Evaluation of the Building Healthy Life Skills Program

Emotion Regulation Clinical Trial

Official title:

Building Healthy Life Skills for Merced County Navigation Center

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05611060
• Other study ID #: Cameron2022
• Status: Recruiting
• Phase: Phase 2
• 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
• 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

Related Conditions & MeSH terms

• Adverse Childhood Experiences
• Emotion Regulation
• Housing Problems

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