NCT03878186

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: National Institute of Medical Sciences and Nutrition, Salvador Zubiran · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• HIV
• Threat Appraisal

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-03-26
• Primary completion: 2022-08-31
• Completion: 2023-08-31
• First posted: 2019-03-18
• Last updated: 2021-03-05

Locations

1 site across 1 country: Mexico