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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method called Therapeutic Evaluative Conditioning to reduce suicidal thoughts and behaviors in adolescents. It targets a critical period when these young people face high risk, specifically during and after leaving psychiatric inpatient care. Participants will use a mobile device for either the active intervention or a placebo (inactive) version. Adolescents aged 12-19, who have been hospitalized due to self-harm or suicidal thoughts and have a smartphone, may qualify for this study. As an unphased trial, this study offers participants the chance to contribute to innovative research that could significantly impact adolescent mental health care.

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 prior data suggests that this intervention is safe for adolescents?

Research has shown that Therapeutic Evaluative Conditioning (TEC) has helped reduce thoughts and behaviors related to self-harm in several studies. Delivered through a smartphone app, TEC reduced self-cutting by 32% to 40% and plans for suicide by 21% to 77% over a month.

Although these studies focused on adults, they provide some insight into the safety of TEC. Multiple trials have tested TEC, and no serious side effects were reported, suggesting it is generally safe to use.

Since TEC is delivered through a smartphone, it offers a convenient and low-risk way to manage suicidal thoughts and behaviors. However, discussing any concerns with a healthcare professional before joining a trial is always important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Therapeutic Evaluative Conditioning for addressing suicidal thoughts and behaviors because it offers a fresh approach by using a mobile device-based intervention. Unlike traditional treatments that often involve medication or in-person therapy sessions, this method leverages technology to potentially deliver support in real-time, making it more accessible and immediate. This innovative approach could provide an alternative for those who may face barriers to traditional care, such as geographic limitations or stigma associated with seeking help. By conditioning the mind to evaluate and respond differently to negative thoughts, this technique might offer quicker, more personalized interventions, which is a promising advancement in mental health care.

What evidence suggests that Therapeutic Evaluative Conditioning could be effective for reducing suicidal thoughts and behaviors?

Research shows that Therapeutic Evaluative Conditioning (TEC), which participants in this trial may receive, can help reduce suicidal thoughts and behaviors. In studies with adults, TEC has been linked to a 21-77% decrease in thoughts and actions related to self-harm over a month. Trials have also shown a significant drop in self-cutting by 32-40% and in making suicide plans by 21%. TEC changes how people feel about harmful behaviors, making them less appealing. These findings suggest that TEC could effectively lower the risk of suicide among teenagers, especially during high-risk times like after leaving the hospital. Participants in the control arm will receive a neutral comparison condition to evaluate TEC's effectiveness. ^{2 3 5 6 7}

Who Is on the Research Team?

Alexander Millner, PhD

Principal Investigator

Principal Investigator

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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 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]

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]

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]

Citations

1. mhealth.jmir.org mhealth.jmir.org/2020/1/e12516/PDF

Mobile Health Technology Interventions for Suicide Prevention In terms of efficacy, 2 studies described a statistically significant positive effect of the mobile app intervention on 1 or more suicide ...

2. reporter.nih.gov reporter.nih.gov/search/14EBC10F4A88C0D57598B8961CAA4A01A2FFCEB861BF/project-details/10922719

Project Details - NIH RePORTER In studies among adults, TEC was associated with a 21-77% reduction in SITB over a month. The current project aims to test whether TEC can reduce SITB among ...

3. msrc.fsu.edu msrc.fsu.edu/blog/tec-tec-app-evaluative-conditioning/

TEC-TEC: An app for evaluative conditioning Across three web-based randomized controlled trials, results indicated that TEC significantly reduced self-cutting (32%-40% reductions) and suicide plans (21%- ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05541900

Study Details | NCT05541900 | A Conditioning Paradigm to ... TEC is based in evaluative conditioning principles and is a brief (1-2 minutes) digital intervention designed to increase aversion to self-injurious behaviors ...

5. trialx.com trialx.com/clinical-trials/listings/275828/therapeutic-evaluative-conditioning-to-reduce-adolescents-self-injurious-thoughts-and-behaviors-during-and-after-psychiatric-inpatient-hospitalization/

Therapeutic Evaluative Conditioning ... The investigators propose testing a brief, scalable intervention using evaluative conditioning aimed at reducing suicidal thoughts and behaviors ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06686901

A Randomized Controlled Trial of a Smartphone Delivered ... This study aims to evaluate the acceptability, safety, and efficacy of a smartphone-delivered intervention called Therapeutic Evaluative ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06967545?cond=Suicide&aggFilters=funderType:nih,status:not%20rec&rank=7

A One-Arm Open Trial of a Smartphone Delivered ... The study's aim is to evaluate the safety, acceptability, and preliminary efficacy of Therapeutic Evaluative Conditioning for Suicide (TEC-S). Official Title. A ...