A Pilot Randomized Control Trial Investigating the Effect of a Smartphone-based Serious Game on Depressive Symptoms.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Beck Depression Inventory (BDI-II)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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]
排除标准
- •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.
结局指标
主要结局
Beck Depression Inventory (BDI-II)
时间窗: 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)
Patient Health Questionnaire-9 (PHQ-9)
时间窗: 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.
Positive and negative emotionality Positive and Negative Affect Scale (PANAS)
时间窗: 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)
时间窗: 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)
时间窗: 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
次要结局
- System Usability Scale (SUS)(Up to 12 months)
- Expectation of treatment scale and opinion of treatment scale (CEQ)(Up to 12 months)