Mental Health WellnessNCT05394311
Testing the Feasibility of a Sports-based Mental Health Promotion Intervention for Adolescents in Nepal
A study testing sports based mental health promotion program in people with Mental Health Wellness, run by Transcultural Psychosocial Organization Nepal at 1 site in Nepal.
Trial summary
Each year, one in five adolescents experiences a mental disorder like depression or anxiety, and the rate is rising. Depression is a common mental disorder, one of the leading global causes of Disability Adjusted Life Years among adolescents, and can lead to learning, behavioural and social impairment, as well as… Read more about this study
- Who is it for?
- Ages 12 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Health Wellness
- What is being tested?
- sports based mental health promotion program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 640 participants
- Where
- 1 siteNepal
- Study dates
- 15 Jul 2024to 30 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 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Any adolescent boy or girl aged 12-19 years
- Adolescents in or out of school
- Married or unmarried
- Who lives in the study clusters
- Able to speak and listen
Who cannot join
- Participants who are unable to provide a written consent
- People having severe mental illness or severe physical disability
- Participants who are planning to move from the study sites during the study period
Trial locations and contacts
1 site in 1 country.
Kelly Clarke, PhD contact
Nepal1 site, 1 recruiting
- Recruiting
Patharisanischare municiaplity and Kanepokhari rural municipality
Biratnagar, Koshi, 56600
Nagendra P. Luitel, PhD, 9841333725, luitelnp@gmail.com
Bishnu Lamichhane, MPhil, 9841760038, lamichhanebis11@gmail.com
About this study
Official title: Developing & Testing the Feasibility of a Sports-based Mental Health Promotion Intervention for Adolescents in Nepal: a Community Engagement Approach
Each year, one in five adolescents experiences a mental disorder like depression or anxiety, and the rate is rising. Depression is a common mental disorder, one of the leading global causes of Disability Adjusted Life Years among adolescents, and can lead to learning, behavioural and social impairment, as well as comorbid cardiovascular disease and mental illness in adulthood. An intervention is needed that can protect adolescents from mental disorders, is accessible to all adolescents, and is cheap and easy to sustain. One such intervention is mental health promotion, which focuses on improving positive behaviors and characteristics that protect mental health. There is already a strong evidence base for treatment and indicated prevention approaches, but a lack of research on mental health promotion interventions. In low resourced settings like Nepal, interventions need to be short of duration, and be carried out by lay people in the communities to make them sustainable and feasible to implement on a broader scale. The aim of this study is to develop and test the feasibility and acceptability of an intervention that uses sports groups to engage and improve the mental health of adolescents in Nepal.
Read the detailed description
Depression and anxiety are the leading contributors to the global burden of disease among young people, accounting for over a third (34.8%) of years lived with disability, and contributing significantly to excess mortality through suicide. Adolescence is the peak age of onset for most mental health conditions, with approximately 50% of lifetime mental health conditions having their onset by mid-adolescence. Adolescent depression in turn predicts several adverse life trajectories, such as failure to complete secondary school, unemployment and unplanned pregnancy or parenthood. Early intervention programmes for adolescents can promote mental health, prevent mental disorders, and prevent risky behaviours and other unhealthy lifestyle choices. These programmes have the potential to make positive contributions to adolescents' health, and to their health in later life. One such intervention is mental health promotion, which focuses on improving positive behaviors and characteristics that protect mental health. Mental health promotion is a strategy to improve the positive behaviors and characteristics that protect mental health
A pilot trial will be conducted to assess the feasibility, acceptability and utility of the intervention and trial design; safety and delivery of the intervention in the community settings; and to identify issues around training, supervision and outcomes measures. A household survey will be conducted at baseline and end line data collection points. After a baseline data collection, the implemention of the intervention will be conducted for around 10 months' period, and then collect the follow-up (end line) data with adolescents.
A parallel-group, two-arm, superiority, cluster-randomised controlled trial with 1:1 allocation to intervention and control arms will be done. In total there will be four clusters (2 control and 2 intervention clusters). The unit of randomization will be a geographic village cluster of ~1000 people (approx 160 adolescents in each cluster). Clusters will be separated geographically which will mitigate risk of contamination in the control arm. A researcher will visit each household in the clusters and ask if there are any adolescents living in the household. Where appropriate consent is obtained, the researcher will then interview eligible adolescents using a smartphone or tablet pre-programmed with the survey. The main trial analysis will be a cross-sectional comparison of data from the endline survey, adjusted for baseline differences. Intervention activities will be open to all adolescents aged 12-19 living in the community to participate. The acceptability of the intervention, randomisation, tools, uptake, utility of the intervention, facilitators' fidelity to the manual, mental health outcome trends, and cost of design and delivery of the intervention will be assessed. The intervention process data will be also collected. This will include FGDs and interviews with adolescents and their parents, facilitators and trainers to explore feasibility and acceptability of the intervention and study procedures.
- Conditions
- Mental Health Wellness
- Being tested
- sports based mental health promotion program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sports based mental health promotion programOther
Also called sports related program
sports related programs
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm - sport based mental health promotion program | Experimental | The experimental arm will receive an intervention for around 10 months' period after baseline data collection. Receives: Other: sports based mental health promotion program |
| Control group - treatment as usual | No intervention | This group receive the intervention available in the existing health care and education system in the study area. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mental wellbeing of adolescents
Mental wellbeing is a marker of mental health promotion and defined as subjective evaluation of life satisfaction. This will be measured using the Warwick Edinburgh Mental Wellbeing Scale. The scale is scored by summing responses to each item answered on a 1 to 5 Likert scale where '1' indicates 'none of the time' and '5' indicates 'all of the time'. The minimum scale score is 14 and the maximum is 70 with with higher scores indicating a higher level of mental wellbeing.
Measured: From baseline to endline (10 months after the intervention)
Secondary outcomes (8)
Self-efficacy
Schwarzer General Self-Efficacy (GSE) Scale will be used to measure self-efficacy. For each item there is a four choice response scale where '1' indicates 'not at all true and '4' indicates 'exactly true'. The minimum scale score is 10 and the maximum is 40 with a higher score indicating a higher self-efficacy.
Measured: Baseline (T0) before start of the intervention and Endline (T1) 10-month after baseline
Self-esteem
Rosenberg Self-Esteem Scale (RSES) will be used to measure self-esteem. RSES is a 10-item scale that measure global self-worth by measuring both positive and negative feelings about the self. The scale is believed to be uni-dimensional. All items are answered using a 4-point rating scale format ranging from strongly agree '4' to strongly disagree '1'. The scale ranges from 0-30, with higher score indicating high self-esteem.
Measured: Baseline (T0) before start of the intervention and Endline (T1) 10-month after baseline
Emotion regulation
Emotion Regulation Questionnaire for Children and Adolescents (ERQ-CA) will be used to measure emotion regulation. It is a 10-item self-report measure consisting of two kinds of emotion regulation strategies, namely, cognitive reappraisal (CR) (6 items) and expressive suppression (ES) (4 items). It has a five points rating scale where '1' indicates 'strongly disagree', and '5' indicates 'strongly agree'. Higher scores on each scale indicate greater use of the corresponding emotional regulation strategy.
Measured: Baseline (T0) before start of the intervention and Endline (T1) 10-month after baseline
Depression
Depression Self-Rating Scale (DSRS) will be used to measure depression. DSRS has 18-items and the respondents are asked to score their experience of 18 common symptoms of depression in the past one week. It has a 3-point rating scale where '0' indicates 'not at all' and '2' indicates 'always'. The total score of DSRS ranges from 0 to 36 with higher score indicating severity of depression.
Measured: Baseline (T0) before start of the intervention and Endline (T1) 10-month after baseline
Anxiety
Generalised Anxiety Disorder (GAD-7) will be used to measure anxiety. GAD-7 has 7-items and respondents are asked to score their experience of 7 common symptoms of anxiety in the past two weeks. It has a 4-point rating scale where 0 indicates 'not at all' and 3 indicates 'always'. The minimum scale score is 0 and the maximum is 28 with high score indicating severity of anxiety.
Measured: Baseline (T0) before start of the intervention and Endline (T1) 10-month after baseline
Resilience
Resilience Scale will be used to measure resilience. RS has 8-items which was adapted from the 25-Item Gail M. Wagnild \& Heather M. Young - "The Resilience Scale" (1987) had previously been used in Nepal to determine which items were culturally salient. It has a 4-point rating scale where 0 indicates 'not at all' and 3 indicates 'always'.The total score of RS ranges from 0 to 24 with higher scores indicate higher levels of resilience.
Measured: Baseline (T0) before start of the intervention and Endline (T1) 10-month after baseline
Functional impairment
Functional impairment scale (FIS) will be used to measure impairment in daily activities. FIS is 10-item scale to assess impairment in daily functioning. It consists of 10-items, representing daily activities that adolescents generally do for themselves, family and community. It has a 4-point rating scale where 0 indicates 'not at all' and 3 indicates 'always'. The total score of FIS ranges from 0 to 30 with higher score indicating more impairment in daily activities.
Measured: Baseline (T0) before start of the intervention and Endline (T1) 10-month after baseline
Pro-social behaviour
Strengths and Difficulties Questionnaire (SDQ) will be used to measure prosocial behavior. SDQ is a 25-items scale which assesses emotional symptoms, conduct problems, hyperactivity-inattention, peer relationship problems, and prosocial behaviors of adolescent. Prosocial sub-scale of SDQ assesses the social behavior of adolescents. It has three choice response scales 'not true, 'somewhat true' and 'certainly true'. The total score of SDQ prosocial behavious sub-scale ranges from 0 to 10 with higher score indicating more engagement in social behavious.
Measured: Baseline (T0) before start of the intervention and Endline (T1) 10-month after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2022
- Study start15 Jul 2024
- Primary completion30 Nov 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mental Health WellnessStudies 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
- A parallel-group, two-arm, superiority, cluster-randomised controlled trial with 1:1 allocation to intervention and control arms will be used in the study. Two cross-sectional household surveys of adolescents, one at baseline and one at end line will be conducted.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 640 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Transcultural Psychosocial Organization Nepal
- Sponsor type
- University, hospital or other
- Collaborators
- King's College London
- Responsible party
- Sponsor
- Investigators
- Kamal Gautam, MD, Study director, Transcultural Psychosocial Organization Nepal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05394311
- Sponsor's protocol ID
- MR/T040181/1
- Status last verified
- Jul 2024
- First submitted
- 9 May 2022
- Last updated
- 6 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rose-Clarke K, Rimal D, Morrison J, Pradhan I, Hodsoll J, Jaoude GA, Moore B, Banham L, Richards J, Jordans M, Prost A, Lamichhane N, Regmee J, Gautam K, Luitel NP. Development and testing the feasibility of a sports-based mental health promotion intervention in Nepal: a protocol for a pilot cluster-randomised controlled trial. Pilot Feasibility Stud. 2023 Aug 24;9(1):149. doi: 10.1186/s40814-023-01324-z.
PubMed 37620929
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing & Testing the Feasibility of a Sports-based Mental Health Promotion Intervention for Adolescents in Nepal: a Community Engagement Approach
- ClinicalTrials.gov ID
- NCT05394311
- Acronym / sponsor ID
- MR/T040181/1
- Conditions
- Mental Health Wellness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 640 participants (estimated)
- Lead sponsor
- Transcultural Psychosocial Organization NepalUniversity, hospital or other
- Collaborators
- King's College London
- Study start
- 15 Jul 2024 (actual)
- Primary completion
- 30 Nov 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 27 May 2022 (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.
Each year, one in five adolescents experiences a mental disorder like depression or anxiety, and the rate is rising. Depression is a common mental disorder, one of the leading global causes of Disability Adjusted Life Years among adolescents, and can lead to learning, behavioural and social impairment, as well as comorbid cardiovascular disease and mental illness in adulthood. An intervention is needed that can protect adolescents from mental disorders, is accessible to all adolescents, and is cheap and easy to sustain. One such intervention is mental health promotion, which focuses on improving positive behaviors and characteristics that protect mental health. There is already a strong evidence base for treatment and indicated prevention approaches, but a lack of research on mental health promotion interventions. In low resourced settings like Nepal, interventions need to be short of duration, and be carried out by lay people in the communities to make them sustainable and feasible to implement on a broader scale. The aim of this study is to develop and test the feasibility and acceptability of an intervention that uses sports groups to engage and improve the mental health of adolescents in Nepal.
Detailed description
Depression and anxiety are the leading contributors to the global burden of disease among young people, accounting for over a third (34.8%) of years lived with disability, and contributing significantly to excess mortality through suicide. Adolescence is the peak age of onset for most mental health conditions, with approximately 50% of lifetime mental health conditions having their onset by mid-adolescence. Adolescent depression in turn predicts several adverse life trajectories, such as failure to complete secondary school, unemployment and unplanned pregnancy or parenthood. Early intervention programmes for adolescents can promote mental health, prevent mental disorders, and prevent risky behaviours and other unhealthy lifestyle choices. These programmes have the potential to make positive contributions to adolescents' health, and to their health in later life. One such intervention is mental health promotion, which focuses on improving positive behaviors and characteristics that protect mental health. Mental health promotion is a strategy to improve the positive behaviors and characteristics that protect mental health
A pilot trial will be conducted to assess the feasibility, acceptability and utility of the intervention and trial design; safety and delivery of the intervention in the community settings; and to identify issues around training, supervision and outcomes measures. A household survey will be conducted at baseline and end line data collection points. After a baseline data collection, the implemention of the intervention will be conducted for around 10 months' period, and then collect the follow-up (end line) data with adolescents.
A parallel-group, two-arm, superiority, cluster-randomised controlled trial with 1:1 allocation to intervention and control arms will be done. In total there will be four clusters (2 control and 2 intervention clusters). The unit of randomization will be a geographic village cluster of ~1000 people (approx 160 adolescents in each cluster). Clusters will be separated geographically which will mitigate risk of contamination in the control arm. A researcher will visit each household in the clusters and ask if there are any adolescents living in the household. Where appropriate consent is obtained, the researcher will then interview eligible adolescents using a smartphone or tablet pre-programmed with the survey. The main trial analysis will be a cross-sectional comparison of data from the endline survey, adjusted for baseline differences. Intervention activities will be open to all adolescents aged 12-19 living in the community to participate. The acceptability of the intervention, randomisation, tools, uptake, utility of the intervention, facilitators' fidelity to the manual, mental health outcome trends, and cost of design and delivery of the intervention will be assessed. The intervention process data will be also collected. This will include FGDs and interviews with adolescents and their parents, facilitators and trainers to explore feasibility and acceptability of the intervention and study procedures.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- A parallel-group, two-arm, superiority, cluster-randomised controlled trial with 1:1 allocation to intervention and control arms will be used in the study. Two cross-sectional household surveys of adolescents, one at baseline and one at end line will be conducted.
| Arm | Type | Receives |
|---|---|---|
| Intervention arm - sport based mental health promotion program | Experimental | Other: sports based mental health promotion programThe experimental arm will receive an intervention for around 10 months' period after baseline data collection. |
| Control group - treatment as usual | No intervention | –This group receive the intervention available in the existing health care and education system in the study area. |
Who may qualify
- Ages
- 12 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Any adolescent boy or girl aged 12-19 years
- Adolescents in or out of school
- Married or unmarried
- Who lives in the study clusters
- Able to speak and listen
Key exclusion criteria (3 listed)
- Participants who are unable to provide a written consent
- People having severe mental illness or severe physical disability
- Participants who are planning to move from the study sites during the study period
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 |
|---|---|---|
| sports based mental health promotion programAlso: sports related programsports related programs | Other | Intervention arm - sport based mental health promotion program |
Primary outcome
Change in mental wellbeing of adolescents
Time frame: From baseline to endline (10 months after the intervention)
Mental wellbeing is a marker of mental health promotion and defined as subjective evaluation of life satisfaction. This will be measured using the Warwick Edinburgh Mental Wellbeing Scale. The scale is scored by summing responses to each item answered on a 1 to 5 Likert scale where '1' indicates 'none of the time' and '5' indicates 'all of the time'. The minimum scale score is 14 and the maximum is 70 with with higher scores indicating a higher level of mental wellbeing.
8 secondary outcomes
Self-efficacy
Time frame: Baseline (T0) before start of the intervention and Endline (T1) 10-month after baseline
Self-esteem
Time frame: Baseline (T0) before start of the intervention and Endline (T1) 10-month after baseline
Emotion regulation
Time frame: Baseline (T0) before start of the intervention and Endline (T1) 10-month after baseline
Depression
Time frame: Baseline (T0) before start of the intervention and Endline (T1) 10-month after baseline
Anxiety
Time frame: Baseline (T0) before start of the intervention and Endline (T1) 10-month after baseline
Resilience
Time frame: Baseline (T0) before start of the intervention and Endline (T1) 10-month after baseline
Functional impairment
Time frame: Baseline (T0) before start of the intervention and Endline (T1) 10-month after baseline
Pro-social behaviour
Time frame: Baseline (T0) before start of the intervention and Endline (T1) 10-month after baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
- Derived from this study: PubMed 37620929Rose-Clarke K, Rimal D, Morrison J, Pradhan I, Hodsoll J, Jaoude GA, Moore B, Banham L, Richards J, Jordans M, Prost A, Lamichhane N, Regmee J, Gautam K, Luitel NP. Development and testing the feasibility of a sports-based mental health promotion intervention in Nepal: a protocol for a pilot cluster-randomised controlled trial. Pilot Feasibility Stud. 2023 Aug 24;9(1):149. doi: 10.1186/s40814-023-01324-z.
- 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.
Kelly Clarke, PhD contact
Kamal Gautam, MD study director
Transcultural Psychosocial Organization Nepal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sports based mental health promotion program in people with Mental Health Wellness, run by Transcultural Psychosocial Organization Nepal at 1 site in Nepal.
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 5 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 6 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Nepal. 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 Nagendra Luitel, PhD (9841333725, luitelnp@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in mental wellbeing of adolescents (time frame: From baseline to endline (10 months after the intervention)). 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 NCT05394311, which also lists 1 linked publication.
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 6 Aug 2024; AzTrials last refreshed its copy on 8 Nov 2026.