Clinical trial NCT06145334: VOICES Socials for Older Veterans With Depression
Official title: VOICES Socials for Older Veterans With Depression
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depression
Loneliness
Isolation
Keywords: Veteran
Depression
Loneliness
Isolation
Veteran Socials
Community
Socialization
Older Adults
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2023-11-24
Enrollment: 33
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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 purpose: OTHER

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.

Detailed description: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Patient Health Questionnaire -2 (PHQ-2)- CHANGE IS BEING ASSESSED
timeFrame: Baseline, 4 month, 7 month
measure: Beck Depression Inventory-II (BDI-II)- CHANGE IS BEING ASSESSED
timeFrame: Baseline, 4 month, 7 month
measure: Duke Social Support Index (DSSI)- CHANGE IS BEING ASSESSED
timeFrame: Baseline, 4 month, 7 month
measure: Lubben social network scale - 6 (LSNS-6)- CHANGE IS BEING ASSESSED
timeFrame: Baseline, 4 month, 7 month
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) for Emotional Support and Informational Support- CHANGE IS BEING ASSESSED
timeFrame: Baseline, 4 month, 7 month
measure: UCLA Loneliness Scale, Version 3 (UCLA)- CHANGE IS BEING ASSESSED
timeFrame: Baseline, 4 month, 7 month
measure: Interpersonal Needs Questionnaire-15 (INQ-15)- CHANGE IS BEING ASSESSED
timeFrame: Baseline, 4 month, 7 month
measure: Client Satisfaction Questionaire-8 (CSQ-8)- CHANGE IS BEING ASSESSED
timeFrame: Baseline, 4 month, 7 month
measure: VOICES Social Post-Interview (VSPI)- CHANGE IS BEING ASSESSED
timeFrame: Baseline, 4 month, 7 month
measure: Friend Acquisition Questionnaire- CHANGE IS BEING ASSESSED
timeFrame: Baseline, 4 month, 7 month
measure: VS Facilitator Training Evaluation- CHANGE IS BEING ASSESSED
timeFrame: Baseline, 4 month
measure: VS Fidelity Checklist
timeFrame: Baseline, 4 month, 7 month-- CHANGE IS BEING ASSESSED
measure: The Learning-Transfer Evaluation Model (LTEM)- CHANGE IS BEING ASSESSED
timeFrame: Baseline, 4 month, 7 month
measure: The Berkman-Syme Social Network Index Adapted- CHANGE IS BEING ASSESSED
timeFrame: baseline. 4 month, 7 month
Secondary outcomes:
Other outcomes:
Locations:
city: Bedford
country: United States
facility: VA Bedford HealthCare System, Bedford, MA
state: Massachusetts
Study officials:
affiliation: VA Bedford HealthCare System, Bedford, MA
name: Jay Gorman, PsyD
role: PRINCIPAL_INVESTIGATOR
References: