DepressionNCT06145334

VOICES Socials for Older Veterans With Depression

A study testing Veterans Social in people with Depression and Loneliness, run by VA Office of Research and Development at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 65 years and olderHealthy volunteers can take part
Conditions the study is for: Depression, Loneliness, Isolation
What is being tested?: Veterans Social
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 18 participants
Where: 1 siteUnited States
Study dates: 2 Jan 2024to 1 Jan 2026
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 65 years and older
All sexes
Healthy volunteers accepted
Older adult

Who may be able to join

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)

Who cannot join

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)

Trial locations and contacts

1 site in 1 country.

United States1 site

VA Bedford HealthCare System, Bedford, MA
Bedford, Massachusetts, 01730-1114

Other trials in United States

About this study

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.

Read the 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.

Conditions: Depression, Loneliness, Isolation
Being tested: Veterans Social
Keywords: Veteran, Depression, Loneliness, Isolation, Veteran Socials, Community, Socialization, Older Adults
Medical subject headings: Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Veterans SocialBehavioural
Also called VOICES Veterans Social
Peer-led weekly community-based social groups (16 weeks) that are current treatment at the study site.

Study groups in NCT06145334
Study group	Role	What they receive
Veterans Social	Experimental	Peer-led weekly community-based social groups (16 weeks) Receives: Behavioral: Veterans Social

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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."
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and 7 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Jan 20241 Jan 2026

First posted24 Nov 2023
Study start2 Jan 2024
Primary completion1 Jan 2026
Study completion1 Jan 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for DepressionStudies of the same condition, open and under way.
More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
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.
Masking: None (open label)
Enrolment: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06145334
Sponsor's protocol ID: D4894-P
Other IDs: 1I02RX004872-01P0
Status last verified: Apr 2026
First submitted: 14 Nov 2023
Last updated: 28 Apr 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: VOICES Socials for Older Veterans With Depression
ClinicalTrials.gov ID: NCT06145334
Acronym / sponsor ID: D4894-P
Conditions: Depression, Loneliness, Isolation
Keywords: Veteran, Depression, Loneliness, Isolation, Veteran Socials, Community, Socialization, Older Adults
Study type: Interventional
Recruitment status: Completed
Enrolment: 18 participants (actual)
Lead sponsor: VA Office of Research and DevelopmentUS federal agency
Study start: 2 Jan 2024 (actual)
Primary completion: 1 Jan 2026 (actual)
Study completion: 1 Jan 2026 (actual)
First posted: 24 Nov 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
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.

Arm	Type	Receives
Veterans Social	Experimental	Behavioral: Veterans SocialPeer-led weekly community-based social groups (16 weeks)

Who may qualify

Ages: 65 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Older adult

Key inclusion criteria (3 listed)

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)

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Veterans SocialAlso: VOICES Veterans SocialPeer-led weekly community-based social groups (16 weeks) that are current treatment at the study site.	Behavioural	Veterans Social

Primary outcome

Beck Depression Inventory-II (BDI-II)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
VS Fidelity Checklist
Time frame: 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)
Time frame: 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
Time frame: 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.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jay Gorman, PsyD principal investigator

VA Bedford HealthCare System, Bedford, MA

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Veterans Social in people with Depression and Loneliness, run by VA Office of Research and Development at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Beck Depression Inventory-II (BDI-II) (time frame: Baseline and 7 month). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06145334.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.