Suicidal IdeationNCT06555094
Randomized Clinical Trial of Supplementing Brief Psychotherapy With a Mobile App
A study testing Ecological momentary assessment (EMA), Treatment as usual (TAU) and Brief skills sessions plus EMI skills practice prompts in people with Suicidal Ideation and Suicide, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Suicidal Ideation, Suicide, Suicide Attempt
- What is being tested?
- Ecological momentary assessment (EMA), Treatment as usual (TAU) and Brief skills sessions plus EMI skills practice prompts
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 14 May 2024to Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Rutgers University Behavioral Healthcare
Piscataway, New Jersey, 08854
Evan Kleiman, evan.kleiman@rutgers.edu
Evan Kleiman
About this study
Official title: Supplementing Brief Psychotherapy With a Mobile App
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.
Read the 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.
- Conditions
- Suicidal Ideation, Suicide, Suicide Attempt
- Being tested
- Ecological momentary assessment (EMA), Treatment as usual (TAU), Brief skills sessions plus EMI skills practice prompts
- Keywords
- Suicide Attempt, Suicide, Suicidal Ideation, Unified Protocol, Ecological Momentary Intervention, mhealth
- Medical subject headings
- Suicidal Ideation, Suicide, Suicide, Attempted
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ecological momentary assessment (EMA)Behavioural
4x/day brief smartphone-based EMA surveys assessing negative emotions and STBs
Treatment as usual (TAU)Behavioural
TAU (or usual care) during hospitalization and the 28-day post-discharge period
Brief skills sessions plus EMI skills practice promptsBehavioural
Also called cognitive behavioral therapy, ecological momentary intervention
(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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Treatment as usual (TAU); Behavioral: Brief skills sessions plus EMI skills practice prompts |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Through study completion (up to 28 days after inpatient hospital discharge)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2024
- Study start14 May 2024
- Primary completionDec 2024 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suicidal IdeationStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Evan M. Kleiman, Ph.D., Rutgers, The State University of New Jersey
- Investigators
- EVAN KLEIMAN, Ph.D., Principal investigator, Rutgers, The State University of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06555094
- Sponsor's protocol ID
- Pro2022001944_mod6
- Status last verified
- Aug 2024
- First submitted
- 12 Aug 2024
- Last updated
- 15 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: These data are from a sensitive, high-risk population
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supplementing Brief Psychotherapy With a Mobile App
- ClinicalTrials.gov ID
- NCT06555094
- Acronym / sponsor ID
- Pro2022001944_mod6
- Conditions
- Suicidal Ideation, Suicide, Suicide Attempt
- Keywords
- Suicide Attempt, Suicide, Suicidal Ideation, Unified Protocol, Ecological Momentary Intervention, mhealth
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Study start
- 14 May 2024 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 15 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment as usual (TAU) + EMA | Other | Behavioral: Ecological momentary assessment (EMA), Behavioral: Treatment as usual (TAU)Participants will receive TAU and be prompted to complete 4x/day smartphone-based EMA surveys of negative emotion and STBs. |
| Experimental intervention + TAU | Experimental | Behavioral: Treatment as usual (TAU), Behavioral: Brief skills sessions plus EMI skills practice promptsParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ecological momentary assessment (EMA)4x/day brief smartphone-based EMA surveys assessing negative emotions and STBs | Behavioural | Treatment as usual (TAU) + EMA |
| Treatment as usual (TAU)TAU (or usual care) during hospitalization and the 28-day post-discharge period | Behavioural | Experimental intervention + TAU, Treatment as usual (TAU) + EMA |
| Brief skills sessions plus EMI skills practice promptsAlso: cognitive behavioral therapy, ecological momentary intervention(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 | Behavioural | Experimental intervention + TAU |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2024.
- Individual participant dataSharing planned: No. These data are from a sensitive, high-risk population
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
EVAN KLEIMAN, Ph.D. principal investigator
Rutgers, The State University of New Jersey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ecological momentary assessment (EMA), Treatment as usual (TAU) and Brief skills sessions plus EMI skills practice prompts in people with Suicidal Ideation and Suicide, run by Rutgers, The State University of New Jersey at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Evan Kleiman, Ph.D. (1-848-445-2345, evan.kleiman@rutgers.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2024.