A Study of a Smartphone-based Intervention for Suicidal Inpatients

NCT03121742 | Withdrawn

• 1 other identifier: IRB17-0483
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Suicide, Attempted; Suicidal Ideation; Hopeless

Keywords

Suicide

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Through study completion: ~35 days (7 days inpatient + 28 days post-discharge)

Secondary Outcomes (2)

• Hopelessness

  Through study completion: ~35 days (7 days inpatient + 28 days post-discharge)

• Loneliness

  Through study completion: ~35 days (7 days inpatient + 28 days post-discharge)

Study Arms (2)

Treatment as usual [TAU] plus assessment

PLACEBO COMPARATOR

Patients will receive standard care plus assessment.

Behavioral: Treatment as Usual

Treatment as usual [TAU] plus intervention

EXPERIMENTAL

Patients will receive standard care plus an ecological momentary intervention.

Behavioral: Ecological Momentary Intervention; Behavioral: Treatment as Usual

Interventions

Ecological Momentary Intervention BEHAVIORAL

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 usual [TAU] plus intervention

Treatment as Usual BEHAVIORAL

Standard care as part of inpatient hospitalization.

Treatment as usual [TAU] plus assessment; Treatment as usual [TAU] plus intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Additionally, patients who are on involuntary hospitalization status will be excluded.

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead
• American Psychological Foundation: collaborator
• Massachusetts General Hospital: collaborator

MeSH Terms

Conditions

Suicide, Attempted; Suicidal Ideation; Suicide

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Self-Injurious Behavior; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Associate

Study Record Dates

• First Submitted: April 6, 2017
• First Posted: April 20, 2017
• Study Start: April 1, 2020
• Primary Completion: April 1, 2021
• Study Completion: May 1, 2021
• Last Updated: May 29, 2024

Record last verified: 2024-05