A Pragmatic Superiority Randomized Controlled Trial Comparing Brief Cognitive Behavioral Telepsychotherapy, Brief Interpersonal Telepsychotherapy and Telepsychoeducation for the Reduction of Emotional Distress During COVID-19 Outbreak in Professionals and Students From Essential Services With a High Level of Emotional Distress in Brazil in the Context of COVID-19
试验速览
- 阶段
- 不适用
- 入组人数
- 999
- 试验地点
- 1
- 主要终点
- Symptom Reduction at 1-month
研究概览
简要总结
The study consists in a pragmatic superiority randomized controlled trial comparing different strategies of psychotherapy for professionals and students from essential services with high levels of emotional distress during the COVID-19 pandemic in Brazil. Therapeutic strategies to be evaluated are Brief Cognitive Behavioral Telepsychotherapy, Brief Interpersonal Telepsychotherapy and Telepsychoeducation, as an active control.
Note: This study was approved by the Ethics and Research Committee of the Hospital de Clínicas de Porto Alegre and is originally registered at Plataforma Brasil, a Brazilian study registration platform (under CAAE: 30608420.5.0000.5327). Recruitment began in May 28th 2020.
详细描述
PRAGMATIC TREATMENT TRIAL
TITLE: "A pragmatic superiority randomized controlled trial comparing Brief Cognitive Behavioral Telepsychotherapy, Brief Interpersonal Telepsychotherapy and Telepsychoeducation for the reduction of emotional distress during COVID-19 outbreak in professionals and students from essential services with a high level of emotional distress in Brazil".
IMPORTANCE: COVID-19 outbreak is associated with increased emotional distress (depression, anxiety, and irritability) all over the world. Currently, there are no large randomized trials testing interventions to reduce the burden caused by mental disorders during a pandemic outbreak of these proportions.
OBJECTIVE: To test the effectiveness of two modalities of Brief-Telepsychotherapy (Cognitive Behavioral and Interpersonal) to the reduction of symptoms of emotional distress (anxiety, depression, and irritability) in professionals and students from essential services with a high level of those symptoms in Brazil during the COVID-19 outbreak.
DESIGN, SETTING, AND PARTICIPANTS Thee-arm randomized clinical trial. Participants were recruited in Brazil from the national service of telehealth provided by the ministry of health. Participants included professional and students from essential services suffering from high levels of anxiety, depression, and irritability symptoms during the COVID-19 outbreak. High levels of symptoms were defined by either of the following: (1) T score higher than 70 on the PROMIS Anxiety Scale; (2) T score higher than 70 on the PROMIS Depression Scale; (3) T score higher than 70 on the PROMIS Anger Scale.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Professionals and students from essential services suffering from high levels of emotional distress
- •T score higher than 70 on the PROMIS Anxiety Scale
- •T score higher than 70 on the PROMIS Depression Scale
- •T score higher than 70 on the PROMIS Anger Scale
排除标准
- •Moderate to severe suicide risk assessed by a psychiatrist
研究组 & 干预措施
Intervention I: Cognitive Behavioral Brief-Telepsychotherapy
Four sessions of cognitive-behavioral therapy (CBT) conducted through a video call by a psychologist, accompanied by sending videos of 2 to 3 minutes with psychoeducational content and content related to CBT technique.
干预措施: Cognitive Behavioral Brief-Telepsychotherapy (Behavioral)
Intervention II: Brief Interpersonal Telepsychotherapy
Four sessions of interpersonal therapy (IPT) conducted by video call by a psychologist, accompanied by the sending of 2 to 3 minute videos with psychoeducational content and content related to the ITP technique.
干预措施: Brief Interpersonal Telepsychotherapy (Behavioral)
Active Comparator: Telepsychoeducation group
One single session of psychoeducation conducted through a video call by a psychologist, accompanied by sending videos of 2 to 3 minutes with psychoeducational content for 4 weeks.
干预措施: Telepsychoeducation (Behavioral)
结局指标
主要结局
Symptom Reduction at 1-month
时间窗: 1-month
Proportion of participants with a 50% reduction in T-scores at 1-month in the scales Patient-Reported Outcomes Measurement Information System (PROMIS) of Depression, Anxiety and Anger that were scored above 70 at baseline.
次要结局
- Symptom Reduction at 3 and 6-months follow-up(3 and 6-month)
- Remission Levels in distress scales(1, 3 and 6-months)
- Service Satisfaction(1-month)
- Improvement in Quality of Life(1, 3 and 6-months)
研究者
Giovanni Abrahao Salum Junior
Principal Investigator
Hospital de Clinicas de Porto Alegre