Increasing Veterans' Social Engagement and Connectedness

Browse trials for

• Social Isolation 236

Keywords

• Veterans
• Peer specialists
• Loneliness
• Navigation

Social Isolation

236 studies on the registry are indexed under Social Isolation; 61 are open to participants now.

This study's planned enrollment of 264 is above the median of 80 across 198 interventional studies indexed under Social Isolation.

Lead sponsor

VA Office of Research and Development is the lead sponsor of 1,771 studies on the registry; 392 are open to participants now.

Of its 213 completed or terminated interventional studies of FDA-regulated products, 185 (87%) have results posted.

Study arms

• Experimental
  CONNECTED

  CONNECTED integrates two evidence-based care models--peer support and patient navigation--and involves the delivery of three services by peers: 1) peer support, which includes person-centered assessment for drivers of social isolation; 2) group-based interventions to address Veterans' social isolation and 3) navigation, which involves connecting Veterans to social resources to facilitate social participation. CONNECTED is delivered through individual and group sessions over 8 weeks. All sessions will be delivered via videoconference. Veterans may choose to receive some peer support sessions in person when feasible, to facilitate engagement and retention.

  Behavioral: CONNECTED

• Active comparator
  VET BEFRIENDING

  VET BEFRIENDING (attention control arm) consists of weekly social interactions with a research assistant (RA). It will match the number of social contacts (12 contacts), frequency (weekly), intervention expectancy (positive treatment expectations), and working alliance (rapport with interventionist) in the intervention arm. The control condition has no overlap with CONNECTED in terms of content and therapeutic elements (e.g., goal setting, navigation).

  Behavioral: VET BEFRIENDING

Interventions

• BehavioralCONNECTED

  CONNECTED 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.

• BehavioralVET BEFRIENDING

  VET BEFRIENDING (attention control arm) consists of weekly social interactions with a research assistant (RA) over videoconference or phone.

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 months

Secondary 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 months

2. 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 months

3. 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 months

4. 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 months

5. Social Connectedness Scale

   The Social Connectedness Scale is a widely used 8-item measure that assesses aspects of belongingness, affiliation, and companionship. It is rated on a 6-point Likert scale, 1=strongly disagree to 6=strongly agree. The items are then summed for a total score, ranging from 8 (minimum) to 36 (maximum). A high score indicates more connectedness to others or reflects a greater sense of social connectedness. Internal reliability estimates for the 2 scales were .91 and .82, respectively.

   Time frame: Baseline, 2, 4, 8 months

6. Columbia Suicide Severity Rating Scale Screener

   "The Columbia Protocol, also known as the Columbia-Suicide Severity Rating Scale, supports suicide risk assessment through a series of simple, plain-language questions that anyone can ask. The answers help users identify whether someone is at risk for suicide, assess the severity and immediacy of that risk, and gauge the level of support that the person needs. The Columbia Suicide Severity Rating Scale Screener evidenced excellent internal consistency (ordinal alpha = .95). Users of the tool ask people: Whether and when they have thought about suicide (ideation) What actions they have taken - and when - to prepare for suicide Whether and when they attempted suicide or began a suicide attempt that was either interrupted by another person or stopped of their own volition"

   Time frame: As indicated by endorsement of suicidal ideation on Patient Health Questionnaire-9

7. Veterans RAND-12

   The Veterans RAND 12 Item Health Survey is a brief, generic, multi-use, self-administered health survey comprised of 12 items. The instrument is primarily used to measure health related quality of life, to estimate disease burden and to evaluate disease-specific benchmarks with other populations. The 12 items in the questionnaire correspond to eight principal physical and mental health domains including general health perceptions; physical functioning; role limitations due to physical and emotional problems; bodily pain; energy-fatigue, social functioning and mental health. Its Internal consistency is high (s = .87 to .96).

   Time frame: Baseline, 2, 4, 8 months

8. Life Engagement Test

   The Life Engagement Test is a 6-item survey that measures the extent to which a person engages in activities that are valued (alpha = .80)

   Time frame: Baseline, 2, 4, 8 months

9. PTSD symptoms -Life Event Checklist (PCL-5)

   The PCL-5 is a widely used, 20-item self-report questionnaire used to screen for and diagnose probable PTSD. It evaluates the presence and severity of PTSD symptoms over the past month. The scale has strong internal consistency α =.94, test-retest reliability, convergent and discriminant validity. Items are rated on a 5-point Likert scale, ranging from 0 (not at all) to 4 (extremely). All items are summed to create a total score that ranges from 0 to 80. Higher scores reflect a greater degree of distress or severity of PTSD symptoms. The recommended optimal cut-off score of \>33 will be used to indicate probable PTSD.

   Time frame: Baseline, 2, 4, 8 months

10. Life Events Checklist (LEC-5)

    The LEC-5 is a self-report tool designed to assess exposure to potentially traumatic events in adults, such as physical assault, sexual assault, combat, or life-threatening illness. Respondents indicate whether each event: happened to them personally, was witnessed, learned about in a close family member or friend, occurred as part of their job, or does not apply. The LEC-5 does not produce a formal score and is used in combination with the PCL-5 to evaluate PTSD symptoms.

    Time frame: Baseline only

Individual participant data

Plan to share: Yes — Publications resulting from the research will be made available to the public through the National Library of Medicine PubMed Central website within one year after the date of publication. Final data sets underlying publications resulting from the research will not be shared outside Veterans Administration, except as required under the Freedom of Information Act. If final data sets under Freedom of Information Act will be shared outside Veterans Administration in electronic format. Final data sets underlying publications resulting from such research will be shared upon request. Final data sets, along with raw data and working data, will be maintained locally on a secure Veterans Administration research network drive behind the Veterans Administration firewall. Data sets based on information obtained from human subjects will be shared as a De-identified, Anonymized Dataset.

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report

Time frame: The data will become available once the study team completes all analyses.

Access criteria: Final research datasets underlying all publications reporting results of Veterans Administration research can be made available, upon Freedom of Information Act request.