A One-Arm Open Trial of a Smartphone Delivered Treatment for Suicidal Thoughts and Behavior
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMassachusetts General Hospital
About this trial
This study aims to evaluate the acceptability, safety, and preliminary 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Recent (past 3-month) hypo/manic symptoms or homicidal ideation or lifetime psychosis spectrum diagnosis as assessed via MINI 7.0.2.
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 design
Design model
Single group
Treatments tested in this trial
Smartphone-delivered Therapeutic Evaluative Conditioning for Suicide (TEC-S)
BehavioralTherapeutic 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.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Smartphone-delivered active Therapeutic Evaluative Conditioning for Suicide (active TEC)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
TEC-S Acceptability
(i) Indexed as the proportion of TEC-S sessions accessed within the first week, (ii) adapted items from the Credibility/Expectancy Questionnaire (CEQ), rated on a 9-point scale. : "How satisfied were you with your overall experience with TEC-S?" "How satisfied were you with your understanding of how to complete TEC-S (iii)End-User Mobile Application Rating Scale (uMARS), with items rated on a 5-point scale.
Time frame
Through completion of treatment phase (day 1 through 30)2
TEC-S Safety
Changes in suicide-related thoughts (e.g., intent, desire, urge, preparation) and affective responses (e.g. stress) before and after randomized stimuli in each TEC-S session, assessed via ecological momentary assessment
Time frame
Through completion of treatment phase (day 1 through 30)Secondary outcomes
1
Desire to die by suicide (Likert)
Right now, how strongly do you want to kill yourself? \[0 (not at all) to 10 (extremely)
Time frame
Through completion of treatment phase (day 1 through 30)2
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.
Time frame
Through completion of treatment phase (day 1 through 30)3
Suicide thought incidence
Since the last survey, have you had suicidal thoughts? (yes/no); assessed daily via ecological momentary assessment
Time frame
Through completion of treatment phase (day 1 through 30)4
Suicide preparation incidence
Since the last survey, have you made any preparations to kill yourself? (yes/no); assessed daily via ecological momentary assessment.
Time frame
Through completion of treatment phase (day 1 through 30)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Massachusetts General Hospital
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator
Source ClinicalTrials.gov