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
About this trial
This is an interventional treatment trial for Suicide, Attempted focused on measuring Suicide
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.
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
NCT ID
NCT03121742
First Posted
April 6, 2017
Last Updated
September 9, 2019
Sponsor
Harvard University
Collaborators
American Psychological Foundation, Massachusetts General Hospital
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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