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

Stress Clinical Trial

— COVE  

Official title:

COVE (Caring for Vets and Service Members)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06136234
• Other study ID #: STUDY00019011
• Status: Recruiting
• Phase: N/A
• Start date: April 30, 2024
• Est. completion date: September 30, 2026

Study information

• Verified date: May 2024
• Source: University of Washington
• Contact: Barbara D Wright, MSW
• Phone: 206-744-1760
• Email: bwright5[@]uw.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 510
• Est. completion date: September 30, 2026
• Est. primary completion date: September 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Distress, Emotional
• Stress

Intervention

Behavioral:
• Caring Contacts
Caring Contacts are brief, periodic messages sent over 1 year that express unconditional care and concern
• Best Available Resources Alone
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.

Locations

Country	Name	City	State
United States	University of Washington	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	Face the Fight

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Potential Mechanism: Entrapment	A single item, "I feel trapped," acquired during Ecological Momentary Assessment periods. Min=1, max=7, higher score indicates increased feelings of entrapment.	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)
Other	Potential Mechanism: Personal and Social Responsibility	Responsibility Scale acquired during Ecological Momentary Assessment periods. Min=8, max=40, higher scores indicate greater sense personal and social responsibility.	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)
Other	Potential Mechanism: Mattering	General Mattering Scale acquired during Ecological Momentary Assessment periods. Min=5, max=20, higher scores indicate greater sense of mattering.	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)
Other	Potential Mechanism: Perceived Burdensomeness	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.	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)
Primary	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).	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)
Primary	Suicidal Ideation	Harkavy-Asnis Suicide Scale (HASS-I), adapted version for study procedures. Min=0, max=60, higher scores indicate higher suicidal ideation.	Baseline and 12 month follow-up
Primary	Suicide Cognitions	Suicide Cognitions Scale - Revised, Min=16, max=80, higher scores indicate more suicidal cognitions.	Baseline and 12 month follow-up
Secondary	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	12 month follow-up
Secondary	Depression	Patient Health Questionnaire-9 (PHQ-9), Min=0, max=30, higher scores indicate higher degree of depression severity.	Baseline and 12 month-up
Secondary	Substance Abuse	Short Inventory of Problems - Alcohol and Drugs (SIP-AD)	Baseline and 12 month follow-up
Secondary	Loneliness	NIH Loneliness Scale, Min=5, max=25, higher scores indicate increased loneliness.	Baseline and 12 month follow-up
Secondary	Defeat	The Defeat Scale, Min=0, max=64, higher scores indicate greater defeat.	Baseline and 12 month follow-up
Secondary	Hopelessness	Beck's Hopelessness Scale (BHS), Min=0, max=20, higher scores indicate greater hopelessness.	Baseline and 12 month follow-up
Secondary	Psychological Pain	Unbearable Psychache Scale-3 (UPS-3), Min=3, max=15, higher scores indicate greater psychological pain.	Baseline and 12 month follow-up