Depressive SymptomsNCT04988529
Investigating the Effect of a Smartphone-based Serious Game on Depressive Symptoms.
A study testing Smartphone-based serious game intervention in people with Depressive Symptoms, run by Universitat Jaume I at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depressive Symptoms
- What is being tested?
- Smartphone-based serious game intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2023to Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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]
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Spain1 site
University Jaume I
Castellon, Castelló, 12006
Águeda Gómez, PhD Student, +34964387686 ext. 7686, cambrone@uji.es
Sven Casteleyn, Professor
About this study
Official title: 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.
Read the 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
- Being tested
- Smartphone-based serious game intervention
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smartphone-based serious game interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Smartphone-based supported serious game intervention | Experimental | Group that receives the smartphone-based serious game intervention and receives technical support Receives: Behavioral: Smartphone-based serious game intervention |
| Waiting list control | No intervention | Group that does not receive any treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Health Questionnaire-9 (PHQ-9)
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.
Measured: Up to 12 months
Beck Depression Inventory (BDI-II)
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)
Measured: Up to 12 months
Positive and negative emotionality Positive and Negative Affect Scale (PANAS)
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).
Measured: Up to 12 months
Overall Anxiety Severity and Impairment Scale (OASIS)
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).
Measured: Up to 12 months
Overall Depression Severity and Impairment Scale (ODSIS)
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
Measured: Up to 12 months
Secondary outcomes (2)
System Usability Scale (SUS)
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.
Measured: Up to 12 months
Expectation of treatment scale and opinion of treatment scale (CEQ)
(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)
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2021
- Study startJan 2023 (estimated)
- Primary completionJun 2023 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitat Jaume I
- Sponsor type
- University, hospital or other
- Collaborators
- Conselleria de Innovación, Universidades, Ciencia y Sociedad Digital.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04988529
- Sponsor's protocol ID
- SERGAMIN/278
- Status last verified
- May 2022
- First submitted
- 9 Jul 2021
- Last updated
- 25 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Randomized Control Trial Investigating the Effect of a Smartphone-based Serious Game on Depressive Symptoms.
- ClinicalTrials.gov ID
- NCT04988529
- Acronym / sponsor ID
- SERGAMIN/278
- Conditions
- Depressive Symptoms
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Universitat Jaume IUniversity, hospital or other
- Collaborators
- Conselleria de Innovación, Universidades, Ciencia y Sociedad Digital.
- Study start
- Jan 2023 (estimated)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 3 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Smartphone-based supported serious game intervention | Experimental | Behavioral: Smartphone-based serious game interventionGroup that receives the smartphone-based serious game intervention and receives technical support |
| Waiting list control | No intervention | –Group that does not receive any treatment |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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]
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smartphone-based serious game interventionSmartphone-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. | Behavioural | Smartphone-based supported serious game intervention |
Primary outcome
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.
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)
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).
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).
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
2 secondary outcomes
System Usability Scale (SUS)
Time frame: Up to 12 months
Expectation of treatment scale and opinion of treatment scale (CEQ)
Time frame: Up to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2022.
- Information about GEOTEC, the technical research group of the University Jaume ILink provided by the sponsor.
- Information about the Laboratory of Psychology and Technology of the University Jaume ILink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smartphone-based serious game intervention in people with Depressive Symptoms, run by Universitat Jaume I at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sven Casteleyn, Professor (+34964387693 ext. 7693, sven.casteleyn@uji.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Health Questionnaire-9 (PHQ-9) (time frame: Up to 12 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2022.