SuicidePhase 1ALEXISNCT05724953
Alexithymia Intervention for Suicide
A Phase 1 study testing Affective Awareness in people with Suicide and Schizophrenia, run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Suicide, Schizophrenia, Bipolar Disorder
- What is being tested?
- Affective Awareness
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2023to 30 Jan 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
James J. Peters VA Medical Center, Bronx, NY
The Bronx, New York, 10468-3904
About this study
Official title: Alexithymia Intervention for Suicide (ALEXIS)
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.
Read the 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.
- Conditions
- Suicide, Schizophrenia, Bipolar Disorder, Post Traumatic Stress Disorder, Major Depressive Disorder
- Being tested
- Affective Awareness
- Medical subject headings
- Suicide, Schizophrenia, Bipolar Disorder, Stress Disorders, Post-Traumatic, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Affective AwarenessBehavioural
Intervention involving psychoeducation and daily emotion awareness practices
| Study group | Role | What they receive |
|---|---|---|
| Affective Awareness | Experimental | Intervention involving psychoeducation and daily emotion awareness practices Receives: Behavioral: Affective Awareness |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline, 6 weeks, 8 weeks.
Provision of Social Relations Scale (PSRS) Change
A self-report scale indexing relationship with family and friends.
Measured: Baseline, 6 weeks, 8 weeks.
Secondary outcomes (1)
Emotion Granularity Index Change
An smartphone-based index of emotion granularity based on reports of emotions during daily functioning.
Measured: Baseline, 6 weeks, 8 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2023
- Study start1 Oct 2023
- Primary completion30 Jan 2026
- Study completion30 Jan 2026
Why it stopped: Staff turnover and trouble with recruitment, staffing, and paying invoices.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SuicideStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Marianne S. Goodman, MD, Principal investigator, James J. Peters Veterans Affairs Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05724953
- Sponsor's protocol ID
- D4089-P
- Acronym
- ALEXIS
- Status last verified
- Mar 2026
- First submitted
- 1 Feb 2023
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alexithymia Intervention for Suicide (ALEXIS)
- ClinicalTrials.gov ID
- NCT05724953
- Acronym / sponsor ID
- ALEXIS / D4089-P
- Conditions
- Suicide, Schizophrenia, Bipolar Disorder, Post Traumatic Stress Disorder, Major Depressive Disorder
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Staff turnover and trouble with recruitment, staffing, and paying invoices.
- Enrolment
- 11 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 30 Jan 2026 (actual)
- Study completion
- 30 Jan 2026 (actual)
- First posted
- 13 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Affective Awareness | Experimental | Behavioral: Affective AwarenessIntervention involving psychoeducation and daily emotion awareness practices |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- a DSM-V diagnosis of PTSD
- bipolar disorder
- MDD
- schizophrenia
- at risk of suicide(Columbia Suicide Severity Rating Scale
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Affective AwarenessIntervention involving psychoeducation and daily emotion awareness practices | Behavioural | Affective Awareness |
Primary outcome
Columbia Suicide Severity Rating Scale (C-SSRS) Change
Time frame: Baseline, 6 weeks, 8 weeks.
A semi-structured interview indexing suicide risk and related domains including ideation, severity, intensity, behavior, and lethality.
Toronto Alexithymia Scale (TAS-20) Change
Time frame: Baseline, 6 weeks, 8 weeks.
A self-report scale indexing difficulty identifying, difficulty describing feelings, and externally oriented thinking.
Provision of Social Relations Scale (PSRS) Change
Time frame: Baseline, 6 weeks, 8 weeks.
A self-report scale indexing relationship with family and friends.
1 secondary outcome
Emotion Granularity Index Change
Time frame: Baseline, 6 weeks, 8 weeks.
Results and safety
The study was stopped early (reason given: Staff turnover and trouble with recruitment, staffing, and paying invoices.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marianne S. Goodman, MD principal investigator
James J. Peters Veterans Affairs Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Affective Awareness in people with Suicide and Schizophrenia, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Staff turnover and trouble with recruitment, staffing, and paying invoices.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Columbia Suicide Severity Rating Scale (C-SSRS) Change (time frame: Baseline, 6 weeks, 8 weeks.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.