Randomized Clinical Trial of Supplementing Brief Psychotherapy With a Mobile App

NCT ID: NCT06555094

Last Updated: 2024-08-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-14
• Study Completion Date: 2025-01-31

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.

Detailed Description

This study is a companion project to NCT05848089. 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), 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) 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 for the 28-day post-discharge period.

Conditions

Suicidal Ideation; Suicide; Suicide Attempt

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

Ecological momentary assessment (EMA)

Intervention Type: BEHAVIORAL

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

Treatment as usual (TAU)

Intervention Type: BEHAVIORAL

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

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.

Group Type: EXPERIMENTAL

Treatment as usual (TAU)

Intervention Type: BEHAVIORAL

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

Brief skills sessions plus EMI skills practice prompts

Intervention Type: BEHAVIORAL

(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

Interventions

Ecological momentary assessment (EMA)

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

Intervention Type: BEHAVIORAL

Treatment as usual (TAU)

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

Intervention Type: 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

Intervention Type: BEHAVIORAL

Other Intervention Names

cognitive behavioral therapy; ecological momentary intervention

Eligibility Criteria

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

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rutgers, The State University of New Jersey

OTHER

Sponsor Role: lead

Responsible Party

Evan M. Kleiman, Ph.D.

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

EVAN KLEIMAN, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Rutgers, The State University of New Jersey

Locations

Rutgers University Behavioral Healthcare

Piscataway, New Jersey, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Evan Kleiman, Ph.D.

Role: CONTACT

evan.kleiman@rutgers.edu

1-848-445-2345

Facility Contacts

Evan Kleiman

Role: primary

evan.kleiman@rutgers.edu

Other Identifiers

Pro2022001944_mod6

Identifier Type: -

Identifier Source: org_study_id