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

March 17, 2022 updated by: Pavel Jaime Contreras Carmona, Universidad Peruana Cayetano Heredia

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

182

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Peru
      • Lima, Peru
        • Recruiting
        • Hospital Nacional Alberto Sabogal Sologuren
        • Contact:
        • Principal Investigator:
          • Luis E. Hercilla, MD
        • Principal Investigator:
          • Marcos J. Saavedra, MD
        • Principal Investigator:
          • Juan A. Galvez-Buccollini, MD
        • Principal Investigator:
          • María S. Cuba, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.
No Intervention: Control
They will only receive standard treatment, i.e. psychiatric management with or without drugs.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Quality of life
Time Frame: 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.
Baseline, after 1 and 3 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Anxiety
Time Frame: Baseline, after 1 and 3 month
This condition will be evaluated with the seven-question Generalized Anxiety Disorder (GAD-7), in its Spanish version and with a dichotomous categorization, as well as according to the level of severity. This questionnaire uses a 4-point Likert scale from 0 to 3, with a total score ranging from 0 to 21 points, the higher the score, the greater the degree of anxiety. A score higher than 10 is considered as anxiety.
Baseline, after 1 and 3 month
Change in Depression
Time Frame: Baseline, after 1 and 3 month
This condition will be evaluated using the Patient Health Questionnaire (PHQ-9), a depression scale in its Spanish version, with a dichotomous categorization, as well as according to the level of severity. This nine-question scale awards one point for each response indicating depressive symptoms; the higher the score, the greater the presence of depressive symptoms; from 0 to 4 points is considered normal, mild from 5 to 8 points, moderate from 9 to 10 points and severe from 12 to 15 points.
Baseline, after 1 and 3 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Peruana Cayetano Heredia

Collaborators

University of Minnesota
Hospital Nacional Alberto Sabogal Sologuren

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2022

Primary Completion (Anticipated)

June 1, 2022

Study Completion (Anticipated)

June 1, 2022

Study Registration Dates

First Submitted

January 6, 2022

First Submitted That Met QC Criteria

January 9, 2022

First Posted (Actual)

January 11, 2022

Study Record Updates

Last Update Posted (Actual)

March 31, 2022

Last Update Submitted That Met QC Criteria

March 17, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 207454

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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