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Alexithymia Intervention for Suicide (ALEXIS)

Primary Purpose

Suicide, Schizophrenia, Bipolar Disorder

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Affective Awareness
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

Eligibility Criteria

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

Inclusion Criteria: 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 year) limited emotion awareness (Toronto Alexithymia Scale; TAS-20 52) can understand all the study's risks and benefits Exclusion Criteria: 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

Sites / Locations

  • James J. Peters VA Medical Center, Bronx, NYRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Affective Awareness

Arm Description

Intervention involving psychoeducation and daily emotion awareness practices

Outcomes

Primary Outcome Measures

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.
Toronto Alexithymia Scale (TAS-20) Change
A self-report scale indexing difficulty identifying, difficulty describing feelings, and externally oriented thinking.
Provision of Social Relations Scale (PSRS) Change
A self-report scale indexing relationship with family and friends.

Secondary Outcome Measures

Emotion Granularity Index Change
An smartphone-based index of emotion granularity based on reports of emotions during daily functioning.

Full Information

First Posted
February 1, 2023
Last Updated
October 10, 2023
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT05724953
Brief Title
Alexithymia Intervention for Suicide
Acronym
ALEXIS
Official Title
Alexithymia Intervention for Suicide (ALEXIS)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2023 (Actual)
Primary Completion Date
March 31, 2025 (Anticipated)
Study Completion Date
May 30, 2025 (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
No

5. Study Description

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.
Detailed Description
Suicide rates among veterans with Serious Mental Illness (SMI) are intractably high. Yet, at present available treatments offer only minimal to limited benefits to ameliorate this risk, despite a VA-wide implementation of enriched suicide prevention services and the availability of a national suicide hotline. This dire state represents a serious public health concern and a critical target for interventions. In response to this state, the Rehabilitation Research & Development Service (RR&D)'s Behavioral Health & Social Reintegration Program has highlighted the need for development of suicide prevention interventions that enhance social reintegration, functional outcomes, and improve overall participation in society. Germane to social functioning, extensive evidence from basic affective neuroscience research indicates that effective social functioning requires intact emotion awareness. Specifically, emotions are posited to provide crucial information about the significance of social situations and help to guide potential actions to be taken to navigate such situations. Negative emotional experiences in particular have critical informational value in signaling the need to adjust one's current state or activity. As different emotions may call for the use of distinct response strategies, lack of or reduced awareness of experienced feelings may make it difficult for individuals to choose response strategies for dealing effectively with social situations, resulting in poor social functioning. Consistent with these findings, recent reports indicate alexithymia, a transdiagnostic clinical syndrome characterized by poor emotion awareness, to be highly prevalent among veteran and civilians with SMI, with a recent large systematic review and meta-analysis indicating alexithymia predicting suicide ideation and behavior. Relatedly, previous reports indicate alexithymia has a detrimental impact on treatment outcomes. Altogether, these findings suggest alexithymia may play a key role in impacting suicide risk and treatment response in Veterans. Yet, despite its pervasiveness, chronic presentation, link to SMI and poor social functioning, and impact on clinical outcomes, the putative impact of alexithymia on suicide risk has not been investigated in Veterans with SMI at risk of suicide. Building on these findings, the goal of this project is to test the feasibility and acceptability of a novel, blended psychoeducation and digital mHealth (mobile health) intervention designed to target alexithymia and poor social functioning to reduce suicide risk in Veterans with SMI. Employing a proof-of-concept design, 40 participants will attend weekly group psychoeducation sessions targeting emotion awareness and social functioning along with an innovative mHealth emotion awareness skill training via smartphone to reduce alexithymia, enhance social functioning, and reduce suicide risk. Results from the present study will provide comprehensive characterization of suicide risk among Veterans with SMI, provide preliminary acceptability and feasibility data, and will inform the development of a randomized clinical trial to test the efficacy of the intervention to ameliorate suicide risk in this population.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicide, Schizophrenia, Bipolar Disorder, Post Traumatic Stress Disorder, Major Depressive Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Affective Awareness
Arm Type
Experimental
Arm Description
Intervention involving psychoeducation and daily emotion awareness practices
Intervention Type
Behavioral
Intervention Name(s)
Affective Awareness
Intervention Description
Intervention involving psychoeducation and daily emotion awareness practices
Primary Outcome Measure Information:
Title
Columbia Suicide Severity Rating Scale (C-SSRS) Change
Description
A semi-structured interview indexing suicide risk and related domains including ideation, severity, intensity, behavior, and lethality.
Time Frame
Baseline, 6 weeks, 8 weeks.
Title
Toronto Alexithymia Scale (TAS-20) Change
Description
A self-report scale indexing difficulty identifying, difficulty describing feelings, and externally oriented thinking.
Time Frame
Baseline, 6 weeks, 8 weeks.
Title
Provision of Social Relations Scale (PSRS) Change
Description
A self-report scale indexing relationship with family and friends.
Time Frame
Baseline, 6 weeks, 8 weeks.
Secondary Outcome Measure Information:
Title
Emotion Granularity Index Change
Description
An smartphone-based index of emotion granularity based on reports of emotions during daily functioning.
Time Frame
Baseline, 6 weeks, 8 weeks.
Other Pre-specified Outcome Measures:
Title
MIRECC-GAF Change
Description
A rater-based index of occupational and social functioning.
Time Frame
Baseline, 6 weeks, 8 weeks.
Title
World Health Organization Quality of Life - Brief (WHOQOL-BREF) Change
Description
A self-report scale indexing quality of life.
Time Frame
Baseline, 6 weeks, 8 weeks.
Title
Emotion Regulation Questionnaire (ERQ) Change
Description
A self-report scale indexing emotion regulation.
Time Frame
Baseline, 6 weeks, 8 weeks.
Title
Beck Depression Inventory (BDI) Change
Description
A self-report scale indexing depressed mood.
Time Frame
Baseline, 6 weeks, 8 weeks.
Title
Beck Anxiety Inventory (BAI) Change
Description
A self-report scale indexing anxiety.
Time Frame
Baseline, 6 weeks, 8 weeks.
Title
Structured Clinical Interview for DSM-V Axis I (SCID-I)
Description
A rater-based clinical interview used to establish psychiatric diagnoses.
Time Frame
Baseline.
Title
Clinician-Administered PTSD Scale for DSM-V (CAPS-V)
Description
A rater-based clinical interview used to assess trauma.
Time Frame
Baseline.
Title
Childhood Trauma Questionnaire (CTQ)
Description
A self-report scale indexing childhood trauma.
Time Frame
Baseline.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 year) limited emotion awareness (Toronto Alexithymia Scale; TAS-20 52) can understand all the study's risks and benefits Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David Kimhy, PhD
Phone
(718) 584-9000
Email
David.Kimhy@va.gov
First Name & Middle Initial & Last Name or Official Title & Degree
Marianne S Goodman, MD
Phone
(718) 584-9000
Ext
5188
Email
marianne.goodman@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Kimhy, PhD
Organizational Affiliation
James J. Peters Veterans Affairs Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
James J. Peters VA Medical Center, Bronx, NY
City
Bronx
State/Province
New York
ZIP/Postal Code
10468-3904
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Kimhy, PhD
Phone
718-584-9000
Email
David.Kimhy@va.gov
First Name & Middle Initial & Last Name & Degree
David Kimhy, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Alexithymia Intervention for Suicide

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