Culture and Well-Being for Latinos
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|ClinicalTrials.gov Identifier: NCT05244733|
Recruitment Status : Recruiting
First Posted : February 17, 2022
Last Update Posted : June 21, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Social Isolation Loneliness Suicidal Ideation||Behavioral: Social Engage (S-ENGAGE) Behavioral: The Healthy Lifestyles Education Program||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||65 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Culture and Well-Being for Latinos: Study Protocol for Cultural-Social Engagement and Suicide Among Hispanics (K23MH125078)|
|Actual Study Start Date :||June 1, 2022|
|Estimated Primary Completion Date :||October 31, 2024|
|Estimated Study Completion Date :||October 31, 2024|
Experimental: Social Engage (S-ENGAGE)
S-ENGAGE is a skills-based psychotherapy that focuses on helping patients engage in meaningful rewarding social activities. Subjects will receive 10 one-hour individual sessions of S-ENGAGE over 10 weeks.
Behavioral: Social Engage (S-ENGAGE)
S-ENGAGE uses the process of action planning to foster sustained behavior change. Action planning involves: 1) select a goal; 2) develop ideas to meet this goal; 3) choose one or more of these ideas; 4) identify concrete steps to implement the goal (i.e., form an action plan); 5) identify and address barriers if needed.
Placebo Comparator: The Healthy Lifestyles Education Program
The healthy lifestyles education program consists of a notebook containing evidence-based educational material on mental health, physical activity, and information on community resources. Study staff meet with participants once, individually, for 1 hour to review each section and answer questions participants might have.
Behavioral: The Healthy Lifestyles Education Program
The healthy lifestyles education program is a self-guided psychoeducational program, including a notebook containing evidence-based educational material on mental health, physical activity, and information on community resources.
- Change in Cultural-Social Engagement (A) [ Time Frame: Baseline and 10 weeks ]Average number of cultural-social interactions (measured via EMA), with greater number indicating greater cultural-social engagement (i.e., better outcome).
- Change in Cultural-Social Engagement (B) [ Time Frame: Baseline and 10 weeks ]Time spent in positive Spanish-language conversations (measured via passive monitoring of conversations), with more time indicating greater cultural-social engagement (i.e., better outcome).
- Change in Cultural-Social Engagement (C) [ Time Frame: Baseline and 10 weeks ]Number of visits to cultural-social settings outside the home (measured via GPS), with greater number indicating greater cultural-social engagement (i.e., better outcome).
- Change in Cultural-Social Engagement (D) [ Time Frame: Baseline and 10 weeks ]Self-reported feelings of belonging to Hispanic cultural groups (measured via EMA with the Interpersonal Needs Questionnaire), with greater scores indicating greater cultural-social engagement (i.e., better outcome).
- Change in Suicide Risk (A) [ Time Frame: Baseline and 10 weeks ]Reasons for living total score, measured by the Reasons for Living Inventory, with 48 items rated from 1 to 6, with greater scores indicating greater importance for reasons for living (i.e., better outcome).
- Change in Suicide Risk (B) [ Time Frame: Baseline and 10 weeks ]Suicide ideation total score, measured by the Beck Scale for Suicide Ideation, with scores ranging from 0 to 38, with greater scores indicating greater suicide ideation (i.e., worse outcome).
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Identify as Hispanic/Latino adult (age 18+);
- Primary Spanish-Speaker;
- Patient in the UR health system;
- Low cultural-social engagement (i.e., score ≤ 2 on the adapted Berkman-Syme Social Network Index);
- Elevated suicide risk (i.e., presence of passive or active suicide ideation in the past month on the Columbia-Suicide Severity Rating Scale [C-SSRS]).
- Medical or psychiatric comorbidities that impair ability to consent (e.g., active psychotic or manic episode, cognitive impairment).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05244733
|Contact: Caroline Silva, PhDfirstname.lastname@example.org|
|United States, New York|
|University of Rochester Medical Center||Recruiting|
|Rochester, New York, United States, 14642|
|Contact: Caroline Silva, PhD 585-275-2392 email@example.com|
|Responsible Party:||Caroline Silva, Assistant Professor, University of Rochester|
|Other Study ID Numbers:||
K23MH125078 ( U.S. NIH Grant/Contract )
|First Posted:||February 17, 2022 Key Record Dates|
|Last Update Posted:||June 21, 2022|
|Last Verified:||June 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|