Clinical trial NCT04988529: Investigating the Effect of a Smartphone-based Serious Game on Depressive Symptoms.
Official title: A Pilot Randomized Control Trial Investigating the Effect of a Smartphone-based Serious Game on Depressive Symptoms.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Depressive Symptoms
Lead sponsor: Universitat Jaume I
Sponsor class: OTHER
Collaborators: name: Conselleria de Innovación, Universidades, Ciencia y Sociedad Digital.
First posted: 2021-08-03
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Up to 12 months
measure: Beck Depression Inventory (BDI-II)
timeFrame: Up to 12 months
measure: Positive and negative emotionality Positive and Negative Affect Scale (PANAS)
timeFrame: Up to 12 months
measure: Overall Anxiety Severity and Impairment Scale (OASIS)
timeFrame: Up to 12 months
measure: Overall Depression Severity and Impairment Scale (ODSIS)
timeFrame: Up to 12 months
Secondary outcomes:
measure: System Usability Scale (SUS)
timeFrame: Up to 12 months
measure: Expectation of treatment scale and opinion of treatment scale (CEQ)
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Castelló de la Plana
country: Spain
facility: University Jaume I
state: Castelló
Study officials:
References: