Emotion RegulationMASHUP1NCT05746234
Emotion Regulation For All (ER4ALL) Study
A study testing Emotion Regulation Course in people with Emotion Regulation, run by University of Cyprus at 1 site in Cyprus.
Trial summary
In the present study, the investigators aim to examine the feasibility of a classroom-based emotion regulation skills training within a tertiary curriculum. The primary objective of this study is to assess the acceptability and feasibility of the "ER4ALL", a brief course for enhancing emotion regulation skills for… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Emotion Regulation
- What is being tested?
- Emotion Regulation Course
- 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 siteCyprus
- Study dates
- 1 Mar 2023to 28 Feb 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- No specific exclusion criteria.
Trial locations and contacts
1 site in 1 country.
Cyprus1 site, 1 recruiting
- Recruiting
University of Cyprus
Nicosia, 1678
Marios o Theodorou, PhD, +35722892081, theodorou.marios@ucy.ac.cy
Georgia Panayiotou, PhD, +35722892081, georgiap@ucy.ac.cy
About this study
Official title: A Pilot Feasibility Study for an Emotion Regulation Skills Training (ER4ALL) for Students in Higher Education
In the present study, the investigators aim to examine the feasibility of a classroom-based emotion regulation skills training within a tertiary curriculum.
The primary objective of this study is to assess the acceptability and feasibility of the "ER4ALL", a brief course for enhancing emotion regulation skills for students in higher education.
The secondary objective of this study is to collect preliminary evidence for beneficial effects in increasing students' acquired knowledge on adaptive emotion regulation, thus improvement on general psychological wellbeing.
A two-arm pilot RCT will be conducted in University of Cyprus.
Read the detailed description
Entering Higher Education (HE) marks a turning point for youth learning to function as independent adults, something that can be both exciting and challenging. Students are confronted with a considerable number of changes to manage (e.g. high academic expectations, making new relationships, making independent decisions), for which they may be psychosocially unfamiliar or uncomfortable.
Several studies have indeed shown that rising levels of difficulty in socio-emotional adaptation for students in HE, is linked to decreased levels of engagement and completion rates. On the other hand, the acquisition of psycho-social skills, seems to have a positive effect on students' academic achievement, resilience, employability and thriving in life.
A current challenge for HE Institutions is to ensure that during their studies, their future graduates, will have the opportunity to develop psycho-social skills, for effective management of challenges, which extend beyond academic contexts and outcomes throughout the life span in domains such as success in work, positive interpersonal relationships, and better mental health and overall well-being.
Further examination of the potential impact of integrating empirically supported transversal components that derive from empirical research (e.g. emotion regulation skills), is needed. In addition to that, since the focus is on a university-wide student population, it would be useful to further investigate whether the standard mode of delivery (in which learning capacity, language ability, and executive functions are considered essential ingredients for program success), fits well to student population with diverse learning styles, academic performance or learning abilities, such as language skills (listening, reading, speaking and writing), executive skills (e.g. sustain attention) or cognitive processes such as memory and abstract thinking. A growing literature pinpoints to the potential of incorporating art-based methodologies, such as music which is characterized by personalized methods and has shown promising effects on its effectiveness for inclusive educational practices. Music is a promising means that can afford opportunities for learning not afforded by other modalities. Collectively, music holds the potential to address life-long needs for young adults, by infusing culturally appropriate practices that can be easily integrated into the young adults' everyday experiences at the level of their abilities. Music interventions have been linked to improvements in mental and physical capacities in various settings and populations. Research findings additionally support that music can be used as a tool for emotion regulation by reducing stress and stimulate cognitive processes such as attention, learning and memory. Taking into account the above, it is of great interest to develop and investigate how different modalities, such as music-based methodologies, can alter the effectiveness of existing empirically supported approaches, such as emotion regulation skills training.
The primary objective of this study is to gain insight into the acceptability and feasibility of the "ER4ALL", a brief course for enhancing emotion regulation skills for students in higher education. The secondary objective of this study is to collect preliminary evidence for beneficial effects in increasing students' acquired knowledge on adaptive emotion regulation, thus improvement on general psychological functioning.
The specific objectives of the study are to:
- Determine feasibility and acceptability of the "ER4ALL" course.
- To estimate feasible recruitment and refusal rates.
- To measure key outcome domains such as completion rates, missing data, students-reported measures of social satisfaction (both qualitative and quantitative).
- To determine the acceptability of course resources and factors influencing this (e.g. diverse learning styles or abilities).
- Compare the effectiveness between two "ER4ALL" modalities: standard language-based mode Vs. music-based mode.
- To explore preliminary differences on acceptability.
- To explore preliminary differences on associated changes in acquired knowledge and psychological functioning.
- Conditions
- Emotion Regulation
- Being tested
- Emotion Regulation Course
- Keywords
- Emotion regulation, Mental Health, Socio-Emotional Learning
- Medical subject headings
- Emotional Regulation, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emotion Regulation CourseBehavioural
Also called ER4ALL course
Each module contains a) the session outline, b) review of previous session's homework, c) theoretical background and module's rationale, d) skills activities, and e) homework assignment.
Each group will attend five 1.5-hour sessions with their allocated instructor. Participants in both groups will receive the same training modules in the same chronological order. For consistency across modalities, participants will receive an instructor's manual containing the core material for facilitating the ER4ALL training, and a companion students' workbook with supporting information and activities.
| Study group | Role | What they receive |
|---|---|---|
| Music-Based ER module | Experimental | The program will involve the following modules: a) VALUES \& SETTING GOALS FOR ENHANCING MOTIVATION, b) MODULE 2. UNDERSTANDING EMOTIONS, c) MODULE 3. MINDFUL EMOTION AWARENESS AND RELAXATION, d) MODULE 4. THINKING FLEXIBLY, e) MODULE 5. COUNTERING INAPPROPRIATE BEHAVIORS.
The rationale of the training was built based on the framework of Unified Protocol (Barlow, et al. 2018) and training activities were selected and adapted from a compilation of foundational works on contemporary evidence-based approaches, (i.e. Cognitive Behavioral approach, Acceptance and Commitment approach, and Dialectical Behavior approach). Activities were adapted using core components of music-based interventions (Dingle \& Fay, 2016; McFerran, 2016; Saarikallio, 2019) with emphasis on emotion recognition in music, regulation of stress and negative emotions through active music listening, and self-reflective awareness of emotional responses to music. Receives: Behavioral: Emotion Regulation Course |
| Standard ER module | Active comparator | Participants will receive the same training modules in the same chronological order as the music-based group. The only difference is that modules will be mainly text/language based (instead of using music methodologies). Receives: Behavioral: Emotion Regulation Course |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of the course
At post-training, principal researchers involved in the development and delivery of the intervention in each site, will complete Structured Assessment of FEasibility (SAFE; Bird et al. 2014), a standardised measure of the feasibility of complex interventions (Bird et al. 2014). The SAFE measure comprises 16 items grouped into two sub-scales: Blocks (8 items) and Enablers (8 items). SAFE guidelines recommend that reviewers attend to the individual items of the scale, instead of using summary scores, since items have unequal weight. Τhe tool has shown excellent interrater reliability (k = 0.84, 95% CI 0.79-0.89) and test-retest reliability (k = 0.89, 95% CI 0.85-0.93).
Measured: up to 10 weeks
Acceptability of the course
At post-training, all participants will complete a course satisfaction/acceptability questionnaire. The questionnaire will consist of two parts: In part A (quantitative) students will be asked several Likert-scale questions, while part B (qualitative) while contain open-ended response questions relating to their experience, satisfaction, and the challenges/enablers associated with design and implementation of the course. Qualitative data from open-ended questions will be considered alongside the quantitative measures to assess the feasibility of the intervention. The feasibility and acceptability of the intervention will be evaluated, using multiple primary endpoints such as:
- Adherence (Total registrations, Attendance Rates, Homework Adherence, Dropouts)
- Course acceptability and satisfaction ratings
- Training preference.
Measured: up to 10 weeks
Secondary outcomes (7)
Emotion Beliefs Questionnaire
The EBQ (Becerra, Preece, \& Gross, 2020) is a 16-item self-report measure of beliefs about emotions. Based on Ford and Gross's (2019) theoretical framework, the EBQ assesses two main categories of beliefs about emotions: beliefs about the controllability of emotions and beliefs about the usefulness of emotions. These beliefs are assessed for negative emotions and positive emotions. Four subscale scores and three composite scores are designed to be derived from the measure, with higher scores indicating more maladaptive beliefs about emotions (i.e., stronger beliefs that emotions are uncontrollable and useless). The scale has demonstrated good concurrent validity (EBQ scores correlated significantly in expected ways with various scores from other measures of beliefs about emotions), as well as validity and internal consistency in its initial validation (α = .88; Becerra, Preece, \& Gross, 2020).
Measured: up to 10 weeks
Acceptance and Action Questionnaire-II
Acceptance and Action Questionnaire-II (AAQ-II; Bond et al., 2011) is a 7-item measure of psychological flexibility rated on a 7-point scale (Cronbach's α = 0.84). It assesses the ability to be fully present in the moment and adjusting behaviors based on the situational demands, personal values and goals. Higher total score means less flexibility.
Measured: up to 10 weeks
Psyflex
Psyflex (Gloster, et al 2021) is a 6-item self-report questionnaire designed to measure in a brief and context-sensitive manner all six facets of psychological flexibility based on Acceptance and Commitment Theory. Items are rated on a scale from 5 ("very often") to 1 ("very rarely") and then summed. Higher scores represent higher psychological flexibility. Confirmatory Factor Analysis confirmed a one-factor structure with excellent reliability (Raykov's r = 0.91).
Measured: up to 10 weeks
Positive Mental Health Scale (PMH-scale)
The 9-item PMH-scale was developed in order to provide a brief, uni-dimensional and person-centered instrument to assess positive mental health (Lukat et al. 2016). The PMH-scale assesses mainly emotional, but also psychological and social aspects of well-being. Participants respond to statements such as "I am in good physical and emotional condition" or "I manage well to fulfill my needs" on a scale ranging from 0 (I disagree) to 3 (I agree). Higher scores reflect greater positive mental health. Psychometric testing confirmed the scale to be a unidimensional self-report instrument with high internal consistency (Cronbach's alpha .82-93), good retest-reliability (r between samples >.74), and good convergent and discriminant validity (e.g. positive correlation with satisfaction with life, r = .75), (Lukat et al. 2016).
Measured: up to 10 weeks
Depression Anxiety Stress Scales (DASS-21)
DASS-21 (Henry, \& Crawford, 2005) is a general mental health tool consisting of three scales (7 items per scale) measuring states of depression, anxiety and stress on a 4 point Likert scale (0 'almost always' to 4 'never'). Ηigher scores indicating a greater number of symptoms. The DASS-21 subscales show good internal consistency (Cronbach's α = 0.81- 0.88).
Measured: up to 10 weeks
Brief Multidimensional Students' Life Satisfaction Scale-College (BMSLSS-C)
BMSLSS-C (Zullig et al. 2009) is a brief version of MSLSS addressing circumscribed aspects of college students´ life. In specific it consists of 9 items, one for each of the following life satisfaction domains LSS (family, friends, school, self, and living environment, romantic relationships, physical appearance, and work). Higher scores represent higher college satisfaction. The scale has shown an acceptable reliability (a=.80), and criterion-related validity (significantly correlated with the CDC HRQOL-14 and Social Isolation Scale in predicted directions) in its initial validation.
Measured: up to 10 weeks
University Student Learning Disabilities Questionnaire
University Student Learning Disabilities Questionnaire (Glenn et al., 1997) is a screening evaluation of behavioral and cognitive characteristics exhibited by college students in learning and testing situations. A higher score represents higher Learning Difficulties. During its initial validation, a logistic regression analysis verified the predictive capability of the final subset of items, which has also shown high test-retest reliability (.83; Glenn et al., 1997).
Measured: up to 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2023
- Study start1 Mar 2023
- Primary completion30 Oct 2023 (estimated)
- Study completion28 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The investigators will use a pre-post design with a multi-case study approach to evaluate the feasibility and implementation of the ER intervention in four university settings. A mixed-methods design will be used to determine the feasibility and acceptability of the "ER4ALL" course.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cyprus
- Sponsor type
- University, hospital or other
- Collaborators
- VU University of Amsterdam, University of Crete, Eotvos Lorand University
- Responsible party
- Principal investigator, Prof. Georgia Panayiotou, University of Cyprus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05746234
- Sponsor's protocol ID
- MashUP_FeasibilityRCT1
- Acronym
- MASHUP1
- Status last verified
- Mar 2023
- First submitted
- 17 Feb 2023
- Last updated
- 30 Mar 2023
- 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 30 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Feasibility Study for an Emotion Regulation Skills Training (ER4ALL) for Students in Higher Education
- ClinicalTrials.gov ID
- NCT05746234
- Acronym / sponsor ID
- MASHUP1 / MashUP_FeasibilityRCT1
- Conditions
- Emotion Regulation
- Keywords
- Emotion regulation, Mental Health, Socio-Emotional Learning
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of CyprusUniversity, hospital or other
- Collaborators
- VU University of Amsterdam, University of Crete, Eotvos Lorand University
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 30 Oct 2023 (estimated)
- Study completion
- 28 Feb 2024 (estimated)
- First posted
- 27 Feb 2023 (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.
In the present study, the investigators aim to examine the feasibility of a classroom-based emotion regulation skills training within a tertiary curriculum.
The primary objective of this study is to assess the acceptability and feasibility of the "ER4ALL", a brief course for enhancing emotion regulation skills for students in higher education.
The secondary objective of this study is to collect preliminary evidence for beneficial effects in increasing students' acquired knowledge on adaptive emotion regulation, thus improvement on general psychological wellbeing.
A two-arm pilot RCT will be conducted in University of Cyprus.
Detailed description
Entering Higher Education (HE) marks a turning point for youth learning to function as independent adults, something that can be both exciting and challenging. Students are confronted with a considerable number of changes to manage (e.g. high academic expectations, making new relationships, making independent decisions), for which they may be psychosocially unfamiliar or uncomfortable.
Several studies have indeed shown that rising levels of difficulty in socio-emotional adaptation for students in HE, is linked to decreased levels of engagement and completion rates. On the other hand, the acquisition of psycho-social skills, seems to have a positive effect on students' academic achievement, resilience, employability and thriving in life.
A current challenge for HE Institutions is to ensure that during their studies, their future graduates, will have the opportunity to develop psycho-social skills, for effective management of challenges, which extend beyond academic contexts and outcomes throughout the life span in domains such as success in work, positive interpersonal relationships, and better mental health and overall well-being.
Further examination of the potential impact of integrating empirically supported transversal components that derive from empirical research (e.g. emotion regulation skills), is needed. In addition to that, since the focus is on a university-wide student population, it would be useful to further investigate whether the standard mode of delivery (in which learning capacity, language ability, and executive functions are considered essential ingredients for program success), fits well to student population with diverse learning styles, academic performance or learning abilities, such as language skills (listening, reading, speaking and writing), executive skills (e.g. sustain attention) or cognitive processes such as memory and abstract thinking. A growing literature pinpoints to the potential of incorporating art-based methodologies, such as music which is characterized by personalized methods and has shown promising effects on its effectiveness for inclusive educational practices. Music is a promising means that can afford opportunities for learning not afforded by other modalities. Collectively, music holds the potential to address life-long needs for young adults, by infusing culturally appropriate practices that can be easily integrated into the young adults' everyday experiences at the level of their abilities. Music interventions have been linked to improvements in mental and physical capacities in various settings and populations. Research findings additionally support that music can be used as a tool for emotion regulation by reducing stress and stimulate cognitive processes such as attention, learning and memory. Taking into account the above, it is of great interest to develop and investigate how different modalities, such as music-based methodologies, can alter the effectiveness of existing empirically supported approaches, such as emotion regulation skills training.
The primary objective of this study is to gain insight into the acceptability and feasibility of the "ER4ALL", a brief course for enhancing emotion regulation skills for students in higher education. The secondary objective of this study is to collect preliminary evidence for beneficial effects in increasing students' acquired knowledge on adaptive emotion regulation, thus improvement on general psychological functioning.
The specific objectives of the study are to:
- Determine feasibility and acceptability of the "ER4ALL" course.
- To estimate feasible recruitment and refusal rates.
- To measure key outcome domains such as completion rates, missing data, students-reported measures of social satisfaction (both qualitative and quantitative).
- To determine the acceptability of course resources and factors influencing this (e.g. diverse learning styles or abilities).
- Compare the effectiveness between two "ER4ALL" modalities: standard language-based mode Vs. music-based mode.
- To explore preliminary differences on acceptability.
- To explore preliminary differences on associated changes in acquired knowledge and psychological functioning.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The investigators will use a pre-post design with a multi-case study approach to evaluate the feasibility and implementation of the ER intervention in four university settings. A mixed-methods design will be used to determine the feasibility and acceptability of the "ER4ALL" course.
| Arm | Type | Receives |
|---|---|---|
| Music-Based ER module | Experimental | Behavioral: Emotion Regulation CourseThe program will involve the following modules: a) VALUES \& SETTING GOALS FOR ENHANCING MOTIVATION, b) MODULE 2. UNDERSTANDING EMOTIONS, c) MODULE 3. MINDFUL EMOTION AWARENESS AND RELAXATION, d) MODULE 4. THINKING FLEXIBLY, e) MODULE 5. COUNTERING INAPPROPRIATE BEHAVIORS. The rationale of the training was built based on the framework of Unified Protocol (Barlow, et al. 2018) and training activities were selected and adapted from a compilation of foundational works on contemporary evidence-based approaches, (i.e. Cognitive Behavioral approach, Acceptance and Commitment approach, and Dialectical Behavior approach). Activities were adapted using core components of music-based interventions (Dingle \& Fay, 2016; McFerran, 2016; Saarikallio, 2019) with emphasis on emotion recognition in music, regulation of stress and negative emotions through active music listening, and self-reflective awareness of emotional responses to music. |
| Standard ER module | Active comparator | Behavioral: Emotion Regulation CourseParticipants will receive the same training modules in the same chronological order as the music-based group. The only difference is that modules will be mainly text/language based (instead of using music methodologies). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- No specific exclusion criteria.
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 |
|---|---|---|
| Emotion Regulation CourseAlso: ER4ALL courseEach module contains a) the session outline, b) review of previous session's homework, c) theoretical background and module's rationale, d) skills activities, and e) homework assignment. Each group will attend five 1.5-hour sessions with their allocated instructor. Participants in both groups will receive the same training modules in the same chronological order. For consistency across modalities, participants will receive an instructor's manual containing the core material for facilitating the ER4ALL training, and a companion students' workbook with supporting information and activities. | Behavioural | Music-Based ER module, Standard ER module |
Primary outcome
Feasibility of the course
Time frame: up to 10 weeks
At post-training, principal researchers involved in the development and delivery of the intervention in each site, will complete Structured Assessment of FEasibility (SAFE; Bird et al. 2014), a standardised measure of the feasibility of complex interventions (Bird et al. 2014). The SAFE measure comprises 16 items grouped into two sub-scales: Blocks (8 items) and Enablers (8 items). SAFE guidelines recommend that reviewers attend to the individual items of the scale, instead of using summary scores, since items have unequal weight. Τhe tool has shown excellent interrater reliability (k = 0.84, 95% CI 0.79-0.89) and test-retest reliability (k = 0.89, 95% CI 0.85-0.93).
Acceptability of the course
Time frame: up to 10 weeks
At post-training, all participants will complete a course satisfaction/acceptability questionnaire. The questionnaire will consist of two parts: In part A (quantitative) students will be asked several Likert-scale questions, while part B (qualitative) while contain open-ended response questions relating to their experience, satisfaction, and the challenges/enablers associated with design and implementation of the course. Qualitative data from open-ended questions will be considered alongside the quantitative measures to assess the feasibility of the intervention. The feasibility and acceptability of the intervention will be evaluated, using multiple primary endpoints such as: 1. Adherence (Total registrations, Attendance Rates, Homework Adherence, Dropouts) 2. Course acceptability and satisfaction ratings 3. Training preference.
7 secondary outcomes
Emotion Beliefs Questionnaire
Time frame: up to 10 weeks
Acceptance and Action Questionnaire-II
Time frame: up to 10 weeks
Psyflex
Time frame: up to 10 weeks
Positive Mental Health Scale (PMH-scale)
Time frame: up to 10 weeks
Depression Anxiety Stress Scales (DASS-21)
Time frame: up to 10 weeks
Brief Multidimensional Students' Life Satisfaction Scale-College (BMSLSS-C)
Time frame: up to 10 weeks
University Student Learning Disabilities Questionnaire
Time frame: up to 10 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2023.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Emotion Regulation Course in people with Emotion Regulation, run by University of Cyprus at 1 site in Cyprus.
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 0 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 30 Mar 2023. 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 Cyprus. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the course (time frame: up to 10 weeks). 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 30 Mar 2023.