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

NCT06136234 | Active Not Recruiting DMC

• 1 other identifier: STUDY00019011
• Study Type: interventional
• Target: 521
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress; Distress, Emotional

Keywords

suicidal ideation; suicide cognitions

Outcome Measures

Primary Outcomes (3)

• 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)

• 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

• Suicide Cognitions

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

  Baseline and 12 month follow-up

Secondary Outcomes (7)

• Experience of receiving Caring Contacts

  12 month follow-up

• Depression

  Baseline and 12 month-up

• Substance Abuse

  Baseline and 12 month follow-up

• Loneliness

  Baseline and 12 month follow-up

• Defeat

  Baseline and 12 month follow-up

Other Outcomes (4)

• Potential Mechanism: 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)

• Potential Mechanism: 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)

• Potential Mechanism: 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)

Study Arms (3)

Experimental Condition with intensive assessment

EXPERIMENTAL

Caring Contacts plus best available resources, with monthly EMAs during study year

Behavioral: Caring Contacts; Behavioral: Best Available Resources Alone

Control Condition with intensive assessment

ACTIVE COMPARATOR

Best available resources, with monthly EMAs during study year

Behavioral: Best Available Resources Alone

Experimental Condition without intensive assessment

EXPERIMENTAL

Caring Contacts plus best available resources, without monthly EMAs during study year

Behavioral: Caring Contacts; Behavioral: Best Available Resources Alone

Interventions

Caring Contacts BEHAVIORAL

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

Experimental Condition with intensive assessment; Experimental Condition without intensive assessment

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.

Control Condition with intensive assessment; Experimental Condition with intensive assessment; Experimental Condition without intensive assessment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• US service member or veteran
• 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

You may not qualify if:

• \- 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)

Sponsors & Collaborators

• University of Washington: lead
• Face the Fight: collaborator

Study Sites (1)

University of Washington

Seattle, Washington, 98104, United States

Location

Related Publications (1)

• Wright B, Evanson A, Casey C, Law KC, Rogers AH, Comtois KA. Exploring the Impact of the Caring Contacts Intervention on the Stress and Distress of Veterans and Service Members: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2025 Aug 13;14:e72140. doi: 10.2196/72140.

  PMID: 40801426 DERIVED

MeSH Terms

Conditions

Suicidal Ideation

Condition Hierarchy (Ancestors)

Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Study Officials

• Katherine A Comtois, PhD/MPH

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All outcome measures are completed by the participant via online survey.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor: School of Medicine

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: October 23, 2023
• First Posted: November 18, 2023
• Study Start: April 30, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: September 17, 2025

Record last verified: 2025-09

Locations

US (1)