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A Study of a Smartphone-based Intervention for Suicidal Inpatients

Primary Purpose

Suicide, Attempted, Suicidal Ideation, Hopeless

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Ecological Momentary Intervention
Treatment as Usual
Sponsored by
Harvard University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Suicide, Attempted focused on measuring Suicide

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Inclusion criteria include a recent (i.e., was included as the reason for admission) suicide attempt or serious suicidal ideation (i.e., ideation with at least 50% intent, assessed through either an explicit mention in the intake summary of intent greater than 50% or through this intent being inferred by clinical staff or in the notes [for example, if the patient notes they wanted to die more than they did not want to die during the attempt or episode of suicidal ideation]), English fluency, and access to an internet-capable smartphone (e.g., iPhone or Android).

Exclusion Criteria:

  • Exclusion criteria include any factor that impairs the ability to effectively participate in the study (e.g., intellectual abilities that are too low to understand the study and/or consent process) or a diagnosis of any schizophrenia-spectrum or psychotic disorder.
  • Additionally, patients who are on involuntary hospitalization status will be excluded.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Experimental

    Arm Label

    Treatment as usual [TAU] plus assessment

    Treatment as usual [TAU] plus intervention

    Arm Description

    Patients will receive standard care plus assessment.

    Patients will receive standard care plus an ecological momentary intervention.

    Outcomes

    Primary Outcome Measures

    Momentary Suicidal Ideation
    Suicidal ideation as assessed by the ecological momentary assessment/intervention using a three item assessment of suicidal ideation that assess: (1) the desire to die by suicide, (2) the intention to die by suicide, and (3) the ability to resist the urge to die by suicide. This assessment will be given at four random times per day, as well as any time the participant initiates the survey or assessment.
    Suicidal ideation
    The occurrence of suicidal ideation (present/absent) over the course of the study, as assessed by the self-report version of the Self-Injurious Thoughts and Behaviors Interview (SITBI), administered at the end of the study.
    Suicide attempts
    The occurrence of suicide attempts (present/absent) over the course of the study, as assessed by the self-report version of the Self-Injurious Thoughts and Behaviors Interview (SITBI), administered at the end of the study.

    Secondary Outcome Measures

    Hopelessness
    Hopelessness as assessed by the ecological momentary assessment/intervention item with the heading "how are you feeling RIGHT NOW", with the label "hopeless" and options ranging from (1) not at all to (5) very much. This assessment will be given at four random times per day, as well as any time the participant initiates the survey or assessment.
    Loneliness
    Loneliness as assessed by the ecological momentary assessment/intervention item with the heading "how are you feeling RIGHT NOW", with the label "lonely" and options ranging from (1) not at all to (5) very much. This assessment will be given at four random times per day, as well as any time the participant initiates the survey or assessment.

    Full Information

    First Posted
    April 6, 2017
    Last Updated
    September 9, 2019
    Sponsor
    Harvard University
    Collaborators
    American Psychological Foundation, Massachusetts General Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03121742
    Brief Title
    A Study of a Smartphone-based Intervention for Suicidal Inpatients
    Official Title
    A Pilot Study of a Smartphone-based Intervention for Suicidal Inpatients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 2020 (Anticipated)
    Primary Completion Date
    April 2021 (Anticipated)
    Study Completion Date
    May 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Harvard University
    Collaborators
    American Psychological Foundation, Massachusetts General Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Suicide is the most common form of deadly violence. Indeed, since more than 40,000 people die by suicide each year, people are 2.5 times more likely to die by their own hand than someone else's. The four weeks after discharge from inpatient care is an especially dangerous period in terms of suicide risk, possibly because of poor post-discharge treatment adherence and poor treatment efficacy during a suicide crisis. To reduce suicide risk both in general and during the post-discharge period, interventions are needed that (1) are easily adhered to and (2) are effective during a suicide crisis. The goal of the study is to pilot-test a suite of five smartphone-based ecological momentary interventions (EMI) that can be easily used during a suicide crisis. Two target hopelessness, two target loneliness, and one targets negative automatic thoughts associated with hopelessness and loneliness. Although these interventions are new to the study of suicide, they are all grounded in decades of empirical work and adapted from effective interventions in areas relating to suicide. Participants will be 20 inpatients (n = 10 each in treatment as usual [TAU] plus intervention and TAU plus assessment [i.e., control] groups) from the Massachusetts General Hospital Inpatient Psychiatric Service. The investigators hypothesize that those in the TAU plus intervention group will have lower levels of suicidal ideation during the inpatient and post-discharge period than those in the TAU plus assessment group.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Suicide, Attempted, Suicidal Ideation, Hopeless
    Keywords
    Suicide

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Treatment as usual [TAU] plus assessment
    Arm Type
    Placebo Comparator
    Arm Description
    Patients will receive standard care plus assessment.
    Arm Title
    Treatment as usual [TAU] plus intervention
    Arm Type
    Experimental
    Arm Description
    Patients will receive standard care plus an ecological momentary intervention.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Ecological Momentary Intervention
    Intervention Description
    Patients will be taught four therapeutic intervention skills based on positive psychology and cognitive behavioral therapy. They will then be prompted to complete these interventions on a smartphone four times per day (and as needed) for the duration of their inpatient care and for 28 days afterwards.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Treatment as Usual
    Intervention Description
    Standard care as part of inpatient hospitalization.
    Primary Outcome Measure Information:
    Title
    Momentary Suicidal Ideation
    Description
    Suicidal ideation as assessed by the ecological momentary assessment/intervention using a three item assessment of suicidal ideation that assess: (1) the desire to die by suicide, (2) the intention to die by suicide, and (3) the ability to resist the urge to die by suicide. This assessment will be given at four random times per day, as well as any time the participant initiates the survey or assessment.
    Time Frame
    Through study completion: ~35 days (7 days inpatient + 28 days post-discharge)
    Title
    Suicidal ideation
    Description
    The occurrence of suicidal ideation (present/absent) over the course of the study, as assessed by the self-report version of the Self-Injurious Thoughts and Behaviors Interview (SITBI), administered at the end of the study.
    Time Frame
    Through study completion: ~35 days (7 days inpatient + 28 days post-discharge)
    Title
    Suicide attempts
    Description
    The occurrence of suicide attempts (present/absent) over the course of the study, as assessed by the self-report version of the Self-Injurious Thoughts and Behaviors Interview (SITBI), administered at the end of the study.
    Time Frame
    Through study completion: ~35 days (7 days inpatient + 28 days post-discharge)
    Secondary Outcome Measure Information:
    Title
    Hopelessness
    Description
    Hopelessness as assessed by the ecological momentary assessment/intervention item with the heading "how are you feeling RIGHT NOW", with the label "hopeless" and options ranging from (1) not at all to (5) very much. This assessment will be given at four random times per day, as well as any time the participant initiates the survey or assessment.
    Time Frame
    Through study completion: ~35 days (7 days inpatient + 28 days post-discharge)
    Title
    Loneliness
    Description
    Loneliness as assessed by the ecological momentary assessment/intervention item with the heading "how are you feeling RIGHT NOW", with the label "lonely" and options ranging from (1) not at all to (5) very much. This assessment will be given at four random times per day, as well as any time the participant initiates the survey or assessment.
    Time Frame
    Through study completion: ~35 days (7 days inpatient + 28 days post-discharge)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Inclusion criteria include a recent (i.e., was included as the reason for admission) suicide attempt or serious suicidal ideation (i.e., ideation with at least 50% intent, assessed through either an explicit mention in the intake summary of intent greater than 50% or through this intent being inferred by clinical staff or in the notes [for example, if the patient notes they wanted to die more than they did not want to die during the attempt or episode of suicidal ideation]), English fluency, and access to an internet-capable smartphone (e.g., iPhone or Android). Exclusion Criteria: Exclusion criteria include any factor that impairs the ability to effectively participate in the study (e.g., intellectual abilities that are too low to understand the study and/or consent process) or a diagnosis of any schizophrenia-spectrum or psychotic disorder. Additionally, patients who are on involuntary hospitalization status will be excluded.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Evan M Kleiman, Ph.D.
    Phone
    617-496-8563
    Email
    ekleiman@fas.harvard.edu

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    A Study of a Smartphone-based Intervention for Suicidal Inpatients

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