RECRUITING

Treatment for Relationships and Safety Together

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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. 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.

Official Title

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

Quick Facts

Study Start:2021-04-15
Study Completion:2026-03-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04816149

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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
  2. * an intimate partner who is willing to participate.
  3. * Additional inclusion criteria for both Veterans and Partners include:
  4. * in the committed relationship for at least 6 months
  5. * plans to remain in the San Diego region for 7 months
  6. * capable of informed consent
  7. * agree to have assessment and treatment sessions audio recorded.
  1. * not English speaking
  2. * cannot complete the assessment battery
  3. * current substance use requiring immediate detoxification or outpatient plan directed specifically to residential substance use disorder (not mental health) services
  4. * has or meets criteria for a current diagnosis of psychosis and/or mania in either member of the couple
  5. * under conservatorship requiring proxy consent
  6. * any perpetration of severe physical or sexual relationship aggression in the past year (as assessed by the CTS-2)

Contacts and Locations

Study Contact

Chandra E Khalifian, PhD
CONTACT
Chandra.Khalifian@va.gov
Leslie A Morland, PsyD
CONTACT
(619) 497-8406
Leslie.Morland@va.gov

Principal Investigator

Chandra E Khalifian, PhD
PRINCIPAL_INVESTIGATOR
VA San Diego Healthcare System, San Diego, CA

Study Locations (Sites)

VA San Diego Healthcare System, San Diego, CA
San Diego, California, 92161-0002
United States

Collaborators and Investigators

Sponsor: VA Office of Research and Development

  • Chandra E Khalifian, PhD, PRINCIPAL_INVESTIGATOR, VA San Diego Healthcare System, San Diego, CA

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-04-15
Study Completion Date2026-03-31

Study Record Updates

Study Start Date2021-04-15
Study Completion Date2026-03-31

Terms related to this study

Keywords Provided by Researchers

  • Suicide
  • Interpersonal Relations

Additional Relevant MeSH Terms

  • Suicide
  • Interpersonal Relations