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Treatment for Relationships and Safety Together (TR&ST)

Primary Purpose

Suicide, Interpersonal Relations

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
VA Standard Suicide Intervention
Treatment for Relationships and Safety Together (TR&ST)
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Suicide focused on measuring Suicide, Interpersonal Relations

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Veterans who report present suicidal ideation CSSR-S > 2 ("Active thoughts of killing oneself") in past 1 month 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 intoxication 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
  • under conservatorship requiring proxy consent
  • any perpetration of severe physical or sexual relationship aggression in the past year (as assessed by the CTS-2)

Sites / Locations

  • VA San Diego Healthcare System, San Diego, CARecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

VA Standard Suicide Intervention

Treatment for Relationships and Safety Together (TR&ST)

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.

Full Information

First Posted
March 17, 2021
Last Updated
February 28, 2023
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT04816149
Brief Title
Treatment for Relationships and Safety Together
Acronym
TR&ST
Official Title
Development of a Novel Couples-Based Suicide Intervention: Treatment for Relationships and Safety Together (TR&ST)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 15, 2021 (Actual)
Primary Completion Date
March 31, 2026 (Anticipated)
Study Completion Date
March 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicide, Interpersonal Relations
Keywords
Suicide, Interpersonal Relations

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
144 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
VA Standard Suicide Intervention
Arm Type
Active Comparator
Arm Description
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).
Arm Title
Treatment for Relationships and Safety Together (TR&ST)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
VA Standard Suicide Intervention
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Treatment for Relationships and Safety Together (TR&ST)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in severity of suicidal ideation from baseline
Description
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.
Time Frame
Delivered at baseline, 7 weeks after baseline (mid-treatment), 13 weeks after baseline (post-treatment), and 25 weeks after baseline
Secondary Outcome Measure Information:
Title
Change in positive communication from baseline
Description
The Communication Skills Test has a minimum possible score of 10, and maximum possible score of 70, wherein higher scores reflect more positive communication.
Time Frame
Delivered at baseline, 7 weeks after baseline (mid-treatment), 13 weeks after baseline (post-treatment), and 25 weeks after baseline
Title
Change in negative communication from baseline
Description
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.
Time Frame
Delivered at baseline, 7 weeks after baseline (mid-treatment), 13 weeks after baseline (post-treatment), and 25 weeks after baseline
Title
Change in positive bonding from baseline
Description
The Positive Bonding Scale has a minimum possible score of 9, and maximum possible score of 63, wherein higher scores reflect more positive bonding.
Time Frame
Delivered at baseline, 7 weeks after baseline (mid-treatment), 13 weeks after baseline (post-treatment), and 25 weeks after baseline
Title
Change in perceived burdensomeness and thwarted belonging from baseline
Description
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.
Time Frame
Delivered at baseline, 7 weeks after baseline (mid-treatment), 13 weeks after baseline (post-treatment), and 25 weeks after baseline
Title
Change in relationship satisfaction from baseline
Description
The Couples Satisfaction Index has a minimum possible score of 0, and maximum possible score of 161, wherein higher scores reflect higher relationship satisfaction.
Time Frame
Delivered at baseline, 7 weeks after baseline (mid-treatment), 13 weeks after baseline (post-treatment), and 25 weeks after baseline
Other Pre-specified Outcome Measures:
Title
Expectations of Treatment
Description
The Credibility/Expectancy Questionnaire consists of 6 items rated on a 1-9 or a 0%-100% scale, wherein higher scores reflect higher treatment credibility and expectancy.
Time Frame
baseline
Title
Satisfaction with Care
Description
The Client Satisfaction Questionnaire has a minimum possible score of 8, and a maximum possible score of 32, wherein higher scores reflect greater satisfaction with the intervention.
Time Frame
13 weeks after baseline (post-treatment)
Title
Change in relationship conflict from baseline
Description
The Revised Conflict Tactics Scale consists of 20 items rated on a 0-7 scale, wherein higher scores reflect more conflict.
Time Frame
Delivered at baseline, 7 weeks after baseline (mid-treatment), 13 weeks after baseline (post-treatment), and 25 weeks after baseline
Title
Change in severity of depression from baseline
Description
The Patient Health Questionnaire-9 has a minimum possible score of 0 and a maximum possible score of 27, wherein higher scores reflect higher severity of depression.
Time Frame
Delivered at baseline, 7 weeks after baseline (mid-treatment), 13 weeks after baseline (post-treatment), and 25 weeks after baseline
Title
Changes in Posttraumatic Stress Disorder severity from baseline
Description
The Post-Traumatic Stress Disorder Checklist for Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) has a minimum possible score of 0 and a maximum possible score of 80, wherein higher scores reflect more severe posttraumatic stress disorder symptomatology.
Time Frame
Delivered at baseline, 7 weeks after baseline (mid-treatment), 13 weeks after baseline (post-treatment), and 25 weeks after baseline
Title
Outpatient Engagement
Description
Outpatient engagement will be measured with the Cornell Services Index, which is an instrument that elicits information about the quantity and timing of inpatient and outpatient care (both mental health and non-mental health) as well as self-help groups.
Time Frame
Delivered at baseline, 7 weeks after baseline (mid-treatment), 13 weeks after baseline (post-treatment), and 25 weeks after baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chandra E Khalifian, PhD
Email
Chandra.Khalifian@va.gov
First Name & Middle Initial & Last Name or Official Title & Degree
Leslie A Morland, PsyD
Phone
(619) 497-8406
Email
Leslie.Morland@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chandra E Khalifian, PhD
Organizational Affiliation
VA San Diego Healthcare System, San Diego, CA
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA San Diego Healthcare System, San Diego, CA
City
San Diego
State/Province
California
ZIP/Postal Code
92161-0002
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chandra E Khalifian, PhD
Email
Chandra.Khalifian@va.gov
First Name & Middle Initial & Last Name & Degree
Leslie A Morland, PsyD
Phone
(619) 497-8406
Email
Leslie.Morland@va.gov
First Name & Middle Initial & Last Name & Degree
Chandra E Khalifian, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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