Effectiveness and Mechanisms of Change of Two Mobile Psychological Interventions in Reducing Depressive, Anxiety and Stress Symptoms: PsyPills and Online-Contingent Attention Training (OCAT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 450
- 试验地点
- 2
- 主要终点
- Depressive, Anxiety, and Stress Symptoms
研究概览
简要总结
Investigating the effectiveness of two mobile psychological interventions and the mechanisms of change involved in reducing the symptoms of depression, anxiety and stress, on an adult population with a mild to moderate level of symptoms (sub-clinical).
详细描述
The research design will be a 3-arm controlled clinical trial, with 4 waves of data collection. Once selected using a symptomatic screening questionnaire, participants will be randomly assigned to one of three conditions: 2 experimental conditions (PsyPills and OCAT) and an active control group (shamOCAT).
Measurements will be collected before allocation (baseline), during the intervention (through a momentary ecological assessment paradigm), at the end (post) and at an interval of one month after the intervention (follow-up). Among the constructs evaluated are symptomatic level, affectivity, cognitive processes, emotional regulation and attentional bias. All measurement steps will be collected online.
The interventions consist of an attentional training (Online-Contingent Attention Training, OCAT) which seeks to facilitate the disengagement from the negative content and the engagement on the positive of some personally relevant information by providing instructions and feedback on performance; and prescribing personalized rational thinking strategies to change the intensity of dysfunctional emotionality (PsyPills). The active control group consists of a "fake" version of OCAT (shamOCAT), by offering the same attentional training, without training and feedback on performance. All interventions are delivered in the form of smartphone applications.
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
- Single (Participant)
盲法说明
Participants in all categories will be announced that they have received a mobile intervention aimed at distress reduction, without knowing the the rationale and specifics of each intervention. Outcomes will be assessed only by online questionnaires, so no assessor is involved.
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
- •Have access and able to use a smartphone
排除标准
- 未提供
结局指标
主要结局
Depressive, Anxiety, and Stress Symptoms
时间窗: Baseline
DASS-21, with scores from 0 to 63, higher scores meaning worse outcomes
Change from Baseline Depressive, Anxiety, and Stress Symptoms at 5 days
时间窗: Mid of intervention (5 days)
DASS-21, with scores from 0 to 63, higher scores meaning worse outcomes
Change from Baseline Depressive, Anxiety, and Stress Symptoms at 1 month
时间窗: Follow-up (1 month)
DASS-21, with scores from 0 to 63, higher scores meaning worse outcomes
Change from Baseline Depressive, Anxiety, and Stress Symptoms at 10 days
时间窗: Post intervention (10 day)
DASS-21, with scores from 0 to 63, higher scores meaning worse outcomes
次要结局
- Positive Reappraisal(Baseline)
- Functional Reappraisal(Baseline)
- Change from Baseline Positive Reappraisal at 5 days(Mid of intervention (5 days))
- Change from Baseline Functional Reappraisal at 5 days(Mid of intervention (5 days))
- Change from Baseline Functional Reappraisal at 10 days(Post intervention (10 day))
- Change from Baseline Functional Reappraisal at 1 month(Follow-up (1 month))
- Change from Baseline Positive Reappraisal at 10 days(Post intervention (10 days))
- Change from Baseline Positive Reappraisal at 1 month(Follow-up (1 month))
- Rational and Irrational Beliefs(Baseline)
- Change from Baseline Rational and Irrational Beliefs at 5 days(Mid of intervention (5 days))
- Change from Baseline Rumination at 10 days(Post intervention (10 days))
- Change from Baseline Rumination at 1 month(Follow-up (1 month))
- Change from Baseline Rational and Irrational Beliefs at 10 days(Post intervention (10 days))
- Change from Baseline Attention Bias at 5 days(Mid of intervention (5 days))
- Change from Baseline Rational and Irrational Beliefs at 1 month(Follow-up (1 month))
- Rumination(Baseline)
- Change from Baseline Rumination at 5 days(Mid of intervention (5 days))
- Change from Baseline Functional and Dysfunctional Emotions at 5 days(Mid of intervention (5 days))
- Change from Baseline Functional and Dysfunctional Emotions at 10 days(Post intervention (10 days))
- Change from Baseline Functional and Dysfunctional Emotions at 1 month(Follow-up (1 month))
- Attention bias(Baseline)
- Change from Baseline Attention Bias at 10 days(Post intervention (10 days))
- Change from Baseline Attention Bias at 1 month(Follow-up (1 month))
- Functional and Dysfunctional Emotions(Baseline)
研究者
Sîrbu Vasile
PhD student
Babes-Bolyai University