Using a Smartphone App to Reduce Cognitive Vulnerability and Mild Depressive Symptoms: An Exploratory Study Protocol for a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 255
- 试验地点
- 2
- 主要终点
- Center for Epidemiologic Studies Depression Scale-Revised (CESD-R) (change from baseline)
研究概览
简要总结
Depression is one of the major challenges worldwide, with significant increasing personal, economic, and societal costs. Although empirically supported treatments have been developed, they are not always available for patients in routine clinical care. Even when patients are adequately treated, they do not always respond to treatment and/or face a significant risk for recurrence. Therefore, effective and wide accessible strategies to prevent the onset of the very first depressive symptoms are necessary. Mental health apps could prove a valuable alternative for that. Although preliminary research has indicated that apps could be useful in treating depression, no study has attempted to test their utility in preventing depression symptoms. The current study aims to contrast the efficacy of a smartphone app in preventing depression compared against a waiting list condition. The app includes self-help materials and exercises based on cognitive behavioral therapy (CBT) for depression, presented in a tailored manner and incorporating gamification elements aimed at boosting the motivation to use the app.
This study protocol is the first that capitalizes on the ubiquity of smartphones to large-scale dissemination of CBT-based strategies aimed at preventing depression in nonclinical populations. The objective of this study is to test an app designed to decrease general cognitive vulnerability and promote engagement in protective, adaptive activities, while counteracting the tendency of premature dropout (through gamification and customization).
详细描述
Trials design. This study will include two parallel-randomized trials, with pre-post measurements. The designs of the trials will be similar and compliant with the CONSORT guidelines. In the first trial the efficacy of the preventative version of the application will be tested against a wait list control group, in a healthy sample of participants. In the second trial the efficacy of the app will be tested against a wait list control group, in a sample of participants with mild depressive symptoms.
Participant timeline. Potential participants will be assessed for eligibility through an initial assessment of depressive symptoms. The initial assessment phase consists of administration of the PHQ-9 and a short screening telephone interview. Subsequent assessments consist of all the instruments presented in the Outcome measures section. After the initial assessment, the participants meeting inclusion criteria will be randomly assigned to one of the two conditions: immediate online intervention condition (Group 1) or the delayed-intervention condition (wait-list) (Group 2).
Participants assigned to Group 1 will be given access to the online application along with explicit instructions regarding the use of all of its sections. Participants will be given 4 weeks to complete the intervention, during which time weekly messages will be sent out to them. Messages include regular assignments designed for a complete and thorough use of the application's courses and exercises, and encourage the review of materials whenever possible. However, participants are free to use the application at their own pace.
Participants in the delayed intervention group (Group 2) are placed on a wait-list for 4 weeks.
Sample size. A a total number of 50 participants per study (i.e., 50 participants without depressive symptomatology, and 50 participants with mild depressive symptomatology) was estimated based on previous studies testing mobile phone applications for depression that reported large within group effect sizes. The calculation of the sample size was conducted with G*Power 3.1. for ANOVA (Repeated measures, between factors), assuming an alpha level of 0.05, a statistical power of 0.80, and a large effect size (Cohen's f = 0.355).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Romanian-speaking adults (18 years or older)
- •Access to a computer, a smartphone (Android or iOS) and Internet
- •A Patient Health Questionnaire-9 (PHQ-9) score of 4 or below (for the healthy participants sample)
- •A PHQ-9 score no greater than 9 (for the mildly depressed participants sample)
排除标准
- •Undergoing therapy
- •Substance abuse problems
- •Psychotic symptoms
- •Organic brain disorders (e.g., dementia)
- •Self-injury or harming others
- •Serious legal or health issues that would prevent from using the app
- •Reporting scores larger than 1 to Question 9 (suicidal ideation) on the (PHQ-9)
研究组 & 干预措施
Healthy sample, active intervention
Healthy participants will be testing a depression prevention app employing a self administered online CBT intervention, for 4 weeks.
干预措施: Self administered online CBT (Other)
Healthy sample, delayed intervention
Healthy participants will be put on a wait list for 4 weeks, after which access to the depression prevention app will be given.
Mild depression, active intervention
Mildly depressed participants will be testing a depression prevention app, employing a self administered online CBT intervention, for 4 weeks.
干预措施: Self administered online CBT (Other)
Mild depression, delayed intervention
Mildly depressed participants will be put on a wait list for 4 weeks, after which access to the depression prevention app will be given.
结局指标
主要结局
Center for Epidemiologic Studies Depression Scale-Revised (CESD-R) (change from baseline)
时间窗: Baseline, 1 week after baseline, 2 weeks after baseline, 3 weeks after baseline, post-intervention (4 weeks after baseline), Follow-up 1 (3 months after post-interv.), Follow-up 2 (6 months after post-interv.), Follow-up 3 (12 months after post-interv.)
The CESD-R is a 20-item self-report instrument, which measures symptoms of depression in nine different groups: sadness (dysphoria), loss of interest (anhedonia), appetite, sleep, thinking/concentration, guilt (worthlessness), tired (fatigue), movement (agitation), and suicidal ideation. Participants rate each item on a five-point Likert scale, from 0 (not at all or less than one day) to 4 (nearly every day for 2 weeks) and refer to a time frame of a week or so. The Total CESD-R Score is calculated as a sum of responses to all 20 questions. The CESD-R exhibited good psychometric properties, including high internal consistency, strong factor loadings, and theoretically consistent convergent and divergent validity with anxiety, schizotypy, and positive and negative affect. CESD-R has been adapted to Romanian for the purposes of the current study.
The Automatic Thoughts Questionnaire (ATQ) (change from baseline)
时间窗: Baseline, mid-intervention (2 weeks after baseline), post-intervention (4 weeks after baseline), Follow-up 1 (3 months after post-interv.), Follow-up 2 (6 months after post-interv.), Follow-up 3 (12 months after post-interv.)
The Automatic Thoughts Questionnaire (ATQ) is a 15-item self-report measure used to assess depression-related cognitions. Participants rate, on a five-point Likert scale from 1 (never) to 5 (almost all the time), the frequency of a given thought over the past week. A higher score shows a higher frequency of automatic thoughts. The psychometric properties of the ATQ have been adequately demonstrated in previous studies. The ATQ has been successfully used on the Romanian population before.
The Dysfunctional Attitudes Scale Short Form (DAS-SF) (change from baseline)
时间窗: Baseline, mid-intervention (2 weeks after baseline), post-intervention (4 weeks after baseline), Follow-up 1 (3 months after post-interv.), Follow-up 2 (6 months after post-interv.), Follow-up 3 (12 months after post-interv.)
DAS was designed to measure the intensity of dysfunctional attitudes that, according to the cognitive theory of depression, contribute to vulnerability for depression. For the purpose of this study, the short form of this scale was used. The Dysfunctional Attitudes Scale-Short Form (DAS-SF) consists of two subscales: "dependency" (6 items) and "perfectionism/performance evaluation" (11 items). The 17 items are rated on a seven-point Likert scale, from 1 (total disagreement) to 7 (total agreement). DAS-SF possesses good psychometric properties in terms of model fit, reliability and convergent construct validity. DAS-SF has been adapted to Romanian for the purposes of this study.
The Beliefs Scale (BS) (change from baseline)
时间窗: Baseline, mid-intervention (2 weeks after baseline), post-intervention (4 weeks after baseline), Follow-up 1 (3 months after post-interv.), Follow-up 2 (6 months after post-interv.), Follow-up 3 (12 months after post-interv.)
The Beliefs Scale (BS) measures irrational beliefs. It consists of 20 items and responders indicate the level of agreement/disagreement with each item using a five-point Likert scale that ranges from 1 (strongly disagree) to 5 (strongly agree). The BS shows good psychometric properties regarding construct and discriminant validity. This scale has been translated into Romanian for the purposes of this study.
次要结局
- Satisfaction with Life (SWL) (change from baseline)(Baseline, mid-intervention (2 weeks after baseline), post-intervention (4 weeks after baseline), Follow-up 1 (3 months after post-interv.), Follow-up 2 (6 months after post-interv.), Follow-up 3 (12 months after post-interv.))
- The Positive and Negative Affect Scale (PANAS) (change from baseline)(Baseline, mid-intervention (2 weeks after baseline), post-intervention (4 weeks after baseline), Follow-up 1 (3 months after post-interv.), Follow-up 2 (6 months after post-interv.), Follow-up 3 (12 months after post-interv.))
研究者
Cezar Giosan, PhD
Principal Investigator, PhD
Babes-Bolyai University