Clinical trial NCT05724953: Alexithymia Intervention for Suicide
Official title: Alexithymia Intervention for Suicide (ALEXIS)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Suicide
Schizophrenia
Bipolar Disorder
Post Traumatic Stress Disorder
Major Depressive Disorder
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2023-02-13
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: TREATMENT

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.

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 5 years)

  * 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

Primary outcomes:
measure: Columbia Suicide Severity Rating Scale (C-SSRS) Change
timeFrame: Baseline, 6 weeks, 8 weeks.
measure: Toronto Alexithymia Scale (TAS-20) Change
timeFrame: Baseline, 6 weeks, 8 weeks.
measure: Provision of Social Relations Scale (PSRS) Change
timeFrame: Baseline, 6 weeks, 8 weeks.
Secondary outcomes:
measure: Emotion Granularity Index Change
timeFrame: Baseline, 6 weeks, 8 weeks.
Other outcomes:
measure: MIRECC-GAF Change
timeFrame: Baseline, 6 weeks, 8 weeks.
measure: World Health Organization Quality of Life - Brief (WHOQOL-BREF) Change
timeFrame: Baseline, 6 weeks, 8 weeks.
measure: Emotion Regulation Questionnaire (ERQ) Change
timeFrame: Baseline, 6 weeks, 8 weeks.
measure: Beck Depression Inventory (BDI) Change
timeFrame: Baseline, 6 weeks, 8 weeks.
measure: Beck Anxiety Inventory (BAI) Change
timeFrame: Baseline, 6 weeks, 8 weeks.
measure: Structured Clinical Interview for DSM-V Axis I (SCID-I)
timeFrame: Baseline.
measure: Clinician-Administered PTSD Scale for DSM-V (CAPS-V)
timeFrame: Baseline.
measure: Childhood Trauma Questionnaire (CTQ)
timeFrame: Baseline.
measure: Emotion Recognition task (ER-40)
timeFrame: Baseline, 8 weeks
measure: Loneliness (UCLA Loneliness Scale)
timeFrame: Baseline, 8 weeks
measure: Emodiment of Emotions (EmBody Task)
timeFrame: Baseline, 8 weeks
Locations:
city: Bronx
country: United States
facility: James J. Peters VA Medical Center, Bronx, NY
state: New York
Study officials:
affiliation: James J. Peters Veterans Affairs Medical Center
name: David Kimhy, PhD
role: PRINCIPAL_INVESTIGATOR
References: