Effect of Brief Cognitive Behavioral Therapy Versus Crisis Intervention Therapy Through Telepsychiatry in Medical Staff During the COVID-19 Pandemic: A Multicentric Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 236
- 试验地点
- 2
- 主要终点
- Rate reduction in Depressive symptoms
研究概览
简要总结
The purpose of this randomized controlled trial is to determine the effect of two behavioral interventions: brief cognitive-behavioral therapy and crisis intervention therapy through telepsychiatry, over the level of perceived stress, anxiety, depression and post-traumatic stress symptoms during the COVID-19 pandemic in medical residents and medical staff at three hospitals in two cities of Honduras.
详细描述
The psychotherapeutic interventions are going to be delivered from June to August at each participating center. Subjects will be allocated randomly in each of the two interventional arms independently by stratification in each participating center. The population for intervention will be medical staff from three different national hospitals in the frontline during the pandemic. After valid informed consent, a screening process will take place to identify symptoms as baseline evaluation using validated self-assessment tools delivered through electronic invitation. Post-intervention measurements will take place at 3 and 6 months from baseline. Intention to treat analysis and per-protocol analysis will take place. CONSORT guidelines were followed.
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 (Investigator)
盲法说明
Investigators will not take part in the baseline symptom evaluation of subjects or the post-intervention evaluation.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Medical doctors and medical residents 18 years and older, from UNAH medical school and Hospital de Occidente.
- •Medical doctors and medical residents whom during the initial screening show positive scores in Patient Health Questionnaire-2 and Generalized Anxiety Disorder scale-2
- •Access to internet and an electronic device
排除标准
- •Medical doctors and medical residents referring a history of psychiatric disorders
- •Medical residents that belong to the Psychiatry Residency Program
- •Medical residents and medical doctors that have been diagnosed with COVID-19
- •Medical doctors and residents whom during evaluations show severe symptoms of depression, anxiety and post-traumatic stress symptoms
- •Medical doctors and residents with negative screening in Patient Health Questionnaire-2 and Generalized Anxiety Disorder Scale-2
- •Participants that do not have access to internet connection or an electronic device.
结局指标
主要结局
Rate reduction in Depressive symptoms
时间窗: 6 months after psychotherapeutic intervention has started
Patient Health Questionnaire 9 scale (PHQ-9), a 9 item scale with a score range from 0 to 27. A higher score means a worse outcome.
Rate reduction in Anxiety symptoms
时间窗: 6 months after psychotherapeutic intervention has started
General Anxiety Disorder 7 Scale (GAD-7), a 7 item scale with a score range from 0 to 21. A higher score means a worse outcome.
Rate reduction in Post traumatic Stress symptoms
时间窗: 6 months after psychotherapeutic intervention has started
Post-traumatic Stress Scale for DSM-5 (PCL-5), a 20 item scale with a score range from 0 to 80. A higher score means a worse outcome.
Rate reduction in Perceived stress level
时间窗: 6 months after psychotherapeutic intervention has started
Perceived stress scale (PSS), a 10 item scale with a score range from 0 to 40. A higher score means a worse outcome.
次要结局
未报告次要终点
研究者
Hector Benjamin Valle Rodriguez
Chief Resident
Universidad Nacional Autonoma de Honduras