Quality of LifeCOVIHMENT-19NCT05185921
CBT and Quality of Life of People With HIV, COVID-19 and Anxiety or Depression
A study testing Trial-based Cognitive therapy in people with Quality of Life and Anxiety, run by Universidad Peruana Cayetano Heredia at 1 site in Peru.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Quality of Life, Anxiety, Depression
- What is being tested?
- Trial-based Cognitive therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- 1 sitePeru
- Study dates
- 1 Mar 2022to Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Difficulty to read and to write
- Being currently in psychotherapy
- Clinical diagnoses of neurocognitive or psychotic disorders
Trial locations and contacts
1 site in 1 country.
Peru1 site, 1 recruiting
- Recruiting
Hospital Nacional Alberto Sabogal Sologuren
Lima
Pavel J. Contreras, MD, +51943619988, pavel.contreras.c@upch.pe
Luis E. Hercilla, MD
About this study
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.
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.
Read the 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
- Being tested
- Trial-based Cognitive therapy
- Keywords
- HIV, COVID-19, Cognitive Behavioral Therapy
- Medical subject headings
- Anxiety Disorders, Depression, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trial-based Cognitive therapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Trial-based Cognitive therapy |
| Control | No intervention | They will only receive standard treatment, i.e. psychiatric management with or without drugs. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, after 1 and 3 month
Secondary outcomes (2)
Change in Anxiety
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.
Measured: Baseline, after 1 and 3 month
Change in Depression
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.
Measured: Baseline, after 1 and 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start1 Mar 2022
- Primary completionJun 2022 (estimated)
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 182 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Peruana Cayetano Heredia
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Nacional Alberto Sabogal Sologuren, University of Minnesota
- Responsible party
- Principal investigator, Pavel Jaime Contreras Carmona, Universidad Peruana Cayetano Heredia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05185921
- Sponsor's protocol ID
- 207454
- Acronym
- COVIHMENT-19
- Status last verified
- Mar 2022
- First submitted
- 6 Jan 2022
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05185921
- Acronym / sponsor ID
- COVIHMENT-19 / 207454
- Conditions
- Quality of Life, Anxiety, Depression
- Keywords
- HIV, COVID-19, Cognitive Behavioral Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 182 participants (estimated)
- Lead sponsor
- Universidad Peruana Cayetano HerediaUniversity, hospital or other
- Collaborators
- Hospital Nacional Alberto Sabogal Sologuren, University of Minnesota
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 11 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Cognitive-behavioral therapy virtual | Experimental | Behavioral: Trial-based Cognitive therapyThe 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. |
| Control | No intervention | –They will only receive standard treatment, i.e. psychiatric management with or without drugs. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Difficulty to read and to write
- Being currently in psychotherapy
- Clinical diagnoses of neurocognitive or psychotic disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trial-based Cognitive therapyThe 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. | Behavioural | Cognitive-behavioral therapy virtual |
Primary outcome
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.
2 secondary outcomes
Change in Anxiety
Time frame: Baseline, after 1 and 3 month
Change in Depression
Time frame: Baseline, after 1 and 3 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- 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 EthiopiaLink provided by the sponsor.
- Magnitude and predictors of common mental disorder among people with HIV/AIDS in Ethiopia: a systematic review and meta-analysisLink provided by the sponsor.
- Internet-Delivered Cognitive Behavioural Therapy for Major Depression and Anxiety Disorders: A Health Technology AssessmentLink provided by the sponsor.
- The Role of Telehealth in Reducing the Mental Health Burden from COVID-19Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trial-based Cognitive therapy in people with Quality of Life and Anxiety, run by Universidad Peruana Cayetano Heredia at 1 site in Peru.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Peru. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Quality of life (time frame: Baseline, after 1 and 3 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2022.