LonelinessNCT05484297
Increasing Social Connection Through Crisis Caring Contacts: A Pragmatic Trial
A study testing Crisis Caring Contacts post cards in people with Loneliness, run by VA Office of Research and Development at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Loneliness
- What is being tested?
- Crisis Caring Contacts post cards
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 974 participants
- Where
- 3 sitesUnited States
- Study dates
- 4 Apr 2023to 17 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- diagnosis of neurocognitive disorder or other significant cognitive impairment indicative of inadequate decision-making capacity
Who cannot join
- no valid mailing address
- no valid phone number
Trial locations and contacts
3 sites in 1 country.
United States3 sites
VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, Michigan, 48105-2303
VA Portland Health Care System, Portland, OR
Portland, Oregon, 97207-2964
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, Washington, 98108-1532
About this study
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.
- Conditions
- Loneliness
- Being tested
- Crisis Caring Contacts post cards, Control post cards
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Crisis Caring Contacts post cardsBehavioural
A series of post cards with Crisis Caring Contacts content sent over 10 months
Control post cardsBehavioural
A series of post cards intended to control for attention received but not including elements thought to be "active ingredients" in the intervention
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Participants in the treatment arm will receive the intervention post cards Receives: Behavioral: Crisis Caring Contacts post cards |
| Control | Sham comparator | Participants in the control arm will receive the control post cards Receives: Behavioral: Control post cards |
What is being measured
The primary outcome is the main question the study is designed to answer.
UCLA Loneliness Scale, Version 3
This scale has a score range from 20 -80, with higher scores representing greater degrees of loneliness.
Measured: 12-month follow-up
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.
Measured: The 12-month period from the date of randomization to 12-month follow-up
Secondary outcomes (4)
PROMIS Short Form v2.0 - Emotional Support 4a
This scale has a range from 4 - 20, with higher scores representing greater perceived emotional support.
Measured: 12-month follow-up
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.
Measured: 12-month follow-up
Depressive Symptom Index Suicidality Subscale (DSI-SS)
This scale has a score range from 0 - 12, with higher scores representing greater degrees of suicidality.
Measured: 12-month follow-up
Suicide Ideation Scale (SIS)
This scale has a score range from 10 - 50, with higher scores representing greater degrees of suicidality.
Measured: 12-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2022
- Study start4 Apr 2023
- Primary completion17 Feb 2026
- Study completion17 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LonelinessStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized 1:1 to either the intervention or the control group. Block-randomization schemes using random block sizes to assign the two study arms will be created in R using the blockrand package before study start. Randomization will be stratified by study site. The intervention will consist of a series of post cards with Crisis Caring Contacts content sent over 10 months. The control group will receive similar post cards intended to control for attention received but not including elements thought to be "active ingredients" in the intervention.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 974 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Alan R. Teo, MD MS, Principal investigator, VA Portland Health Care System, Portland, OR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05484297
- Sponsor's protocol ID
- SDR 21-087
- Other IDs
- 1I01HX003428-01
- Status last verified
- Mar 2026
- First submitted
- 12 Jul 2022
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Social Connection Through Crisis Caring Contacts: A Pragmatic Trial
- ClinicalTrials.gov ID
- NCT05484297
- Acronym / sponsor ID
- SDR 21-087
- Conditions
- Loneliness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 974 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 4 Apr 2023 (actual)
- Primary completion
- 17 Feb 2026 (actual)
- Study completion
- 17 Feb 2026 (actual)
- First posted
- 2 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized 1:1 to either the intervention or the control group. Block-randomization schemes using random block sizes to assign the two study arms will be created in R using the blockrand package before study start. Randomization will be stratified by study site. The intervention will consist of a series of post cards with Crisis Caring Contacts content sent over 10 months. The control group will receive similar post cards intended to control for attention received but not including elements thought to be "active ingredients" in the intervention.
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Behavioral: Crisis Caring Contacts post cardsParticipants in the treatment arm will receive the intervention post cards |
| Control | Sham comparator | Behavioral: Control post cardsParticipants in the control arm will receive the control post cards |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
- diagnosis of neurocognitive disorder or other significant cognitive impairment indicative of inadequate decision-making capacity
Key exclusion criteria (2 listed)
- no valid mailing address
- no valid phone number
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Crisis Caring Contacts post cardsA series of post cards with Crisis Caring Contacts content sent over 10 months | Behavioural | Treatment |
| Control post cardsA series of post cards intended to control for attention received but not including elements thought to be "active ingredients" in the intervention | Behavioural | Control |
Primary outcome
UCLA Loneliness Scale, Version 3
Time frame: 12-month follow-up
This scale has a score range from 20 -80, with higher scores representing greater degrees of loneliness.
Count of mental health or primary care visits over 12 months
Time frame: The 12-month period from the date of randomization to 12-month follow-up
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.
4 secondary outcomes
PROMIS Short Form v2.0 - Emotional Support 4a
Time frame: 12-month follow-up
Trust in Public Healthcare System, Institutional Trust Subscale (adapted for VA)
Time frame: 12-month follow-up
Depressive Symptom Index Suicidality Subscale (DSI-SS)
Time frame: 12-month follow-up
Suicide Ideation Scale (SIS)
Time frame: 12-month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alan R. Teo, MD MS principal investigator
VA Portland Health Care System, Portland, OR
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Crisis Caring Contacts post cards in people with Loneliness, run by VA Office of Research and Development at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
UCLA Loneliness Scale, Version 3 (time frame: 12-month follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2026.