Increasing Veterans' Social Engagement and Connectedness
ConditionSocial Isolation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVA Office of Research and Development
About this trial
Social isolation is a negative social determinant of health that affects 1-in-5 adults in the U.S. and 43% of Veterans. Social isolation is estimated to cost the nation $6.7 billion annually in federal healthcare spending. Yet, social isolation has rarely been the direct focus of healthcare interventions. The proposed project is a randomized controlled trial that seeks to test the effectiveness of the Increasing Veterans' Social Engagement and Connectedness (CONNECTED) intervention on social isolation among diverse Veteran groups in primary care clinics. Increasing Veterans' Social Engagement and Connectedness involves three key services delivered by peers via telehealth through individual and group sessions over 8 weeks: 1) peer support, which includes person-centered assessment for social isolation, 2) psychosocial interventions to address social isolation, and 3) navigation (i.e., connecting Veterans to social resources). Findings from this study will contribute to the VA's efforts to address social determinants of health among Veterans and to provide high quality, person-centered, and equitable care to all Veterans.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Must be Veterans at the Roudebush Veterans Affairs Medical Center or its Community-Based Outpatient Clinics who had a primary care encounter in the prior 6 months and
Veteran obtained a score 12, indicating social isolation, on the Lubben Social Isolation Scale (LSNS-6), a validated, 6-item social isolation measure, at the time of screening in Aim 1.
Disqualifiers
Active suicidal ideation needing immediate mental health treatment
severe cognitive, hearing or speech impairment,
current exacerbation of severe psychiatric symptoms (e.g., active psychosis), or
severe illness that makes study participation not feasible.
Trial design
Design model
Parallel
Treatments tested in this trial
CONNECTED
BehavioralCONNECTED is a manualized, peer-led, group-based social isolation intervention for diverse Veteran populations in VA primary care settings. It is delivered via videoconference through individual and group sessions over 8 weeks.
VET BEFRIENDING
BehavioralVET BEFRIENDING (attention control arm) consists of weekly social interactions with a research assistant (RA) over videoconference or phone.
Treatment groups
264 Participants
are divided into 2 treatment groupsGroup A: CONNECTEDExperimental treatment 1 intervention
Group B: VET BEFRIENDINGActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Lubben Social Network Scale-6
The Lubben Social Network Scale-6 is a widely used, 6-item, self-reported measure of social isolation. It measures the frequency, size, and closeness of contact from respondents' social network. The scale has been used in both young and older adult populations, in racially diverse groups and in various settings and countries. Items are scored on a 6-point Likert scale, with total scores ranging from 0 (minimum) to 30 (maximum). Scores ≤ 12 indicate social isolation. The Lubben Social Network Scale-6 has strong internal consistency ( alpha = 0.83) and item reliability. There are no subscales.
Time frame
Baseline, 2, 4, 8 monthsSecondary outcomes
1
UCLA Loneliness Scale Short Form
The UCLA Loneliness Scale Short Form is a 6-item, self-reported measure, rated on a 4-point Likert Scale, ranging from 1 (never) to 4 (often). Items are summed for a total score ranging from 6 (minimum) to 24 (maximum). There is no subscale. The scale has demonstrated internal consistency. Higher scores indicate greater loneliness. The Cronbach coefficient alpha for this sample was 0.90.
Time frame
Baseline, 2, 4, 8 months2
General Anxiety Disorder
General Anxiety Disorder-7, a validated self-reported measure of anxiety. It has 7 items rated on a 4-point Likert scale, 0=not at all to 3= nearly every day. The scale has a total summed score of 0 (minimum) to 21 (maximum). It has shown reliability, internal consistency ( = 0.89), and good sensitivity. A meaningful change is indicated by 5 or more points. A total score of 1-4 indicates minimal symptoms, 5-9 mild symptoms, 10-14 moderate symptoms, and 12-21 severe symptoms.
Time frame
Baseline, 2, 4, 8 months3
Patient Health Questionnaire-9
The Patient Health Questionnaire-9 is a self-administered instrument used for screening, diagnosing, and monitoring the severity of depression. It has 9 items rated on a 4-point Likert Scale, ranging from 0=not at all to 3= nearly every day. The Patient Health Questionnaire-9 score is obtained by adding score for each item, for a total points ranging from 0 (minimum) to 27 (maximum). Total scores of 5, 10, 15, and 20 represent cutpoints for mild, moderate, moderately severe, and severe depression respectively. The internal reliability of the Patient Health Questionnaire-9 was excellent, with a Cronbach's alpha of 0.89.
Time frame
Baseline, 2, 4, 8 months4
Multidimensional Scale of Perceived Social Support
Multi-dimensional Scale of Perceived Social Support scale is self-administered. It has 12-items, measured on a 7-point a Likert scale (1=very strongly disagree) to 7=(very strongly agree). Total scale score is the sum across all 12 items. It can also be calculated as a mean score (divided by 12). Summed total score ranges from 12 (minimum) to 84 (maximum). The scale has high internal consistency ( alpha = .88). There is no established population norms on the Multidimensional Scale of Perceived Social Support. There are 3 subscales. There are 3 subscales, with 4 item each. Their scores are the sum of the items divided by 4. Significant Other subscale (items 1, 2, 5, 10), Family subscale (3, 4, 8, 11), and Friends subscale (6, 7, 9, 12).
Time frame
Baseline, 2, 4, 8 monthsSponsors and contacts
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Source ClinicalTrials.gov