RECRUITING

Alexithymia Intervention for Suicide

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 rates among Veterans with Serious Mental Illness (SMI) are intractably high, representing a serious public health concern and a critical target for interventions. Yet, at present available treatments offer modest benefits. Thus, there remains an urgent need to identify novel approaches to address suicide risk in this population. Previous reports have linked suicide risk with poor social functioning. Emerging evidence from basic affective neuroscience research has indicated that effective social functioning is contingent on intact emotion awareness. Consistent with these findings, individuals with SMI at risk of suicide display social functioning difficulties along with poor emotion awareness (i.e., alexithymia). Employing a proof-of-concept design, the aim of the present study is to test the feasibility and acceptability of a novel, blended psychoeducation and digital mHealth (mobile health) intervention with smartphones designed to target alexithymia and poor social functioning to reduce suicide risk in Veterans with SMI.

Official Title

Alexithymia Intervention for Suicide (ALEXIS)

Quick Facts

Study Start:2023-10-01
Study Completion:2025-05-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05724953

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. * a DSM-V diagnosis of PTSD
  2. * bipolar disorder
  3. * MDD
  4. * schizophrenia
  5. * at risk of suicide(Columbia Suicide Severity Rating Scale
  6. * C-SSRS \>=3 or a suicide attempt in the past 5 years)
  7. * limited emotion awareness (Toronto Alexithymia Scale; TAS-20 \>=52)
  8. * can understand all the study's risks and benefits
  1. * have medical/neurological conditions that could interfere with study participation
  2. * enrolled in another treatment study
  3. * unable/unwilling to provide a verifiable contact for emergency purposes

Contacts and Locations

Study Contact

David Kimhy, PhD
CONTACT
(718) 584-9000
David.Kimhy@va.gov

Principal Investigator

David Kimhy, PhD
PRINCIPAL_INVESTIGATOR
James J. Peters Veterans Affairs Medical Center

Study Locations (Sites)

James J. Peters VA Medical Center, Bronx, NY
Bronx, New York, 10468-3904
United States

Collaborators and Investigators

Sponsor: VA Office of Research and Development

  • David Kimhy, PhD, PRINCIPAL_INVESTIGATOR, James J. Peters Veterans Affairs Medical Center

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 Date2023-10-01
Study Completion Date2025-05-30

Study Record Updates

Study Start Date2023-10-01
Study Completion Date2025-05-30

Terms related to this study

Additional Relevant MeSH Terms

  • Suicide
  • Schizophrenia
  • Bipolar Disorder
  • Post Traumatic Stress Disorder
  • Major Depressive Disorder