Youth Mental HealthNCT05944263
WeRISE: Youth-led Mental Health Transformation Through Cultivating Gratitude, Kindness, and Hope
A study testing weRISE; The gratitude, kindness and hope (GKH) program and The [adapted] Stan Kutcher Teen Mental Health (TMH) program in people with Youth Mental Health, run by citiesRISE at 2 sites in 2 countries.
Trial summary
The weRISE study's primary aim is to develop and test the effects of an arts-based train-the-trainer intervention developed to cultivate gratitude, kindness, and hope among youth in schools and informal settlements in both India and Kenya, on mental health and well-being outcomes. Read more about this study
- Who is it for?
- Ages 12 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Youth Mental Health
- What is being tested?
- weRISE; The gratitude, kindness and hope (GKH) program and The [adapted] Stan Kutcher Teen Mental Health (TMH) program
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 840 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Jul 2023to 19 Jun 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 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Adolescents between the ages of 12-14 will be recruited in the community matching the demographic of the and living within 5 kilometers of the community-based organization will be recruited
- Parents in the community consent and the adolescent's assent to participate in the program at the community-based organization
- Students in grade 7-9 in schools that are demographically similar to the community clusters.
- Participating schools and parents in schools provide consent and the adolescents assent to participate in the program at the schools
- Youth trainers should be between the ages 18-24
- Youth trainers' who consent to participate in the program
Who cannot join
- Young people with forms of disabilities (e.g. sight, intellectual) that make it hard for them to meaningfully participate in the programs will be excluded.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Kenya1 site
African Population and Health Research Center (APHRC, Nairobi)
Nairobi
About this study
Official title: Effectiveness of an Intervention on Cultivating Character Values of Gratitude, Kindness and Hope to Enhance Mental Well-Being Among Young People in School and Community Settings in India and Nairobi: a Cluster Randomized Controlled Trial
The weRISE study's primary aim is to develop and test the effects of an arts-based train-the-trainer intervention developed to cultivate gratitude, kindness, and hope among youth in schools and informal settlements in both India and Kenya, on mental health and well-being outcomes. The core theory of change for weRISE is that through cultivating these key strengths, youth will undergo empowering mindset shifts that equip them to navigate past, present, and future life challenges, including mental ill-health.
Through a cross-country, phased, cluster randomized controlled design, this study will explore the question: what impacts the weRISE intervention has on gratitude, kindness, hope compared with a standard mental health literacy intervention. The investigators will also assess the impacts of weRISE on secondary outcomes such as self-efficacy, the feasibility of the youth-led delivery model, and whether impacts differ depending on setting (schools versus informal settlements, India versus Kenya). The investigators hypothesize that the weRISE intervention will result in greater improvements in mental health and well-being outcomes for youth recipients compared with a standard mental health literacy intervention, and that there will be strong positive relationships between gratitude, kindness, hope, and the mental health and well-being outcomes. The investigators hypothesize that the effects of weRISE will be similar across settings (schools and informal settlements in India and Kenya) and that the youth-led train-the-trainer model will prove effective.
Through this project, investigators will work together with leading experts and youth to develop an overall intervention model, contextualize it for India and Kenya respectively, and package a set of implementation tools for weRISE. Importantly, investigators plan to iterate on the content developed and contextualized for India and Kenya and publish a youth-targeted weRISE guide that will provide any young person anywhere with content and concrete activities. The investigators will also develop a series of academic outputs including scientific articles and conference presentations to disseminate evidence and lessons learned. Finally, the investigators will produce and disseminate a policy brief to facilitate uptake and scaling of weRISE by government officials and other decision-makers.
Read the detailed description
The adolescent years for young people is a period of crucial life transitions and is fraught with a range of internal and external challenges. Young people in low- and middle-income countries (LMICs) are particularly vulnerable to mental ill health given the exposure to multiple adverse life experiences. Positive psychological interventions have been brought into the social-emotional learning curriculum of western countries and has shown efficacy in supporting the salutary effects of the same in the health and wellbeing of the young people. In most LMICs, where there is less access to psychologists and psychiatrists, the models that are used have only a limited amount of application to the young people who are struggling.
The primary goal of this project is to design and test the effects on mental health and well-being outcomes of an arts-based train-the-trainer intervention, cultivating gratitude, kindness, and hope among youth in schools and informal settlements. The central change theory is that by cultivating these key strengths, youth will experience empowering mind-set shifts that will prepare them to navigate past, present, and future life challenges, including mental illness.
In order to create a robustly tested, adaptable, and scalable intervention that speaks directly to the realities of young people in schools and informal settlements in LMICs, this project will integrate the research currently available in the fields of character development, positive psychology, and mental health. This project will support cross-border collaboration in a number of ways to successfully bridge these rich and diverse sectors. It will bring together specialists from LMICs and high-income countries (HICs), mental health and character development professionals, as well as youth and adult researchers, to produce the fundamental evidence at the nexus of character development and health outcomes.
This project will use a single-blind cluster randomized controlled trial design with 10 clusters 60 young people within schools and 30 in communities recruited from informal settlements in Nairobi and India. The evaluation will employ a mixed methods approach to determine the impact of the intervention on mental wellbeing of young people. Quantitative data will be collected through a survey at baseline and end-line while focus group discussions (FGD) will only be conducted at end-line. These will be analyzed using STATA and NVivo softwares respectively.
This project proposes that, the model and evidence generated will be innovative in a number of ways: 1) it is designed to scale in low-resource settings and takes replicability into account from the start. 2) the intervention's accessibility to a diverse range of youth in LMICs, including the most marginalized, is considered from the start; 3) it departs from the traditional approach of testing interventions based on individual character strengths in order to weave gratitude, kindness, and hope together through an integrated life course (past, present, and future) approach and; 4) the focus is on young people's leadership and their ability to support themselves and their peers. Character strengthening is associated with independent critical thinking inherently required in developing leaders. While this is not an outcome of the study the ability to lead oneself and others with compassion signifies likelihood of a longer-term impact of the character strengthening intervention. Findings from the study would contribute towards improving mental health policies and programs.
- Conditions
- Youth Mental Health
- Being tested
- weRISE; The gratitude, kindness and hope (GKH) program, The [adapted] Stan Kutcher Teen Mental Health (TMH) program
- Keywords
- adolescents, character strengths, cluster Randomized Controlled Trial (cRCT), co-design, arts based mental health intervention, positive psychology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
weRISE; The gratitude, kindness and hope (GKH) programBehavioural
weRISE is an arts based train the trainer intervention that promotes positive mental health through cultivating gratitude, kindness and hope among youth in schools and informal settlements in India and Kenya
The [adapted] Stan Kutcher Teen Mental Health (TMH) programBehavioural
The 'Teen Mental Health' curriculum developed by Dr. Stan Kutcher, aims to increase mental health literacy among young people ;will be used in the control group (active comparator group). The control intervention consists of eight sessions (45 minutes each) delivered by older groups of young people (ages 18-24) in schools and community settings through a didactic approach.
| Study group | Role | What they receive |
|---|---|---|
| The gratitude, kindness and hope (GKH) program | Experimental | This gratitude, kindness and hope (GKH) program will be a structured manual-based intervention that has been adapted and contextualized from the previous work that has been done in this field. Each intervention session will be conducted in the school and community settings by 2 youth trainers aged 18 - 24 and who will be trained in the delivery of the intervention.
The sessions will be held twice a week, concurrently in schools and in the community. Fifty per cent of the sessions will be supervised by master trainers (who are experts in charge of training the youth trainers on the intervention). The rest of the sessions will be audio-recorded and reviewed randomly during supervision meetings.
The total duration of each session will be 45 minutes distributed as shown below:
iv. 5 minutes warm up activity v. 30 minutes practice and explanation of concepts through interactive activities and discussions vi. 10 mins answering questions and designing homework Receives: Behavioral: weRISE; The gratitude, kindness and hope (GKH) program |
| The [adapted] Stan Kutcher Teen Mental Health (TMH) program | Active comparator | The program delivered to the control group is adapted from the Stan Kutcher Teen Mental Health Curriculum. It was initially developed to help enhance the mental health literacy of students and was developed for ages 13 to 15 years which was further adapted for a slightly lower age group (12-14 yrs) as that targeted in this study through simplification of terminologies to ensure age-appropriate content.
Just like the GKH program, the TMH sessions will be delivered by 2 trained youth trainers in the school and community settings. The program will be delivered over 8 sessions, two sessions a week (i.e. over a span of 4 weeks). Half of the sessions will be supervised by master trainers. Like the GKH program, each session will go for 45 minutes each . Receives: Behavioral: The [adapted] Stan Kutcher Teen Mental Health (TMH) program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mental health wellbeing
Mental health well-being will be measured using Warwick-Edinburgh Mental Wellbeing Scale. The scale measures aspects of positive affect, functioning and interpersonal relationships as components of wellbeing. The scale has 14 items and scores can range from a minimum of 14 to a maximum of 70 points. Higher scores are associated with higher levels of mental well--being.
Measured: Baseline status of the mental health well-being will be assessed before the intervention. Any change in status of mental health well-being when compared with the baseline will be assessed within 2 weeks and at 2 months post intervention.
Character strengths of gratitude, kindness and hope
Character strengths of gratitude, kindness and hope have been found to be associated with mental wellbeing and will be measured using the Values in Action Questionnaire (VIA) - Youth Version (25-item questionnaire) among adolescents and youth facilitators.
Measured: Baseline status of the character strengths will be assessed before the intervention. Any change in the character strengths when compared with the baseline will be assessed within 2 weeks and at 2 months post intervention.
Secondary outcomes (2)
Depression
Patient Health Questionnaire - 9 (PHQ - 9) scale will be used to measure depression among adolescents and youth facilitators. It is a short, self-reported, screening tool for the screening of depression in primary care using the Diagnostic and Statistical Manual (DSM)-IV criteria. The PHQ-9 total score ranges from 0 to 27 (scores of 5-9 are classified as mild depression; 10-14 as moderate depression; 15-19 as moderately severe depression; ≥ 20 as severe depression)
Measured: Baseline status of depression will be assessed before the intervention. Any change in depression when compared with the baseline will be assessed within 2 weeks and at 2 months post intervention.
Anxiety
Generalized Anxiety Disorder - 7 (GAD - 7) scale will be used to measure anxiety among adolescents and youth facilitators. It is a 7 item self-reported questionnaire used as a screening tool for measuring generalized anxiety disorder. The GAD-7 total score for the seven items ranges from 0 to 21. Scores of 5, 10, and 15 represent cut-points for mild, moderate, and severe anxiety, respectively.
Measured: Baseline status of anxiety will be assessed before the intervention. Any change in anxiety when compared with the baseline will be assessed within 2 weeks and at 2 months post intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2023
- Study start1 Jul 2023
- Primary completion30 Apr 2024
- Study completion19 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Youth Mental HealthStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 840 participants (actual)
Sponsor and investigators
- Lead sponsor
- citiesRISE
- Sponsor type
- University, hospital or other
- Collaborators
- Schizophrenia Research Foundation (SCARF India), African Population and Health Research Center
- Responsible party
- Sponsor
- Investigators
- Moiteryee Sinha, PhD, Principal investigator, citiesRISE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05944263
- Sponsor's protocol ID
- TWCF0631
- Status last verified
- Sep 2024
- First submitted
- 19 Jun 2023
- Last updated
- 27 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: This will be updated in due course of time
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of an Intervention on Cultivating Character Values of Gratitude, Kindness and Hope to Enhance Mental Well-Being Among Young People in School and Community Settings in India and Nairobi: a Cluster Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05944263
- Acronym / sponsor ID
- TWCF0631
- Conditions
- Youth Mental Health
- Keywords
- adolescents, character strengths, cluster Randomized Controlled Trial (cRCT), co-design, arts based mental health intervention, positive psychology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 840 participants (actual)
- Lead sponsor
- citiesRISEUniversity, hospital or other
- Collaborators
- Schizophrenia Research Foundation (SCARF India), African Population and Health Research Center
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 19 Jun 2024 (actual)
- First posted
- 13 Jul 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.
The weRISE study's primary aim is to develop and test the effects of an arts-based train-the-trainer intervention developed to cultivate gratitude, kindness, and hope among youth in schools and informal settlements in both India and Kenya, on mental health and well-being outcomes. The core theory of change for weRISE is that through cultivating these key strengths, youth will undergo empowering mindset shifts that equip them to navigate past, present, and future life challenges, including mental ill-health.
Through a cross-country, phased, cluster randomized controlled design, this study will explore the question: what impacts the weRISE intervention has on gratitude, kindness, hope compared with a standard mental health literacy intervention. The investigators will also assess the impacts of weRISE on secondary outcomes such as self-efficacy, the feasibility of the youth-led delivery model, and whether impacts differ depending on setting (schools versus informal settlements, India versus Kenya). The investigators hypothesize that the weRISE intervention will result in greater improvements in mental health and well-being outcomes for youth recipients compared with a standard mental health literacy intervention, and that there will be strong positive relationships between gratitude, kindness, hope, and the mental health and well-being outcomes. The investigators hypothesize that the effects of weRISE will be similar across settings (schools and informal settlements in India and Kenya) and that the youth-led train-the-trainer model will prove effective.
Through this project, investigators will work together with leading experts and youth to develop an overall intervention model, contextualize it for India and Kenya respectively, and package a set of implementation tools for weRISE. Importantly, investigators plan to iterate on the content developed and contextualized for India and Kenya and publish a youth-targeted weRISE guide that will provide any young person anywhere with content and concrete activities. The investigators will also develop a series of academic outputs including scientific articles and conference presentations to disseminate evidence and lessons learned. Finally, the investigators will produce and disseminate a policy brief to facilitate uptake and scaling of weRISE by government officials and other decision-makers.
Detailed description
The adolescent years for young people is a period of crucial life transitions and is fraught with a range of internal and external challenges. Young people in low- and middle-income countries (LMICs) are particularly vulnerable to mental ill health given the exposure to multiple adverse life experiences. Positive psychological interventions have been brought into the social-emotional learning curriculum of western countries and has shown efficacy in supporting the salutary effects of the same in the health and wellbeing of the young people. In most LMICs, where there is less access to psychologists and psychiatrists, the models that are used have only a limited amount of application to the young people who are struggling.
The primary goal of this project is to design and test the effects on mental health and well-being outcomes of an arts-based train-the-trainer intervention, cultivating gratitude, kindness, and hope among youth in schools and informal settlements. The central change theory is that by cultivating these key strengths, youth will experience empowering mind-set shifts that will prepare them to navigate past, present, and future life challenges, including mental illness.
In order to create a robustly tested, adaptable, and scalable intervention that speaks directly to the realities of young people in schools and informal settlements in LMICs, this project will integrate the research currently available in the fields of character development, positive psychology, and mental health. This project will support cross-border collaboration in a number of ways to successfully bridge these rich and diverse sectors. It will bring together specialists from LMICs and high-income countries (HICs), mental health and character development professionals, as well as youth and adult researchers, to produce the fundamental evidence at the nexus of character development and health outcomes.
This project will use a single-blind cluster randomized controlled trial design with 10 clusters 60 young people within schools and 30 in communities recruited from informal settlements in Nairobi and India. The evaluation will employ a mixed methods approach to determine the impact of the intervention on mental wellbeing of young people. Quantitative data will be collected through a survey at baseline and end-line while focus group discussions (FGD) will only be conducted at end-line. These will be analyzed using STATA and NVivo softwares respectively.
This project proposes that, the model and evidence generated will be innovative in a number of ways: 1) it is designed to scale in low-resource settings and takes replicability into account from the start. 2) the intervention's accessibility to a diverse range of youth in LMICs, including the most marginalized, is considered from the start; 3) it departs from the traditional approach of testing interventions based on individual character strengths in order to weave gratitude, kindness, and hope together through an integrated life course (past, present, and future) approach and; 4) the focus is on young people's leadership and their ability to support themselves and their peers. Character strengthening is associated with independent critical thinking inherently required in developing leaders. While this is not an outcome of the study the ability to lead oneself and others with compassion signifies likelihood of a longer-term impact of the character strengthening intervention. Findings from the study would contribute towards improving mental health policies and programs.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The gratitude, kindness and hope (GKH) program | Experimental | Behavioral: weRISE; The gratitude, kindness and hope (GKH) programThis gratitude, kindness and hope (GKH) program will be a structured manual-based intervention that has been adapted and contextualized from the previous work that has been done in this field. Each intervention session will be conducted in the school and community settings by 2 youth trainers aged 18 - 24 and who will be trained in the delivery of the intervention. The sessions will be held twice a week, concurrently in schools and in the community. Fifty per cent of the sessions will be supervised by master trainers (who are experts in charge of training the youth trainers on the intervention). The rest of the sessions will be audio-recorded and reviewed randomly during supervision meetings. The total duration of each session will be 45 minutes distributed as shown below: iv. 5 minutes warm up activity v. 30 minutes practice and explanation of concepts through interactive activities and discussions vi. 10 mins answering questions and designing homework |
| The [adapted] Stan Kutcher Teen Mental Health (TMH) program | Active comparator | Behavioral: The [adapted] Stan Kutcher Teen Mental Health (TMH) programThe program delivered to the control group is adapted from the Stan Kutcher Teen Mental Health Curriculum. It was initially developed to help enhance the mental health literacy of students and was developed for ages 13 to 15 years which was further adapted for a slightly lower age group (12-14 yrs) as that targeted in this study through simplification of terminologies to ensure age-appropriate content. Just like the GKH program, the TMH sessions will be delivered by 2 trained youth trainers in the school and community settings. The program will be delivered over 8 sessions, two sessions a week (i.e. over a span of 4 weeks). Half of the sessions will be supervised by master trainers. Like the GKH program, each session will go for 45 minutes each . |
Who may qualify
- Ages
- 12 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Adolescents between the ages of 12-14 will be recruited in the community matching the demographic of the and living within 5 kilometers of the community-based organization will be recruited
- Parents in the community consent and the adolescent's assent to participate in the program at the community-based organization
- Students in grade 7-9 in schools that are demographically similar to the community clusters.
- Participating schools and parents in schools provide consent and the adolescents assent to participate in the program at the schools
- Youth trainers should be between the ages 18-24
Key exclusion criteria (1 listed)
- Young people with forms of disabilities (e.g. sight, intellectual) that make it hard for them to meaningfully participate in the programs will be excluded.
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 |
|---|---|---|
| weRISE; The gratitude, kindness and hope (GKH) programweRISE is an arts based train the trainer intervention that promotes positive mental health through cultivating gratitude, kindness and hope among youth in schools and informal settlements in India and Kenya | Behavioural | The gratitude, kindness and hope (GKH) program |
| The [adapted] Stan Kutcher Teen Mental Health (TMH) programThe 'Teen Mental Health' curriculum developed by Dr. Stan Kutcher, aims to increase mental health literacy among young people ;will be used in the control group (active comparator group). The control intervention consists of eight sessions (45 minutes each) delivered by older groups of young people (ages 18-24) in schools and community settings through a didactic approach. | Behavioural | The [adapted] Stan Kutcher Teen Mental Health (TMH) program |
Primary outcome
Mental health wellbeing
Time frame: Baseline status of the mental health well-being will be assessed before the intervention. Any change in status of mental health well-being when compared with the baseline will be assessed within 2 weeks and at 2 months post intervention.
Mental health well-being will be measured using Warwick-Edinburgh Mental Wellbeing Scale. The scale measures aspects of positive affect, functioning and interpersonal relationships as components of wellbeing. The scale has 14 items and scores can range from a minimum of 14 to a maximum of 70 points. Higher scores are associated with higher levels of mental well--being.
Character strengths of gratitude, kindness and hope
Time frame: Baseline status of the character strengths will be assessed before the intervention. Any change in the character strengths when compared with the baseline will be assessed within 2 weeks and at 2 months post intervention.
Character strengths of gratitude, kindness and hope have been found to be associated with mental wellbeing and will be measured using the Values in Action Questionnaire (VIA) - Youth Version (25-item questionnaire) among adolescents and youth facilitators.
2 secondary outcomes
Depression
Time frame: Baseline status of depression will be assessed before the intervention. Any change in depression when compared with the baseline will be assessed within 2 weeks and at 2 months post intervention.
Anxiety
Time frame: Baseline status of anxiety will be assessed before the intervention. Any change in anxiety when compared with the baseline will be assessed within 2 weeks and at 2 months post intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2024.
- Individual participant dataSharing planned: Yes. This will be updated in due course of time
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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.
Moiteryee Sinha, PhD principal investigator
citiesRISE
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing weRISE; The gratitude, kindness and hope (GKH) program and The [adapted] Stan Kutcher Teen Mental Health (TMH) program in people with Youth Mental Health, run by citiesRISE at 2 sites in 2 countries.
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 6 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: finished, as of the sponsor's last update on 27 Sep 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 India, Kenya. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Mental health wellbeing (time frame: Baseline status of the mental health well-being will be assessed before the intervention. Any change in status of mental health well-being when compared with the baseline will be assessed within 2 weeks and at 2 months post intervention.). 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 27 Sep 2024.