NCT05185921

CBT and Quality of Life of People With HIV, COVID-19 and Anxiety or Depression

Effectiveness of Virtual Cognitive Behavioral Therapy(CBT) on the Quality of Life of HIV-infected Persons, COVID-19, With Anxiety and Depression, 2021-2022.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 182 (estimated)
• Sponsor: Universidad Peruana Cayetano Heredia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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. Ethical aspects: The study will be reviewed by the hospital services and the institutional ethics committee. The confidentiality of each participant's information will be maintained through codes that do not allow patient identification.

Conditions

• Quality of Life
• Anxiety
• Depression

Interventions

Type	Name	Description
BEHAVIORAL	Trial-based Cognitive therapy	The virtual CBT will be provided by 02 psychotherapists, who will follow a protocol developed for this study. The number of sessions will be eight, which will be held weekly, projecting an intervention time of 2 to 3 months considering the possibility of rescheduling any of the sessions for reasons derived from the participant People with relevant cognitive impairment that prevents them from answering the questionnaire questions or providing informed consent are excluded.

Timeline

• Start date: 2022-03-01
• Primary completion: 2022-06-01
• Completion: 2022-06-01
• First posted: 2022-01-11
• Last updated: 2022-03-31

Locations

1 site across 1 country: Peru