Improvement of Mental Health in Adolescents Using E-health Interventions

Sponsor

Aga Khan University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05865834

Collaborator

(none)

200

Enrollment

Location

Arms

3.5

Anticipated Duration (Months)

57.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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:

Primary Objective To develop a smart phone application for reduction in depressive and anxiety symptoms in Pakistani adolescents aged 12-18 years
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.

Condition or Disease	Intervention/Treatment	Phase
Mental Disorder in Adolescence Depression in Adolescence Anxiety Disorders	Other: A smartphone application Other: Pictorial educational leaflets	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

A two-stage cluster sampling will be employed. Randomization will occur at school level for 2 arms i.e. interventional and control groups. Students will be selected randomly from each groupA two-stage cluster sampling will be employed. Randomization will occur at school level for 2 arms i.e. interventional and control groups. Students will be selected randomly from each group

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

Effectiveness of E-health Intervention Using Smart Phone App to Reduce Anxiety & Depressive Symptoms Among Adolescents: A Cluster Randomized Controlled Trial

Anticipated Study Start Date :

Aug 1, 2023

Anticipated Primary Completion Date :

Oct 31, 2023

Anticipated Study Completion Date :

Nov 15, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Other: 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.
Active Comparator: 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.	Other: 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.

Arm

Intervention/Treatment

Experimental: 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.

Other: 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.

Active Comparator: 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.

Other: 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.

Outcome Measures

Primary Outcome Measures

Anxiety [6 months]
change in the level of anxiety symptoms using the Generalized anxiety scale (GAD-7)
Depression [6 months]
Change in the level of depressive symptoms assessed using Patient Health Questionnaire (PHQ-A) adapted for adolescents
Mental well-being [6 months]
change in the mental well-being scores assessed using WHO-5 scale

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Registered secondary schools with the Board of Secondary Education Karachi who will provide consent to participate in the study
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 authorities who did not grant permission to conduct the research study in their school
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