Real-time Intervention for Suicide Risk Reduction

Suicidal Ideation Clinical Trial

Official title:

Real-time Intervention for Suicide Risk Reduction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05848089
• Other study ID #: 2023P000221
• Status: Recruiting
• Phase: N/A
• Start date: September 25, 2023
• Est. completion date: October 1, 2024

Study information

• Verified date: December 2023
• Source: Massachusetts General Hospital
• Contact: Kate Bentley, PhD
• Phone: 617-724-7741
• Email: kbentley[@]mgh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to determine whether learning three skills for managing negative emotions and receiving reminders via smartphone to practice these skills reduces how often and how intensely one experiences emotional distress and suicidal thoughts.

Description:

The present study is a two-arm parallel design RCT to test the efficacy of using ecological momentary intervention (EMI) to deliver therapeutic content based on the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (UP) - an evidence-based transdiagnostic cognitive behavioral therapy (CBT) that focuses on delivering adaptive skills for managing strong emotions. Participants in this study will be 50 adult psychiatric inpatients with recent suicidal thoughts or behaviors (STBs). Participants will be randomized to receive either the control condition, which consists of treatment as usual (TAU; n = 25) and 4x/daily daily ecological momentary assessment (EMA) of emotions and STBs, or the experimental condition, consisting of TAU, 4x/daily EMA, 3 brief sessions to deliver CBT skills (mindful emotion awareness, cognitive flexibility, and changing emotional behaviors, all drawn from the UP), one discretionary skills booster session, and EMI to prompt guided skills practice (n = 25).

Control participants will receive TAU and be prompted to complete 4x/day EMA of emotions and STBs for the duration of their hospital stay and the 28-day post-discharge period. Participants randomized to the experimental conditions will receive TAU plus three brief treatment sessions delivering core UP skills content (during inpatient stays) and a discretionary booster session to reinforce treatment sessions that may be offered after discharge via either phone or telehealth. Those in the experimental condition will also receive training to use the EMI (which prompts guided skills practice), followed by smartphone-based EMA/EMI for the duration of the inpatient stay and the 28-day post-discharge period.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: October 1, 2024
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• adult status (18+ years),

• a recent suicide attempt or any report of current suicidal ideation,

• the ability to speak and write English fluently,

• ownership of and consistent access to an internet-capable smartphone (e.g., an iPhone or Android phone), and

• providing at least one collateral contact in cases where we cannot reach the participant

Exclusion criteria:

• the presence of any factor that impairs an individual's ability to provide informed consent and comprehend and effectively participate in the study including: an inability to speak or write English fluently, the presence of gross cognitive impairment due to florid psychosis, intellectual disability, dementia, acute intoxication, or the presence of extremely agitated or violent behavior.

Related Conditions & MeSH terms

• Suicidal Ideation
• Suicide
• Suicide Attempt
• Suicide, Attempted

Intervention

Behavioral:
• Brief skills sessions plus EMI skills practice prompts
(1) Three brief treatment sessions delivering core cognitive behavioral therapy (CBT) skills (mindful emotion awareness, cognitive flexibility, and changing emotional behaviors) (during hospitalization), (2) a discretionary booster session to reinforce treatment session content (that may be offered after discharge via either phone or telehealth), and (3) ecological momentary intervention (EMI) prompts to engage in guided skills practice exercises via smartphone
• Ecological momentary assessment (EMA)
4x/day brief smartphone-based EMA surveys assessing negative emotions and STBs
• Treatment as usual (TAU)
TAU (or usual care) during hospitalization and the 28-day post-discharge period

Locations

Country	Name	City	State
United States	Brigham and Women's Faulkner Hospital	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Massachusetts General Hospital	National Institute of Mental Health (NIMH), Rutgers University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Within-person changes in momentary self-reported intensity of suicidal urges (measured on a 11-point rating scale via ecological momentary assessment) from pre- to post-EMI	Overall changes in momentary self-reported intensity of suicidal urges (measured on a 11-point rating scale up to 4x/day via ecological momentary assessment) from pre- to post-EMI use, among those in the experimental condition only	Through study completion (up to 28 days after inpatient hospital discharge)
Primary	Between-condition differences in momentary self-reported intensity of suicidal urges (measured on a 11-point rating scale via ecological momentary assessment)	Means and slopes of momentary self-reported intensity of suicidal urges (measured on a 11-point rating scale up to 4x/day via ecological momentary assessment) will be compared between the experimental and control conditions	Through study completion (up to 28 days after inpatient hospital discharge)