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

National Institute of Medical Sciences and Nutrition, Salvador Zubiran

Status: Unknown

Conditions: HIV; Threat Appraisal

Treatments: Other: Usual Care (UC); Behavioral: Cognitive Behavioral Therapy (CBT)

Study type: Interventional

Funder types: Other

Identifiers

NCT03878186

REF. 2695

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Cognitive behavioral therapy (CBT)

Experimental group

Description:

Cognitive behavioral therapy (CBT). Participants will receive the usual care and 6 sessions of cognitive behavioral therapy

Treatment:

Other: Usual Care (UC)

Behavioral: Cognitive Behavioral Therapy (CBT)

Usual Care (UC)

Other group

Description:

Participants will receive Usual Care only

Treatment:

Other: Usual Care (UC)