NCT05791643

Brief Summary

The goal of this study is to learn about a new, real-time, smartphone-based intervention aimed to decrease risk for suicide in adults who have been hospitalized for suicidal thoughts or behaviors. The main questions the investigators aim to answer are:

  • Is a real-time, smartphone-based intervention that promotes the use of safety plans and other coping strategies for suicidal thoughts feasible and acceptable?
  • Does the real-time intervention result in increased use of safety plans and other coping strategies, and reduce suicidal thoughts? Participants will:
  • Answer questions about current suicidal thoughts on their smartphone up to 6 times each day while they are in the hospital and during the 4 weeks after they leave the hospital
  • When they report elevated suicidal thoughts on a smartphone survey, be randomly assigned to receive or not receive automated, interactive reminders to use content from their personalized safety plan or general coping strategies
  • Answer brief follow-up questions on their smartphone within a couple hours of receiving or not receiving automated reminders
  • Give feedback on their experience with the real-time intervention

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
103

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2023

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 7, 2023

Completed
23 days until next milestone

First Posted

Study publicly available on registry

March 30, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

July 5, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 3, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 3, 2024

Completed
Last Updated

October 23, 2025

Status Verified

October 1, 2025

Enrollment Period

1.2 years

First QC Date

March 7, 2023

Last Update Submit

October 21, 2025

Conditions

Suicide

Keywords

SuicideSuicidal ThoughtsMicro-Randomized TrialEcological Momentary AssessmentReal-Time Intervention

Outcome Measures

Primary Outcomes (3)

  • Intervention engagement as assessed by the number of real-time interventions received and percentage of real-time interventions completed

    Engagement with the real-time intervention will be assessed by analyzing the total number interventions participants receive and the percentage of those received that they complete.

    4 weeks after hospital discharge

  • Extent to which the real-time intervention may be successfully used or implemented as assessed by the Feasibility of Intervention Measure

    The extent to which the real-time intervention may be successfully used will be assessed by scoring and analyzing self-reported responses to the Feasibility of Intervention Measure.

    4 weeks after hospital discharge

  • Participant approval of the real-time intervention as assessed by the Acceptability of Intervention Measure

    Participants' approval of the real-time intervention will be assessed by scoring and analyzing self-reported responses to the Acceptability of Intervention Measure.

    4 weeks after hospital discharge

Secondary Outcomes (2)

  • Self-reported safety plan and coping strategy use

    Within two hours of each micro-randomization

  • Self-reported momentary suicidal urges and intent

    Within two hours of each micro-randomization

Study Arms (1)

Real-time intervention for promoting safety plan and coping strategy use

EXPERIMENTAL

Momentary surveys in which elevated (non-zero but \< 8 out of 10) levels of suicidal intent or high (\>= 8 out of 10) suicidal urges are reported will be randomized either to receive a real-time intervention that consists of automated, interactive reminders with suggested strategies for coping with suicidal thoughts or no intervention. If randomized to receive an intervention, the intervention type will also be randomized (at equal probabilities) to suggest either coping strategies from the participant's personalized safety plan or general common coping strategies.

Behavioral: Personalized internal and external coping strategiesBehavioral: Personalized internal coping strategiesBehavioral: Personalized external coping strategiesBehavioral: General internal and external coping strategiesBehavioral: General internal coping strategiesBehavioral: General external coping strategiesBehavioral: General internal coping strategies, relaxationBehavioral: General internal coping strategies, distractionBehavioral: General internal coping strategies, physical activity

Interventions

Personalized internal and external coping strategiesBEHAVIORAL

A series of interactive, automated messages will recommend use of the internal coping strategies and external coping strategies (i.e., sources of social support/distraction) from the participant's personalized safety plan.

Real-time intervention for promoting safety plan and coping strategy use
Personalized internal coping strategiesBEHAVIORAL

A series of interactive, automated messages will recommend use of the internal coping strategies from the participant's personalized safety plan.

Real-time intervention for promoting safety plan and coping strategy use
Personalized external coping strategiesBEHAVIORAL

A series of interactive, automated messages will recommend use of the external coping strategies (i.e., sources of social support/distraction) from the participant's personalized safety plan.

Real-time intervention for promoting safety plan and coping strategy use
General internal and external coping strategiesBEHAVIORAL

A series of interactive, automated messages will recommend use of general (non-personalized) common internal and external coping strategies for suicidal thoughts.

Real-time intervention for promoting safety plan and coping strategy use
General internal coping strategiesBEHAVIORAL

A series of interactive, automated messages will recommend use of general (non-personalized) common internal coping strategies for suicidal thoughts.

Real-time intervention for promoting safety plan and coping strategy use
General external coping strategiesBEHAVIORAL

A series of interactive, automated messages will recommend use of general (non-personalized) external coping strategies (i.e., sources of social support/distraction) for suicidal thoughts.

Real-time intervention for promoting safety plan and coping strategy use
General internal coping strategies, relaxationBEHAVIORAL

A series of interactive, automated messages will recommend use of general (non-personalized) common internal (and specifically, relaxation-based) coping strategies for suicidal thoughts.

Real-time intervention for promoting safety plan and coping strategy use
General internal coping strategies, distractionBEHAVIORAL

A series of interactive, automated messages will recommend use of general (non-personalized) common internal (and specifically, distraction-based) coping strategies for suicidal thoughts.

Real-time intervention for promoting safety plan and coping strategy use
General internal coping strategies, physical activityBEHAVIORAL

A series of interactive, automated messages will recommend use of general (non-personalized) common internal (and specifically, physical activity-based) coping strategies for suicidal thoughts.

Real-time intervention for promoting safety plan and coping strategy use

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Experiencing suicidal thoughts as part of their inpatient admission
  • Ownership of and access to a smartphone (while on the unit and following discharge)
  • Ability to speak and write English fluently

You may not qualify if:

  • Any factor that impairs the ability to effectively participate in the study (e.g., significant cognitive impairment, intellectual disability, presence of violent behavior, psychotic illness/symptoms determined by the treating clinician to impair ability to understand the study or provide informed consent)
  • Failure to correctly answer all true/false questions in the consent form

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

McLean Hospital

Belmont, Massachusetts, 02478, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (4)

  • Stanley B, Brown GK. Safety planning intervention: A brief intervention to mitigate suicide risk. Cognitive and Behavioral Practice. 2012; 19(2): 256-264. doi:10.1016/j.cbpra.2011.01.001

    BACKGROUND

  • Nuij C, van Ballegooijen W, de Beurs D, Juniar D, Erlangsen A, Portzky G, O'Connor RC, Smit JH, Kerkhof A, Riper H. Safety planning-type interventions for suicide prevention: meta-analysis. Br J Psychiatry. 2021 Aug;219(2):419-426. doi: 10.1192/bjp.2021.50.

    PMID: 35048835BACKGROUND

  • Stanley B, Chaudhury SR, Chesin M, Pontoski K, Bush AM, Knox KL, Brown GK. An Emergency Department Intervention and Follow-Up to Reduce Suicide Risk in the VA: Acceptability and Effectiveness. Psychiatr Serv. 2016 Jun 1;67(6):680-3. doi: 10.1176/appi.ps.201500082. Epub 2016 Feb 1.

    PMID: 26828397BACKGROUND

  • Klasnja P, Hekler EB, Shiffman S, Boruvka A, Almirall D, Tewari A, Murphy SA. Microrandomized trials: An experimental design for developing just-in-time adaptive interventions. Health Psychol. 2015 Dec;34S(0):1220-8. doi: 10.1037/hea0000305.

    PMID: 26651463BACKGROUND

MeSH Terms

Conditions

SuicideSuicidal Ideation

Interventions

Exercise

Condition Hierarchy (Ancestors)

Self-Injurious BehaviorBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: During the four weeks after hospital discharge, each time a participant reports elevated (\&gt; 0 but \&lt; 8 out of 10) levels of suicidal intent or high (\&gt;= 8 out of 10) suicidal urge on a momentary smartphone survey, they will be randomized to either receive a real-time intervention or no real-time intervention promoting safety plan or coping strategy use. If randomized to receive a real-time intervention, the intervention type will also be randomized to consist of either recommended coping strategies from their personalized safety plan or general coping strategies for suicidal thoughts. During the post-discharge phase, participants will have 24/7 access to their full safety plan within the study app. At reported high (\&gt;= 8 out of 10) levels of suicidal intent, no micro-randomization will occur, and a longstanding risk management protocol that includes direct, phone-based outreach to participants for further risk assessment and intervention will be used.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Department of Psychiatry, Harvard Medical School

Study Record Dates

First Submitted

March 7, 2023

First Posted

March 30, 2023

Study Start

July 5, 2023

Primary Completion

September 3, 2024

Study Completion

September 3, 2024

Last Updated

October 23, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations

US(2)