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

U

Universitat Jaume I

Status

Not yet enrolling

Conditions

Depressive Symptoms

Treatments

Behavioral: Smartphone-based serious game intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT04988529
SERGAMIN/278

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

40 participants in 2 patient groups

Smartphone-based supported serious game intervention
Experimental group
Description:
Group that receives the smartphone-based serious game intervention and receives technical support
Treatment:
Behavioral: Smartphone-based serious game intervention
Waiting list control
No Intervention group
Description:
Group that does not receive any treatment

Trial contacts and locations

1

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Central trial contact

Sven Casteleyn, Professor

Data sourced from clinicaltrials.gov

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