An interventional study of A smartphone application and Pictorial educational leaflets in Mental Disorder in Adolescence, Depression in Adolescence and Anxiety Disorders, sponsored by Aga Khan University. Not yet recruiting at 1 site in Pakistan. Open to participants aged 12 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-05-19.
Sponsored by Aga Khan University · Not applicable, Interventional, and Supportive care
the goal of this cluster randomized controlled trial is to assess the effectiveness of smartphone application in reducing the symptoms of Anxiety and depression among adolescents. The main objectives of this trial are:
Secondary Objectives
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.
As per World Health Organization (WHO), 13% of adolescents worldwide experience a mental disorder. Also, depression, anxiety, and other behavioral disorders are leading causes of mortality and disability in this age bracket. The advent of the pandemic has further worsened the mental health situation in adolescents. If the increasing burden of mental health issues is not addressed in adolescence, they can culminate into established mental disorders extending to adulthood, impairing overall wellbeing and limiting opportunities. In order to cater to mental health issues in adolescents at an early stage, we aim to develop a smartphone application for the reduction of depression and anxiety symptoms in school-going adolescents aged 12-18 years.
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.
8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's planned enrollment of 200 is above the median of 84 across 6,720 interventional studies indexed under Depression.
Browse Depression studies →Aga Khan University is the lead sponsor of 290 studies on the registry; 44 are open to participants now.
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Exclusion Criteria:
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.
Other: A smartphone application
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.
Other: Pictorial educational leaflets
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.
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.
Anxiety
change in the level of anxiety symptoms using the Generalized anxiety scale (GAD-7)
Time frame: 6 months
Depression
Change in the level of depressive symptoms assessed using Patient Health Questionnaire (PHQ-A) adapted for adolescents
Time frame: 6 months
Mental well-being
change in the mental well-being scores assessed using WHO-5 scale
Time frame: 6 months
Plan to share: No
This study is not yet recruiting, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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Aga Khan University