Emotion RegulationNCT06509360
How do You Feelee? Emotion-based Smartphone App in the Forensic Outpatient Setting
A study testing Feelee app in people with Emotion Regulation and Emotional Neglect, run by Amsterdam UMC, location VUmc at 2 sites in Netherlands.
Trial summary
This intervention study aims to explore the addition of the Feelee app (using active emoji data with passive behavioral data through phone sensing) in treatment as usual for adolescents in the forensic outpatient setting. Read more about this study
- Who is it for?
- Ages 12 to 23 years
- Conditions the study is for
- Emotion Regulation, Emotional Neglect
- What is being tested?
- Feelee app
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesNetherlands
- Study dates
- 3 Aug 2023to Dec 2024
- 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 12 to 23 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- At the time of the study in treatment at a forensic outreach youth care organization.
- Expected to be in treatment for at least another 3 months.
- Using a smartphone with Android or IOS operating system.
- Have basic understanding about the use of a smartphone
Who cannot join
- Adolescents with serious psychiatric problems, such as psychosis or high risk of suicide
- Insufficient understanding of spoken and written Dutch language.
- Adolescents without a smartphone.
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites, 2 recruiting
- Recruiting
Inforsa
Amsterdam, North Holland, 1058 AA
Thimo van der Pol, dr.
- Recruiting
Levvel
Amsterdam, North Holland, 1076 EC
René Breuk, dr.
About this study
Official title: How do You Feelee? Does an Ordinary Question a Day Supports Youth in a Forensic Outpatient Setting to Become More Emotional Balanced? A Multiple Case Experimental Design
This intervention study aims to explore the addition of the Feelee app (using active emoji data with passive behavioral data through phone sensing) in treatment as usual for adolescents in the forensic outpatient setting.
Participants will use Feelee for 4 weeks, which means specifying an emoji each day and collecting the passive data on the background. The collected active and passive data will be discussed through the clinicians during the participants' weekly treatment sessions.
Read the detailed description
Participants will be subjected to a ABA baseline design: including a 2-weeks baseline phase (A), 4-weeks intervention phase (B) and 2-weeks follow-up phase.
During the baseline phase (A), participants will fill in a daily questionnaire that measures different aspects of their emotion regulation skills. The use of the Feelee app is not allowed yet. After 2-weeks, the intervention phase starts, meaning participants will use the Feelee app every day during a 4-weeks period. The use of the Feelee app includes specifying an emoji and collecting the passive data on the background. Furthermore, the collected active and passive data will be discussed through the clinicians during the participants weekly treatment sessions. Participants will also be continuing to complete the daily questionnaire. After 4-weeks, the follow-up phase starts. Participants need to remove the Feelee app and will follow their treatment as usual. However, participants still need to complete the daily questionnaire. After 2-weeks the follow-up phase and main study part has ended.
Throughout the ABA baseline, pre-measurement (T0), post-measurement (T1) follow-up measurement (Tf1) will be conducted before and after the intervention and during follow-up. Last, a 3-months follow-up will be conducted to identify possible long-term effects.
- Conditions
- Emotion Regulation, Emotional Neglect
- Being tested
- Feelee app
- Keywords
- Smartphone data, Emoji, Emotion regulation, Adolescents, Forensic outpatient care
- Medical subject headings
- Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Feelee appDevice
Adolescents uses the Feelee app for 4-weeks in addition to treatment as usual in the forensic outpatient setting. The use of Feelee involves: submitting one emoji every day and allow the Feelee app to read the following passive data from the health app on the smartphone: number of steps and number of hours of sleep. The collected Feelee data will be presented in a dashboard in the Feelee app itself which will be discussed by the clinician in the weekly treatment session (in case the adolescents agreed to show the Feelee data to the clinician).
| Study group | Role | What they receive |
|---|---|---|
| Feelee app | Other | Following a Single Case Experimental Design, all participants will follow a ABA baseline: 2-weeks baseline phase without intervention (A), 4-weeks intervention phase using the Feelee app (B) and a 2-weeks follow-up phase without intervention again (B). Receives: Device: Feelee app |
What is being measured
The primary outcome is the main question the study is designed to answer.
Emotion regulation: measured by a composite of items from the Difficulties in Emotional Dysregulation Scale (DERS-36) and Regulation of Emotion Systems Survey for daily usage (RESS-EMA)
Emotion regulation involves the ability to recognize, comprehends and manage emotions.
The first 2 items are from the DERS-36 scale and measure construct recognize (clarity) and manage (impulse) of emotion regulation. Answers on these scales can be given on a 5-point Likert-scale (0= almost never too 5= almost always).
The other 4 items are from the RESS-EMA survey The RESS-EMA questionnaire consists of different aspects of the emotion regulation systems and strategies that are suitable for daily usage. The items included in the daily questionnaire are: comprehends (rumination), comprehends (reappraisal), manage (distraction) and manage (suppression). Answers can be given from 0 = not at all to 10 = very much.
Measured: Daily questionnaire (24 hour interval). From Day 0 (Week 1) up to Day 56 (Week 8).
Secondary outcomes (3)
Emotional differentiation: Positive and Negative Affect Schedule (PANAS)
Emotional differentiation includes the ability to recognize and distinct different emotional expressions.
Participants will be asked to rate the extent they experienced one of the 20 items that describes different emotions. The instruments consist of 2 subscales: positive affect and negative affect. These concepts will be scored on a 5-point Likert scale, using the following options: 1 = 'Very slightly/not at all', 2 = 'A little', 3 = 'Moderately', 4 = 'Quite a bit' and 5 = 'Extremely'.
Measured: Pre-measurement (T0) at Week 1, post-measurement (T1) at Week 6 and follow-up-measurement at Week 8
Self-reflection: Self-Reflection and Insight Scale for Youth (SRIS-Y)
Self-reflection involves the process of looking back at experiences, emotions and behavior in order help individuals to clarify a meaning to it and gain more self-awareness.
The SRIS-Y is a 17-item self-report questionnaire, answered with a 6-point Likert scale ranging from 1 = 'disagree strongly' to 6= 'agree strongly'. The instrument consists of two subscales self-reflection and and insight resulting in two separate scores. A higher score represents a higher degree of self-reflection and self-insight.
Measured: Pre-measurement (T0) at Week 1, post-measurement (T1) at Week 6 and follow-up-measurement at Week 8.
Emotional awareness: Emotional awareness subscale of the Multidimensional Assessment of Interoceptive Awareness (MAIA)
Emotional awareness involves a subjective understanding of the emotional states and ability to recognize possible causes underlying the emotional states.
In this study, only the emotional awareness subscale of the MAIA will be used. Answers can be given on a 6-point Likert scale ranging from 0 = 'never' to 5 = 'always'. Scores of the subscale can easily been calculating the total score and dividing it by the number of items belonging to the subscale. A higher score represents a higher degree of emotional awareness.
Measured: Pre-measurement (T0) at Week 1, post-measurement (T1) at Week 6 and follow-up-measurement at Week 8.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2024
- Study start3 Aug 2023
- Primary completionSep 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Emotion RegulationStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single Case Experimental Design
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amsterdam UMC, location VUmc
- Sponsor type
- University, hospital or other
- Collaborators
- Levvel, Arkin, KFZ-J
- Responsible party
- Principal investigator, Prof. dr. Arne Popma, Amsterdam UMC, location VUmc
- Investigators
- Arne Popma, Prof. dr., Principal investigator, Amsterdam UMC, location VUmc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06509360
- Sponsor's protocol ID
- NL78889.029.22
- Status last verified
- Jul 2024
- First submitted
- 1 Sep 2023
- Last updated
- 19 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Van Dam L, Rietstra S, Van der Drift E, Stams GJJM, Van der Mei R, Mahfoud M, Popma A, Schlossberg E, Pentland A, Reid TG. Can an Emoji a Day Keep the Doctor Away? An Explorative Mixed-Methods Feasibility Study to Develop a Self-Help App for Youth With Mental Health Problems. Front Psychiatry. 2019 Aug 23;10:593. doi: 10.3389/fpsyt.2019.00593. eCollection 2019.
PubMed 31507464Krasny-Pacini A, Evans J. Single-case experimental designs to assess intervention effectiveness in rehabilitation: A practical guide. Ann Phys Rehabil Med. 2018 May;61(3):164-179. doi: 10.1016/j.rehab.2017.12.002. Epub 2017 Dec 15.
PubMed 29253607Victor SE, Klonsky ED. Validation of a Brief Version of the Difficulties in Emotion Regulation Scale (DERS-18) in Five Samples. Journal Psychopathologic behavior Assess. 2016; 38(4): 582-589. doi: 10.1007/s10862-016-9547-9
Medland H, De France K, Hollenstein T, Mussoff D, Koval P. Regulating emotion systems in everyday life: Reliability and validity of the RESS-EMA scale. European Journal of Psychological Assessment. 2020; 36(3): 437-446. doi:10.1027/1015-5759/a000595
Watson D, Clark LA, Tellegen A. Development and validation of brief measures of positive and negative affect: the PANAS scales. J Pers Soc Psychol. 1988 Jun;54(6):1063-70. doi: 10.1037//0022-3514.54.6.1063.
PubMed 3397865Sauter FM, Heyne D, Blote AW, van Widenfelt BM, Westenberg PM. Assessing therapy-relevant cognitive capacities in young people: development and psychometric evaluation of the self-reflection and insight scale for youth. Behav Cogn Psychother. 2010 May;38(3):303-17. doi: 10.1017/S1352465810000020. Epub 2010 Apr 12.
PubMed 20380777Mehling WE, Price C, Daubenmier JJ, Acree M, Bartmess E, Stewart A. The Multidimensional Assessment of Interoceptive Awareness (MAIA). PLoS One. 2012;7(11):e48230. doi: 10.1371/journal.pone.0048230. Epub 2012 Nov 1.
PubMed 23133619Van der Helm GH, Wissink IB, De Jongh T, Stams GJ. Measuring treatment motivation in secure juvenile facilities. Int J Offender Ther Comp Criminol. 2013 Aug;57(8):996-1008. doi: 10.1177/0306624X12443798. Epub 2012 May 23.
PubMed 22627687Horvath AO, Greenberg LS. Development and validation of the Working Alliance Inventory. Journal of Counseling Psychology. 1989; 36(2): 223-233. https://doi.org/10.1037/0022-0167.36.2.223
Kelders SM, Kip H, Greeff J. Psychometric Evaluation of the TWente Engagement with Ehealth Technologies Scale (TWEETS): Evaluation Study. J Med Internet Res. 2020 Oct 9;22(10):e17757. doi: 10.2196/17757.
PubMed 33021487Ensink CJ, Keijsers NLW, Groen BE. Translation and validation of the System Usability Scale to a Dutch version: D-SUS. Disabil Rehabil. 2024 Jan;46(2):395-400. doi: 10.1080/09638288.2022.2160837. Epub 2022 Dec 27.
PubMed 36573399Leijse MML, van Dam L, Bouwmeester S, van der Pol TM, Breuk R, Popma A. 'I gotta Feeling': Exploring the effects of a smartphone app (Feelee) to enhance adolescents' emotion regulation in forensic outpatient settings: A multiple single-case experimental design. PLoS One. 2026 Feb 6;21(2):e0332111. doi: 10.1371/journal.pone.0332111. eCollection 2026.
PubMed 41650199Leijse MML, van Dam L, van der Pol TM, Breuk R, Popma A. The Effects of a Smartphone App (Feelee) to Enhance Adolescents' Emotion Regulation Skills in a Forensic Outpatient Setting: Protocol for a Multiple Single-Case Experimental Design. JMIR Res Protoc. 2025 Jul 2;14:e64756. doi: 10.2196/64756.
PubMed 40601926
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How do You Feelee? Does an Ordinary Question a Day Supports Youth in a Forensic Outpatient Setting to Become More Emotional Balanced? A Multiple Case Experimental Design
- ClinicalTrials.gov ID
- NCT06509360
- Acronym / sponsor ID
- NL78889.029.22
- Conditions
- Emotion Regulation, Emotional Neglect
- Keywords
- Smartphone data, Emoji, Emotion regulation, Adolescents, Forensic outpatient care
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Amsterdam UMC, location VUmcUniversity, hospital or other
- Collaborators
- Levvel, Arkin, KFZ-J
- Study start
- 3 Aug 2023 (actual)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 19 Jul 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.
This intervention study aims to explore the addition of the Feelee app (using active emoji data with passive behavioral data through phone sensing) in treatment as usual for adolescents in the forensic outpatient setting.
Participants will use Feelee for 4 weeks, which means specifying an emoji each day and collecting the passive data on the background. The collected active and passive data will be discussed through the clinicians during the participants' weekly treatment sessions.
Detailed description
Participants will be subjected to a ABA baseline design: including a 2-weeks baseline phase (A), 4-weeks intervention phase (B) and 2-weeks follow-up phase.
During the baseline phase (A), participants will fill in a daily questionnaire that measures different aspects of their emotion regulation skills. The use of the Feelee app is not allowed yet. After 2-weeks, the intervention phase starts, meaning participants will use the Feelee app every day during a 4-weeks period. The use of the Feelee app includes specifying an emoji and collecting the passive data on the background. Furthermore, the collected active and passive data will be discussed through the clinicians during the participants weekly treatment sessions. Participants will also be continuing to complete the daily questionnaire. After 4-weeks, the follow-up phase starts. Participants need to remove the Feelee app and will follow their treatment as usual. However, participants still need to complete the daily questionnaire. After 2-weeks the follow-up phase and main study part has ended.
Throughout the ABA baseline, pre-measurement (T0), post-measurement (T1) follow-up measurement (Tf1) will be conducted before and after the intervention and during follow-up. Last, a 3-months follow-up will be conducted to identify possible long-term effects.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Case Experimental Design
| Arm | Type | Receives |
|---|---|---|
| Feelee app | Other | Device: Feelee appFollowing a Single Case Experimental Design, all participants will follow a ABA baseline: 2-weeks baseline phase without intervention (A), 4-weeks intervention phase using the Feelee app (B) and a 2-weeks follow-up phase without intervention again (B). |
Who may qualify
- Ages
- 12 to 23 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- At the time of the study in treatment at a forensic outreach youth care organization.
- Expected to be in treatment for at least another 3 months.
- Using a smartphone with Android or IOS operating system.
- Have basic understanding about the use of a smartphone
Key exclusion criteria (3 listed)
- Adolescents with serious psychiatric problems, such as psychosis or high risk of suicide
- Insufficient understanding of spoken and written Dutch language.
- Adolescents without a smartphone.
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 |
|---|---|---|
| Feelee appAdolescents uses the Feelee app for 4-weeks in addition to treatment as usual in the forensic outpatient setting. The use of Feelee involves: submitting one emoji every day and allow the Feelee app to read the following passive data from the health app on the smartphone: number of steps and number of hours of sleep. The collected Feelee data will be presented in a dashboard in the Feelee app itself which will be discussed by the clinician in the weekly treatment session (in case the adolescents agreed to show the Feelee data to the clinician). | Device | Feelee app |
Primary outcome
Emotion regulation: measured by a composite of items from the Difficulties in Emotional Dysregulation Scale (DERS-36) and Regulation of Emotion Systems Survey for daily usage (RESS-EMA)
Time frame: Daily questionnaire (24 hour interval). From Day 0 (Week 1) up to Day 56 (Week 8).
Emotion regulation involves the ability to recognize, comprehends and manage emotions. The first 2 items are from the DERS-36 scale and measure construct recognize (clarity) and manage (impulse) of emotion regulation. Answers on these scales can be given on a 5-point Likert-scale (0= almost never too 5= almost always). The other 4 items are from the RESS-EMA survey The RESS-EMA questionnaire consists of different aspects of the emotion regulation systems and strategies that are suitable for daily usage. The items included in the daily questionnaire are: comprehends (rumination), comprehends (reappraisal), manage (distraction) and manage (suppression). Answers can be given from 0 = not at all to 10 = very much.
3 secondary outcomes
Emotional differentiation: Positive and Negative Affect Schedule (PANAS)
Time frame: Pre-measurement (T0) at Week 1, post-measurement (T1) at Week 6 and follow-up-measurement at Week 8
Self-reflection: Self-Reflection and Insight Scale for Youth (SRIS-Y)
Time frame: Pre-measurement (T0) at Week 1, post-measurement (T1) at Week 6 and follow-up-measurement at Week 8.
Emotional awareness: Emotional awareness subscale of the Multidimensional Assessment of Interoceptive Awareness (MAIA)
Time frame: Pre-measurement (T0) at Week 1, post-measurement (T1) at Week 6 and follow-up-measurement at Week 8.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2024.
- Background: PubMed 31507464Van Dam L, Rietstra S, Van der Drift E, Stams GJJM, Van der Mei R, Mahfoud M, Popma A, Schlossberg E, Pentland A, Reid TG. Can an Emoji a Day Keep the Doctor Away? An Explorative Mixed-Methods Feasibility Study to Develop a Self-Help App for Youth With Mental Health Problems. Front Psychiatry. 2019 Aug 23;10:593. doi: 10.3389/fpsyt.2019.00593. eCollection 2019.
- Background: PubMed 29253607Krasny-Pacini A, Evans J. Single-case experimental designs to assess intervention effectiveness in rehabilitation: A practical guide. Ann Phys Rehabil Med. 2018 May;61(3):164-179. doi: 10.1016/j.rehab.2017.12.002. Epub 2017 Dec 15.
- BackgroundVictor SE, Klonsky ED. Validation of a Brief Version of the Difficulties in Emotion Regulation Scale (DERS-18) in Five Samples. Journal Psychopathologic behavior Assess. 2016; 38(4): 582-589. doi: 10.1007/s10862-016-9547-9
- BackgroundMedland H, De France K, Hollenstein T, Mussoff D, Koval P. Regulating emotion systems in everyday life: Reliability and validity of the RESS-EMA scale. European Journal of Psychological Assessment. 2020; 36(3): 437-446. doi:10.1027/1015-5759/a000595
- Background: PubMed 3397865Watson D, Clark LA, Tellegen A. Development and validation of brief measures of positive and negative affect: the PANAS scales. J Pers Soc Psychol. 1988 Jun;54(6):1063-70. doi: 10.1037//0022-3514.54.6.1063.
- Background: PubMed 20380777Sauter FM, Heyne D, Blote AW, van Widenfelt BM, Westenberg PM. Assessing therapy-relevant cognitive capacities in young people: development and psychometric evaluation of the self-reflection and insight scale for youth. Behav Cogn Psychother. 2010 May;38(3):303-17. doi: 10.1017/S1352465810000020. Epub 2010 Apr 12.
- Background: PubMed 23133619Mehling WE, Price C, Daubenmier JJ, Acree M, Bartmess E, Stewart A. The Multidimensional Assessment of Interoceptive Awareness (MAIA). PLoS One. 2012;7(11):e48230. doi: 10.1371/journal.pone.0048230. Epub 2012 Nov 1.
- Background: PubMed 22627687Van der Helm GH, Wissink IB, De Jongh T, Stams GJ. Measuring treatment motivation in secure juvenile facilities. Int J Offender Ther Comp Criminol. 2013 Aug;57(8):996-1008. doi: 10.1177/0306624X12443798. Epub 2012 May 23.
- BackgroundHorvath AO, Greenberg LS. Development and validation of the Working Alliance Inventory. Journal of Counseling Psychology. 1989; 36(2): 223-233. https://doi.org/10.1037/0022-0167.36.2.223
- Background: PubMed 33021487Kelders SM, Kip H, Greeff J. Psychometric Evaluation of the TWente Engagement with Ehealth Technologies Scale (TWEETS): Evaluation Study. J Med Internet Res. 2020 Oct 9;22(10):e17757. doi: 10.2196/17757.
- Background: PubMed 36573399Ensink CJ, Keijsers NLW, Groen BE. Translation and validation of the System Usability Scale to a Dutch version: D-SUS. Disabil Rehabil. 2024 Jan;46(2):395-400. doi: 10.1080/09638288.2022.2160837. Epub 2022 Dec 27.
- Derived from this study: PubMed 41650199Leijse MML, van Dam L, Bouwmeester S, van der Pol TM, Breuk R, Popma A. 'I gotta Feeling': Exploring the effects of a smartphone app (Feelee) to enhance adolescents' emotion regulation in forensic outpatient settings: A multiple single-case experimental design. PLoS One. 2026 Feb 6;21(2):e0332111. doi: 10.1371/journal.pone.0332111. eCollection 2026.
- Website Feelee appLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Arne Popma, Prof. dr. principal investigator
Amsterdam UMC, location VUmc
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Feelee app in people with Emotion Regulation and Emotional Neglect, run by Amsterdam UMC, location VUmc at 2 sites in Netherlands.
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 4 inclusion and 3 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 19 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. 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 Merel Leijse, Msc (+31 6 40043394, m.m.l.leijse@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Emotion regulation: measured by a composite of items from the Difficulties in Emotional Dysregulation Scale (DERS-36) and Regulation of Emotion Systems Survey for daily usage (RESS-EMA) (time frame: Daily questionnaire (24 hour interval). From Day 0 (Week 1) up to Day 56 (Week 8).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06509360, which also lists 13 linked publications.
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 19 Jul 2024.