Suicide, AttemptedNCT03121742
A Study of a Smartphone-based Intervention for Suicidal Inpatients
A study testing Ecological Momentary Intervention and Treatment as Usual in people with Suicide, Attempted and Suicidal Ideation, run by Rutgers, The State University of New Jersey.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Suicide, Attempted, Suicidal Ideation, Hopeless
- What is being tested?
- Ecological Momentary Intervention and Treatment as Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2020to 1 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
About this study
Official title: A Pilot Study of a Smartphone-based Intervention for Suicidal Inpatients
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.
- Conditions
- Suicide, Attempted, Suicidal Ideation, Hopeless
- Being tested
- Ecological Momentary Intervention, Treatment as Usual
- Keywords
- Suicide
- Medical subject headings
- Suicide, Attempted, Suicidal Ideation, Suicide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ecological Momentary InterventionBehavioural
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.
Treatment as UsualBehavioural
Standard care as part of inpatient hospitalization.
| Study group | Role | What they receive |
|---|---|---|
| Treatment as usual [TAU] plus assessment | Placebo comparator | Patients will receive standard care plus assessment. Receives: Behavioral: Treatment as Usual |
| Treatment as usual [TAU] plus intervention | Experimental | Patients will receive standard care plus an ecological momentary intervention. Receives: Behavioral: Ecological Momentary Intervention; Behavioral: Treatment as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion: ~35 days (7 days inpatient + 28 days post-discharge)
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.
Measured: Through study completion: ~35 days (7 days inpatient + 28 days post-discharge)
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.
Measured: Through study completion: ~35 days (7 days inpatient + 28 days post-discharge)
Secondary outcomes (2)
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.
Measured: Through study completion: ~35 days (7 days inpatient + 28 days post-discharge)
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.
Measured: Through study completion: ~35 days (7 days inpatient + 28 days post-discharge)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2017
- Study start1 Apr 2020 (estimated)
- Primary completion1 Apr 2021 (estimated)
- Study completion1 May 2021 (estimated)
Why it stopped: Superseded by NCT03950765
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suicide, AttemptedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- American Psychological Foundation, Massachusetts General Hospital
- Responsible party
- Principal investigator, Evan M. Kleiman, Ph.D., Harvard University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03121742
- Sponsor's protocol ID
- IRB17-0483
- Status last verified
- May 2024
- First submitted
- 6 Apr 2017
- Last updated
- 29 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of a Smartphone-based Intervention for Suicidal Inpatients
- ClinicalTrials.gov ID
- NCT03121742
- Acronym / sponsor ID
- IRB17-0483
- Conditions
- Suicide, Attempted, Suicidal Ideation, Hopeless
- Keywords
- Suicide
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Superseded by NCT03950765
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Collaborators
- American Psychological Foundation, Massachusetts General Hospital
- Study start
- 1 Apr 2020 (estimated)
- Primary completion
- 1 Apr 2021 (estimated)
- Study completion
- 1 May 2021 (estimated)
- First posted
- 20 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment as usual [TAU] plus assessment | Placebo comparator | Behavioral: Treatment as UsualPatients will receive standard care plus assessment. |
| Treatment as usual [TAU] plus intervention | Experimental | Behavioral: Ecological Momentary Intervention, Behavioral: Treatment as UsualPatients will receive standard care plus an ecological momentary intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ecological Momentary InterventionPatients 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. | Behavioural | Treatment as usual [TAU] plus intervention |
| Treatment as UsualStandard care as part of inpatient hospitalization. | Behavioural | Treatment as usual [TAU] plus assessment, Treatment as usual [TAU] plus intervention |
Primary outcome
Momentary Suicidal Ideation
Time frame: Through study completion: ~35 days (7 days inpatient + 28 days post-discharge)
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
Time frame: Through study completion: ~35 days (7 days inpatient + 28 days post-discharge)
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
Time frame: Through study completion: ~35 days (7 days inpatient + 28 days post-discharge)
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.
2 secondary outcomes
Hopelessness
Time frame: Through study completion: ~35 days (7 days inpatient + 28 days post-discharge)
Loneliness
Time frame: Through study completion: ~35 days (7 days inpatient + 28 days post-discharge)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Ecological Momentary Intervention and Treatment as Usual in people with Suicide, Attempted and Suicidal Ideation, run by Rutgers, The State University of New Jersey.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 29 May 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Momentary Suicidal Ideation (time frame: Through study completion: ~35 days (7 days inpatient + 28 days post-discharge)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2024.