NCT06555094 · Rutgers, The State University of New Jersey
Randomized Clinical Trial of Supplementing Brief Psychotherapy With a Mobile App
What this study is about
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.
View original scientific description
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.
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)
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
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)
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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Piscataway, New Jersey
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 15, 2024 · Source of record for eligibility and locations