Efficacy Of A Cognitive Behavioral Therapy To Decrease Threat Appraisal In HIV Participants Initiating Antiretroviral (AppraHIV)

March 4, 2021 updated by: Jessica Mejía Castrejón, National Institute of Medical Sciences and Nutrition, Salvador Zubiran

Efficacy Of A Cognitive Behavioral Therapy To Decrease Threat Appraisal In Participants With HIV Infection Initiating Antiretroviral Treatment: Clinical Trial

Studies in the field of health and HIV indicate that threat appraisal is associated with poor adherence to treatment, anxiety, poor quality of life, avoidance behavior, less antiretroviral adherence, negative affect, social, instrumental and emotional stress, depression, global distrés, poor subjective health and psychological distres. Most psychological interventions have been oriented to behavioral aspects, leaving aside cognitive aspects such as threat appraisal, so is necessary to investigate psychological treatments and its impact in threat appraisal an in an clinical and psychological outcomes.

Primary objective: To evaluate the efficacy of a cognitive behavioral therapy (CBT) to decrease threat appraisal in comparison with Usual Care (UC) in HIV patients initiating antiretroviral treatment at week 8.

Secondary objectives: To evaluate the effect of a cognitive behavioral therapy intervention compared with Usual Care in HIV patients initiating antiretroviral treatment in the following variables: challenge appraisal, affect (positive and negative), adherence, quality of life, anxiety and depression, HIV viral load and loss to follow-up at weeks 8, 20 and 52.

Exploratory objectives: To assess the threat appraisal cut-off value that predicts favorable outcomes in adherence, virologic suppression, retention in care and adverse events at week 52.

The study is an open label, single center, parallel group clinical trial, in which 50 participants will be randomly assigned using a blocked design to one of the 2 arms: Usual Care (single individual psycho-educative session) or Cognitive Behavioral Therapy (Usual care + 6 sessions of individual Cognitive Behavioral Therapy). The sample will be conformed with 50 adults with HIV, naïve to ARV treatment, starting care at INCMNSZ, who have scores of threat appraisal ≥40 in the CEAT scale, without severe mental disorders or cognitive impairment. We will use independent t test and chi square and intention to treat analysis for the primary outcome, also for secondary outcomes t student for continuous variables, chi square for categorical variables and per protocol analysis in participants adherent to the intervention.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

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

  • Mexico
      • Mexico City, Mexico, 14080
        • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

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:

  • At least 18 years of age
  • HIV diagnosis confirmed
  • Naïve to antiretroviral treatment
  • Threat appraisal greater than or equal to 40%
  • Enrolled at INCMNSZ for medical care
  • Be able to read and write
  • Willing and able to provide written informed consent

Exclusion Criteria:

  • Psychotic symptoms
  • Severe depression
  • Severe anxiety
  • Suicide risk
  • Substance dependence
  • Cognitive dysfunction
  • Psychological or psychiatric treatment within previous 3 months
  • Require emergency medical attention

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cognitive behavioral therapy (CBT)
Cognitive behavioral therapy (CBT). Participants will receive the usual care and 6 sessions of cognitive behavioral therapy
Other: Usual Care (UC)
Usual Care: single in-person psycho-educative session with information about HIV, transmission, natural history of the disease, importance of antiretroviral adherence. All the information is based on guidelines and information sheets from InfoVIHt
Behavioral: Cognitive Behavioral Therapy (CBT)
Cognitive behavioral therapy (CBT): Usual Care + Cognitive-behavioral therapy program intervention (AppraHIV). This intervention involves 7 in-person weekly sessions based on Adjuvant Psychological Therapy centered in three areas: cognitive appraisal, affect and adherence and self-care, everyone with different techniques: cognitive techniques, diaphragmatic breathing, scheduling pleasurable activities, use of pillbox, solving problems, planning for the future, etc. The intervention was manualized (according to Template for Intervention Description and Replication TIDieR), piloted and validated.
Other: Usual Care (UC)
Participants will receive Usual Care only
Other: Usual Care (UC)
Usual Care: single in-person psycho-educative session with information about HIV, transmission, natural history of the disease, importance of antiretroviral adherence. All the information is based on guidelines and information sheets from InfoVIHt

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Threat appraisal: Difference in the average scores of threat appraisal at week 8 (continuous)
Time Frame: Measured at baseline and week 8
Subscale of threat appraisal from HIV/AIDS Stress Scale (EAC-VIH). The subescale of threat appraisal is a validated self-report questionnaire, with 6 items. Participants rate how much they perceived HIV-related problem has damaged different areas (including life goals, self-respect and health) according to likert scale from 1 (no harm) to 5 (extremely harmful). Scores are summed and transformed in percentages. High values indicate worst severity of threat.
Measured at baseline and week 8
Threat appraisal: Proportion of subjects with success (change >54% in threat appraisal at week 8 (nominal binary)
Time Frame: Measured at baseline and week 8
Subscale of threat appraisal from HIV/AIDS Stress Scale (EAC-VIH). The subescale of threat appraisal is a validated self-report questionnaire, with 6 items. Participants rate how much they perceived HIV-related problem has damaged different areas (including life goals, self-respect and health) according to likert scale from 1 (no harm) to 5 (extremely harmful). Scores are summed and transformed in percentages. High values indicate worst severity of threat.
Measured at baseline and week 8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Challenge appraisal: Difference in the average scores of challenge appraisal
Time Frame: Measured at baseline and weeks 8, 20 and 52
Subscale of challenge appraisal from HIV/AIDS Stress Scale (EAC-VIH). The subescale of challenge appraisal is a validated self-report questionnaire with 3 items. Participants indicate the extent to which the HIV-problem related provided potential for personal growth, personal challenge or strengthening for a relationship. Challenge appraisal is rated according to 5 Likert scale from 1 (nil potential) to 5 (high potential). Scores are summed and transformed in percentages. High values indicate high potential for growth.
Measured at baseline and weeks 8, 20 and 52
Positive and negative affect: Difference in the average scores of positive and negative affect
Time Frame: Measured at baseline and weeks 8, 20 and 52
Positive and negative affect Schedule (PANAS): PANAS is a validated self-report measure of affect. This scale has 20 items distributed in 2 scales (positive affect and negative affect) The subjects are instructed to rate the extent to which they experienced each mood state on a 5-point scale (1= very slightly or not at all - 5 = extremely) during the past week. The total score is the sum of the 10 positive items and the 10 negative items. Scores range from 10 to 50 for both set of items. High scores in positive affect indicate high pleasant states. High scores in negative affect indicate high unpleasant states.
Measured at baseline and weeks 8, 20 and 52
Adherence to HIV therapy: Proportion of subjects with adherence >85%
Time Frame: Measured at baseline and weeks 8, 20 and 52
Questionnaire to evaluate the adherence to HIV therapy (CEAT-VIH). CEAT-VIH is a self-reported questionnaire that assess the level of adherence to antiretroviral therapy. This multidimensional questionnaire has 20 items. Most items are rated using likert scale. The scores range from 17 to 89. Strict adherence = percentile ≥ 85, insufficient adherence = ≤84.
Measured at baseline and weeks 8, 20 and 52
Health related quality of life: Difference in the average scores of quality of life
Time Frame: Measured at baseline and weeks 8, 20 and 52
Medical Outcomes Study HIV Health Survey (MOS-HIV). MOS-HIV is a self-administered measure of functional status and well-being in HIV patients. It includes 35 items and assesses 10 dimensions. The scores are transformed to a standardized scale ranging from 0% to 100%, where higher scores indicate better quality of life.
Measured at baseline and weeks 8, 20 and 52
Depression and anxiety: Difference in the average scores of depression and anxiety
Time Frame: Measured at baseline and weeks 8, 20 and 52
Hospital Anxiety and Depression Scale (HAD). HADS is a fourteen ítem scale with 2 scales. Seven of the items evaluate anxiety, and seven evaluate depression. Each scale rage from 0 to 21. Higher scores indicate higher anxiety/depression complains.
Measured at baseline and weeks 8, 20 and 52
Social support: Propotion of subjects with high social support and success in CBT
Time Frame: Measured at baseline and weeks 8, 20 and 52
Social Support Questionnaire (SSQ-6). The SSQ-6 quantifies the number of social supports, and satisfaction with social support that is available. The satisfaction ratings are on a 6 point scale ranging from 1 (very dissatisfied) to 6 (very satisfied). The score is calculated averaging the satisfaction score ratings. Scores ≥ 5 in satisfaction with social support will be considered as high social support in this investigation.
Measured at baseline and weeks 8, 20 and 52
Viral load: Proportion of subjects with viral supression
Time Frame: Measured at baseline and month 2, 6 and 10
Changes in RNA viral load. Viral suprression (cv<400copies/ml)
Measured at baseline and month 2, 6 and 10
Loss to follow-up. Proportion of subjects with loss to follow-up
Time Frame: Measured at weeks 8, 20 and 52
Measure of any missing visit (any missing visits = loss to follow-up)
Measured at weeks 8, 20 and 52
Adverse events: Frequency and severity of adverse events
Time Frame: Intentional evaluation: Every week until week 8 Report of adverse events until week 52
Intentional detection of adverse events will be done using a checklist designed for this study. Classification of adverse events will be done using a modified version of Color-Risk Psychiatric Triage (CRPT)
Intentional evaluation: Every week until week 8 Report of adverse events until week 52
Demographic data: Proportion of subjects by subgroups (age, viral load, etc.), with success in CBT.
Time Frame: Measured at week 8, 20 and 52
Demographic data. Succes: change of 54% in threat appraisal
Measured at week 8, 20 and 52
Change in threat appraisal and challenge appraisal in every group (CBT, UC)
Time Frame: Measured at week 8, 20 and 52
The subescale of threat appraisal is a validated self-report questionnaire, with 6 items. Participants rate how much they perceived HIV-related problem has damaged different areas (including life goals, self-respect and health) according to likert scale from 1 (no harm) to 5 (extremely harmful). Scores are summed and transformed in percentages. High values indicate worst severity of threat.
Measured at week 8, 20 and 52

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence
Time Frame: Measured at week 52
Proportion of participants with adherence ≥95% (Pharmacy pick-up)
Measured at week 52
Viral supression
Time Frame: Measured at month 10
Proportion of participants with viral suppression (viral load ≤400/ml)
Measured at month 10
Retention in care
Time Frame: Measured at week 52
Proportion of participants retained in care (at least 2 clinic visits per year separated by at least 90 days)
Measured at week 52
Adverse events
Time Frame: Measured at week 52
Proportion of participants with adverse events
Measured at week 52

Collaborators and Investigators

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

Sponsor

National Institute of Medical Sciences and Nutrition, Salvador Zubiran

Collaborators

Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente

Investigators

  • Principal Investigator: Jessica Mejía Castrejón, Universidad Nacional Autonoma de Mexico

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.

General Publications

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 26, 2019

Primary Completion (Anticipated)

August 31, 2022

Study Completion (Anticipated)

August 31, 2023

Study Registration Dates

First Submitted

February 9, 2019

First Submitted That Met QC Criteria

March 13, 2019

First Posted (Actual)

March 18, 2019

Study Record Updates

Last Update Posted (Actual)

March 5, 2021

Last Update Submitted That Met QC Criteria

March 4, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • REF. 2695

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No. There is not a plan to make individual participant data IPD available

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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