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SuicideTR&STNCT04816149

Treatment for Relationships and Safety Together

A study testing VA Standard Suicide Intervention and Treatment for Relationships and Safety Together (TR&ST) in people with Suicide and Interpersonal Relations, run by VA Office of Research and Development at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Suicide prevention is the top clinical priority for VA/DoD. Suicide is one of the leading causes of death in the United States and worldwide with suicide rates among U.S. military Veterans doubling (27.7 per 100,000) the rate of civilian levels. Despite a rise in prevention efforts, rates have continued to increase. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Suicide, Interpersonal Relations
What is being tested?
VA Standard Suicide Intervention and Treatment for Relationships and Safety Together (TR&ST)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
104 participants
Where
1 siteUnited States
Study dates
15 Apr 2021to 31 Mar 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Veterans who report present suicidal ideation CSSR-S > 2 ("Active thoughts of killing oneself") in past 1 month at phone screen and/or a suicide attempt in the prior 3 months, and
  • an intimate partner who is willing to participate.
  • Additional inclusion criteria for both Veterans and Partners include:
  • in the committed relationship for at least 6 months
  • plans to remain in the San Diego region for 7 months
  • capable of informed consent
  • agree to have assessment and treatment sessions audio recorded.

Who cannot join

  • The following are our Exclusion Criteria for both Veterans and Partners:
  • not English speaking
  • cannot complete the assessment battery
  • current substance use requiring immediate detoxification or outpatient plan directed specifically to residential substance use disorder (not mental health) services
  • has or meets criteria for a current diagnosis of psychosis and/or mania in either member of the couple
  • under conservatorship requiring proxy consent
  • any perpetration of severe physical or sexual relationship aggression in the past year (as assessed by the CTS-2)

Trial locations and contacts

1 site in 1 country.

United States1 site
  • VA San Diego Healthcare System, San Diego, CA

    San Diego, California, 92161-0002

Other trials in United States

About this study

Official title: Development of a Novel Couples-Based Suicide Intervention: Treatment for Relationships and Safety Together (TR&ST)

Suicide prevention is the top clinical priority for VA/DoD. Suicide is one of the leading causes of death in the United States and worldwide with suicide rates among U.S. military Veterans doubling (27.7 per 100,000) the rate of civilian levels. Despite a rise in prevention efforts, rates have continued to increase. Theories of suicide and rehabilitation psychology stress the importance of the person-environment interaction in contributing to one's disability experience. Several studies have found that the most frequent situation precipitating suicide was a problem with a romantic partner. In contrast, people with higher relationship satisfaction are less likely to have suicidal thoughts. Prevention of suicide in high risk Veterans is of vital importance and the quality of one's intimate relationship is an understudied intervention target for suicide prevention. Despite the fact that VA/DoD recommend and Veterans desire treatments that involve family members, currently no couple-based suicide-specific interventions exist. The goals of this CDA-II proposal are to refine and pilot a novel suicide-specific couple-based intervention: Treatment for Relationships and Safety Together (TR\&ST). TR\&ST adapts an evidence-based intervention for suicide, Brief Cognitive Behavioral Therapy (BCBT) for Suicide, to be dyadically focused and integrates Cognitive Behavioral Couple Therapy (CBCT) skills. The proposed 5-year study consists of two phases. Phase 1: treatment refinement with 12 couples (N=24) and Phase 2: pilot Randomized Controlled Trial (RCT) of TR\&ST compared to VA Standard Suicide Intervention, which will involve suicide risk assessment, VA safety planning, Suicide Prevention Coordinator (SPC) follow-up, and referral to outpatient mental health with 60 couples (N=120). The intervention period is 11-weeks and the entire study period is approximately 7 months. Couples in both phases will be quantitatively assessed at baseline, mid-treatment, post-treatment, and 3-months post-treatment. The primary outcome to be evaluated is change in severity of suicidal thoughts. Secondary outcomes concern changes in interpersonal functioning theorized to influence suicidal thoughts and behavior.

Read the detailed description

Suicide prevention is the top clinical priority for VA/DoD. Suicide is one of the leading causes of death in the United States and worldwide with suicide rates among U.S. military Veterans doubling (27.7 per 100,000) the rate of civilian levels. Despite a rise in prevention efforts, rates have continued to increase. Theories of suicide and rehabilitation psychology stress the importance of the person-environment interaction in contributing to one's disability experience. Several studies have found that the most frequent situation precipitating suicide was a problem with a romantic partner. In contrast, people with higher relationship satisfaction are less likely to have suicidal thoughts. The International Classification of Functioning, Disability and Health (ICF) identifies social engagement and communication as important components of functioning. Prevention of suicide in at-risk Veterans is of vital importance and the quality of one's intimate relationship is an understudied intervention target for suicide prevention. The importance of including family members in Veterans' suicide related care is a critical component of the National Strategy for Preventing Veteran Suicides 2018-2028, the National Action Alliance on Suicide Prevention, and a key finding from VA/DoD patient focus groups conducted for the 2019 VA/DoD Clinical Practice Guidelines for the Assessment and Management of Patients at Risk for Suicide. Despite the fact that VA/DoD recommend and Veterans desire treatments that involve family members, currently no couple-based suicide-specific interventions exist. The goals of this CDA-II are to refine and pilot a novel suicide-specific couple-based intervention-Treatment for Relationships and Safety Together (TR\&ST). TR\&ST adapts an evidence-based intervention for suicide, Brief Cognitive Behavioral Therapy (BCBT) for Suicide, to be dyadically focused and integrates Cognitive Behavioral Couple Therapy (CBCT) skills.

The proposed 5-year study consists of two phases. Phase 1: treatment refinement with 12 couples (N=24) and Phase 2: pilot Randomized Controlled Trial (RCT) of TR\&ST compared to VA Standard Suicide Intervention, which will involve suicide risk assessment, VA safety planning, Suicide Prevention Coordinator (SPC) follow-up, and referral to outpatient mental health with 60 couples (N=120). The intervention period is 11-weeks and the entire study period is approximately 7 months. Couples in both phases will be quantitatively assessed at baseline, mid-treatment, post-treatment, and 3-months post-treatment. The primary outcome to be evaluated is change in severity of suicidal ideation. Secondary outcomes concern changes in interpersonal functioning theorized to influence suicidal ideation and behavior.

The Specific Aims of the study are:

Aim 1 (Phase 1): refine TR\&ST in a population of Veterans with active suicidal ideation Aim 2 (Phase 2): evaluate feasibility and acceptability of TR\&ST Hypothesis 1 is that TR\&ST will be feasible to deliver, as evidenced by attainment of recruitment goals, retention rates 70%, and high credibility and expectancy ratings and satisfaction.

Aim 3 (Phase 2): estimate the preliminary impact of TR\&ST vs. VA Standard Suicide Intervention on suicidal ideation severity and proximal targets of interpersonal functioning over 7 months to determine if a future efficacy trial is warranted.

Hypothesis 2a is that Veterans engaged in TR\&ST (vs. VA Standard Suicide Intervention) will have greater reduction in suicidal ideation severity (primary outcome) Hypothesis 2b is that Veterans and partners engaged in TR\&ST (vs. VA Standard Suicide Intervention) will have improved interpersonal functioning (i.e., communication, bonding, relationship satisfaction) Hypothesis 2c is that the effect of TR\&ST on Veteran's reduced suicidal ideation will be mediated by improvements in Veteran and partner interpersonal functioning Exploratory Aim 1: examine rates of suicide related behavior for Veterans in TR\&ST (vs. VA Standard Suicide Intervention) Exploratory Aim 2: examine links between weekly changes in suicidal ideation and relationship quality Exploratory Aim 3: examine the impact of TR\&ST on depression, PTSD, and relationship conflict

Being tested
VA Standard Suicide Intervention, Treatment for Relationships and Safety Together (TR&ST)
Keywords
Suicide, Interpersonal Relations
Medical subject headings
Suicide

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VA Standard Suicide InterventionBehavioural

    Our active control condition is standardized and contains the elements of standard practice suicide-specific intervention delivered at the VA, which include: 1) suicide risk assessment using the CSSR-S, 2) VA Safety Planning Intervention, 3) timely referral to VA mental health outpatient care, including couples intervention (engagement will be tracked), and 4) Suicide Prevention Coordinator (SPC) follow-up contacts (which have been found to significantly reduce suicidal behavior).

  • Treatment for Relationships and Safety Together (TR&ST)Behavioural

    TR\&ST consists of eleven 90-minute sessions delivered in three phases. During phase one, couples receive a tailored cognitive-behavioral conceptualization of suicide and relationship distress based on clinical interview, as well as psychoeducation about their bidirectional influences. They also engage in behavioral activation focused on positive couple activities, emotion regulation, distress tolerance, and conflict management strategies. In phase two, couples learn communication skills and discuss suicidal thoughts and behaviors, as well as their relationship challenges that interact with suicidal thoughts and behavior. Phase three is focused on conjoint thought challenging to shift dysfunctional cognitions related to suicide and relationship problems.

Study groups in NCT04816149
Study groupRoleWhat they receive
VA Standard Suicide InterventionActive comparatorOur active control condition is standardized and contains the elements of standard practice suicide-specific intervention delivered at the VA, which include: 1) suicide risk assessment using the CSSR-S, 2) VA Safety Planning Intervention, 3) timely referral to VA mental health outpatient care, including couples intervention (engagement will be tracked), and 4) Suicide Prevention Coordinator (SPC) follow-up contacts (which have been found to significantly reduce suicidal behavior).
Receives: Behavioral: VA Standard Suicide Intervention
Treatment for Relationships and Safety Together (TR&ST)ExperimentalTR\&ST consists of eleven 90-minute sessions delivered in three phases. During phase one, couples receive a tailored cognitive-behavioral conceptualization of suicide and relationship distress based on clinical interview, as well as psychoeducation about their bidirectional influences. They also engage in behavioral activation focused on positive couple activities, emotion regulation, distress tolerance, and conflict management strategies. In phase two, couples learn communication skills and discuss suicidal thoughts and behaviors, as well as their relationship challenges that interact with suicidal thoughts and behavior. Phase three is focused on conjoint thought challenging to shift dysfunctional cognitions related to suicide and relationship problems.
Receives: Behavioral: Treatment for Relationships and Safety Together (TR&ST)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in severity of suicidal ideation from baseline

    The Beck Scale for Suicidal Ideation has a minimum possible score of 0, and maximum possible score of 38, wherein higher scores reflect more severe suicidal ideation.

    Measured: Delivered at baseline, 7 weeks after baseline (mid-treatment), 13 weeks after baseline (post-treatment), and 25 weeks after baseline

Secondary outcomes (5)
  1. Change in positive communication from baseline

    The Communication Skills Test has a minimum possible score of 10, and maximum possible score of 70, wherein higher scores reflect more positive communication.

    Measured: Delivered at baseline, 7 weeks after baseline (mid-treatment), 13 weeks after baseline (post-treatment), and 25 weeks after baseline

  2. Change in negative communication from baseline

    The Communication Danger Signs Scale has a minimum possible score of 5, and maximum possible score of 15, wherein higher scores reflect more negative communication.

    Measured: Delivered at baseline, 7 weeks after baseline (mid-treatment), 13 weeks after baseline (post-treatment), and 25 weeks after baseline

  3. Change in positive bonding from baseline

    The Positive Bonding Scale has a minimum possible score of 9, and maximum possible score of 63, wherein higher scores reflect more positive bonding.

    Measured: Delivered at baseline, 7 weeks after baseline (mid-treatment), 13 weeks after baseline (post-treatment), and 25 weeks after baseline

  4. Change in perceived burdensomeness and thwarted belonging from baseline

    The Interpersonal Needs Questionnaire has a minimum possible score of 15, and maximum possible score of 105, wherein higher scores reflect higher perceived burdensomeness and thwarted belonging.

    Measured: Delivered at baseline, 7 weeks after baseline (mid-treatment), 13 weeks after baseline (post-treatment), and 25 weeks after baseline

  5. Change in relationship satisfaction from baseline

    The Couples Satisfaction Index has a minimum possible score of 0, and maximum possible score of 161, wherein higher scores reflect higher relationship satisfaction.

    Measured: Delivered at baseline, 7 weeks after baseline (mid-treatment), 13 weeks after baseline (post-treatment), and 25 weeks after baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Mar 2021
  2. Study start15 Apr 2021
  3. Primary completion31 Mar 2026
  4. Study completion31 Mar 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
104 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04816149
Sponsor's protocol ID
D3490-W
Other IDs
RX003490
Acronym
TR&ST
Status last verified
Apr 2026
First submitted
17 Mar 2021
Last updated
7 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing VA Standard Suicide Intervention and Treatment for Relationships and Safety Together (TR&ST) in people with Suicide and Interpersonal Relations, run by VA Office of Research and Development at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in severity of suicidal ideation from baseline (time frame: Delivered at baseline, 7 weeks after baseline (mid-treatment), 13 weeks after baseline (post-treatment), and 25 weeks after baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2026.

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