NCT04988529

Investigating the Effect of a Smartphone-based Serious Game on Depressive Symptoms.

A Pilot Randomized Control Trial Investigating the Effect of a Smartphone-based Serious Game on Depressive Symptoms.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Universitat Jaume I · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The objective of the present project is to study the effect of a smartphone-based serious game intervention for depressive symptoms. The serious game is based on Cognitive Behavior Therapy CBT, being behavioural activation and the promotion of physical activity one of the most important components.

Detailed description

Due to the current COVID-19 pandemic and the effects of quarantine on people's daily lives, a dramatic increase in people suffering from symptoms of depression is expected; one of the most common mental disorders globally, the primary cause of suicide deaths in Europe and the major contributor to the overall global burden of disease. Although there are effective treatments for depression, more than half of those affected worldwide (and more than 90% in many countries) do not receive these treatments. The dominant model of treatment delivery (individual face-to-face therapy) will not be enough to reach the majority of people who need treatment. Hence, one of the most important challenges within this scope is the design of new forms of treatment delivery to maximize the efficacy and dissemination of psychological treatment. The use of the Information and Communication Technologies (ICTs) has allowed a new effective ways of treatment, endorsed by several studies; and the use of serious video games as a partial or complete form of treatment, whose own characteristics make them potentially effective for the treatment of mental health, has opened the possibility of a still very new field of study. The arrival of smartphones has increased the possibilities of designing online therapies for mental health and facilitated the use of games as therapy. Therefore, the objective of the present project is to study the effect of a smartphone-based serious game intervention for depressive symptoms through a two armed pilot randomized control trial. A minimum of 40 participants diagnosed with mild to moderate depression symptoms will be randomly assigned to one of the two experimental conditions: a smartphone-based serious game condition, and a waiting list control condition. The researchers' hypothesis is that the smartphone-based serious game intervention will produce a significant improvement in depressive, anxious symptomatology and improved well-being after treatment compared to the waiting list control group.

Conditions

• Depressive Symptoms

Interventions

Type	Name	Description
BEHAVIORAL	Smartphone-based serious game intervention	Smartphone-based serious game intervention consists in the use of a serious game designed specifically to improve depressive symptoms. The psychological content consists of CBT intervention with the following psychotherapeutic components: Motivation for change, Psychoeducation, Cognitive Flexibility, Behavioural Activation, and positive psychotherapeutic strategies. To encourage physical activity, the serious game incorporates a mixed reality through physical activities such as taking a walk in real life affects aspects inside the game.

Timeline

• Start date: 2023-01-01
• Primary completion: 2023-06-01
• Completion: 2024-06-01
• First posted: 2021-08-03
• Last updated: 2022-05-25

Locations

1 site across 1 country: Spain