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

NCT05185921 | Unknown

• 1 other identifier: 207454
• Study Type: interventional
• Target: 182
• Locations: 1 country
• Sites: 1

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.

Conditions

Quality of Life; Anxiety; Depression

Keywords

HIV; COVID-19; Cognitive Behavioral Therapy

Outcome Measures

Primary Outcomes (1)

• Change in Quality of life

  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 Outcomes (2)

• Change in Anxiety

  Baseline, after 1 and 3 month

• Change in Depression

  Baseline, after 1 and 3 month

Study Arms (2)

Cognitive-behavioral therapy virtual

EXPERIMENTAL

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

Control

NO INTERVENTION

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

Interventions

Trial-based Cognitive therapy 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.

Cognitive-behavioral therapy virtual

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Universidad Peruana Cayetano Heredia: lead
• Hospital Nacional Alberto Sabogal Sologuren: collaborator
• University of Minnesota: collaborator

Study Sites (1)

Hospital Nacional Alberto Sabogal Sologuren

Lima, Peru

RECRUITING

Related Links

• Major depressive disorder and its association with adherence to antiretroviral therapy and quality of life: cross-sectional survey of people living with HIV/AIDS in Northwest Ethiopia
• Magnitude and predictors of common mental disorder among people with HIV/AIDS in Ethiopia: a systematic review and meta-analysis
• Internet-Delivered Cognitive Behavioural Therapy for Major Depression and Anxiety Disorders: A Health Technology Assessment
• The Role of Telehealth in Reducing the Mental Health Burden from COVID-19

MeSH Terms

Conditions

Anxiety Disorders; Depression; COVID-19

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: January 6, 2022
• First Posted: January 11, 2022
• Study Start: March 1, 2022
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2022
• Last Updated: March 31, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

PE (1)