Improvement of Mental Health in Adolescents Using E-health Interventions

NCT05865834 | Unknown DMC

• 1 other identifier: 8053
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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:

• 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.

Conditions

Mental Disorder in Adolescence; Depression in Adolescence; Anxiety Disorders

Keywords

Mental health; anxiety; depression; e-heath intervention; mental health application; adolescents

Outcome Measures

Primary Outcomes (3)

• Anxiety

  change in the level of anxiety symptoms using the Generalized anxiety scale (GAD-7)

  6 months

• Depression

  Change in the level of depressive symptoms assessed using Patient Health Questionnaire (PHQ-A) adapted for adolescents

  6 months

• Mental well-being

  change in the mental well-being scores assessed using WHO-5 scale

  6 months

Study Arms (2)

intervention arm

EXPERIMENTAL

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

control arm

ACTIVE COMPARATOR

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

Interventions

A smartphone application OTHER

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.

intervention arm

Pictorial educational leaflets OTHER

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.

control arm

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Registered secondary schools with the Board of Secondary Education Karachi who will provide consent to participate in the study
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Aga Khan University: lead

Study Sites (1)

Aga Khan University- Hospital

Karachi, Sindh, 75070, Pakistan

Location

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MeSH Terms

Conditions

Anxiety Disorders; Psychological Well-Being; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Personal Satisfaction; Behavior; Behavioral Symptoms

Study Officials

• Shafquat Rozi, Ph D.

  Aga Khan Hospital -Karachi

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shafquat Rozi, Ph.D.

CONTACT

+92 300 2278976; shafquat.rozi@aku.edu

Sana Qamar, Master

CONTACT

+923423727054; sana.qamar@aku.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor/ Director of MSc. Epidemiology and Biostatistics

Model Details: 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 group

Study Record Dates

• First Submitted: May 8, 2023
• First Posted: May 19, 2023
• Study Start: August 1, 2023
• Primary Completion: October 31, 2023
• Study Completion: November 15, 2023
• Last Updated: May 19, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)