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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04069754
Other study ID # IRB00203504
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 28, 2019
Est. completion date December 2024

Study information

Verified date November 2023
Source Johns Hopkins University
Contact Patty Wilson, PhD, PMHNP
Phone 443-287-5719
Email pwilso23@jhu.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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..


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date December 2024
Est. primary completion date November 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Adapted Passport to Freedom
5 weekly, 90 minute group sessions that cover topics such as mindfulness, health, healthy relationships, family matters, and reflections.

Locations

Country Name City State
United States House of Ruth Maryland Baltimore Maryland

Sponsors (1)

Lead Sponsor Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 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. Baseline, 9 weeks
Secondary 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. Baseline, 9 weeks
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