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

Sponsor
University of Washington (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06136234
Collaborator
Face the Fight (Other)
510
2
34.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Caring Contacts
  • Behavioral: Best Available Resources Alone
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
510 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized Controlled TrialRandomized Controlled Trial
Masking:
Double (Investigator, Outcomes Assessor)
Masking Description:
All outcome measures are completed by the participant via online survey.
Primary Purpose:
Treatment
Official Title:
COVE (Caring for Vets and Service Members)
Anticipated Study Start Date :
Nov 15, 2023
Anticipated Primary Completion Date :
Sep 30, 2026
Anticipated Study Completion Date :
Sep 30, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: Experimental Condition

Caring Contacts plus best available resources

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

Behavioral: 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.

Active Comparator: Control Condition

Best available resources

Behavioral: 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.

Outcome Measures

Primary Outcome Measures

  1. Suicide risk Visual Analog Scales (VAS) [3 EMA assessments/day for 7 days/month over 12 months]

    Suicide risk indicators rated on Visual Analog Scales (VAS; 0-100) 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 [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 [Baseline and 12 month follow-up]

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

Secondary Outcome Measures

  1. Experience of receiving Caring Contacts [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 [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 [Baseline and 12 month follow-up]

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

  4. Loneliness [Baseline and 12 month follow-up]

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

  5. Defeat [Baseline and 12 month follow-up]

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

  6. Hopelessness [Baseline and 12 month follow-up]

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

  7. Psychological Pain [Baseline and 12 month follow-up]

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

Other Outcome Measures

  1. Potential Mechanism: Entrapment [3 EMA assessments/day for 7 days/month over 12 months]

    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 [3 EMA assessments/day for 7 days/month over 12 months]

    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 [3 EMA assessments/day for 7 days/month over 12 months]

    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 [3 EMA assessments/day for 7 days/month over 12 months]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of Washington
  • Face the Fight

Investigators

  • Principal Investigator: Katherine A Comtois, PhD/MPH, University of Washington

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Kate Comtois, Professor: School of Medicine, University of Washington
ClinicalTrials.gov Identifier:
NCT06136234
Other Study ID Numbers:
  • STUDY00019011
First Posted:
Nov 18, 2023
Last Update Posted:
Nov 18, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Kate Comtois, Professor: School of Medicine, University of Washington

Study Results

No Results Posted as of Nov 18, 2023