Improvement of Mental Health in Adolescents Using E-health Interventions
NCT ID: NCT05865834
Last Updated: 2023-05-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
200 participants
INTERVENTIONAL
2023-08-01
2023-11-15
Brief Summary
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1. Primary Objective To develop a smart phone application for reduction in depressive and anxiety symptoms in Pakistani adolescents aged 12-18 years
2. Secondary Objectives
* To determine the effectiveness of a smart phone application in reduction of anxiety symptoms in Pakistani adolescents aged 12-18 years via a randomized controlled trial
* To determine the effectiveness of a smart phone application in reduction of depressive symptoms in Pakistani adolescents aged 12-18 years via a randomized controlled trial
* To determine the effectiveness of a smart phone application in improvements of well-being of Pakistani adolescents aged 12-18 years via a randomized controlled trial
the randomization will occur at the school level for the intervention group and control group.
Students in the intervention group will receive the access to a smartphone application designed to improve the mental health of adolescents, they will be briefed on how to use the application and its advantages. while the students in the control group will receive self-reading pictorial educational leaflets related to mental health improvement.
the researcher will conduct the assessment of depression, anxiety and mental wellbeing using PHQ-A, GAD-7 and WHO-5 at baseline, 1 month and at 3 months to compare if the smartphone application is effective in reducing the symptoms of depression and anxiety of adolescents and overall improvement in the mental wellbeing.
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Detailed Description
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Also, we plan to assess the effectiveness of the smartphone application via a cluster randomized controlled trial. The curated smartphone application will have two modules: Chill zone and sleep; Chill zone will comprise of 9 sub-modules and sleep 5 sub-modules. The 9 sub-modules of the Chill zone will be as follows; meditation, breathing techniques, family time, art time, funny sayings, reframe stress and relax, diet and cooking tips, mini-courses, and how to become better. The sub-modules of sleep will be winding down, sleep music, storytelling, nature sounds, and beautiful nature. Each module will be designed to be completed on separate days with daily push notifications.
Once the application is designed, the trial will be conducted in schools of Karachi. The intervention and control arm will have two schools with 50 students/school from grades 6-10. The total sample size will be 200 students. A two-stage cluster sampling with stratification on school type (government or private) will be employed to select schools and recruit students. Participants allocated to the intervention arm will be given mental health intervention, and the students in the control arm will be given educational leaflets. PHQ-A, GAD-7, and WHO depression wellbeing scale for assessing depressive symptoms, anxiety symptoms, and wellbeing will be used at baseline, 1 month, and three months. Generalized estimating equation, will be used to compare mean scores of depression, anxiety and wellbeing scores between both arms.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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intervention arm
One public and one private school will be randomly placed into intervention arm. Students from grade 6th - grade 10th will be recruited on their willingness to participant.
A smartphone application will be installed on the personal gadgets of the students in the interventional arm at baseline. For assessing the effectiveness of this app, the first follow-up will be done at one month after the intervention and the second follow up after 3 months to evaluate whether the application had an impact on their depressive and anxiety symptom using PHQ-A, GAD-7 and WHO-5 scales.
A smartphone application
app will have 2 modules: Chill zone and sleep; Chill zone has 9 sub-modules which are meditation, breathing techniques, family time, art time, funny sayings, reframe stress and relax, diet and cooking tips, mini courses and how to become better. The sub-modules of sleep are: wind down, sleep music, storytelling, nature sounds and beautiful nature. These modules will be approved by a clinical psychologist to help people with symptoms of depression and anxiety. Skills learned include emotion recognition, emotional management, behavioral activation (being active), recognizing and challenging unhelpful thoughts and cognitive restructuring to plan for their future.
control arm
one public and one private school will be randomly allocated to control arm. Students from grade 6th - grade 10th will be recruited on their willingness to participant.
the control group will receive self-reading educational leaflets. the first follow-up will be done at one month after the intervention and the second follow up after 3 months to evaluated whether the application had an impact on their depressive and anxiety symptom using PHQ-A, GAD-7 and WHO-5 scales.
Pictorial educational leaflets
the control group will receive self-reading educational leaflets, the majority of which are pictorial. These leaflets will be approved by a clinical psychologist to help people with symptoms of depression and anxiety.
Interventions
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A smartphone application
app will have 2 modules: Chill zone and sleep; Chill zone has 9 sub-modules which are meditation, breathing techniques, family time, art time, funny sayings, reframe stress and relax, diet and cooking tips, mini courses and how to become better. The sub-modules of sleep are: wind down, sleep music, storytelling, nature sounds and beautiful nature. These modules will be approved by a clinical psychologist to help people with symptoms of depression and anxiety. Skills learned include emotion recognition, emotional management, behavioral activation (being active), recognizing and challenging unhelpful thoughts and cognitive restructuring to plan for their future.
Pictorial educational leaflets
the control group will receive self-reading educational leaflets, the majority of which are pictorial. These leaflets will be approved by a clinical psychologist to help people with symptoms of depression and anxiety.
Eligibility Criteria
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Inclusion Criteria
* 12-18-year-olds adolescents enrolled in public and private school of Karachi Pakistani
* The intervention and control arm must understand English or Urdu in order to use the mobile-based application.
* Intervention group must have access to a smartphone or portable smart device (Electronic Tablets, iPad, etc.).
* Participants having access to Wi-Fi at home- or on the phone for downloading the app.
* Parenteral consent is required for an adolescent to participate in this study; simultaneously, an individual's consent is equally important to be included in this trial.
* Moreover, students will be asked to participate in the study if they:(a) experience mild to moderate depression defined as scoring above the cut-off score of 4 on the Patient Health Questionnaire for adolescents (PHQ-A) and/or anxiety symptoms defined as scoring above the cut-off score of 5 on the Generalized Anxiety Disorder scale-7 items (GAD-7 (b) had a well-being score of ≤50 on World Health Organization Well-Being scale (WHO-5) at basic screening level.
Exclusion Criteria
* School unable or unwilling to provide informed consent /assent
* students not willing to participate in the study
* Use of a mobile device that does not comply with the app requirements (non- android phone holders)
* Have no internet access or smartphone
* Students will be excluded if they: (a) any chronic disease (c) currently taking psychiatric consultation/ treatment for depression/ anxiety, or have received treatment/therapy in the past 12 months
12 Years
18 Years
ALL
Yes
Sponsors
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Aga Khan University
OTHER
Responsible Party
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Shafquat Rozi
Assistant Professor/ Director of MSc. Epidemiology and Biostatistics
Principal Investigators
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Shafquat Rozi, Ph D.
Role: PRINCIPAL_INVESTIGATOR
Aga Khan Hospital -Karachi
Locations
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Aga Khan University- Hospital
Karachi, Sindh, Pakistan
Countries
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Central Contacts
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Facility Contacts
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References
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Dawson KS, Watts S, Carswell K, Shehadeh MH, Jordans MJD, Bryant RA, Miller KE, Malik A, Brown FL, Servili C, van Ommeren M. Improving access to evidence-based interventions for young adolescents: Early Adolescent Skills for Emotions (EASE). World Psychiatry. 2019 Feb;18(1):105-107. doi: 10.1002/wps.20594. No abstract available.
Day V, McGrath PJ, Wojtowicz M. Internet-based guided self-help for university students with anxiety, depression and stress: a randomized controlled clinical trial. Behav Res Ther. 2013 Jul;51(7):344-51. doi: 10.1016/j.brat.2013.03.003. Epub 2013 Mar 28.
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Ha T, van Roekel E, Iida M, Kornienko O, Engels RCME, Kuntsche E. Depressive Symptoms Amplify Emotional Reactivity to Daily Perceptions of Peer Rejection in Adolescence. J Youth Adolesc. 2019 Nov;48(11):2152-2164. doi: 10.1007/s10964-019-01146-4. Epub 2019 Oct 16.
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Moore SE, Norman RE, Suetani S, Thomas HJ, Sly PD, Scott JG. Consequences of bullying victimization in childhood and adolescence: A systematic review and meta-analysis. World J Psychiatry. 2017 Mar 22;7(1):60-76. doi: 10.5498/wjp.v7.i1.60. eCollection 2017 Mar 22.
Rao S, Shah N, Jawed N, Inam S, Shafique K. Nutritional and lifestyle risk behaviors and their association with mental health and violence among Pakistani adolescents: results from the National Survey of 4583 individuals. BMC Public Health. 2015 Apr 28;15:431. doi: 10.1186/s12889-015-1762-x.
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Salam RA, Das JK, Lassi ZS, Bhutta ZA. Adolescent Health and Well-Being: Background and Methodology for Review of Potential Interventions. J Adolesc Health. 2016 Oct;59(4S):S4-S10. doi: 10.1016/j.jadohealth.2016.07.023.
van Dalen M, Dierckx B, Pasmans SGMA, Aendekerk EWC, Mathijssen IMJ, Koudstaal MJ, Timman R, Williamson H, Hillegers MHJ, Utens EMWJ, Okkerse JME. Anxiety and depression in adolescents with a visible difference: A systematic review and meta-analysis. Body Image. 2020 Jun;33:38-46. doi: 10.1016/j.bodyim.2020.02.006. Epub 2020 Feb 21.
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Other Identifiers
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8053
Identifier Type: -
Identifier Source: org_study_id
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