Recruiting

Brief Psychotherapy

Sponsor:

Rutgers, The State University of New Jersey

Code:

NCT06555094

Conditions

Suicidal Ideation

Suicide

Suicide Attempt

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Ecological momentary assessment (EMA)

Treatment as usual (TAU)

Brief skills sessions plus EMI skills practice prompts

Study Details

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

Study ID

NCT06555094

Start date

May 14, 2024

Status verified date

Aug, 2024

Completion date

Jan, 2025

Anticipated

Primary completion date

Dec, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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

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

Primary outcome measure

  • 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 [ Time Frame: 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) [ Time Frame: Through study completion (up to 28 days after inpatient hospital discharge) ]

Central Contacts and Locations

Central contacts

Evan Kleiman, Ph.D.

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

Locations

Rutgers University Behavioral Healthcare

Recruiting

Piscataway, New Jersey, United States, 08854

Contacts

Evan Kleiman

evan.kleiman@rutgers.edu

Principal Investigator:

Evan Kleiman

More Information

Sponsor

Rutgers, The State University of New Jersey

Last update posted

Aug 15, 2024

Last verified

Aug, 2024

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Rutgers, The State University of New Jersey on 2024-08-15.