Efficacy Of A Cognitive Behavioral Therapy To Decrease Threat Appraisal In Participants With HIV Infection Initiating Antiretroviral Treatment: Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Threat appraisal: Difference in the average scores of threat appraisal at week 8 (continuous)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Psychotic symptoms
- •Severe depression
- •Severe anxiety
- •Suicide risk
- •Substance dependence
- •Cognitive dysfunction
- •Psychological or psychiatric treatment within previous 3 months
- •Require emergency medical attention
结局指标
主要结局
Threat appraisal: Difference in the average scores of threat appraisal at week 8 (continuous)
时间窗: 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.
Threat appraisal: Proportion of subjects with success (change >54% in threat appraisal at week 8 (nominal binary)
时间窗: 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.
次要结局
- Adherence to HIV therapy: Proportion of subjects with adherence >85%(Measured at baseline and weeks 8, 20 and 52)
- Challenge appraisal: Difference in the average scores of challenge appraisal(Measured at baseline and weeks 8, 20 and 52)
- Adverse events: Frequency and severity of adverse events(Intentional evaluation: Every week until week 8 Report of adverse events until week 52)
- Health related quality of life: Difference in the average scores of quality of life(Measured at baseline and weeks 8, 20 and 52)
- Depression and anxiety: Difference in the average scores of depression and anxiety(Measured at baseline and weeks 8, 20 and 52)
- Social support: Propotion of subjects with high social support and success in CBT(Measured at baseline and weeks 8, 20 and 52)
- Loss to follow-up. Proportion of subjects with loss to follow-up(Measured at weeks 8, 20 and 52)
- Change in threat appraisal and challenge appraisal in every group (CBT, UC)(Measured at week 8, 20 and 52)
- Positive and negative affect: Difference in the average scores of positive and negative affect(Measured at baseline and weeks 8, 20 and 52)
- Viral load: Proportion of subjects with viral supression(Measured at baseline and month 2, 6 and 10)
- Demographic data: Proportion of subjects by subgroups (age, viral load, etc.), with success in CBT.(Measured at week 8, 20 and 52)
研究者
Jessica Mejía Castrejón
Doctoral student. Staff psychologist
Universidad Nacional Autonoma de Mexico