Suicidal IdeationNCT06686901
A Randomized Controlled Trial of a Smartphone Delivered Treatment for Suicidal Thoughts and Behavior
A study testing Smartphone-delivered Therapeutic Evaluative Conditioning for Suicide (TEC-S) and Smartphone-delivered inactive Therapeutic Evaluative Conditioning in people with Suicidal Ideation and Suicide Attempt, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
This study aims to evaluate the acceptability, safety, and efficacy of a smartphone-delivered intervention called Therapeutic Evaluative Conditioning for Suicide (TEC-S) in reducing suicidal thoughts and behaviors (STB) among adults with recent and frequent suicide ideation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Suicidal Ideation, Suicide Attempt
- What is being tested?
- Smartphone-delivered Therapeutic Evaluative Conditioning for Suicide (TEC-S) and Smartphone-delivered inactive Therapeutic Evaluative Conditioning
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jan 2027to 31 Aug 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Adults ages 18+
- Relatively frequent and recent (≥5 days within the past-month) active suicidal thoughts as assessed via SITBI-R.
- Willing and able to provide at least one emergency contact (name, phone number, relation).
- Owns an Android or iOS smartphone.
- Possesses at least occasional access to Wi-Fi-enabled internet for data down/uploads.
- Fluent in English and willing to provide informed consent.
- Living in the Boston metropolitan area (i.e., ~50 mile radius around Boston, MA)
Who cannot join
- Recent (past 3-month) hypo/manic symptoms or homicidal ideation or lifetime psychosis spectrum diagnosis as assessed via MINI 7.0.2.
- Recent acute suicide risk operationalized as affirmative responses to BOTH below items during structured clinical interview AND evaluation by the PI in consultation with Mentors/Advisor Drs. Wilhelm, Kleiman, and/or Bentley:
- At any time in past week: ≥ 8/10 current intent to act on suicidal thoughts (0 ["not at all"] to 10 ["extremely strong"]); AND
- At any time in past week: thought of a specific suicide plan (i.e, known method/means and/or location) with access to lethal means
- Impaired vision (e.g., legal blindness), technological illiteracy, or intellectual disability that might impair ability to provide valid data and/or informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
Adam Jaroszewski, PhD, 781-258-3082, ajaroszewski@mgh.harvard.edu
About this study
This study aims to evaluate the acceptability, safety, and efficacy of a smartphone-delivered intervention called Therapeutic Evaluative Conditioning for Suicide (TEC-S) in reducing suicidal thoughts and behaviors (STB) among adults with recent and frequent suicide ideation.
Read the detailed description
The present study is a two-arm randomized controlled trial (RCT) designed to evaluate the safety, acceptability, and efficacy of Therapeutic Evaluative Conditioning for Suicide (TEC-S), a smartphone-delivered intervention aimed at reducing suicidal thoughts and behaviors (STB). Participants in this study will be 60 adult participants (ages 18+) who report recent and frequent STB, residing within the greater-Boston, Ma area.
Participants will be randomized to receive either the control condition, which consists of 3x/daily ecological momentary assessment (EMA) of emotions and STBs and optional inactive TEC (n = 30), or the experimental condition, consisting of 3x/daily EMA and optional active TEC-S (n = 30). Evaluative conditioning uses classical conditioning to alter attitudes. The aim of TEC-S is to alter attitudes toward suicide and, in turn, reduce STB. EMAs will monitor STB, safety, and acceptability, and efficacy. Weekly behavioral and self-report assays will assess hypothesized treatment mechanisms. The study's aim is to determine if the active TEC-S condition reduces STB and to explore if altered attitudes toward suicide mediates this effect.
- Conditions
- Suicidal Ideation, Suicide Attempt
- Being tested
- Smartphone-delivered Therapeutic Evaluative Conditioning for Suicide (TEC-S), Smartphone-delivered inactive Therapeutic Evaluative Conditioning
- Keywords
- Suicide, ecological momentary assessment (EMA), Therapeutic Evaluative Conditioning (TEC)
- Medical subject headings
- Suicidal Ideation, Suicide, Attempted, Suicide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smartphone-delivered Therapeutic Evaluative Conditioning for Suicide (TEC-S)Behavioural
Therapeutic Evaluative Conditioning for Suicide (active TEC-S) is a behavioral treatment where participants are given optional access to a computerized task/game where they repeatedly pair suicidal behavior stimuli (pictures, words) with other negative stimuli and self-related stimuli with positive stimuli.
Smartphone-delivered inactive Therapeutic Evaluative ConditioningBehavioural
Therapeutic Evaluative Conditioning (inactive TEC-S) is a behavioral treatment where participants are given optional access to a computerized task/game where they repeatedly pair positive and negative stimuli (pictures, words) with each other.
| Study group | Role | What they receive |
|---|---|---|
| Smartphone-delivered inactive Therapeutic Evaluative Conditioning (inactive TEC) | Placebo comparator | Optional smartphone-delivered inactive Therapeutic Evaluative Conditioning (inactive TEC) for 30 days. Receives: Behavioral: Smartphone-delivered inactive Therapeutic Evaluative Conditioning |
| Smartphone-delivered active Therapeutic Evaluative Conditioning for Suicide (active TEC) | Experimental | Optional smartphone-delivered active Therapeutic Evaluative Conditioning for Suicide (active TEC-S) for 30 days. Receives: Behavioral: Smartphone-delivered Therapeutic Evaluative Conditioning for Suicide (TEC-S) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Desire to die by suicide (Likert)
Right now, how strongly do you want to kill yourself? [0 (not at all) to 10 (extremely)]; assessed via 3x/day ecological momentary assessment (Kleiman et al., 2018)
Measured: Through completion of treatment phase (day 1 through 30)
Secondary outcomes (10)
Suicide intent (Likert)
Right now, how strong is your intention to kill yourself today? [0 (I am definitely not going to kill myself today) to 10 (I am definitely going to kill myself today)]; assessed via 3x/day ecological momentary assessment
Measured: Through completion of treatment phase (day 1 through 30)
Suicide urge (Likert)
Right now, how strong is your urge to kill yourself [0 (not at all) to 10 (very strong)]; assessed via 3x/day ecological momentary assessment.
Measured: Through completion of treatment phase (day 1 through 30)
Suicide thought incidence
Since the last survey, have you had suicidal thoughts? (yes/no); assessed daily via ecological momentary assessment
Measured: Through treatment phase completed (day 1 through 30)
Suicide planning incidence
Since the last survey, have you made a plan to kill yourself? (yes/no); assessed daily via ecological momentary assessment
Measured: Through completion of treatment phase (day 1 through 30)
Suicide preparation incidence
Since the last survey, have you made any preparations to kill yourself? (yes/no); assessed daily via ecological momentary assessment.
Measured: Through completion of treatment phase (day 1 through 30)
Suicide attempt incidence
Since the last survey, have you attempted to kill yourself? (yes/no); assessed daily via ecological momentary assessment
Measured: Through completion of treatment phase (day 1 through 30)
Suicidal behaviors (composite)
A composite variable consisting of (i) suicide plan incidence, (ii) suicide preparation incidence, (iii) suicide attempt incidence, each assessed via ecological momentary assessment
Measured: Through completion of treatment phase (day 1 through 30)
Suicide aversion (AMP)
Suicide aversion assessed implicitly/behaviorally via the Affect Misattribution Procedure (AMP; Payne et al., 2005)
Measured: Through completion of treatment phase (day 1 through 30)
Suicide aversion (Likert)
Valence ratings of suicide-related pictures using a 9-point scale (-4 [extremely unpleasant] to 0 [neutral] to 4 [extremely pleasant]); assessed weekly (Jaroszewski et al., 2022).
Measured: Through completion of treatment phase (day 1 through 30)
Self affection (AMP)
Self affection assessed implicitly/behaviorally via the Affect Misattribution Procedure (AMP; Payne et al., 2005)
Measured: Through completion of treatment phase (day 1 through 30)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2024
- Study start30 Jan 2027 (estimated)
- Primary completion1 Jul 2029 (estimated)
- Study completion31 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suicidal IdeationStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Adam C. Jaroszewski, PhD, Massachusetts General Hospital
- Investigators
- Adam C Jaroszewski, PhD, Principal investigator, Harvard Medical School, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06686901
- Sponsor's protocol ID
- 2024P003049-phase2
- Other IDs
- K23MH133876
- Status last verified
- Apr 2026
- First submitted
- 12 Nov 2024
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of a Smartphone Delivered Treatment for Suicidal Thoughts and Behavior
- ClinicalTrials.gov ID
- NCT06686901
- Acronym / sponsor ID
- 2024P003049-phase2
- Conditions
- Suicidal Ideation, Suicide Attempt
- Keywords
- Suicide, ecological momentary assessment (EMA), Therapeutic Evaluative Conditioning (TEC)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 30 Jan 2027 (estimated)
- Primary completion
- 1 Jul 2029 (estimated)
- Study completion
- 31 Aug 2029 (estimated)
- First posted
- 13 Nov 2024 (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.
This study aims to evaluate the acceptability, safety, and efficacy of a smartphone-delivered intervention called Therapeutic Evaluative Conditioning for Suicide (TEC-S) in reducing suicidal thoughts and behaviors (STB) among adults with recent and frequent suicide ideation.
Detailed description
The present study is a two-arm randomized controlled trial (RCT) designed to evaluate the safety, acceptability, and efficacy of Therapeutic Evaluative Conditioning for Suicide (TEC-S), a smartphone-delivered intervention aimed at reducing suicidal thoughts and behaviors (STB). Participants in this study will be 60 adult participants (ages 18+) who report recent and frequent STB, residing within the greater-Boston, Ma area.
Participants will be randomized to receive either the control condition, which consists of 3x/daily ecological momentary assessment (EMA) of emotions and STBs and optional inactive TEC (n = 30), or the experimental condition, consisting of 3x/daily EMA and optional active TEC-S (n = 30). Evaluative conditioning uses classical conditioning to alter attitudes. The aim of TEC-S is to alter attitudes toward suicide and, in turn, reduce STB. EMAs will monitor STB, safety, and acceptability, and efficacy. Weekly behavioral and self-report assays will assess hypothesized treatment mechanisms. The study's aim is to determine if the active TEC-S condition reduces STB and to explore if altered attitudes toward suicide mediates this effect.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Smartphone-delivered inactive Therapeutic Evaluative Conditioning (inactive TEC) | Placebo comparator | Behavioral: Smartphone-delivered inactive Therapeutic Evaluative ConditioningOptional smartphone-delivered inactive Therapeutic Evaluative Conditioning (inactive TEC) for 30 days. |
| Smartphone-delivered active Therapeutic Evaluative Conditioning for Suicide (active TEC) | Experimental | Behavioral: Smartphone-delivered Therapeutic Evaluative Conditioning for Suicide (TEC-S)Optional smartphone-delivered active Therapeutic Evaluative Conditioning for Suicide (active TEC-S) for 30 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adults ages 18+
- Relatively frequent and recent (≥5 days within the past-month) active suicidal thoughts as assessed via SITBI-R.
- Willing and able to provide at least one emergency contact (name, phone number, relation).
- Owns an Android or iOS smartphone.
- Possesses at least occasional access to Wi-Fi-enabled internet for data down/uploads.
Key exclusion criteria (5 listed)
- Recent (past 3-month) hypo/manic symptoms or homicidal ideation or lifetime psychosis spectrum diagnosis as assessed via MINI 7.0.2.
- Recent acute suicide risk operationalized as affirmative responses to BOTH below items during structured clinical interview AND evaluation by the PI in consultation with Mentors/Advisor Drs. Wilhelm, Kleiman, and/or Bentley:
- At any time in past week: ≥ 8/10 current intent to act on suicidal thoughts (0 ["not at all"] to 10 ["extremely strong"]); AND
- At any time in past week: thought of a specific suicide plan (i.e, known method/means and/or location) with access to lethal means
- Impaired vision (e.g., legal blindness), technological illiteracy, or intellectual disability that might impair ability to provide valid data and/or informed consent.
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 |
|---|---|---|
| Smartphone-delivered Therapeutic Evaluative Conditioning for Suicide (TEC-S)Therapeutic Evaluative Conditioning for Suicide (active TEC-S) is a behavioral treatment where participants are given optional access to a computerized task/game where they repeatedly pair suicidal behavior stimuli (pictures, words) with other negative stimuli and self-related stimuli with positive stimuli. | Behavioural | Smartphone-delivered active Therapeutic Evaluative Conditioning for Suicide (active TEC) |
| Smartphone-delivered inactive Therapeutic Evaluative ConditioningTherapeutic Evaluative Conditioning (inactive TEC-S) is a behavioral treatment where participants are given optional access to a computerized task/game where they repeatedly pair positive and negative stimuli (pictures, words) with each other. | Behavioural | Smartphone-delivered inactive Therapeutic Evaluative Conditioning (inactive TEC) |
Primary outcome
Desire to die by suicide (Likert)
Time frame: Through completion of treatment phase (day 1 through 30)
Right now, how strongly do you want to kill yourself? [0 (not at all) to 10 (extremely)]; assessed via 3x/day ecological momentary assessment (Kleiman et al., 2018)
10 secondary outcomes
Suicide intent (Likert)
Time frame: Through completion of treatment phase (day 1 through 30)
Suicide urge (Likert)
Time frame: Through completion of treatment phase (day 1 through 30)
Suicide thought incidence
Time frame: Through treatment phase completed (day 1 through 30)
Suicide planning incidence
Time frame: Through completion of treatment phase (day 1 through 30)
Suicide preparation incidence
Time frame: Through completion of treatment phase (day 1 through 30)
Suicide attempt incidence
Time frame: Through completion of treatment phase (day 1 through 30)
Suicidal behaviors (composite)
Time frame: Through completion of treatment phase (day 1 through 30)
Suicide aversion (AMP)
Time frame: Through completion of treatment phase (day 1 through 30)
Suicide aversion (Likert)
Time frame: Through completion of treatment phase (day 1 through 30)
Self affection (AMP)
Time frame: Through completion of treatment phase (day 1 through 30)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
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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.
Adam C Jaroszewski, PhD principal investigator
Harvard Medical School, Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smartphone-delivered Therapeutic Evaluative Conditioning for Suicide (TEC-S) and Smartphone-delivered inactive Therapeutic Evaluative Conditioning in people with Suicidal Ideation and Suicide Attempt, run by Massachusetts General Hospital 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 7 inclusion and 5 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: opening soon, as of the sponsor's last update on 13 Jul 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Adam C Jaroszewski, PhD (781-258-3082, ajaroszewski@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Desire to die by suicide (Likert) (time frame: Through completion of treatment phase (day 1 through 30)). 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 13 Jul 2026.