently residing at an emergency shelter for women and children will participate in group sessions that cover topics that promote physical and emotional well-being through a combination of mindfulness exercises and health promotion activities..

Conditions

Trauma

Keywords

trauma; stress; depression; coping; mindfulness

Outcome Measures

Primary Outcomes (2)

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

  The Perceived Health Competence Scale measures the degree to which an individual feels capable of effectively managing their health. The score could range from 2-10. The higher the score, the greater the patient's perceived health competence.

  Baseline, 9 weeks

• Change in Mental Health as assessed by the Patient Health Questionnaire

  Patient Health Questionnaire assesses patient's level of distress and functional impairment. Score ranges from 0-4 depression severity is minimal or none. Score range from 5-9 is mild depression severity. Score range from 10-14 is moderate depression severity. 15-19 range is moderately severe depression. Range 20-27 indicates severe depression.

  Baseline, 9 weeks

Secondary Outcomes (2)

• Change in Stress as assessed by Everyday Stressor Index

  Baseline, 9 weeks

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

  Baseline, 9 weeks

Study Arms (1)

Adapted Passport to Freedom Intervention Arm

EXPERIMENTAL

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

Behavioral: Adapted Passport to Freedom

Interventions

Adapted Passport to Freedom BEHAVIORAL

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

Adapted Passport to Freedom Intervention Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• Able to read and write English
• Currently residing at the House of Ruth Maryland emergency shelter or onsite transitional housing.

You may not qualify if:

• Under 18 years of age
• Inability to speak or write English
• Physical or mental health conditions that would prevent meaningful group participation.

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

House of Ruth Maryland

Baltimore, Maryland, 21218, United States

Location

MeSH Terms

Conditions

Wounds and Injuries; Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Patty Wilson, PhD, RN

  Johns Hopkins University School of Nursing

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All participants will receive the intervention. There are no other groups.

Study Record Dates

• First Submitted: August 23, 2019
• First Posted: August 28, 2019
• Study Start: October 28, 2019
• Primary Completion: October 23, 2021
• Study Completion: October 23, 2021
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)