- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04069754
Passport to Freedom (P2F): Adaptation and Implementation of a Wellness Program
Passport to Freedom: Adaptation and Implementation of a Wellness Program to Educate and Empower Women Living in Transitional Housing Due to Intimate Partner Violence
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21218
- House of Ruth Maryland
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Under 18 years of age
- Inability to speak or write English
- Physical or mental health conditions that would prevent meaningful group participation.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Adapted Passport to Freedom Intervention Arm
The intervention consists of 5 weekly, 90 minute group sessions that cover topics such as mindfulness, health, healthy relationships, family matters, and reflections
|
5 weekly, 90 minute group sessions that cover topics such as mindfulness, health, healthy relationships, family matters, and reflections.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline, 9 weeks
|
|
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.
|
Baseline, 9 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Stress as assessed by Everyday Stressor Index
Time Frame: Baseline, 9 weeks
|
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.
|
Baseline, 9 weeks
|
|
Change in Emotions as assessed by Difficulties in Emotion Regulation Scale-Short Form
Time Frame: Baseline, 9 weeks
|
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.
|
Baseline, 9 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Patty Wilson, PhD, RN, Johns Hopkins University School of Nursing
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00203504
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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