Suicidal IdeationAMPERENCT06704958
Augmented Momentary Personal Ecological Risk Evaluation
A study testing AMPERE EMA app in people with Suicidal Ideation and Self Harm, run by University of Washington at 1 site in United States.
Trial summary
The goal of this intervention study is to co-design and test an Ecological Momentary Assessment (EMA) prototype tool with young adults aged 16-30 experiencing suicidality to see if it is an acceptable and usable clinical tool for risk management. Read more about this study
- Who is it for?
- Ages 16 to 30 years
- Conditions the study is for
- Suicidal Ideation, Self Harm
- What is being tested?
- AMPERE EMA app
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Sep 2025to 25 Mar 2026
- 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 16 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Young adults (age 16-30 years)
- Receiving care at University of Washington Primary Care for suicidal ideation as determined by Electronic Health Record problem list or PHQ-9 suicide risk item >0 in previous year and/or recent (past year) history of suicide attempt and/or active suicidal ideation.
- Ability to consent to participate
Who cannot join
- Age <16 or >30,
- Non-English speaking
- No smart phone access
- Any clinical medical/psychiatric condition, severity of that condition, or life situation that would compromise safe and voluntary study participation.
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this intervention study is to co-design and test an Ecological Momentary Assessment (EMA) prototype tool with young adults aged 16-30 experiencing suicidality to see if it is an acceptable and usable clinical tool for risk management.
The main study aims are:
Read more
- To co-design a prototype EMA suicide risk monitoring system with patients and health care provider input using Human Centered Design (HCD) methods.
- To test the developed EMA protype with providers and their young adult patients aged 16-30 experiencing suicidality to determine if the EMA prototype is an acceptable and usable clinical tool.
Young adult participants receiving care for active suicidal ideation will
- Download and use the EMA prototype for a total of two months.
- Complete 3 online surveys at 0, 1 and 2 months after enrolled in the study.
Read the detailed description
Death by suicide is a leading cause of preventable mortality for young adults in the United States, yet the health care delivery system is poorly equipped to address this preventable issue. Ecological momentary assessment (EMA) allows patients to easily self-monitor and track symptoms using devices young adults already use (e.g., smartphones) in their natural environments, and can combine self-reported assessment with digital indicators of wellbeing via native smartphone sensors (e.g., daily step counts; number of device unlocks during the night, which may indicate sleep problems). EMA suicide risk detection systems show promise, but acceptability among patients at risk for suicide is unknown, and an actionable system for response to these signals by outpatient health care providers has not been developed.
The current project aims to design (Aim 1) and to examine the acceptability and feasibility of an EMA tool with young adults at risk of suicide in typical outpatient medical settings (Aim 2). Specifically, the goal of this intervention study is to see how EMA based signals of suicide risk can be used in primary health care to support management and care of young adults aged 16-30 experiencing suicidality. We will use human centered design (HCD) to co-develop and test an EMA protype with young adult patients and their health care providers to determine if acceptable and usable clinical tool. The goal of the project is to develop an EMA based prototype that improves management and care for young adults experiencing suicidality and has the potential to be used in other effective risk monitoring strategies to follow.
The specific aims of this proposed study are:
Aim 1: Co-design a prototype EMA suicide risk monitoring system with patients and health care providers through human centered design (HCD).
Aim 1.1 Iteratively co-design an EMA prototype with patient and providers; Aim 1.2 Develop training, and support materials for EMA clinical use. Aim 2: Conduct a feasibility and acceptability pilot of the EMA prototype to inform its revision and further development.
The pilot will consist of approximately 50 University of Washington Primary Care (UWPC) patients receiving care for active suicidal ideation in a UWPC clinical site. Following consent, the pilot participants will download the EMA prototype to their smart phone and use it for two months. During the two months, participants will use the EMA prototype to complete a weekly depression screener and brief daily surveys on mood, activity level, sleep, diet, substance use and social support. Patient participants will be asked to complete three online surveys, one right after they enroll, one at 1 month and one at 2 months following enrollment. The surveys will ask about demographic information (age, race, ethnicity, etc.), suicidal ideation, self-injury, substance use, social support and their experience using the EMA prototype.
- Conditions
- Suicidal Ideation, Self Harm
- Being tested
- AMPERE EMA app
- Keywords
- suicidal ideation, self harm
- Medical subject headings
- Suicidal Ideation, Self-Injurious Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMPERE EMA appOther
AMPERE EMA smartphone app using MyCap
| Study group | Role | What they receive |
|---|---|---|
| Use of AMPERE EMA prototype | Other | An EMA risk monitoring system using a smartphone EMA app to collect self-reported data from participating patients experiencing suicidal ideation. Receives: Other: AMPERE EMA app |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of Intervention Scale (AIM)
This is a four-item measure of intervention acceptability, where each item is rated on a 1-5 scale, with 1 = not at all acceptable and 5 = very acceptable. Total mean scores range from 1 - 5, with higher scores indicating higher acceptability. Participants will complete this measure after 4 weeks of using the mobile mental health app to which they are randomized.
Measured: 2 month post-initiation of AMPERE EMA use
System Usability Scale (SUS)
This is a 10 item measure of system usability with 5 response options. SUS score can range from 0 to 100 with a higher score indicating high usability.
Measured: 2 month post-initiation of AMPERE EMA use
Client Satisfaction Questionnaire (CSQ)
This is a 3 item measure to assess consumer satisfaction with health and human services
Measured: 2 month post-initiation of AMPERE EMA use
Secondary outcomes (2)
Suicide Related Coping Scale (SRCS)
Suicide-Related Coping Scale (SRCS) measures how well a person manages suicidal thoughts through the use of internal and external coping strategies. A 17-item tool with two score factors, internal and external coping strategies.
Measured: 0, 1, 2 month post-initiation of AMPERE EMA use
Helping Alliance Questionnaire (Haq-II)
The Helping Alliance Questionnaire is a 11-item patient self-report measure which assesses the extent to which the patient experiences the therapist and the therapy as helpful. It contains two types of helping alliance: Type I -- Perceived Helpfulness -- defined as the patient's experience of the therapist as providing or being capable of providing the help that is needed; and Type II -- Collaboration or Bonding -- defined as the patient's experience of treatment as a process of working together with the therapist toward the goals of treatment. The HAQ contains 11 items rated on a 4-point scale (completely disagree, disagree, agree, and completely agree).
Measured: 1, 2 month post-initiation of AMPERE EMA use
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2024
- Study start25 Sep 2025
- Primary completion11 Nov 2025
- Study completion25 Mar 2026
Why it stopped: NIMH stopped the study early at all study sites due to slow recruitment and limited time remaining to complete the study. Only one participant enrolled.
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 University of WashingtonThe 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Iterative intervention Development
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Ian Bennett, University of Washington
- Investigators
- Ian M Bennett, MD, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06704958
- Sponsor's protocol ID
- STUDY00017404
- Other IDs
- P50MH129708-02
- Acronym
- AMPERE
- Status last verified
- Aug 2026
- First submitted
- 21 Nov 2024
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Augmented Momentary Personal Ecological Risk Evaluation
- ClinicalTrials.gov ID
- NCT06704958
- Acronym / sponsor ID
- AMPERE / STUDY00017404
- Conditions
- Suicidal Ideation, Self Harm
- Keywords
- suicidal ideation, self harm
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: NIMH stopped the study early at all study sites due to slow recruitment and limited time remaining to complete the study. Only one participant enrolled.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 25 Sep 2025 (actual)
- Primary completion
- 11 Nov 2025 (actual)
- Study completion
- 25 Mar 2026 (actual)
- First posted
- 26 Nov 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 goal of this intervention study is to co-design and test an Ecological Momentary Assessment (EMA) prototype tool with young adults aged 16-30 experiencing suicidality to see if it is an acceptable and usable clinical tool for risk management.
The main study aims are:
- To co-design a prototype EMA suicide risk monitoring system with patients and health care provider input using Human Centered Design (HCD) methods.
- To test the developed EMA protype with providers and their young adult patients aged 16-30 experiencing suicidality to determine if the EMA prototype is an acceptable and usable clinical tool.
Young adult participants receiving care for active suicidal ideation will
- Download and use the EMA prototype for a total of two months.
- Complete 3 online surveys at 0, 1 and 2 months after enrolled in the study.
Detailed description
Death by suicide is a leading cause of preventable mortality for young adults in the United States, yet the health care delivery system is poorly equipped to address this preventable issue. Ecological momentary assessment (EMA) allows patients to easily self-monitor and track symptoms using devices young adults already use (e.g., smartphones) in their natural environments, and can combine self-reported assessment with digital indicators of wellbeing via native smartphone sensors (e.g., daily step counts; number of device unlocks during the night, which may indicate sleep problems). EMA suicide risk detection systems show promise, but acceptability among patients at risk for suicide is unknown, and an actionable system for response to these signals by outpatient health care providers has not been developed.
The current project aims to design (Aim 1) and to examine the acceptability and feasibility of an EMA tool with young adults at risk of suicide in typical outpatient medical settings (Aim 2). Specifically, the goal of this intervention study is to see how EMA based signals of suicide risk can be used in primary health care to support management and care of young adults aged 16-30 experiencing suicidality. We will use human centered design (HCD) to co-develop and test an EMA protype with young adult patients and their health care providers to determine if acceptable and usable clinical tool. The goal of the project is to develop an EMA based prototype that improves management and care for young adults experiencing suicidality and has the potential to be used in other effective risk monitoring strategies to follow.
The specific aims of this proposed study are:
Aim 1: Co-design a prototype EMA suicide risk monitoring system with patients and health care providers through human centered design (HCD).
Aim 1.1 Iteratively co-design an EMA prototype with patient and providers; Aim 1.2 Develop training, and support materials for EMA clinical use. Aim 2: Conduct a feasibility and acceptability pilot of the EMA prototype to inform its revision and further development.
The pilot will consist of approximately 50 University of Washington Primary Care (UWPC) patients receiving care for active suicidal ideation in a UWPC clinical site. Following consent, the pilot participants will download the EMA prototype to their smart phone and use it for two months. During the two months, participants will use the EMA prototype to complete a weekly depression screener and brief daily surveys on mood, activity level, sleep, diet, substance use and social support. Patient participants will be asked to complete three online surveys, one right after they enroll, one at 1 month and one at 2 months following enrollment. The surveys will ask about demographic information (age, race, ethnicity, etc.), suicidal ideation, self-injury, substance use, social support and their experience using the EMA prototype.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Iterative intervention Development
| Arm | Type | Receives |
|---|---|---|
| Use of AMPERE EMA prototype | Other | Other: AMPERE EMA appAn EMA risk monitoring system using a smartphone EMA app to collect self-reported data from participating patients experiencing suicidal ideation. |
Who may qualify
- Ages
- 16 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Young adults (age 16-30 years)
- Receiving care at University of Washington Primary Care for suicidal ideation as determined by Electronic Health Record problem list or PHQ-9 suicide risk item >0 in previous year and/or recent (past year) history of suicide attempt and/or active suicidal ideation.
- Ability to consent to participate
Key exclusion criteria (4 listed)
- Age <16 or >30,
- Non-English speaking
- No smart phone access
- Any clinical medical/psychiatric condition, severity of that condition, or life situation that would compromise safe and voluntary study participation.
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 |
|---|---|---|
| AMPERE EMA appAMPERE EMA smartphone app using MyCap | Other | Use of AMPERE EMA prototype |
Primary outcome
Acceptability of Intervention Scale (AIM)
Time frame: 2 month post-initiation of AMPERE EMA use
This is a four-item measure of intervention acceptability, where each item is rated on a 1-5 scale, with 1 = not at all acceptable and 5 = very acceptable. Total mean scores range from 1 - 5, with higher scores indicating higher acceptability. Participants will complete this measure after 4 weeks of using the mobile mental health app to which they are randomized.
System Usability Scale (SUS)
Time frame: 2 month post-initiation of AMPERE EMA use
This is a 10 item measure of system usability with 5 response options. SUS score can range from 0 to 100 with a higher score indicating high usability.
Client Satisfaction Questionnaire (CSQ)
Time frame: 2 month post-initiation of AMPERE EMA use
This is a 3 item measure to assess consumer satisfaction with health and human services
2 secondary outcomes
Suicide Related Coping Scale (SRCS)
Time frame: 0, 1, 2 month post-initiation of AMPERE EMA use
Helping Alliance Questionnaire (Haq-II)
Time frame: 1, 2 month post-initiation of AMPERE EMA use
Results and safety
The study was stopped early (reason given: NIMH stopped the study early at all study sites due to slow recruitment and limited time remaining to complete the study. Only one participant enrolled.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Individual participant dataSharing planned: Undecided
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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.
Ian M Bennett, MD, PhD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AMPERE EMA app in people with Suicidal Ideation and Self Harm, run by University of Washington 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 4 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: stopped early, as of the sponsor's last update on 21 Aug 2026. 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?
The study was stopped early (reason given: NIMH stopped the study early at all study sites due to slow recruitment and limited time remaining to complete the study. Only one participant enrolled.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of Intervention Scale (AIM) (time frame: 2 month post-initiation of AMPERE EMA use). The study lists 3 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 21 Aug 2026.