Effectiveness of Virtual Cognitive Behavioral Therapy(CBT) on the Quality of Life of HIV-infected Persons, COVID-19, With Anxiety and Depression, 2021-2022.
试验速览
- 阶段
- 不适用
- 入组人数
- 182
- 试验地点
- 1
- 主要终点
- Change in Quality of life
研究概览
简要总结
Experimental open-label randomized clinical trial to determine the effect of virtual Cognitive Behavioral Therapy (CBT) on the quality of life of patients with HIV, COVID-19 and anxiety or depression. It will be carried out at the hospital for 6 months, where people over 18 years of age with HIV from the infectious disease service will participate.
In the study, patients will be randomized 1:1 in an intervention group, who will receive eight sessions of virtual CBT by 02 psychotherapists, and a control group. Additionally, patients will be consulted about the participation of at least one adult family member or caregiver in the study, if the patient and the family member agree, the family member or caregiver will enter the study.
The informed consent process will be conducted by telephone, during the call the recruiting staff will read the consent document and the participant (patient and family member or caregiver) will give their consent by answering affirmatively to the questions asked at the end of the document. The main objective will be evaluated by comparing the quality of life measurement at three months with the baseline measurement, as well as the variation of anxiety and depression scores.
详细描述
Introduction: Confrontational measures such as social isolation and confinement due to the COVID-19 pandemic and the experience of illness have affected people's emotional health by generating or exacerbating anxious and depressive symptoms. This effect may be magnified in people with HIV, contributing to the deterioration of their quality of life.
Objective: To determine the effect of virtual Cognitive Behavioral Therapy on the quality of life of patients with HIV, COVID-19, and anxiety or depression of Social Security.
Design: Experimental open-label randomized clinical trial. To be conducted at the hospital during 6 months.
Materials and Methods:
Participants will be over 18 years of age with HIV from the infectious disease service of the hospital selected for this study. Quality of life, depression, anxiety, multimorbidity and post COVID-19 symptoms will be evaluated. Data will be collected by telephone calls and online questionnaires. Data will be recorded using Redcap online software. To evaluate the effect of virtual cognitive behavioral therapy measured at 4 months, McNemar's Chi-square tests will be used for categorical dependent variables and Student's t-tests for related samples in the case of numerical dependent variables using STATA v. 17.0 statistical software.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients affiliated with Social Security.
- •HIV patients diagnosed with COVID-19, anxiety or depression.
- •Have a telephone to contact them.
- •Family member or adult caregiver of the patient selected for the study and who previously authorized the invitation to the family member or caregiver to participate in the study.
排除标准
- •Difficulty to read and to write
- •Being currently in psychotherapy
- •Clinical diagnoses of neurocognitive or psychotic disorders
结局指标
主要结局
Change in Quality of life
时间窗: Baseline, after 1 and 3 month
Quality of life will be assessed with the Spanish 5-dimensional quality of life questionnaire (EQ-5D-3L). This questionnaire can be used in the general population and essentially consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D-3L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale where the endpoints are labelled 'Best imaginable health state' and 'Worst imaginable health state'. The VAS can be used as a quantitative measure of health outcome that reflects the patient's own judgement.
次要结局
- Change in Anxiety(Baseline, after 1 and 3 month)
- Change in Depression(Baseline, after 1 and 3 month)
研究者
Pavel Jaime Contreras Carmona
Principal Investigator
Universidad Peruana Cayetano Heredia