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VOICES Socials for Older Veterans With Depression

NCT ID: NCT06145334

Last Updated: 2024-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-02

Study Completion Date

2026-01-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Depression Loneliness Isolation

Keywords

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Veteran Depression Loneliness Isolation Veteran Socials Community Socialization Older Adults

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Veterans Social

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

Group Type EXPERIMENTAL

Veterans Social

Intervention Type BEHAVIORAL

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

Interventions

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Veterans Social

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

Intervention Type BEHAVIORAL

Other Intervention Names

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VOICES Veterans Social

Eligibility Criteria

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Inclusion Criteria

* 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)

Exclusion Criteria

* 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)
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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VA Office of Research and Development

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jay Gorman, PsyD

Role: PRINCIPAL_INVESTIGATOR

VA Bedford HealthCare System, Bedford, MA

Locations

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VA Bedford HealthCare System, Bedford, MA

Bedford, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Jay Gorman, PsyD

Role: CONTACT

Phone: (781) 687-4562

Email: [email protected]

Kendra Pugh, PhD

Role: CONTACT

Phone: (781) 957-6538

Email: [email protected]

Facility Contacts

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John M Wells, PhD

Role: primary

Denise Carr

Role: backup

Other Identifiers

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1I02RX004872-01P0

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

D4894-P

Identifier Type: -

Identifier Source: org_study_id