Randomized Clinical Trial of Supplementing Brief Psychotherapy With a Mobile App

NCT06555094 | Recruiting DMC

• 1 other identifier: Pro2022001944_mod6
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Suicidal Ideation; Suicide; Suicide Attempt

Keywords

Suicide Attempt; Suicide; Suicidal Ideation; Unified Protocol; Ecological Momentary Intervention; mhealth

Outcome Measures

Primary Outcomes (2)

• 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)

• 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)

Study Arms (2)

Treatment as usual (TAU) + EMA

OTHER

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); Behavioral: Treatment as usual (TAU)

Experimental intervention + TAU

EXPERIMENTAL

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: Treatment as usual (TAU); Behavioral: Brief skills sessions plus EMI skills practice prompts

Interventions

Ecological momentary assessment (EMA) BEHAVIORAL

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

Treatment as usual (TAU) + EMA

Treatment as usual (TAU) BEHAVIORAL

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

Experimental intervention + TAU; Treatment as usual (TAU) + EMA

Brief skills sessions plus EMI skills practice prompts 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

Also known as: cognitive behavioral therapy, ecological momentary intervention

Experimental intervention + TAU

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead

Study Sites (1)

Rutgers University Behavioral Healthcare

Piscataway, New Jersey, 08854, United States

RECRUITING

MeSH Terms

Conditions

Suicidal Ideation; Suicide; Suicide, Attempted

Interventions

Ecological Momentary Assessment; Therapeutics; Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Self-Injurious Behavior; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Psychological Tests; Behavioral Disciplines and Activities; Behavior Therapy; Psychotherapy

Study Officials

• EVAN KLEIMAN, Ph.D.

  Rutgers, The State University of New Jersey

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Evan Kleiman, Ph.D.

CONTACT

1-848-445-2345; evan.kleiman@rutgers.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 12, 2024
• First Posted: August 15, 2024
• Study Start: May 14, 2024
• Primary Completion: December 1, 2024
• Study Completion: January 1, 2025
• Last Updated: August 15, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)