VOICES Socials for Older Veterans With Depression

NCT06145334 | Completed

• 2 other identifiers: D4894-P1I02RX004872-01P0
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Loneliness; Isolation; Depression

Keywords

Veteran; Depression; Loneliness; Isolation; Veteran Socials; Community; Socialization; Older Adults

Outcome Measures

Primary Outcomes (13)

• Beck Depression Inventory-II (BDI-II)

  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.

  Baseline and 7 month

• Duke Social Support Index (DSSI)

  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.

  Baseline and 7 month

• Lubben social network scale - 6 (LSNS-6)

  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.

  Baseline and 7 month

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

  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.

  Baseline, 4 month, 7 month

• UCLA Loneliness Scale, Version 3 (UCLA)

  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.

  Baseline and 7 month

• Interpersonal Needs Questionnaire-15 (INQ-15)

  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."

  Baseline and 7 month

• Client Satisfaction Questionaire-8 (CSQ-8)

  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

  Baseline, 4 month, 7 month

• VOICES Social Post-Interview (VSPI)

  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.

  Baseline and 7 month

• Friend Acquisition Questionnaire

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

  Baseline and 7 month

• VS Facilitator Training Evaluation

  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

  Baseline and 7 month

• VS Fidelity Checklist

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

  Baseline, 4 month, 7 month-- CHANGE IS BEING ASSESSED

• The Learning-Transfer Evaluation Model (LTEM)

  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.

  Baseline and 7 month

• The Berkman-Syme Social Network Index Adapted

  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.

  Baseline and 7 month

Other Outcomes (1)

• Patient Health Questionnaire -2 (PHQ-2)

  Screener

Study Arms (1)

Veterans Social

EXPERIMENTAL

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

Behavioral: Veterans Social

Interventions

Veterans Social BEHAVIORAL

Peer-led weekly community-based social groups (16 weeks) that are current treatment at the study site.

Also known as: VOICES Veterans Social

Veterans Social

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Bedford HealthCare System, Bedford, MA

Bedford, Massachusetts, 01730-1114, United States

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Jay Gorman, PsyD

  VA Bedford HealthCare System, Bedford, MA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Twenty Veterans aged 65 or older with depression will engage in the intervention, Veterans Socials (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. Each VS will be held in a community setting across 4 months. The investigators will evaluate the feasibility of VS including fidelity, retention, acceptability of the intervention and preliminary outcomes around social functioning.

Study Record Dates

• First Submitted: November 14, 2023
• First Posted: November 24, 2023
• Study Start: January 2, 2024
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)