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| ID | Type | Description | Link |
|---|---|---|---|
| K23MH125078 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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The proposed K23 study is an intervention study using an experimental therapeutics approach. This pilot RCT asks: "Does SOCIAL-ENGAGE increase cultural-social engagement and decrease suicide risk among Spanish-speaking adults?" We will first optimize a behavioral intervention - SOCIAL ENGAGE (S-ENGAGE) - for target engagement using human-centered design approaches with Spanish-speaking adults at risk for suicide (n=5) and then conduct a pilot RCT (n=60) to test target engagement (cultural-social engagement) and clinical impact (suicide risk) of S-ENGAGE with this population. The ultimate goal is for S-ENGAGE to be offered as a suicide prevention program for Hispanics at risk for suicide.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Social Engage (S-ENGAGE) | Experimental | 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. |
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| The Healthy Lifestyles Education Program | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Social Engage (S-ENGAGE) | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Cultural-Social Engagement (A) | Average number of cultural-social interactions (measured via EMA), with greater number indicating greater cultural-social engagement (i.e., better outcome). | Baseline and 10 weeks |
| Change in Cultural-Social Engagement (B) | 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). | Baseline and 10 weeks |
| Change in Cultural-Social Engagement (C) | 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). | Baseline and 10 weeks |
| Change in Cultural-Social Engagement (D) | 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). | Baseline and 10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Suicide Risk (A) | 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). | Baseline and 10 weeks |
| Change in Suicide Risk (B) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rochester Medical Center | Rochester | New York | 14642 | United States |
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| ID | Term |
|---|---|
| D012934 | Social Isolation |
| D059020 | Suicidal Ideation |
| ID | Term |
|---|---|
| D012919 | Social Behavior |
| D001519 | Behavior |
| D013405 | Suicide |
| D016728 | Self-Injurious Behavior |
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| The Healthy Lifestyles Education Program | Behavioral | 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. |
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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). |
| Baseline and 10 weeks |
| D001526 |
| Behavioral Symptoms |