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StressCOVENCT06136234

Caring for Vets and Service Members: Caring Contacts for Stressed and Distressed Veterans and Service Members

A study testing Caring Contacts and Best Available Resources Alone in people with Stress and Distress, Emotional, run by University of Washington at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The goal of this clinical trial is to study stressed or distressed veterans and service members. Researchers will compare Caring Contacts plus best available resources to best available resources alone to see if reduces distress and prevents thoughts of suicide. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stress, Distress, Emotional
What is being tested?
Caring Contacts and Best Available Resources Alone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
521 participants
Where
1 siteUnited States
Study dates
30 Apr 2024to 30 Sep 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • US service member or veteran
  • 18 years or older
  • Lives in the United States
  • Stressed (recent separation from or in transition out of the military, unemployment, financial strain, unhoused, or suicide loss, etc.) or distressed (isolation, depression, substance use, loneliness, defeat, hopelessness, psychological pain, or suicidal ideation, etc.)
  • Willingness to be contacted periodically by text message and either email or postal mail

Who cannot join

  • Unable to consent due to inability to understand the consent form due to cognitive limitations or insufficient English (as determined by inability to pass the consent quiz items)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Washington

    Seattle, Washington, 98104

Other trials in United States

About this study

Official title: COVE (Caring for Vets and Service Members)

The goal of this clinical trial is to study stressed or distressed veterans and service members. Researchers will compare Caring Contacts plus best available resources to best available resources alone to see if reduces distress and prevents thoughts of suicide.

Read the detailed description

The objective of this study is to evaluate whether Caring Contacts via text message are beneficial to veterans and service members experiencing stress or distress. In the past, Caring Contacts interventions have focused on individuals who are already suicidal and not a more general population. In addition, a core objective of this study is to understand the mechanisms of action of Caring Contacts and thus has included an ecological momentary assessment (EMA) component that will allow us to determine when and how Caring Contacts is making an impact.

Study aims are to

Evaluate if stressed or distressed veterans receiving Caring Contacts are at greater or less risk of suicidal ideation or behavior as evidenced by:

Decreased mean and reduction in variability of indicators of suicide risk (motivation to live, passive ideation, active ideation, suicide intent, and urges to harm self) acquired during Ecological Momentary Assessment periods.

Reduced risk of suicidal ideation (HASS-I) and cognitions (SCS-R) during follow-up.

Examine diverse veterans' experiences with Caring Contacts (i.e., access, satisfaction, preferences, potential mechanisms)

Evaluate if veterans receiving Caring Contacts will show a decrease in distress (i.e., isolation, depression, substance use, loneliness, defeat, hopelessness, and psychological pain)

Identify potential mechanisms of action for Caring Contacts by exploring the relationship between potential mechanisms (i.e., mattering, connectedness, social responsibility, and entrapment), distress, and suicide risk observed during ecological momentary assessment periods to identify potential mechanisms of action of Caring Contacts on decreasing distress and suicide risk

Being tested
Caring Contacts, Best Available Resources Alone
Keywords
suicidal ideation, suicide cognitions
Medical subject headings
Suicidal Ideation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Caring ContactsBehavioural

    Caring Contacts are brief, periodic messages sent over 1 year that express unconditional care and concern

  • Best Available Resources AloneBehavioural

    Participants will be offered information about best available resources and will receive an email summarizing the resources with links and contact information. These resources are tailored to best serve the participant based on information they share during the online survey or during conversations with study staff.

Study groups in NCT06136234
Study groupRoleWhat they receive
Experimental Condition with intensive assessmentExperimentalCaring Contacts plus best available resources, with monthly EMAs during study year
Receives: Behavioral: Caring Contacts; Behavioral: Best Available Resources Alone
Control Condition with intensive assessmentActive comparatorBest available resources, with monthly EMAs during study year
Receives: Behavioral: Best Available Resources Alone
Experimental Condition without intensive assessmentExperimentalCaring Contacts plus best available resources, without monthly EMAs during study year
Receives: Behavioral: Caring Contacts; Behavioral: Best Available Resources Alone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Suicide risk Visual Analog Scales (VAS)

    Suicide risk indicators rated on Visual Analog Scales (VAS; 0-10) acquired during Ecological Momentary Assessment periods. Core constructs of suicide risk selected and worded to maximize face validity: motivation to live, passive ideation, active ideation, and urges for suicide. Higher scores indicate higher suicidal risk (motivation to live is reverse coded).

    Measured: 3 EMA assessments/day for 14 days at baseline; then either 3 EMA assessments/day for 7 days at 12 months OR 3 EMA assessments/day for 7 days/month for 12 months (depending on EMA condition)

  2. Suicidal Ideation

    Harkavy-Asnis Suicide Scale (HASS-I), adapted version for study procedures. Min=0, max=60, higher scores indicate higher suicidal ideation.

    Measured: Baseline and 12 month follow-up

  3. Suicide Cognitions

    Suicide Cognitions Scale - Revised, Min=16, max=80, higher scores indicate more suicidal cognitions.

    Measured: Baseline and 12 month follow-up

Secondary outcomes (7)

  1. Experience of receiving Caring Contacts

    Participants will be asked to describe their experiences with Caring Contacts via an online survey and a qualitative interview with a subset of participants

    Measured: 12 month follow-up

  2. Depression

    Patient Health Questionnaire-9 (PHQ-9), Min=0, max=30, higher scores indicate higher degree of depression severity.

    Measured: Baseline and 12 month-up

  3. Substance Abuse

    Short Inventory of Problems - Alcohol and Drugs (SIP-AD)

    Measured: Baseline and 12 month follow-up

  4. Loneliness

    NIH Loneliness Scale, Min=5, max=25, higher scores indicate increased loneliness.

    Measured: Baseline and 12 month follow-up

  5. Defeat

    The Defeat Scale, Min=0, max=64, higher scores indicate greater defeat.

    Measured: Baseline and 12 month follow-up

  6. Hopelessness

    Beck's Hopelessness Scale (BHS), Min=0, max=20, higher scores indicate greater hopelessness.

    Measured: Baseline and 12 month follow-up

  7. Psychological Pain

    Unbearable Psychache Scale-3 (UPS-3), Min=3, max=15, higher scores indicate greater psychological pain.

    Measured: Baseline and 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.

  1. First posted18 Nov 2023
  2. Study start30 Apr 2024
  3. Primary completion30 Sep 2026 (estimated)
  4. Study completion30 Sep 2026 (estimated)

Resources

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
Randomized Controlled Trial
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
521 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06136234
Sponsor's protocol ID
STUDY00019011
Acronym
COVE
Status last verified
Sep 2025
First submitted
23 Oct 2023
Last updated
17 Sep 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: We will only make de-identified data and associated documentation available to users outside the research team under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed.

Publications

  • Wright B, Evanson A, Casey C, Law KC, Rogers AH, Comtois KA. Exploring the Impact of the Caring Contacts Intervention on the Stress and Distress of Veterans and Service Members: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2025 Aug 13;14:e72140. doi: 10.2196/72140.

    PubMed 40801426

Questions about this trial

What is this clinical trial studying?

A study testing Caring Contacts and Best Available Resources Alone in people with Stress and Distress, Emotional, run by University of Washington at 1 site 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 1 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: under way, not looking for participants, as of the sponsor's last update on 17 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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. 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?

This study is still under way. Results are not available in the source record yet.

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?

Suicide risk Visual Analog Scales (VAS) (time frame: 3 EMA assessments/day for 14 days at baseline; then either 3 EMA assessments/day for 7 days at 12 months OR 3 EMA assessments/day for 7 days/month for 12 months (depending on EMA condition)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06136234, which also lists 1 linked publication.

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 17 Sep 2025.

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COVE Clinical Trial NCT06136234 | AzTrials