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Active, Not Recruiting

NCT Number: NCT06136234

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Washington

Seattle, Washington, 98104, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Treatment and study plan

Caring Contacts

Behavioral

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

Best Available Resources Alone

Behavioral

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.

Primary outcomes

  1. 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)

    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).

  2. Suicidal Ideation

    Time frame: Baseline and 12 month follow-up

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

  3. Suicide Cognitions

    Time frame: Baseline and 12 month follow-up

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

Secondary outcomes

  1. Experience of receiving Caring Contacts

    Time frame: 12 month follow-up

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

  2. Depression

    Time frame: Baseline and 12 month-up

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

  3. Substance Abuse

    Time frame: Baseline and 12 month follow-up

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

  4. Loneliness

    Time frame: Baseline and 12 month follow-up

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

  5. Defeat

    Time frame: Baseline and 12 month follow-up

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

  6. Hopelessness

    Time frame: Baseline and 12 month follow-up

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

  7. Psychological Pain

    Time frame: Baseline and 12 month follow-up

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

Other outcomes

  1. Potential Mechanism: Entrapment

    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)

    A single item, "I feel trapped," acquired during Ecological Momentary Assessment periods. Min=1, max=7, higher score indicates increased feelings of entrapment.

  2. Potential Mechanism: Personal and Social Responsibility

    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)

    Responsibility Scale acquired during Ecological Momentary Assessment periods. Min=8, max=40, higher scores indicate greater sense personal and social responsibility.

  3. Potential Mechanism: Mattering

    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)

    General Mattering Scale acquired during Ecological Momentary Assessment periods. Min=5, max=20, higher scores indicate greater sense of mattering.

  4. Potential Mechanism: Perceived Burdensomeness

    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)

    A single item, "I felt that I was a burden to other people, or that they would be better off without me," acquired during Ecological Momentary Assessment periods. Min=1, max=7, higher score indicates increased feelings of burdensomeness.

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • Face the Fight

Registry information

Official study title

COVE (Caring for Vets and Service Members)

Acronym: COVE

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Nov 18, 2023
Registry last updated
Sep 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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