Real-time Intervention for Suicide Risk Reduction

Sponsor

Massachusetts General Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05848089

Collaborator

Rutgers University (Other), National Institute of Mental Health (NIMH) (NIH)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Suicidal Ideation Suicide Attempt	Behavioral: Brief skills sessions plus EMI skills practice prompts Behavioral: Ecological momentary assessment (EMA) Behavioral: Treatment as usual (TAU)	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Real-time Intervention for Suicide Risk Reduction

Anticipated Study Start Date :

Jul 1, 2023

Anticipated Primary Completion Date :

Oct 1, 2024

Anticipated Study Completion Date :

Oct 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Other: Treatment as usual (TAU) + EMA Participants will receive TAU and be prompted to complete 4x/day smartphone-based EMA surveys of negative emotion and STBs.	Behavioral: Ecological momentary assessment (EMA) 4x/day brief smartphone-based EMA surveys assessing negative emotions and STBs Behavioral: Treatment as usual (TAU) TAU (or usual care) during hospitalization and the 28-day post-discharge period
Experimental: Experimental intervention + TAU Participants will receive TAU plus 3 brief sessions of CBT skills, one discretionary post-discharge skills booster session, and 4x/day EMA and prompted EMI, which guides in-the-moment CBT skills practice.	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 Other Names: cognitive behavioral therapy ecological momentary intervention Behavioral: Ecological momentary assessment (EMA) 4x/day brief smartphone-based EMA surveys assessing negative emotions and STBs Behavioral: Treatment as usual (TAU) TAU (or usual care) during hospitalization and the 28-day post-discharge period

Arm

Intervention/Treatment

Other: Treatment as usual (TAU) + EMA

Participants will receive TAU and be prompted to complete 4x/day smartphone-based EMA surveys of negative emotion and STBs.

Behavioral: Ecological momentary assessment (EMA)

4x/day brief smartphone-based EMA surveys assessing negative emotions and STBs

Behavioral: Treatment as usual (TAU)

TAU (or usual care) during hospitalization and the 28-day post-discharge period

Experimental: Experimental intervention + TAU

Participants will receive TAU plus 3 brief sessions of CBT skills, one discretionary post-discharge skills booster session, and 4x/day EMA and prompted EMI, which guides in-the-moment CBT skills practice.

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

Other Names:

cognitive behavioral therapy

ecological momentary intervention

Behavioral: Ecological momentary assessment (EMA)

4x/day brief smartphone-based EMA surveys assessing negative emotions and STBs

Behavioral: Treatment as usual (TAU)

TAU (or usual care) during hospitalization and the 28-day post-discharge period

Outcome Measures

Primary Outcome Measures

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 [Through study completion (up to 28 days after inpatient hospital discharge)]
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
Between-condition differences in momentary self-reported intensity of suicidal urges (measured on a 11-point rating scale via ecological momentary assessment) [Through study completion (up to 28 days after inpatient hospital discharge)]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.