NCT05724953

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Oct 2023

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 1, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 13, 2023

Completed
8 months until next milestone

Study Start

First participant enrolled

October 1, 2023

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2026

Completed
Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

2.3 years

First QC Date

February 1, 2023

Last Update Submit

March 23, 2026

Conditions

SuicideSchizophreniaBipolar DisorderPost Traumatic Stress DisorderMajor Depressive Disorder

Outcome Measures

Primary Outcomes (3)

  • Columbia Suicide Severity Rating Scale (C-SSRS) Change

    A semi-structured interview indexing suicide risk and related domains including ideation, severity, intensity, behavior, and lethality.

    Baseline, 6 weeks, 8 weeks.

  • Toronto Alexithymia Scale (TAS-20) Change

    A self-report scale indexing difficulty identifying, difficulty describing feelings, and externally oriented thinking.

    Baseline, 6 weeks, 8 weeks.

  • Provision of Social Relations Scale (PSRS) Change

    A self-report scale indexing relationship with family and friends.

    Baseline, 6 weeks, 8 weeks.

Secondary Outcomes (1)

  • Emotion Granularity Index Change

    Baseline, 6 weeks, 8 weeks.

Other Outcomes (11)

  • MIRECC-GAF Change

    Baseline, 6 weeks, 8 weeks.

  • World Health Organization Quality of Life - Brief (WHOQOL-BREF) Change

    Baseline, 6 weeks, 8 weeks.

  • Emotion Regulation Questionnaire (ERQ) Change

    Baseline, 6 weeks, 8 weeks.

  • +8 more other outcomes

Study Arms (1)

Affective Awareness

EXPERIMENTAL

Intervention involving psychoeducation and daily emotion awareness practices

Behavioral: Affective Awareness

Interventions

Affective AwarenessBEHAVIORAL

Intervention involving psychoeducation and daily emotion awareness practices

Affective Awareness

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • a DSM-V diagnosis of PTSD
  • bipolar disorder
  • MDD
  • schizophrenia
  • at risk of suicide(Columbia Suicide Severity Rating Scale
  • C-SSRS \>=3 or a suicide attempt in the past 5 years)
  • limited emotion awareness (Toronto Alexithymia Scale; TAS-20 \>=52)
  • can understand all the study's risks and benefits

You may not qualify if:

  • have medical/neurological conditions that could interfere with study participation
  • enrolled in another treatment study
  • unable/unwilling to provide a verifiable contact for emergency purposes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

James J. Peters VA Medical Center, Bronx, NY

The Bronx, New York, 10468-3904, United States

Location

MeSH Terms

Conditions

SuicideSchizophreniaBipolar DisorderStress Disorders, Post-TraumaticDepressive Disorder, Major

Condition Hierarchy (Ancestors)

Self-Injurious BehaviorBehavioral SymptomsBehaviorSchizophrenia Spectrum and Other Psychotic DisordersMental DisordersBipolar and Related DisordersMood DisordersStress Disorders, TraumaticTrauma and Stressor Related DisordersDepressive Disorder

Study Officials

  • Marianne S. Goodman, MD

    James J. Peters Veterans Affairs Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Participants will attend 8 weeks of blended psychoeducation and digital mHealth (mobile health) intervention using smartphones designed to target poor emotion awareness to reduce suicide risk in veterans with SMI.
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 1, 2023

First Posted

February 13, 2023

Study Start

October 1, 2023

Primary Completion

January 30, 2026

Study Completion

January 30, 2026

Last Updated

March 27, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)