Ignite Creation Date:
2024-05-06 @ 3:57 PM
Last Modification Date:
2024-10-26 @ 2:00 PM
Study NCT ID:
NCT04816149
Status:
RECRUITING
Last Update Posted:
2024-02-05
First Post:
2021-03-17
Brief Title:
Treatment for Relationships and Safety Together
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Development of a Novel Couples-Based Suicide Intervention Treatment for Relationships and Safety Together TRST
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TRST
Brief Summary:
Suicide prevention is the top clinical priority for VADoD Suicide is one of the leading causes of death in the United States and worldwide with suicide rates among US military Veterans doubling 277 per 100000 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 ones 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 ones intimate relationship is an understudied intervention target for suicide prevention Despite the fact that VADoD 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 TRST TRST 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 N24 and Phase 2 pilot Randomized Controlled Trial RCT of TRST 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 N120 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 VADoD Suicide is one of the leading causes of death in the United States and worldwide with suicide rates among US military Veterans doubling 277 per 100000 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 ones 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 ones 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 VADoD patient focus groups conducted for the 2019 VADoD Clinical Practice Guidelines for the Assessment and Management of Patients at Risk for Suicide Despite the fact that VADoD 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 TRST TRST 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 N24 and Phase 2 pilot Randomized Controlled Trial RCT of TRST 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 N120 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 TRST in a population of Veterans with active suicidal ideation Aim 2 Phase 2 evaluate feasibility and acceptability of TRST Hypothesis 1 is that TRST 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 TRST 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 TRST vs VA Standard Suicide Intervention will have greater reduction in suicidal ideation severity primary outcome Hypothesis 2b is that Veterans and partners engaged in TRST vs VA Standard Suicide Intervention will have improved interpersonal functioning ie communication bonding relationship satisfaction Hypothesis 2c is that the effect of TRST on Veterans 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 TRST 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 TRST on depression PTSD and relationship conflict
The proposed 5-year study consists of two phases Phase 1 treatment refinement with 12 couples N24 and Phase 2 pilot Randomized Controlled Trial RCT of TRST 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 N120 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 TRST in a population of Veterans with active suicidal ideation Aim 2 Phase 2 evaluate feasibility and acceptability of TRST Hypothesis 1 is that TRST 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 TRST 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 TRST vs VA Standard Suicide Intervention will have greater reduction in suicidal ideation severity primary outcome Hypothesis 2b is that Veterans and partners engaged in TRST vs VA Standard Suicide Intervention will have improved interpersonal functioning ie communication bonding relationship satisfaction Hypothesis 2c is that the effect of TRST on Veterans 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 TRST 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 TRST on depression PTSD and relationship conflict
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| RX003490 | OTHER_GRANT | VA RRD | None |