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Completed

NCT Number: NCT05180331

Feasibility, Acceptability, and Preliminary Efficacy of a Novel Personalized Mobile Intervention for Suicide - Open Trial

The primary aim of this grant is to conduct pilot testing on a novel personalized mobile intervention for suicide - Mobile Application to Prevent Suicide (MAPS) - and to establish feasibility, acceptability, safety, and primary outcomes (i.e., suicidal ideation and behavior; re-hospitalization).

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Key information

Conditions

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

Age range

18 year–26 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Butler Hospital

Providence, Rhode Island, 02906, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Suicidal ideation and/or suicidal behavior in the past month verified by the C-SSRS
  • Between the ages of 18 and 26
  • English proficiency
  • Comfortable with smartphone technology
  • Deemed by the treatment team to be stable enough to complete study procedures

Exclusion criteria

  • Current psychotic or manic symptoms severe enough to interfere with 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.

Primary outcomes

  1. Acceptability of Research (Recruitment)

    Time frame: Baseline

    Measured by recruitment rate.

  2. Acceptability of Research (Dropout)

    Time frame: 1 month

    Measured by dropout rate.

  3. Acceptability of Research Procedures

    Time frame: 1 month

    Feedback on qualitative interview

  4. 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.

  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.

Secondary outcomes

  1. Suicidal Ideation and Behavior

    Time frame: 1 month

    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.

  2. Rehospitalization

    Time frame: 1 month

    Will be assessed using the Treatment History Interview and medical records review.

Sponsors and collaborators

Lead sponsor

Butler Hospital

Other

Collaborators

  • American Foundation for Suicide Prevention

Registry information

Official study title

Feasibility, Acceptability, and Preliminary Efficacy of a Novel Personalized Mobile Intervention for Suicide

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 6, 2022
Registry last updated
Jul 19, 2024

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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