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

May 17, 2022 updated by: Universitat Jaume I

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
    • Castelló
      • Castelló de la Plana, Castelló, Spain, 12006
        • University Jaume I
        • Contact:
          • Águeda Gómez, PhD Student
          • Phone Number: 7686 +34964387686
          • Email: cambrone@uji.es
        • Principal Investigator:
          • Sven Casteleyn, Professor
        • Principal Investigator:
          • Adriana Mira, Phd

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Health Questionnaire-9 (PHQ-9)
Time Frame: Up to 12 months
The PHQ-9 is the depression module of the self-administered version of the PRIME-MD diagnostic instrument for common mental disorders. The PHQ-9 consists of 9 items ranging from "0" (not at all) to "3" (nearly every day). It has a dual-purpose instrument since it can establish both depressive disorder diagnoses and grade depressive symptom severity. Scores can range from zero to 27. Scores of 15 or greater indicated major depression.
Up to 12 months
Beck Depression Inventory (BDI-II)
Time Frame: Up to 12 months
The BDI-II is widely used to detect and assess the severity of depressive symptoms. The BDI-II consists of 21 multiple-choice items ranging from 0 to 3. It covers the different symptoms of major depression disorder in the DSM-IV. Scores can range from zero to 63. Scores greater than 29 mean major depression. The BDI-II has high internal consistency (alpha = 0.76 to 0.95) and for the Spanish version (alpha = 0.89) (Sanz, 2003)
Up to 12 months
Positive and negative emotionality Positive and Negative Affect Scale (PANAS)
Time Frame: Up to 12 months
The PANAS is used to measure trait and state affectivity. The PANAS consists of 20 items divided in two independent 10-item dimensions to assess positive affect (PA) and negative affect (NA). Each item rated on a 5-point Likert-type scale. Low levels of PA predict the onset depreesion, reduce positive emotions, and increase the severity of depressive symptoms.Patients with more comorbid diagnoses had significantly higher NA and lower PA. It is brief, reliable, and has shown excellent internal consistency (alpha = 0.84 to 0.90) and convergent and divergent validity. The Spanish version has also shown high internal consistency (alpha = 0.87 and 0.89 for PA and NA in men, respectively, and alpha = 0.89 and 0.91 for PA and NA in women, respectively (Díaz-García, 2020).
Up to 12 months
Overall Anxiety Severity and Impairment Scale (OASIS)
Time Frame: Up to 12 months
The OASIS is used to assess the severity and frequency of anxiety symptoms. Moreover, the scale provides information about behavioral avoidance and functional impairments in pleasurable activities, work, school or social relationship interference related to these symptoms in the last week. The OASIS consists of a 5-item self-report measure rated from 0 to 4 and are summed to obtain one total score. OASIS score of 8 or above would be indicative of a probable anxiety disorder. It has demonstrated strong psychometric properties with good internal consistency (alpha = 0.86), as well as test-retest reliability (K = 0.82) and convergent validity (Norman, 2006; Campbell-Sill, 2009; Norman, 2011).
Up to 12 months
Overall Depression Severity and Impairment Scale (ODSIS)
Time Frame: Up to 12 months
The ODSIS is used to assess the severity and frequency of depressive symptomatology and functional deficits in pleasurable activities due to the depressive symptomatology. The ODSIS consists of a 5-item self-report measure rated from 0 to 4 with higher scores indicating greater depression-related severity and impairment. It has excellent internal consistency (alpha = 0.92) and it shows good convergent/discriminant validity (Bentley, 2014) Spanish version will be used (Mira, 2019
Up to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
System Usability Scale (SUS)
Time Frame: Up to 12 months
he SUS is used to measure the usability of a software collecting the user's opinion. The SUS consists of a questionnaire of 10 items with 5 answer options rated from "o" (strongly disagree) to "4" (strongly agree)is a brief, reliable scale for measuring the usability of a program. It consists of a 10-item questionnaire with 5 response options, from 0 ("strongly disagree") to 4 ("strongly agree"). It could indicate that the user has had technical difficulties with the program. The Spanish version has been used in several research studies (Botella, 2016; Campos, 2018) and its validation process is currently ongoing.
Up to 12 months
Expectation of treatment scale and opinion of treatment scale (CEQ)
Time Frame: Up to 12 months
(Devilly & Borkovec, 2000). The CEQ is a quick and easy-to-administer scale used to measure treatment expectations before the intervention and the satisfactions after the receiving intervention. Both instruments consist of 6 items rated from "0" (not at all) to 10 ("very much"). The Spanish version has been used in previous studies (Botella 2016; Mira, 2019; Tortella-Feliu, 2011)
Up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitat Jaume I

Collaborators

Conselleria de Innovación, Universidades, Ciencia y Sociedad Digital.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2023

Primary Completion (Anticipated)

June 1, 2023

Study Completion (Anticipated)

June 1, 2024

Study Registration Dates

First Submitted

July 9, 2021

First Submitted That Met QC Criteria

July 23, 2021

First Posted (Actual)

August 3, 2021

Study Record Updates

Last Update Posted (Actual)

May 25, 2022

Last Update Submitted That Met QC Criteria

May 17, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SERGAMIN/278

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe