TraumaNCT04069754
Passport to Freedom (P2F): Adaptation and Implementation of a Wellness Program
A study testing Adapted Passport to Freedom in people with Trauma, run by Johns Hopkins University at 1 site in United States.
Trial 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.. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Trauma
- What is being tested?
- Adapted Passport to Freedom
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Oct 2019to 23 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 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.
Who cannot join
- Under 18 years of age
- Inability to speak or write English
- Physical or mental health conditions that would prevent meaningful group participation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Passport to Freedom: Adaptation and Implementation of a Wellness Program to Educate and Empower Women Living in Transitional Housing Due to Intimate Partner Violence
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..
Read the detailed description
In a group setting, the intervention will cover topics such as Mindfulness, Health (examine impact of trauma and stress on physical and mental well-being), Healthy relationships, Family matters (coping with conflicts) and Reflection session.
Each group session (5) will last approximately 90 minutes, once weekly, and begin and end with mindfulness exercises. The women are also encouraged to download free mindfulness apps to practice the exercises between sessions.
Women enrolled will receive health information that will cover a range of chronic health topics (pain, asthma, hypertension, diabetes, obesity), to complement already existing tools on mental health and post traumatic syndrome.
Women enrolled will complete surveys:
baseline questionnaires, a pre and post survey during each session, and follow-up questionnaires 4 weeks after the intervention.
- Conditions
- Trauma
- Being tested
- Adapted Passport to Freedom
- Keywords
- trauma, stress, depression, coping, mindfulness
- Medical subject headings
- Wounds and Injuries, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adapted Passport to FreedomBehavioural
5 weekly, 90 minute group sessions that cover topics such as mindfulness, health, healthy relationships, family matters, and reflections.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Adapted Passport to Freedom |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline, 9 weeks
Secondary outcomes (2)
Change in Stress as assessed by Everyday Stressor Index
The Everyday Stressor Index assesses the problems faced on a daily basis by low-income mothers with young children. The instrument has a possible range of 20-80. A higher score indicates a higher level of daily stress.
Measured: Baseline, 9 weeks
Change in Emotions as assessed by Difficulties in Emotion Regulation Scale-Short Form
The Difficulties in Emotion Regulation Scale is a self report measure of subjective emotion ability. The measure yields a total score sum as well as scores on six sub-scales. All subscales are scored so that higher values reflect greater difficulty with emotion regulation.
Measured: Baseline, 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start28 Oct 2019
- Primary completion23 Oct 2021
- Study completion23 Oct 2021
Why it stopped: lack of staff to conduct study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TraumaStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants will receive the intervention. There are no other groups.
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patty Wilson, PhD, RN, Principal investigator, Johns Hopkins University School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04069754
- Sponsor's protocol ID
- IRB00203504
- Status last verified
- Dec 2025
- First submitted
- 23 Aug 2019
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Passport to Freedom: Adaptation and Implementation of a Wellness Program to Educate and Empower Women Living in Transitional Housing Due to Intimate Partner Violence
- ClinicalTrials.gov ID
- NCT04069754
- Acronym / sponsor ID
- IRB00203504
- Conditions
- Trauma
- Keywords
- trauma, stress, depression, coping, mindfulness
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of staff to conduct study
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 28 Oct 2019 (actual)
- Primary completion
- 23 Oct 2021 (actual)
- Study completion
- 23 Oct 2021 (actual)
- First posted
- 28 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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..
Detailed description
In a group setting, the intervention will cover topics such as Mindfulness, Health (examine impact of trauma and stress on physical and mental well-being), Healthy relationships, Family matters (coping with conflicts) and Reflection session.
Each group session (5) will last approximately 90 minutes, once weekly, and begin and end with mindfulness exercises. The women are also encouraged to download free mindfulness apps to practice the exercises between sessions.
Women enrolled will receive health information that will cover a range of chronic health topics (pain, asthma, hypertension, diabetes, obesity), to complement already existing tools on mental health and post traumatic syndrome.
Women enrolled will complete surveys:
baseline questionnaires, a pre and post survey during each session, and follow-up questionnaires 4 weeks after the intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants will receive the intervention. There are no other groups.
| Arm | Type | Receives |
|---|---|---|
| Adapted Passport to Freedom Intervention Arm | Experimental | Behavioral: Adapted Passport to FreedomThe intervention consists of 5 weekly, 90 minute group sessions that cover topics such as mindfulness, health, healthy relationships, family matters, and reflections |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 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.
Key exclusion criteria (3 listed)
- Under 18 years of age
- Inability to speak or write English
- Physical or mental health conditions that would prevent meaningful group participation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adapted Passport to Freedom5 weekly, 90 minute group sessions that cover topics such as mindfulness, health, healthy relationships, family matters, and reflections. | Behavioural | Adapted Passport to Freedom Intervention Arm |
Primary outcome
Change in Physical Health as assessed by the Perceived Health Competence Scale
Time frame: Baseline, 9 weeks
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.
Change in Mental Health as assessed by the Patient Health Questionnaire
Time frame: Baseline, 9 weeks
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.
2 secondary outcomes
Change in Stress as assessed by Everyday Stressor Index
Time frame: Baseline, 9 weeks
Change in Emotions as assessed by Difficulties in Emotion Regulation Scale-Short Form
Time frame: Baseline, 9 weeks
Results and safety
The study was stopped early (reason given: lack of staff to conduct study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
- Individual participant dataSharing planned: No. Individual participant data will not be shared with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patty Wilson, PhD, RN principal investigator
Johns Hopkins University School of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adapted Passport to Freedom in people with Trauma, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: lack of staff to conduct study). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Physical Health as assessed by the Perceived Health Competence Scale (time frame: Baseline, 9 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2025.