Therapeutic Evaluative Conditioning for Suicidal Thoughts and Behaviors

(TEC Trial)

Overseen By Kelly Zuromski, PhD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Franciscan Hospital For Children, INC.

Disqualifiers: Cognitive impairment, Agitated behavior, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

155 Participants Needed

Trial Summary

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's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Therapeutic Evaluative Conditioning for reducing suicidal thoughts and behaviors?

Preliminary studies have shown that Therapeutic Evaluative Conditioning (TEC), a scalable app-based treatment, can reduce self-injurious behaviors, including suicidal actions. This suggests that TEC might be effective in addressing suicidal thoughts and behaviors. ^{1 2 3 4 5}

How is the treatment Therapeutic Evaluative Conditioning (TEC) different from other treatments for suicidal thoughts and behaviors?

Therapeutic Evaluative Conditioning (TEC) is unique because it is a scalable, app-based treatment that can be self-administered, making it more accessible than traditional therapies. Unlike other treatments, TEC focuses on reducing self-injurious behaviors through a mobile platform, which allows for widespread use and integration into traditional clinical settings. ^{1 2 6 7 8}

What is the purpose of this trial?

Suicide is the 2nd leading cause of death among adolescents, with the highest risk period for suicide being the month following psychiatric inpatient hospitalization. The investigators propose testing a brief, scalable intervention using evaluative conditioning aimed at reducing suicidal thoughts and behaviors among adolescents during and after inpatient hospitalization. Scalable interventions, such as the one proposed that reduce suicide risk during this markedly high-risk period, could result in large-scale decreases in suicide death.

Research Team

Alexander Millner, PhD

Principal Investigator

Principal Investigator

Eligibility Criteria

This trial is for adolescents aged 12-19 who are patients at the McLean-Franciscan Child and Adolescent Inpatient Program, have experienced self-harm or suicidal thoughts, can assent to participate, own a smartphone, and have parental permission. It excludes those heading to long-term residential care post-discharge or with cognitive impairments that prevent full participation.

Inclusion Criteria

Be a patient on McLean-Franciscan Child and Adolescent Inpatient Program (MF-CAIP) of Franciscan Children's (FC)

I have been to the hospital for self-harm, thoughts of suicide, or a suicide attempt.

Have a parent/guardian that can provide permission

Exclusion Criteria

Any factor that impairs an individual's ability to comprehend and effectively participate in the study, including inability to speak or write English fluently

I expect to be discharged to a residential program where I'll stay for more than 14 days.

Presence of gross cognitive impairment due to florid psychosis, intellectual disability, dementia, acute intoxication, etc., or the presence of extremely agitated or violent behavior

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Inpatient period

Baseline data collection, TEC intervention initiation, and assessment of treatment targets and outcomes

2 weeks

Daily sessions (in-person)

Post-discharge intervention period

Daily TEC intervention and assessments via smartphone app

4 weeks

Remote monitoring

Post-intervention follow-up

Assessment of treatment effects persistence without intervention

4 weeks

Remote assessments

Treatment Details

Interventions

• Neutral comparison condition
• Therapeutic Evaluative Conditioning

Trial Overview The study tests a brief intervention called Therapeutic Evaluative Conditioning against a neutral condition to reduce suicidal thoughts and behaviors in hospitalized adolescents. The goal is to find an easily scalable method that could significantly lower suicide risks during the critical period after hospitalization.

Participant Groups

Group I: Active intervention arm Active Control 1 Intervention

Participants will complete the intervention on a mobile device.

Group II: Control arm Placebo Group 1 Intervention

Participants will complete the sham comparator on a mobile device.

Therapeutic Evaluative Conditioning is already approved in United States for the following indications:

Approved in United States as Therapeutic Evaluative Conditioning for:

• Suicidal thoughts and behaviors in adolescents during and after psychiatric inpatient hospitalization

Who Is Running the Clinical Trial?

Franciscan Hospital For Children, INC.

Lead Sponsor

Trials

2

Recruited

230+

Harvard University

Collaborator

Trials

237

Recruited

588,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Findings from Research

Electroconvulsive therapy (ECT) is a rapid and effective treatment for severe depression, capable of quickly reducing or eliminating suicidal thoughts and behaviors, as demonstrated in a case study of an 88-year-old man who showed significant improvement after just one session.

The patient remained free of suicidal ideation for 5 months following the treatment, highlighting the potential long-term benefits of ECT even with a minimal number of sessions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Resolution of severe suicidality with a single electroconvulsive therapy. Kobeissi, J., Aloysi, A., Tobias, K., et al.[2011]

The app-based treatment called Therapeutic Evaluative Conditioning (TEC) has shown promise in reducing self-injurious behaviors (SIBs) in preliminary studies, addressing a significant public health issue.

A case illustration of a young adult female with a history of SIBs suggests that TEC can be effectively implemented in traditional clinical settings, potentially enhancing treatment options for individuals with limited success from previous interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How to Implement Therapeutic Evaluative Conditioning in a Clinical Setting. Franklin, JC., Fox, KR., Ribeiro, JD.[2019]

In a study of 14,810 patients who received electroconvulsive therapy (ECT) and 58,369 matched controls, ECT did not significantly reduce the short-term risk of suicide compared to other mental health treatments, indicating that its effectiveness in this regard is inconclusive.

Despite ECT being effective in reducing suicidal ideation, the study found that patients who received ECT remained at a high risk for suicide, suggesting that additional interventions may be necessary to address this risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Electroconvulsive Therapy on Short-Term Suicide Mortality in a Risk-Matched Patient Population. Peltzman, T., Shiner, B., Watts, BV.[2022]

In a study of 37 patients receiving electroconvulsive therapy (ECT), suicidal ideation scores showed significant improvement earlier than energy-related symptoms, suggesting ECT may quickly reduce suicidal thoughts in depressed patients.

Despite the positive findings on suicidal ideation, clinicians should remain cautious and not overlook the ongoing risk of suicide during depression treatment, emphasizing the importance of careful monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Response of energy and suicidal ideation to ECT. Rich, CL., Spiker, DG., Jewell, SW., et al.[2007]

A nationwide study involving 487 patients with unipolar and bipolar disorders found that electroconvulsive therapy (ECT) significantly reduced the risk of suicide by 19.7% compared to those receiving psychopharmacotherapy.

ECT was particularly effective in lowering suicide risk in patients with unipolar disorder and those experiencing bipolar depression, but did not show superior effects in patients with bipolar mania or mixed states.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Superior anti-suicidal effects of electroconvulsive therapy in unipolar disorder and bipolar depression. Liang, CS., Chung, CH., Ho, PS., et al.[2019]

The authors emphasize the urgent need for effective interventions to reduce self-injurious thoughts and behaviors (SITBs), as national rates have been rising and have not significantly declined in recent decades.

They also address misconceptions in the commentary by Nielsen et al., particularly regarding the nature of interventions and the causes of SITBs, which they believe could hinder progress in developing effective prevention strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Understanding the context of novel interventions for self-injurious thoughts and behaviors: A reply to Nielsen et al. Franklin, JC., Fox, KR., Ribeiro, JD., et al.[2019]

The TEC app is an evidence-based mobile health intervention designed to address self-injurious thoughts and behaviors (SITBs), but it faces challenges in ensuring that users develop lasting coping skills beyond the app's use.

There are ethical concerns regarding the potential stigma associated with the stimuli used in TEC, which could affect users' willingness to seek help; exploring a positive-only approach may enhance treatment effectiveness and reduce stigma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"Great powers and great responsibilities": A brief comment on "A brief mobile app reduces nonsuicidal and suicidal self-injury: Evidence from three randomized controlled trials" (Franklin et al., 2016). Nielsen, E., Kirtley, OJ., Townsend, E.[2019]

Electroconvulsive therapy (ECT) significantly reduced emergency department (ED) visits among homeless veterans, with a 35% lower likelihood of using ED services 30 days after treatment compared to those who did not receive ECT.

While ECT led to reductions in suicidal ideation and attempts, these improvements were less pronounced than in veterans who did not receive ECT, indicating that while ECT is beneficial, further research is needed to understand its full impact on this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Electroconvulsive Therapy on Suicidal Behavior and Emergency Department Use Among Homeless Veterans: A Propensity Score-Matched Study. Tsai, J., Peltzman, T., Watts, BV., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Resolution of severe suicidality with a single electroconvulsive therapy. [2011]

2. United States pubmed.ncbi.nlm.nih.gov

How to Implement Therapeutic Evaluative Conditioning in a Clinical Setting. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Effects of Electroconvulsive Therapy on Short-Term Suicide Mortality in a Risk-Matched Patient Population. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Response of energy and suicidal ideation to ECT. [2007]

5. Denmark pubmed.ncbi.nlm.nih.gov

Superior anti-suicidal effects of electroconvulsive therapy in unipolar disorder and bipolar depression. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Understanding the context of novel interventions for self-injurious thoughts and behaviors: A reply to Nielsen et al. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

"Great powers and great responsibilities": A brief comment on "A brief mobile app reduces nonsuicidal and suicidal self-injury: Evidence from three randomized controlled trials" (Franklin et al., 2016). [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Effects of Electroconvulsive Therapy on Suicidal Behavior and Emergency Department Use Among Homeless Veterans: A Propensity Score-Matched Study. [2022]