Clinical trial NCT04816149: Treatment for Relationships and Safety Together
Official title: Development of a Novel Couples-Based Suicide Intervention: Treatment for Relationships and Safety Together (TR&ST)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Suicide
Interpersonal Relations
Keywords: Suicide
Interpersonal Relations
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2021-03-25
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

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

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

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)

Primary outcomes:
measure: Change in severity of suicidal ideation from baseline
timeFrame: Delivered at baseline, 7 weeks after baseline (mid-treatment), 13 weeks after baseline (post-treatment), and 25 weeks after baseline
Secondary outcomes:
measure: Change in positive communication from baseline
timeFrame: Delivered at baseline, 7 weeks after baseline (mid-treatment), 13 weeks after baseline (post-treatment), and 25 weeks after baseline
measure: Change in negative communication from baseline
timeFrame: Delivered at baseline, 7 weeks after baseline (mid-treatment), 13 weeks after baseline (post-treatment), and 25 weeks after baseline
measure: Change in positive bonding from baseline
timeFrame: Delivered at baseline, 7 weeks after baseline (mid-treatment), 13 weeks after baseline (post-treatment), and 25 weeks after baseline
measure: Change in perceived burdensomeness and thwarted belonging from baseline
timeFrame: Delivered at baseline, 7 weeks after baseline (mid-treatment), 13 weeks after baseline (post-treatment), and 25 weeks after baseline
measure: Change in relationship satisfaction from baseline
timeFrame: Delivered at baseline, 7 weeks after baseline (mid-treatment), 13 weeks after baseline (post-treatment), and 25 weeks after baseline
Other outcomes:
measure: Expectations of Treatment
timeFrame: baseline
measure: Satisfaction with Care
timeFrame: 13 weeks after baseline (post-treatment)
measure: Change in relationship conflict from baseline
timeFrame: Delivered at baseline, 7 weeks after baseline (mid-treatment), 13 weeks after baseline (post-treatment), and 25 weeks after baseline
measure: Change in severity of depression from baseline
timeFrame: Delivered at baseline, 7 weeks after baseline (mid-treatment), 13 weeks after baseline (post-treatment), and 25 weeks after baseline
measure: Changes in Posttraumatic Stress Disorder severity from baseline
timeFrame: Delivered at baseline, 7 weeks after baseline (mid-treatment), 13 weeks after baseline (post-treatment), and 25 weeks after baseline
measure: Outpatient Engagement
timeFrame: Delivered at baseline, 7 weeks after baseline (mid-treatment), 13 weeks after baseline (post-treatment), and 25 weeks after baseline
Locations:
city: San Diego
country: United States
facility: VA San Diego Healthcare System, San Diego, CA
state: California
Study officials:
affiliation: VA San Diego Healthcare System, San Diego, CA
name: Chandra E Khalifian, PhD
role: PRINCIPAL_INVESTIGATOR
References: