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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

182 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-01

Study Completion Date

2022-06-30

Brief Summary

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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.

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Detailed Description

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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

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Quality of Life Anxiety Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

182 patients selected by simple randomization from a list of people at the Health Center who meet the eligibility criteria will be divided at study enrollment into an intervention group (n=91) and a control group (n=91). Assignment to each group will be 1:1.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cognitive-behavioral therapy virtual

The intervention will be provided by 2 psychotherapists. The total of sessions will be eight carried out weekly, for 2 to 3 months. They will also receive standard treatment, i.e. psychiatric management with or without drugs.

Group Type EXPERIMENTAL

Trial-based Cognitive therapy

Intervention Type BEHAVIORAL

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.

Control

They will only receive standard treatment, i.e. psychiatric management with or without drugs.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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.