Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2025-12-27 @ 10:55 AM
Study NCT ID:
NCT06136234
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-17
First Post:
2023-10-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Caring for Vets and Service Members: Caring Contacts for Stressed and Distressed Veterans and Service Members
Sponsor:
University of Washington
Organization:
Study Overview
Official Title:
COVE (Caring for Vets and Service Members)
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COVE
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
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
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: