Clinical trial NCT05185921: CBT and Quality of Life of People With HIV, COVID-19 and Anxiety or Depression
Official title: Effectiveness of Virtual Cognitive Behavioral Therapy(CBT) on the Quality of Life of HIV-infected Persons, COVID-19, With Anxiety and Depression, 2021-2022.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Quality of Life
Anxiety
Depression
Keywords: HIV
COVID-19
Cognitive Behavioral Therapy
Lead sponsor: Universidad Peruana Cayetano Heredia
Sponsor class: OTHER
Collaborators: name: Hospital Nacional Alberto Sabogal Sologuren
name: University of Minnesota
First posted: 2022-01-11
Enrollment: 182
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Exclusion Criteria:

* Difficulty to read and to write
* Being currently in psychotherapy
* Clinical diagnoses of neurocognitive or psychotic disorders

Primary outcomes:
measure: Change in Quality of life
timeFrame: Baseline, after 1 and 3 month
Secondary outcomes:
measure: Change in Anxiety
timeFrame: Baseline, after 1 and 3 month
measure: Change in Depression
timeFrame: Baseline, after 1 and 3 month
Other outcomes:
Locations:
city: Lima
country: Peru
facility: Hospital Nacional Alberto Sabogal Sologuren
Study officials:
References: