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

Study Overview
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Brief Summary
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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.

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

Conditions
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HIV, Threat Appraisal

Intervention / Treatment
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* Other: Usual Care (UC)
* Behavioral: Cognitive Behavioral Therapy (CBT)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cognitive behavioral therapy (CBT)<br>Cognitive behavioral therapy (CBT). Participants will receive the usual care and 6 sessions of cognitive behavioral therapy | Other: Usual Care (UC)<br>* 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<br>Behavioral: Cognitive Behavioral Therapy (CBT)<br>* 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.<br>|
| Other: Usual Care (UC)<br>Participants will receive Usual Care only | Other: Usual Care (UC)<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Threat appraisal: Difference in the average scores of threat appraisal at week 8 (continuous) | 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) | 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 | 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 | 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% | 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 | 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 | 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 | 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 | 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 | 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 | 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. | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, Threat appraisal, Cognitive behavioral therapy, Antiretroviral-naïve, Challenge appraisal, Affect, Adherence, Quality of life, Anxiety, Depression, Viral load, Loss to follow-up