Randomized Clinical Trial of Supplementing Brief Psychotherapy With a Mobile App

Part of paid clinical trials in Piscataway, New Jersey.

Sponsor
Rutgers, The State University of New Jersey
Study ID
NCT06555094
Status
Recruiting
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Conditions

  • Suicidal Ideation
  • Suicide
  • Suicide Attempt

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ecological momentary assessment (EMA) — BEHAVIORAL
    4x/day brief smartphone-based EMA surveys assessing negative emotions and STBs
  • Treatment as usual (TAU) — BEHAVIORAL
    TAU (or usual care) during hospitalization and the 28-day post-discharge period
  • 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

Study Details

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.

Key Dates

Start date
May 14, 2024
Status verified
Aug 2024
Primary completion
Dec 31, 2024
Completion
Jan 31, 2025

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

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) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Rutgers University Behavioral HealthcarePiscatawayNew Jersey08854
Evan Kleiman
[email protected]
Evan Kleiman (PRINCIPAL_INVESTIGATOR)

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By research site
Rutgers University Behavioral Healthcare· Piscataway, NJ

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