Clinical trial NCT06136234: Caring for Vets and Service Members: Caring Contacts for Stressed and Distressed Veterans and Service Members
Official title: COVE (Caring for Vets and Service Members)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stress
Distress, Emotional
Keywords: suicidal ideation
suicide cognitions
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Face the Fight
First posted: 2023-11-18
Enrollment: 510
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial
Primary purpose: TREATMENT

Brief 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.

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

Eligibility criteria: 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)

Primary outcomes:
measure: Suicide risk Visual Analog Scales (VAS)
timeFrame: 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)
measure: Suicidal Ideation
timeFrame: Baseline and 12 month follow-up
measure: Suicide Cognitions
timeFrame: Baseline and 12 month follow-up
Secondary outcomes:
measure: Experience of receiving Caring Contacts
timeFrame: 12 month follow-up
measure: Depression
timeFrame: Baseline and 12 month-up
measure: Substance Abuse
timeFrame: Baseline and 12 month follow-up
measure: Loneliness
timeFrame: Baseline and 12 month follow-up
measure: Defeat
timeFrame: Baseline and 12 month follow-up
measure: Hopelessness
timeFrame: Baseline and 12 month follow-up
measure: Psychological Pain
timeFrame: Baseline and 12 month follow-up
Other outcomes:
measure: Potential Mechanism: Entrapment
timeFrame: 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)
measure: Potential Mechanism: Personal and Social Responsibility
timeFrame: 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)
measure: Potential Mechanism: Mattering
timeFrame: 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)
measure: Potential Mechanism: Perceived Burdensomeness
timeFrame: 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)
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Katherine A Comtois, PhD/MPH
role: PRINCIPAL_INVESTIGATOR
References: