Affective Awareness for Suicide Prevention

(ALEXIS Trial)

Recruiting at 1 trial location

Overseen By Marianne S Goodman, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: VA Office of Research and Development

Disqualifiers: Medical conditions, Other study, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

Duration: 8 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment approach for Veterans with serious mental illnesses such as PTSD, bipolar disorder, major depression, or schizophrenia, who are also at risk of suicide. The focus is on a unique blend of psychoeducation and mobile health technology, called Affective Awareness, to enhance emotion awareness and social functioning. The goal is to determine if this method can effectively reduce suicide risk. Veterans who have difficulty expressing or understanding their emotions and have recently experienced suicidal thoughts or attempts may be well-suited for this trial. As a Phase 1 trial, the research aims to understand how the treatment works in people, offering participants the chance to be among the first to receive this innovative approach.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that this intervention is safe for Veterans with Serious Mental Illness?

Research shows that the Affective Awareness treatment remains in the early stages of testing, so solid information about its safety is limited. The treatment uses education and digital tools to enhance emotional awareness. Although specific safety data for Affective Awareness is unavailable, similar digital and educational treatments are generally safe and well-received.

In these early trials, the main goal is to assess the treatment's practicality and acceptability for participants. While safety is important, no major negative effects have been reported so far. However, as this is a new method, researchers will closely monitor to ensure everyone's safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Affective Awareness is unique because it focuses on psychoeducation combined with daily emotion awareness practices, which is a departure from the standard treatment options for suicide prevention, such as medication and cognitive behavioral therapy. Most traditional treatments aim to manage symptoms or restructure thought patterns, but Affective Awareness targets the root of emotional regulation by enhancing individuals' awareness and understanding of their emotions. Researchers are excited about this approach because it empowers individuals with tools to recognize and process their emotions in real-time, potentially offering a more sustainable and proactive way to prevent suicidal thoughts and behaviors.

What evidence suggests that this intervention is effective for reducing suicide risk in Veterans with SMI?

Research has shown that greater emotional awareness can improve social skills, which is crucial for reducing the risk of suicide. Studies have found that people with serious mental illness (SMI) often struggle to recognize their own emotions, a condition known as alexithymia. This difficulty can lead to poor social interactions and a higher risk of suicide. In this trial, participants will receive the Affective Awareness intervention, which combines learning about emotions with digital tools to help individuals better understand and express their feelings. Early results suggest that focusing on emotion awareness could enhance social skills and potentially reduce suicide risk in Veterans with SMI. ^{1 2 6 7 8}

Who Is on the Research Team?

David Kimhy, PhD

Principal Investigator

James J. Peters Veterans Affairs Medical Center

Are You a Good Fit for This Trial?

This trial is for Veterans with serious mental illnesses like PTSD, bipolar disorder, schizophrenia, and depression who are at risk of suicide. Participants must have limited emotion awareness and understand the study's risks and benefits. Those with certain medical conditions or involved in another treatment study cannot join.

Inclusion Criteria

I have been diagnosed with PTSD.

Can understand all the study's risks and benefits

Limited emotion awareness (Toronto Alexithymia Scale; TAS-20 score of 52)

Exclusion Criteria

Medical/neurological conditions that could interfere with study participation

Enrolled in another treatment study

Unable/unwilling to provide a verifiable contact for emergency purposes

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants attend weekly group psychoeducation sessions and engage in mHealth emotion awareness skill training via smartphone

8 weeks

8 visits (in-person), daily smartphone activities

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Affective Awareness

Trial Overview The trial is testing a new intervention combining psychoeducation with digital mHealth tools to improve emotion awareness and social functioning, aiming to reduce suicide risk among Veterans with serious mental illness.

How Is the Trial Designed?

Group I: Affective Awareness Experimental Treatment 1 Intervention

Intervention involving psychoeducation and daily emotion awareness practices

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Published Research Related to This Trial

Alexithymia, a condition where individuals struggle to identify and express emotions, is linked to higher levels of anxiety, depression, and psychological suffering, which may increase the risk of suicide.

Most studies reviewed indicate that alexithymia is associated with an increased suicide risk, often mediated by depressive symptoms, highlighting the need for routine screening for alexithymia in clinical settings to improve suicide prevention efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Alexithymia and Suicide Risk in Psychiatric Disorders: A Mini-Review. De Berardis, D., Fornaro, M., Orsolini, L., et al.[2022]

Alexithymia, a condition characterized by difficulty in identifying and expressing emotions, requires better validation and measurement methods to enhance clinical understanding.

The paper reviews various questionnaires designed to assess alexithymia, highlighting existing challenges in their use and the necessity for more comparative clinical studies to improve assessment accuracy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Alexithymia: concept and measurement. Apfel, RJ., Sifneos, PE.[2018]

A 20-week group therapy intervention for 169 participants with a history of recurrent suicide attempts showed that alexithymia, the difficulty in identifying and describing emotions, can be significantly reduced, with 16.6% of participants experiencing a notable decrease in their alexithymia scores.

Improving emotional literacy through this intervention may also lead to better outcomes in related areas such as depression, hopelessness, and overall life satisfaction, suggesting that addressing alexithymia could be beneficial for individuals at risk of suicide.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Alexithymia in People With Recurrent Suicide Attempts. Bergmans, Y., Guimond, T., Lambert, C., et al.[2021]

In a study of 103 drug-naïve adults with their first episode of major depression, higher levels of alexithymia and lower resilience were linked to increased suicide ideation, highlighting the importance of emotional awareness and coping skills in mental health.

The research found that individuals with difficulty identifying their feelings (alexithymia) and lower resilience scores were more likely to have higher suicide ideation scores, suggesting these factors could be critical targets for intervention in depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Alexithymia, resilience, somatic sensations and their relationships with suicide ideation in drug naïve patients with first-episode major depression: An exploratory study in the "real world" everyday clinical practice. De Berardis, D., Fornaro, M., Valchera, A., et al.[2021]

Alexithymia, a condition characterized by disrupted emotional awareness, is linked to various psychiatric and neurological disorders, negatively affecting treatment outcomes and functional abilities.

The chapter reviews the functional deficits and neural correlates of alexithymia, highlighting the critical role of emotional awareness in human functioning and suggesting that improved measurement and computational models could enhance research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Alexithymia. Hogeveen, J., Grafman, J.[2023]

The scoping review analyzed 27 studies on the relationship between alexithymia (difficulty in identifying and expressing emotions) and suicidality, revealing a heterogeneous evidence base with mixed results, indicating that the connection is not clearly established.

The review suggests that interoception, or the awareness of internal body states, could be an important factor to explore in future research to better understand how emotion regulation relates to suicidal behavior.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A scoping review of suicidality and alexithymia: The need to consider interoception. Davey, S., Halberstadt, J., Bell, E., et al.[2019]

Patients with somatoform disorders often struggle with recognizing and expressing emotions, a condition known as alexithymia, which requires a specialized psychotherapeutic approach.

The treatment is divided into two stages: the first focuses on overcoming alexithymia through cognitive interventions in group therapy, while the second stage emphasizes psychodynamic issues and the analysis of dysfunctional beliefs and past traumas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[A combination of cognitive and psychodynamic components in the psychotherapy of somatoform disorders]. Kholmogorova, A., Garanjan, N.[2018]

Patients with major depressive disorder (MDD) who have alexithymia tend to have a lower educational level, higher rates of previous psychiatric drug use, and increased current antidepressant use compared to those without alexithymia, indicating a more complex clinical profile.

Alexithymia is linked to higher psychiatric comorbidity and difficulties in identifying and communicating feelings, suggesting that recognizing this condition can help tailor more personalized treatment approaches for affected individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Alexithymia as a possible specifier of adverse outcomes: Clinical correlates in euthymic unipolar individuals. Serafini, G., De Berardis, D., Valchera, A., et al.[2021]

In a study of 1380 individuals over 10 years, alexithymia was found to significantly increase the risk of all-cause mortality, particularly in men, with a hazard ratio of 1.050.

The specific subfactors of alexithymia, namely 'difficulties identifying feelings' and 'difficulties describing feelings,' were validated as contributing to this increased mortality risk, indicating a need for further exploration of underlying factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Alexithymia is associated with increased all-cause mortality risk in men, but not in women: A 10-year follow-up study. Terock, J., Klinger-König, J., Janowitz, D., et al.[2021]

Citations

1. reporter.nih.gov reporter.nih.gov/project-details/10851706

Alexithymia Intervention for Suicide (ALEXIS) - NIH RePORTER Building on these findings, the goal of this project is to test the feasibility and acceptability of a novel, blended psychoeducation and digital mHealth ( ...

2. trialx.com trialx.com/clinical-trials/listings/238074/alexithymia-intervention-for-suicide/

Alexithymia Intervention for Suicide Emerging evidence from basic affective neuroscience research has indicated that effective social functioning is contingent on intact emotion awareness.

3. withpower.com withpower.com/trial/affective-awareness-for-suicide-prevention-9f5fa

Affective Awareness for Suicide Prevention (ALEXIS Trial) Trial Overview The trial is testing a new intervention combining psychoeducation with digital mHealth tools to improve emotion awareness and social functioning, ...

4. centerwatch.com centerwatch.com/clinical-trials/listings/condition/7/affective-disorders?activelyRecruiting=false&page=35

Affective Disorders Clinical Research Trials Affective disorders refer to a group of mental health conditions that affect a person's mood or emotions. These disorders can range from mild to severe and ...

5. tandfonline.com tandfonline.com/doi/pdf/10.2147/JMDH.S472264

A Scoping Review of Digital-Based Intervention for ... Research on suicide prevention has shown that traditional prevention methods and digital interventions yield varying outcomes in preventing ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11283240/

A Scoping Review of Digital-Based Intervention for ... This study aims to describe a digital intervention to reduce the risk of suicidal behavior in adults. The design used in this study was a scoping review.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT04772677

Building Emotional Awareness and Mental Health (BEAM) The BEAM program is a novel mobile app-based therapeutic intervention that incorporates key parenting concepts and Unified Protocol (UP) therapy modules with ...

8. researchprotocols.org researchprotocols.org/2025/1/e64518

Protocol for a Randomized Controlled Trial This research evaluates the effectiveness and cost-effectiveness of OkeyMind, a mobile-based psychoeducation program, for reducing social anxiety symptoms ...