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Completed

NCT Number: NCT05202756

Examining Feasibility, Acceptability, and Sustainability of a Novel Personalized Smartphone Intervention for Suicide - Randomized Trial

The primary aim of the present study is leverage existing infrastructure to develop novel technological features for a novel personalized smartphone intervention system, called the Mobile Application to Prevent Suicide (MAPS), and to establish feasibility, acceptability, safety, and estimate key parameters for primary outcomes (i.e., suicidal ideation and behavior; re-hospitalization), and target mechanisms.

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Key information

Conditions

Suicide and Self-harm Behavior Behavioral Symptoms Self-Injurious Behavior Suicidal Ideation Suicide Suicide, Attempted

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brown University, Providence, Rhode Island, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Presence of suicidal ideation and/or suicidal behavior in the past month
  • Between the ages of 18 and 70
  • Able to read, write, and understand English well enough to complete study procedures
  • Owns a smartphone

Exclusion criteria

  • Current psychotic or manic symptoms severe enough to interfere with completion of study procedures

Treatment and study plan

Mobile Application to Prevent Suicide (MAPS)

Behavioral

Safety Planning Intervention, ecological momentary intervention smartphone app system, and bidirectional communication with study clinician.

EMA Monitoring Only

Behavioral

Safety Planning Intervention; ecological momentary assessment only

Primary outcomes

  1. Patient Satisfaction

    Time frame: 1 month

    Measured using the Client Satisfaction Questionnaire, a self-report measure of satisfaction with treatment. Scores range from 8 to 32, with higher scores representing higher satisfaction.

  2. Acceptability of Research (Recruitment)

    Time frame: Baseline

    Measured by recruitment rate.

  3. Acceptability of Research (Dropout)

    Time frame: 6 months

    Measured by dropout rate.

  4. Acceptability of Research Procedures

    Time frame: 1 month

    Feedback on qualitative interview.

  5. Acceptability of MAPS Intervention

    Time frame: 1 month

    Feedback on qualitative interview.

  6. Satisfaction with MAPS Intervention

    Time frame: 4 weeks

    Measured by protocol completion rate.

  7. Ecological Momentary Assessment (EMA) Adherence

    Time frame: 4 weeks

    Number of assessments completed out of total

  8. Suicidal Ideation and Behavior

    Time frame: 6 months

    Will be assessed using the Columbia Suicide Severity Rating Scale, items from the Modified Scale for Suicidal Ideation, and ecological momentary assessment of suicidal ideation and behavior. The Columbia Suicide Severity Rating Scale can provide presence/absence of suicidal ideation and suicidal behavior, as well as a suicidal ideation score ranging from 0 to 5 with higher scores representing more severe ideation, and a suicidal ideation intensity rating from 0-25 with higher scores representing more intense ideation.

  9. Rehospitalization

    Time frame: 6 months

    Number of inpatient rehospitalizations will be assessed using the Treatment History Interview and medical records review.

  10. Emergency Department Visits

    Time frame: 6 months

    Number of emergency department visits will be assessed using the Treatment History Interview and medical records review.

Secondary outcomes

  1. Use of MAPS Intervention-delivered Coping Strategies (target mechanism)

    Time frame: 4 weeks

    Coping strategy use will be measured in three ways: (1) when participants are prompted to use a coping strategy via MAPS, followup prompts ask whether or not they used the coping skill, (2) in each EMA survey, participants are asked whether or not they used any coping skills since the last survey, and (3) the system provides output with regard to how many times participants dial a support contact phone number through the MAPS app.

  2. Reduction of Negative Affect (target mechanism)

    Time frame: 4 weeks

    Negative affect will be measured using Positive and Negative Affect Scale (PANAS-X) items on ecological momentary assessment surveys. Each emotion item on the PANAS-X is rated on a 1-5 scale based on how participants feel, with 1 indicating "very slightly or not at all" and 5 indicating "extremely."

  3. Self-Efficacy (target mechanism)

    Time frame: 4 weeks

    Coping self-efficacy will be measured using the Coping Self-Efficacy Scale. Self-efficacy for seeking mental health care will be measured by the Self-Efficacy to Seek Mental Health Care Scale. The total score can range from 0-260; the higher the score, the higher the level of coping self-efficacy.

Sponsors and collaborators

Lead sponsor

Butler Hospital

Other

Collaborators

  • Brown University
  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Examining Feasibility, Acceptability, and Sustainability of a Novel Personalized Smartphone Intervention for Suicide

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 21, 2022
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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