CClinicalTrials.gg
CompletedNCT05484297Updated Apr 2, 2026

Increasing Social Connection Through Crisis Caring Contacts: A Pragmatic Trial

An interventional study of Crisis Caring Contacts post cards and Control post cards in Loneliness, sponsored by VA Office of Research and Development. Completed at 3 sites in United States. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2026-04-02.

Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
974
Allocation
Randomized
Ages
50 Years and older
Sex
All
01

Study summary

The main purpose is to learn if sending messages from the VA (called "Caring Contacts") reduces loneliness and improves mental health. The investigators want to understand if these messages are effective in Veterans aged 60 and above who have missed appointments at the VA even though they have health problems. Participants will receive up to 10 postcards mailed in envelopes from a fellow Veteran (Peer Specialist) from their local VA, and will be asked to fill out four surveys. The investigators are recruiting 920 Veterans aged 50 years and older who have felt isolated and have missed appointments at the VA to join this study.

Read the detailed description

Lack of social connection is a common and powerful predictor of suicidal ideation, suicide attempts, functional decline, and death, even after adjustment for sociodemographic and clinical variables. Loneliness, specifically, is associated with a 26% increased likelihood of all-cause mortality. The urgency of addressing these problems is only amplified by the COVID-19 pandemic, which for some time may further increase loneliness, suicide, and other causes of mortality. Due to their risk for loneliness and negative health outcomes, a group of particular concern is older adults and patients with medical or psychiatric comorbidity who have poor treatment engagement.

Caring Contacts is an intervention that can address loneliness and treatment disengagement. It involves periodically sending brief messages to at-risk individuals with nondemanding expressions of care and concern. It is one of just two non-pharmacologic interventions to have evidence in randomized controlled trials (RCTs) for reducing rates of suicide. However, Caring Contacts has only been evaluated in a relatively narrowly indicated population of patients with acute psychiatric issues.

Major gaps in the understanding of Caring Contacts include whether it reduces loneliness, whether it can diminish causes of mortality besides suicide, and whether it is effective older Veterans and patients with treatment disengagement. The overarching objective of this project is to evaluate "Crisis Caring Contacts" (CCC), an adaptation of Caring Contacts tailored to Veterans at risk for lack of social connection and lapses in treatment amidst the COVID-19 pandemic and its aftermath.

Primary aims for this study are: 1) Among older Veterans with poor treatment engagement, evaluate the effectiveness of Crisis Caring Contacts in decreasing loneliness, compared to enhanced usual care; 2) Evaluate the effect of Crisis Caring Contacts on other important outcomes, including treatment engagement and suicidal ideation; 3) Explore potential moderators of treatment response to Crisis Caring Contacts; and 4) Explore the effect of Crisis Caring Contacts on all-cause mortality, suicide attempts, and drug overdoses.

Impact: This project will advance scientific understanding of key gaps related to the mechanisms and outcomes of Caring Contacts, while also evaluating a timely, pragmatic, low-cost, and scalable intervention for Veterans affected by lack of social connection and treatment engagement.

02

Conditions studied

  • Loneliness
03

In context

Lead sponsor

VA Office of Research and Development is the lead sponsor of 1,733 studies on the registry; 396 are open to participants now.

Of its 206 completed or terminated interventional studies of FDA-regulated products, 180 (87%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:

  • age 50 years and above
  • have at least four VA appointments in the prior 6-18 months in primary care or mental health
  • have at least two comorbidities contained in the Elixhauser Index
  • a) zero completed appointments in the past 6 months and zero appointments scheduled, or b) in the 90th percentile or higher in terms of no-shows or appointments canceled by patient in the prior 12 months

Exclusion Criteria:

  • no valid mailing address
  • no valid phone number
  • inclusion in an existing Caring Contacts program
  • diagnosis of neurocognitive disorder or other significant cognitive impairment indicative of inadequate decision-making capacity
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
974 participants (actual)

Study arms

  • Experimental
    Treatment

    Participants in the treatment arm will receive the intervention post cards

    Behavioral: Crisis Caring Contacts post cards

  • Sham comparator
    Control

    Participants in the control arm will receive the control post cards

    Behavioral: Control post cards

Interventions

  • BehavioralCrisis Caring Contacts post cards

    A series of post cards with Crisis Caring Contacts content sent over 10 months

  • BehavioralControl post cards

    A series of post cards intended to control for attention received but not including elements thought to be "active ingredients" in the intervention

06

What researchers measure

Primary outcomes

  1. UCLA Loneliness Scale, Version 3

    This scale has a score range from 20 -80, with higher scores representing greater degrees of loneliness.

    Time frame: 12-month follow-up

  2. Count of mental health or primary care visits over 12 months

    Treatment engagement will be assessed by counting VA outpatient visits to mental health or primary care during the 12 months after randomization. More visits will represent greater treatment engagement.

    Time frame: The 12-month period from the date of randomization to 12-month follow-up

Secondary outcomes

  1. PROMIS Short Form v2.0 - Emotional Support 4a

    This scale has a range from 4 - 20, with higher scores representing greater perceived emotional support.

    Time frame: 12-month follow-up

  2. Trust in Public Healthcare System, Institutional Trust Subscale (adapted for VA)

    Adapted to assess trust in the VA specifically, this scale has a score range from 3 - 15, with higher scores representing more trust.

    Time frame: 12-month follow-up

  3. Depressive Symptom Index Suicidality Subscale (DSI-SS)

    This scale has a score range from 0 - 12, with higher scores representing greater degrees of suicidality.

    Time frame: 12-month follow-up

  4. Suicide Ideation Scale (SIS)

    This scale has a score range from 10 - 50, with higher scores representing greater degrees of suicidality.

    Time frame: 12-month follow-up

07

Study locations

3 sites
  • VA Ann Arbor Healthcare System, Ann Arbor, MI
    Ann Arbor, Michigan 48105-2303, United States
  • VA Portland Health Care System, Portland, OR
    Portland, Oregon 97207-2964, United States
  • VA Puget Sound Health Care System Seattle Division, Seattle, WA
    Seattle, Washington 98108-1532, United States
08

References and documents

Study documents

  • Informed consent form · Nov 29, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05484297
Lead sponsor
VA Office of Research and Development
Responsible party
Sponsor
First posted
Aug 2, 2022
Start date
Apr 4, 2023
Primary completion
Feb 17, 2026
Completion
Feb 17, 2026
Last update
Apr 2, 2026

Study contacts

Alan R. Teo, MD MS
principal investigator · VA Portland Health Care System, Portland, OR

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion