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临床试验/NCT06145334
NCT06145334已完成不适用

VOICES Socials for Older Veterans With Depression

VA Office of Research and Development1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2024年1月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
18
试验地点
1
主要终点
Patient Health Questionnaire -2 (PHQ-2)- CHANGE IS BEING ASSESSED

研究概览

简要总结

VOICES Veterans Socials (VS) support Veterans in the community through weekly social groups. Veterans socials have the potential to improve social functioning, mental health symptoms, and create lasting social support. This project aims to evaluate and improve Veterans Socials to help older Veterans with depression by adapting materials, interviewing VS attendees, and collecting questionnaires. The goal is to improve the program based on the results for future use and research.

详细描述

VOICES Veterans Socials is a peer-led weekly social group based in the community designed to promote sustainable social support among Veterans. The research seeks to adapt and conduct a preliminary evaluation of the Veterans Socials (VS) intervention with older Veterans. The study will develop a training procedure for VS facilitators and evaluate an open trial of this intervention. This study will determine whether a larger-scale, more definitive VS study is indicated

Phase 1: 13 total participants will engage in semi-structured interviews about barriers to social engagement, challenges around community-based activities, social support acquisition, and how their age and Veteran status intersects with these constructs.

Phase 2: 20 participants will be recruited for VOICES Veterans Socials (VS) which will be conducted in 2-4 community-based social groups, with 5-10 participants in each social group. The investigators will conduct data collection on three occasions; at enrollment (pre; 0 months), at intervention completion (post; including semi-structured interview; 4 months) and at follow-up (7 months).

VS Procedures. Twenty Veterans aged 65 or older with depression will engage in VS. Veterans will receive 90-minutes of weekly social engagement in a community-setting in accordance with the VS manual. Each week will focus on social connections, engagement in social activities, and reinforcing behaviors that give individuals meaning and purpose.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Documented depressive disorder or score of 2 or more on the Patient Health Questionnaire-2 (PHQ-2)
  • Capacity to consent as determined by the University of California, San Diego Brief Assessment of Capacity to Consent (UBACC)
  • Score of 1 or more on question 3 of the UCLA-3 OR score of 3 or less on question 4 of the Lubben Social Network Scale 6 (LSNS-6)

排除标准

  • DSM-5 diagnosis of Schizophrenia Spectrum Disorder or Bipolar Disorder
  • Symptoms of psychosis that would interfere with study participation
  • Probable Dementia as determined by the 6-item Cognitive Impairment Screener
  • Suicidal ideation with plan or intent
  • Non-English speaking
  • Active substance use disorder (DSM-5) (within 30 days of study entry)

研究组 & 干预措施

Veterans Social

Experimental

Peer-led weekly community-based social groups (16 weeks)

干预措施: Veterans Social (Behavioral)

结局指标

主要结局

Patient Health Questionnaire -2 (PHQ-2)- CHANGE IS BEING ASSESSED

时间窗: Baseline, 4 month, 7 month

Patient Health Questionnaire -2 (PHQ-2) is a 2-item screening tool that includes the first two items of the PHQ-9. It is frequently used to identify patients in which major depressive disorder is likely. A PHQ-2 score ranges from 0-6, with a score of 3 or greater indicating major depressive disorder is likely.

Beck Depression Inventory-II (BDI-II)- CHANGE IS BEING ASSESSED

时间窗: Baseline, 4 month, 7 month

Beck Depression Inventory-II (BDI-II) is a 21-item self-administered screening tool measuring the severity of depression in adolescents and adults. Higher scores indicate more depressive symptoms. The highest score is 63 and the lowest possible score for the test is zero.

Duke Social Support Index (DSSI)- CHANGE IS BEING ASSESSED

时间窗: Baseline, 4 month, 7 month

The Duke Social Support Index (DSSI) includes twenty-three items in three subscales: social interaction, subjective social support, and instrumental support). They are scored using a 3-point Likert scale and together assess social isolation. The scale ranges from 7 to 21 with higher scores indicating more social support. Only the Social Interaction (4 items) and Subjective Social Support (7 items) subscales will be used.

Lubben social network scale - 6 (LSNS-6)- CHANGE IS BEING ASSESSED

时间窗: Baseline, 4 month, 7 month

The Lubben social network scale - 6 (LSNS-6) is a 6 item self-report measure of social engagement including family and friends. Scores range from 0-5 with higher scores indicating higher social engagement.

Patient-Reported Outcomes Measurement Information System (PROMIS) for Emotional Support and Informational Support- CHANGE IS BEING ASSESSED

时间窗: Baseline, 4 month, 7 month

The Patient-Reported Outcomes Measurement Information System (PROMIS) for Emotional Support and Informational Support consists of eight items each. The PROMIS Emotional Support (PROMIS-ES) measures the availability of others to speak with and feel appreciated by, whereas the PROMIS Informational Support (PROMIS-IS) measure captures perceived availability of advice or helpful information. Scores range from 1-5 with higher scores indicating higher support.

UCLA Loneliness Scale, Version 3 (UCLA)- CHANGE IS BEING ASSESSED

时间窗: Baseline, 4 month, 7 month

UCLA Loneliness Scale, Version 3 (UCLA) is a 20-item questionnaire that measures one's subjective feelings of loneliness and social isolation. Response options for each item range from 0 (Never) to 4 (often). Total scores range from 0 to 80 with higher scores indicating higher loneliness.

Interpersonal Needs Questionnaire-15 (INQ-15)- CHANGE IS BEING ASSESSED

时间窗: Baseline, 4 month, 7 month

The INQ-15 (19) is a self-report measure composed of 15 items that evaluate the main constructs of interpersonal suicide theory (8): PB (items 1-6), and TB (items 7-15). The items are answered on a 1-7 Likert scale with response options ranging from "Not at all true for me" to "Very true for me."

Client Satisfaction Questionaire-8 (CSQ-8)- CHANGE IS BEING ASSESSED

时间窗: Baseline, 4 month, 7 month

Client Satisfaction Questionaire-8 (CSQ-8) is an 8-item measure of participant satisfaction with the intervention. Scores on the CSQ-8 range from 8-32 with a higher score indicating higher satisfaction

VOICES Social Post-Interview (VSPI)- CHANGE IS BEING ASSESSED

时间窗: Baseline, 4 month, 7 month

VOICES Social Post-Interview (VSPI) is a brief interview (up to 30 minutes) that will consist of open and closed questions about initiation of the event, process of engaging with other participants, friend acquisition, as well as resources or key knowledge (e.g., healthcare, community opportunities) discovered.

Friend Acquisition Questionnaire- CHANGE IS BEING ASSESSED

时间窗: Baseline, 4 month, 7 month

Friend Acquisition Questionnaire is a 3-item questionnaire measuring utilization of the Veterans Socials for building structural social connections.

VS Facilitator Training Evaluation- CHANGE IS BEING ASSESSED

时间窗: Baseline, 4 month

The VS Facilitator Training Evaluation consists of approximately seventeen open and multiple-choice questions that immediately follow training and approximately four open and multiple-choice questions after a delay, when the VS facilitators begin implementing VS

VS Fidelity Checklist

时间窗: Baseline, 4 month, 7 month-- CHANGE IS BEING ASSESSED

The VS Fidelity Checklist measure consists of nineteen elements that guide facilitators through how best to maintain successful VS.

The Learning-Transfer Evaluation Model (LTEM)- CHANGE IS BEING ASSESSED

时间窗: Baseline, 4 month, 7 month

The Learning-Transfer Evaluation Model (LTEM) is an eight level model that divides the learning process into eight stages (attendance, activity, learner perceptions, knowledge, Decision making competence, task competence, transfer, and effects of transfer) and identifies the relevant assessment aspects for learning success at each stage.

The Berkman-Syme Social Network Index Adapted- CHANGE IS BEING ASSESSED

时间窗: baseline. 4 month, 7 month

a 4 item self report measure, and selected items will be used to assess the type, size, closeness, and frequency of contacts in a respondent's current social network. Respondents are categorized into four levels of social connection: socially isolated, moderately isolated, moderately integrated, and socially integrated. Scores range from 0 to 4, with 0 representing the highest level of social isolation and 4 representing the lowest level of social isolation.

Beck Depression Inventory-II (BDI-II)

时间窗: Baseline and 7 month

Beck Depression Inventory-II (BDI-II) is a 21-item self-administered screening tool measuring the severity of depression in adolescents and adults. Higher scores indicate more depressive symptoms. The highest score is 63 and the lowest possible score for the test is zero.

Duke Social Support Index (DSSI)

时间窗: Baseline and 7 month

The Duke Social Support Index (DSSI) includes twenty-three items in three subscales: social interaction, subjective social support, and instrumental support). They are scored using a 3-point Likert scale and together assess social isolation. The scale ranges from 7 to 21 with higher scores indicating more social support. Only the Social Interaction (4 items) and Subjective Social Support (7 items) subscales will be used.

Lubben social network scale - 6 (LSNS-6)

时间窗: Baseline and 7 month

The Lubben social network scale - 6 (LSNS-6) is a 6 item self-report measure of social engagement including family and friends. Scores range from 0-5 with higher scores indicating higher social engagement.

Patient-Reported Outcomes Measurement Information System (PROMIS) for Emotional Support and Informational Support

时间窗: Baseline, 4 month, 7 month

The Patient-Reported Outcomes Measurement Information System (PROMIS) for Emotional Support and Informational Support consists of eight items each. The PROMIS Emotional Support (PROMIS-ES) measures the availability of others to speak with and feel appreciated by, whereas the PROMIS Informational Support (PROMIS-IS) measure captures perceived availability of advice or helpful information. Scores range from 1-5 with higher scores indicating higher support.

UCLA Loneliness Scale, Version 3 (UCLA)

时间窗: Baseline and 7 month

UCLA Loneliness Scale, Version 3 (UCLA) is a 20-item questionnaire that measures one's subjective feelings of loneliness and social isolation. Response options for each item range from 0 (Never) to 4 (often). Total scores range from 0 to 80 with higher scores indicating higher loneliness.

Interpersonal Needs Questionnaire-15 (INQ-15)

时间窗: Baseline and 7 month

The INQ-15 (19) is a self-report measure composed of 15 items that evaluate the main constructs of interpersonal suicide theory (8): PB (items 1-6), and TB (items 7-15). The items are answered on a 1-7 Likert scale with response options ranging from "Not at all true for me" to "Very true for me."

Client Satisfaction Questionaire-8 (CSQ-8)

时间窗: Baseline, 4 month, 7 month

Client Satisfaction Questionaire-8 (CSQ-8) is an 8-item measure of participant satisfaction with the intervention. Scores on the CSQ-8 range from 8-32 with a higher score indicating higher satisfaction

VOICES Social Post-Interview (VSPI)

时间窗: Baseline and 7 month

VOICES Social Post-Interview (VSPI) is a brief interview (up to 30 minutes) that will consist of open and closed questions about initiation of the event, process of engaging with other participants, friend acquisition, as well as resources or key knowledge (e.g., healthcare, community opportunities) discovered.

Friend Acquisition Questionnaire

时间窗: Baseline and 7 month

Friend Acquisition Questionnaire is a 3-item questionnaire measuring utilization of the Veterans Socials for building structural social connections.

VS Facilitator Training Evaluation

时间窗: Baseline and 7 month

The VS Facilitator Training Evaluation consists of approximately seventeen open and multiple-choice questions that immediately follow training and approximately four open and multiple-choice questions after a delay, when the VS facilitators begin implementing VS

The Learning-Transfer Evaluation Model (LTEM)

时间窗: Baseline and 7 month

The Learning-Transfer Evaluation Model (LTEM) is an eight level model that divides the learning process into eight stages (attendance, activity, learner perceptions, knowledge, Decision making competence, task competence, transfer, and effects of transfer) and identifies the relevant assessment aspects for learning success at each stage.

The Berkman-Syme Social Network Index Adapted

时间窗: Baseline and 7 month

a 4 item self report measure, and selected items will be used to assess the type, size, closeness, and frequency of contacts in a respondent's current social network. Respondents are categorized into four levels of social connection: socially isolated, moderately isolated, moderately integrated, and socially integrated. Scores range from 0 to 4, with 0 representing the highest level of social isolation and 4 representing the lowest level of social isolation.

次要结局

未报告次要终点

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (1)

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VOICES Socials for Older Veterans With Depression | 临床试验