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

NCT ID: NCT04988529

Last Updated: 2022-05-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-31
• Study Completion Date: 2024-06-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Smartphone-based supported serious game intervention

Group that receives the smartphone-based serious game intervention and receives technical support

Group Type: EXPERIMENTAL

Smartphone-based serious game intervention

Intervention Type: BEHAVIORAL

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.

Waiting list control

Group that does not receive any treatment

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 18-65 years old
• Being able to read and understand Spanish
• Being able to use a smartphone
• Having an Android smartphone with internet connection
• Suffering from mild to moderate depressive symptoms (from 14 to 28 on the Beck Depression Inventory-II [BDI-II]

Exclusion Criteria

• Suffering a severe mental disorder: bipolar disorder, alcohol and/ or substance dependence disorder, psychotic disorder, or dementia
• Having a high suicide risk (ideation or plan assessed by the MINI and item 9 of the BDI-II)
• Receiving another psychological treatment while the study is still ongoing.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Conselleria de Innovación, Universidades, Ciencia y Sociedad Digital.

UNKNOWN

Sponsor Role: collaborator

Universitat Jaume I

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University Jaume I

Castellon, Castelló, Spain

Countries

Spain

Central Contacts

Sven Casteleyn, Professor

Role: CONTACT

sven.casteleyn@uji.es

+34964387693 ext. 7693

Facility Contacts

Águeda Gómez, PhD Student

Role: primary

cambrone@uji.es

+34964387686 ext. 7686

Related Links

http://geotec.uji.es/

Information about GEOTEC, the technical research group of the University Jaume I

http://www.labpsitec.uji.es/esp/index.php

Information about the Laboratory of Psychology and Technology of the University Jaume I

Other Identifiers

SERGAMIN/278

Identifier Type: -

Identifier Source: org_study_id