VOICES Socials for Older Veterans With Depression

Depression Clinical Trial

Official title:

VOICES Socials for Older Veterans With Depression

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06145334
• Other study ID #: D4894-P
• Secondary ID: 1I02RX004872-01P
• Status: Recruiting
• Phase: N/A
• Start date: January 2, 2024
• Est. completion date: January 1, 2026

Study information

• Verified date: January 2024
• Source: VA Office of Research and Development
• Contact: Jay Gorman, PsyD
• Phone: (781) 687-4562
• Email: Jay.Gorman[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 33
• Est. completion date: January 1, 2026
• Est. primary completion date: January 1, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Documented depressive disorder or score of > 2 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)

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)

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Isolation
• Loneliness

Intervention

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

Locations

Country	Name	City	State
United States	VA Bedford HealthCare System, Bedford, MA	Bedford	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Health Questionnaire -2 (PHQ-2)- CHANGE IS BEING ASSESSED	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.	Baseline, 4 month, 7 month
Primary	Beck Depression Inventory-II (BDI-II)- CHANGE IS BEING ASSESSED	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, 4 month, 7 month
Primary	Duke Social Support Index (DSSI)- CHANGE IS BEING ASSESSED	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, 4 month, 7 month
Primary	Lubben social network scale - 6 (LSNS-6)- CHANGE IS BEING ASSESSED	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, 4 month, 7 month
Primary	Patient-Reported Outcomes Measurement Information System (PROMIS) for Emotional Support and Informational Support- CHANGE IS BEING ASSESSED	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
Primary	UCLA Loneliness Scale, Version 3 (UCLA)- CHANGE IS BEING ASSESSED	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, 4 month, 7 month
Primary	Interpersonal Needs Questionnaire-15 (INQ-15)- CHANGE IS BEING ASSESSED	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, 4 month, 7 month
Primary	Client Satisfaction Questionaire-8 (CSQ-8)- CHANGE IS BEING ASSESSED	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
Primary	VOICES Social Post-Interview (VSPI)- CHANGE IS BEING ASSESSED	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, 4 month, 7 month
Primary	Friend Acquisition Questionnaire- CHANGE IS BEING ASSESSED	Friend Acquisition Questionnaire is a 3-item questionnaire measuring utilization of the Veterans Socials for building structural social connections.	Baseline, 4 month, 7 month
Primary	VS Facilitator Training Evaluation- CHANGE IS BEING ASSESSED	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, 4 month
Primary	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
Primary	The Learning-Transfer Evaluation Model (LTEM)- CHANGE IS BEING ASSESSED	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, 4 month, 7 month