Clinical Research Directory

Improving Digital Wellbeing in Saudi Adolescents

Background: In Saudi Arabia, the rapid expansion of digital technology use-particularly among adolescents-has raised growing concerns about internet addiction and its impact on mental health and overall wellbeing. Building on formative work including national surveys, stakeholder interviews, and pilot testing, there is now a pressing need to rigorously evaluate interventions that can promote healthy digital habits among youth. Study aims/objective: This study aims to evaluate the effectiveness of a school-based digital wellbeing intervention, with and without a supplemental parent engagement component, using a cluster randomized controlled trial design. The primary objective is to determine whether exposure to the student curriculum alone or in combination with a parent-focused intervention improves digital literacy, technology use behaviors, and psychosocial wellbeing among high school students. Secondary objectives include assessing changes in parent-child communication and parental attitudes toward digital media use. Methods: Twenty (20) high schools across Qassim and Riyadh regions in Saudi Arabia will be randomly assigned to one of two study arms: (1) treatment as usual (TAU) will receive the Ministry of Education (MOE) Digital Wellbeing Unit that is implemented in 12th grad as part of the Digital Citizenship Curriculum and a brief self-paced online teacher training, or (2) enhanced treatment including the MOE Digital Wellbeing Unit plus a WhatsApp-based intervention for parents and a brief self-paced online teacher training. Approximately 125 students per school (\~2,500 total) will complete surveys before and after the intervention period, assessing digital media habits, wellbeing, and communication patterns. Parent surveys will be administered in the enhanced arm to assess intervention engagement and parenting practices. Surveys with teachers will assess motivation and self-efficacy in delivering the digital wellbeing unit and fidelity of delivery. Results: The study will generate evidence on the efficacy of school- and family-based strategies for improving adolescent digital wellbeing in the Saudi context. It will also provide insight into mechanisms of change, including the role of parental involvement in shaping adolescent digital habits. Conclusion: Findings from this cluster randomized trial will inform national digital wellbeing policy and practice, offering a scalable model for youth-targeted behavioral health interventions in Saudi Arabia and similar settings.

CBT Treatment for Internet Gaming Disorder

For most people, gaming is perceived as a positive activity. In some cases, however, gaming may turn into an addiction with consequences for the individual health, quality of life and everyday life. Today, there is a lack of evidence-based interventions to treat this condition, called Gaming Disorder (GD). This study will evaluate a new manual for treatment of GD, divided into a number of modules and based on cognitive behavioural therapy (CBT). The study is designed as a randomized controlled trial (RCT) and will be conducted at a clinic specialized in the treatment of gambling and gaming addiction. Participants included in the study will be randomized to one of to groups. The intervention group will receive twelve weeks of individual CBT-treatment while participants allocated to the control group will be put on a twelve-week wait-list. The hypothesis is that the manual based CBT treatment will result in a greater reduction in symptoms of criteria for GD.

Mechanisms and Interventions of Social Reward on Cognitive Control in Internet Gaming Disorder

Internet Gaming Disorder (IGD) involves impaired cognitive control linked to reduced social reward and dACC-DLPFC brain circuit dysfunction. Enhancing social reward may restore this circuit and improve symptoms. This study uses psychological interventions and neuroimaging to explore and treat IGD.

Chatbot Intervention to Reduce Common Digital Addictions, Sedentary Behaviors and Mental Distress Among Adolescents

The goal of the study is to investigate the efficacy of a secondary low-intensity stage of change (SoC) and motivational interviewing (MI)-based Chatbot-assisted intervention in reducing digital addictions in adolescents with Internet gaming disorder (IGD) and/or social media addiction (SMA) by conducting a RCT. Hypothesis: The intervention group will show a greater reduction in rates of IGD and/or SMA at post-treatment and 3-month follow-up than the control group. Design and subjects: A two-armed RCT between the intervention group and psycho-educational control group for adolescents aged 10-19 with excessive screen time. Screening, baseline, post-programme, and 3-month follow-up evaluations will be conducted. Participants will: Be randomly assigned to online brief intervention or psycho-educational control Complete questionnaires evaluating 1 ) Primary outcomes (IGD, SMA), 2) Secondary outcomes (sedentary lifestyle, mental distress, quality of life, eHealth literacy) and 3) Mediators/mechanisms (autonomy, competence)

Targeted TDCS Intervention for Internet Gaming Disorder

The aim of this project is to compare the effects of the newly discovered parietal cortex (Pz electrode point) with the dorsolateral prefrontal cortex (F3 electrode point), which has been commonly used in previous studies, and to further develop a closed-loop intervention method of real-time tDCS under on-line electroencephalography (EEG-tDCS), so as to realise an individualised diagnosis and treatment for online game addicts. This study is divided into two parts, the first part to explore the effectiveness of the new target, using a randomised group design, using tDCS intervention, the subject population is online game addicts, the sample size is about 120. Participants underwent baseline information collection on the first day of the experiment including: basic demographic information, assessment of internet addiction severity and craving; EEG collection in resting state as well as task state (Game Cue Response Task, Signal Stop Task, Iowa Gambling Task). The tDCS intervention under the game cue response task was conducted on the second and third days of the experiment, divided into four groups (the first and second groups were the true-false stimulation groups with the anode at the trapezius muscle at the base of the right neck and the cathode at the subject\'s central parietal cortex; and the third and fourth groups had the anode at the subject\'s left dorsolateral prefrontal cortex, and the cathode at the trapezius muscle at the base of the right neck), with 20 min of intervention each time and the Game craving level was assessed before and after the intervention. Resting-state and task-state (Game Cue Response Task, Signal Stop Task, Iowa Gambling Task) EEG acquisitions were performed at the end of the intervention.The second part of the EEG-tDCS closed-loop intervention was conducted, using a randomised group design with a sample size of about 60 subjects who are addicted to online games. On the first day of the experiment, baseline information was collected, and a personalised EEG classifier model was built for each subject based on the EEG signals of the game cue response task; on the second and third days of the experiment, EEG-tDCS closed-loop intervention was conducted, divided into true intervention and sham intervention groups, with the true intervention group identifying whether subjects were in an addictive state in real time under the game cue response task, and addictive states were identified by giving real-time short-time short-time short-time short-time short-time short-time short-time intervention at target locations. The real-time short-term tDCS intervention was given at the target location for a total duration of 20 minutes, and the level of game craving was assessed after the intervention; at the end of the intervention, the EEG was collected in the resting state and the task state (game cue response task, signal stopping task, and Iowa gambling task). The two-part experiment followed up subjects with weekly post-intervention versus one-month post-intervention gaming severity assessments, with resting-state and task-state (gaming cue-response task, signal-stopping task, Iowa gambling task) electroencephalogram acquisitions.

The Effect of Repetitive Transcranial Magnetic Stimulation for Internet Gaming Disorder

This study aims to investigate the intervention effects of navigated repetitive transcranial magnetic stimulation (rTMS) on craving regulation in individuals with internet gaming disorder (IGD). The primary objectives include: (1) examining the impact of navigated rTMS over the dorsolateral prefrontal cortex (DLPFC) on the gaming cravings, and craving regulation capacity; and (2) exploring the potential neural mechanisms by which rTMS over the DLPFC improves craving intensity, and craving regulation ability.

Collective Motivational Interviewing (CMI) for Adolescents With Internet Gaming Disorder

The present study examines the efficacy of CMI in reducing adolescent IGD symptoms and enhancing social support given by CSOs among adolescents with high risk of IGD (probable IGD cases screened positive by validated tools). It is hypothesized that the intervention group (with CMI plus IGD education materials for both the clients and his/her selected CSO) would show more improvements in reduction in the severity of IGD, motivation to change maladaptive gaming behaviour, craving on gaming, and social support obtained from CSOs than to the control group (only educational materials for both the client and the CSOs).

Effect of Computer-Based Game and HIIT Towards Symptoms, Executive Function and Neuroplasticity in Teens with IGD

The goal of this clinical trial is to learn how effective a combined therapy of computer-based game and also high-intensity interval training (HIIT) physical exercise to improve the clinical symptoms, executive function and neuroplasticity in teenagers with Internet Gaming Disorder (IGD). Executive function refers to the brain's ability to manage tasks such as planning, problem-solving, and decision-making. BDNF is a protein crucial for brain health and development. Neuroplasticity is the brain's ability to change and adapt throughout life. High-intensity interval training involves short bursts of intense exercise followed by periods of rest or recovery. The main questions it aims to answer are: * How effective are computer-based game and HIIT exercises in reducing addiction symptoms of IGD? * Will computer-based game and HIIT exercise help teens who are addicted to video games to improve their executive function (become more able to plan ahead and meet goals, display self-control and also follow multiple-step directions)? * Do computer-based game and HIIT exercise help brains of teens with IGD to be more able to change and adapt? Researchers will compare the improvement before and after the therapies. Participants will: * Undergo both therapies (computer-based game and HIIT) every week for 7 weeks. Computer-based game will be done 3 times/week and HIIT 2 times/week * fill out forms, interviewed and also have their blood sample taken for a total of three times (before the start of the therapy, during the 4th week of therapy and after the final therapy session on the 7th week)