Affective Awareness for Suicide Prevention

(ALEXIS Trial)

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

Trial Summary

What is the purpose of this trial?

This trial tests a new approach to help veterans with serious mental illness who are at risk of suicide. The treatment combines group education sessions and a smartphone app to improve emotional awareness and social functioning. By helping veterans understand their emotions better, the goal is to reduce their suicide risk.

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 data supports the effectiveness of the treatment Affective Awareness for Suicide Prevention?

Research shows that improving emotional awareness, particularly in people who struggle to identify and describe their emotions (a condition known as alexithymia), can reduce depression and hopelessness, which are linked to suicide risk. A study found that a group therapy intervention focusing on emotional literacy led to a significant reduction in alexithymia scores, suggesting that such treatments can be effective in suicide prevention. ^{1 2 3 4 5}

Is the Affective Awareness treatment safe for humans?

The research does not provide specific safety data for Affective Awareness treatment, but it suggests that addressing alexithymia (difficulty in identifying and describing emotions) through interventions may improve emotional awareness and related mental health outcomes without indicating any safety concerns. ^{1 2 3 4 6}

How is the Affective Awareness treatment different from other treatments for suicide prevention?

Affective Awareness is unique because it targets alexithymia, which is the difficulty in identifying and describing emotions, a known risk factor for suicide. This treatment focuses on improving emotional literacy, which can help reduce depression and hopelessness, potentially lowering suicide risk. ^{1 2 7 8 9}

Research Team

David Kimhy, PhD

Principal Investigator

James J. Peters Veterans Affairs Medical Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

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]

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 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]

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]

References

1. Canada pubmed.ncbi.nlm.nih.gov

Alexithymia in People With Recurrent Suicide Attempts. [2021]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Alexithymia and Suicide Risk in Psychiatric Disorders: A Mini-Review. [2022]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Alexithymia. [2023]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Alexithymia as a possible specifier of adverse outcomes: Clinical correlates in euthymic unipolar individuals. [2021]

5. Germany pubmed.ncbi.nlm.nih.gov

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

6. England 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. [2021]

7. Australia 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. [2021]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Alexithymia: concept and measurement. [2018]

9. Netherlands pubmed.ncbi.nlm.nih.gov

A scoping review of suicidality and alexithymia: The need to consider interoception. [2019]