Randomized Clinical Trial of Supplementing Brief Psychotherapy With a Mobile App
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ecological momentary assessment (EMA), Treatment as usual (TAU), Brief skills sessions plus EMI skills practice prompts.
- Who it may be relevant to
- Registry conditions: Suicidal Ideation, Suicide, Suicide Attempt. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Supplementing Brief Psychotherapy With a Mobile App
Overview
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.
Interventions
- 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 - 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
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 [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)]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Rutgers University Behavioral Healthcare — Piscataway
Identifiers
NCT: NCT06555094 · Pro2022001944_mod6