NCT03878186: AppraHIV

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

Status unknown NA Last updated 5 March 2021

What this trial tests

NA trial testing Usual Care (UC) in HIV in 50 participants. Status unknown.

Timeline

26 March 2019

Primary endpoint
31 August 2022

31 August 2023

Quick facts

Lead sponsor	National Institute of Medical Sciences and Nutrition, Salvador Zubiran
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	50
Start date	26 March 2019
Primary completion	31 August 2022
Estimated completion	31 August 2023
Sites	1 location across Mexico

Drugs / interventions tested

• Usual Care (UC)
• Cognitive Behavioral Therapy (CBT)

Conditions studied

• HIV — all drugs for HIV →
• Threat Appraisal — all drugs for Threat Appraisal →

Sponsor

National Institute of Medical Sciences and Nutrition, Salvador Zubiran

Who can join

18 and older, any sex, with HIV or Threat Appraisal. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Development and content validity of EVAD: A novel tool for evaluating and classifying the severity of adverse events for psychotherapeutic clinical trials.
   Mejía-Castrejón J, Sierra-Madero JG, Belaunzarán-Zamudio PF, Fresan-Orellana A, et al · · 2024 · cited 1× · PMID 37552872 · DOI 10.1080/10503307.2023.2239448