- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06145334
VOICES Socials for Older Veterans With Depression
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Massachusetts
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Bedford, Massachusetts, United States, 01730-1114
- VA Bedford HealthCare System, Bedford, MA
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Veterans Social
Peer-led weekly community-based social groups (16 weeks)
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Peer-led weekly community-based social groups (16 weeks) that are current treatment at the study site.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
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Baseline, 4 month, 7 month-- CHANGE IS BEING ASSESSED
|
|
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.
|
Baseline and 7 month
|
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Duke Social Support Index (DSSI)
Time Frame: Baseline and 7 month
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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)
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.
|
Baseline and 7 month
|
|
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.
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Baseline, 4 month, 7 month
|
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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.
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Baseline and 7 month
|
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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."
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Baseline and 7 month
|
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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
|
Baseline, 4 month, 7 month
|
|
VOICES Social Post-Interview (VSPI)
Time Frame: Baseline and 7 month
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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.
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Baseline and 7 month
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Friend Acquisition Questionnaire
Time Frame: Baseline and 7 month
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Friend Acquisition Questionnaire is a 3-item questionnaire measuring utilization of the Veterans Socials for building structural social connections.
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Baseline and 7 month
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VS Facilitator Training Evaluation
Time Frame: Baseline and 7 month
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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
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Baseline and 7 month
|
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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.
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Baseline and 7 month
|
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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.
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Baseline and 7 month
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient Health Questionnaire -2 (PHQ-2)
Time Frame: Screener
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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.
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Screener
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Collaborators and Investigators
Investigators
- Principal Investigator: Jay Gorman, PsyD, VA Bedford HealthCare System, Bedford, MA
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- D4894-P
- 1I02RX004872-01P0 (Other Grant/Funding Number: RR&D)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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