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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05611060
Other study ID # Cameron2022
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date October 10, 2022
Est. completion date July 2023

Study information

Verified date November 2022
Source University of California, Merced
Contact Linda D Cameron, Ph.D.
Phone 209-626-6892
Email lcameron@ucmerced.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this intervention trial is to learn test whether participation in the Building Health Life Skills Program leads to improvements in psychological well-being and stress management skills for people who are experiencing homelessness and housing insecurity. The main questions it aims to answer are: - Will participation in the Building Healthy Life Skills Program lead to better skills in managing negative emotions? - Will participation in the Building Healthy Life Skills Program lead to improvements in psychological well-being, sleep quality, and health-related quality of life? Participants will be asked to complete three surveys: one prior to the first session of the program, one at the end of the program, and one three months later. The surveys include measures of skills for managing negative emotions, mood states, sleep quality, health-related quality of life, illness experiences, and history of childhood adversity.


Description:

Community members who are experiencing homelessness and receiving support services from the Merced County Navigation Center and who have enrolled in the center's Building Healthy Life Skills Program will be invited to participate in this intervention evaluation study. The Building Healthy Life Skills program is a 10-week program designed to provide participants with an understanding of how abuse, neglect and household dysfunctions during childhood affect emotional, social, and cognitive well-being; and to provide training in emotion regulation skills, including adaptive emotional processing and expression, mindfulness, and cognitive reappraisal. The sessions are two hours in duration and conducted in classroom style. Open enrollment will be conducted four times a year, serving approximately 60 individuals.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date July 2023
Est. primary completion date July 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Individuals who are receiving support services from the Merced County Navigation Center due their current experiences of housing insecurity or homelessness, and - have enrolled in the Building Healthy Life Skills program Exclusion Criteria: - Individuals under the age of 18 years and those who cannot speak English or Spanish

Study Design


Intervention

Behavioral:
Building Healthy Life Skills Program
The intervention provides education and training in the long-term mental and physical health consequences of childhood adversity and emotion regulation skills.

Locations

Country Name City State
United States University of California Merced Merced California

Sponsors (1)

Lead Sponsor Collaborator
University of California, Merced

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in health-related quality of life as assessed by the SF-12, for which scores range from 0 to 100 with higher scores reflecting better quality of life Health-related quality of life as assessed by the SF 12 Assessed at baseline, immediately following completion of the intervention, and 3 months following intervention completion
Primary Change in depressive symptoms as assessed by the Center for Epidemiological Studies Depression measure, for which averaged rating scores range from 0 to 3 with higher scores reflecting more depressive symptoms Scores on the Center for Epidemiological Studies Depression measure Assessed at baseline, immediately following completion of the intervention, and 3 months following intervention completion
Primary Change in stress as assessed by the Perceived Stress Scale, for which averaged rating scores range from 1 to 5 with higher scores reflecting greater stress Scores on the Perceived Stress Scale Assessed at baseline, immediately following completion of the intervention, and 3 months following intervention completion
Primary Change in rumination as an emotion regulation behavior as assessed by the Rumination and Reflections Questionnaire,for which averaged rating scores range from 1 to t with higher scores reflecting more rumination Scores on the Rumination and Reflections Questionnaire Assessed at baseline, immediately following completion of the intervention, and 3 months following intervention completion
Primary Change in emotional suppression as assessed by the Cortauld Emotional Control Scale (scores range is 1-4, higher scores reflect higher suppression) and the Emotion Regulation Questionnaire (scores range is 1-5, higher scores reflect higher suppression) Scores on the Cortauld Emotional Control Scale and the Emotion Regulation Questionnaire Assessed at baseline, immediately following completion of the intervention, and 3 months following intervention completion
Primary Change in mindfulness as an emotional regulation tendency as assessed by the Mindful Awareness Attention Scale, for which averaged rating scores range from 1 to 5 with higher scores reflecting greater mindfulness tendencies Scores on the Mindful Awareness Attention Scale Assessed at baseline, immediately following completion of the intervention, and 3 months following intervention completion
Primary Change in cognitive reappraisal as an emotion regulation strategy as assessed by the Emotion Regulation Questionnaire, for which averaged rating scores range from 1 to 5 with higher scores reflecting higher use of cognitive reappraisal Scores on the Emotion Regulation Questionnaire Assessed at baseline, immediately following completion of the intervention, and 3 months following intervention completion
Primary Change in general self-efficacy as assessed by the General Self-Efficacy Survey, for which averaged rating scores range from 1 to 5 with higher scores reflecting higher sense of self-efficacy in managing challenging situations Scores on the General Self-Efficacy Survey Assessed at baseline, immediately following completion of the intervention, and 3 months following intervention completion
Primary Change in resilience as assessed by the Ego Resilience 89, for which averaged rating scores range from 1 to 5 with higher scores reflecting higher resilience in managing challenging situations Scores on the Ego Resilience 89 Assessed at baseline, immediately following completion of the intervention, and 3 months following intervention completion
Primary Change in sleep quality as assessed by the Pittsburgh Sleep Quality Inventory, for which averaged rating scores range from 0 to 21 with higher scores reflecting poorer sleep quality Scores on the Pittsburgh Sleep Quality Inventory Assessed at baseline, immediately following completion of the intervention, and 3 months following intervention completion
Primary Change in physical health as assessed by self-reported number of sick days in the past month (ranging from 0 to 31) and a the frequency of 17 symptoms each rated 1 to 5 and higher averaged rating scores reflecting higher symptom loads Scores on a symptom checklist and number of sick days Assessed at baseline, immediately following completion of the intervention, and 3 months following intervention completion
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