Efficacy Of A Cognitive Behavioral Therapy To Decrease Threat Appraisal In HIV Participants Initiating Antiretroviral
NCT ID: NCT03878186
Last Updated: 2021-03-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
50 participants
INTERVENTIONAL
2019-03-26
2023-08-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Cognitive behavioral therapy (CBT)
Cognitive behavioral therapy (CBT). Participants will receive the usual care and 6 sessions of cognitive behavioral therapy
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
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.
Usual Care (UC)
Participants will receive Usual Care only
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
Interventions
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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
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Severe depression
* Severe anxiety
* Suicide risk
* Substance dependence
* Cognitive dysfunction
* Psychological or psychiatric treatment within previous 3 months
* Require emergency medical attention
18 Years
ALL
No
Sponsors
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Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente
OTHER
National Institute of Medical Sciences and Nutrition, Salvador Zubiran
OTHER
Responsible Party
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Jessica Mejía Castrejón
Doctoral student. Staff psychologist
Principal Investigators
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Jessica Mejía Castrejón
Role: PRINCIPAL_INVESTIGATOR
Universidad Nacional Autonoma de Mexico
Locations
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Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
Mexico City, , Mexico
Countries
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References
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Ahrari S, Mohammadpour A, Amouzeshi Z, Agha-Yousefi A. The Relationship between Cognitive Appraisal and Adherence to Medical Regimens in Type 2 Diabetic Patients. J Caring Sci. 2014 Dec 1;3(4):277-85. doi: 10.5681/jcs.2014.030. eCollection 2014 Dec.
Kennedy P, Lude P, Elfstrom ML, Smithson E. Cognitive appraisals, coping and quality of life outcomes: a multi-centre study of spinal cord injury rehabilitation. Spinal Cord. 2010 Oct;48(10):762-9. doi: 10.1038/sc.2010.20. Epub 2010 Mar 9.
Bigatti SM, Steiner JL, Miller KD. Cognitive appraisals, coping and depressive symptoms in breast cancer patients. Stress Health. 2012 Dec;28(5):355-61. doi: 10.1002/smi.2444. Epub 2012 Aug 10.
Nogueda-Orozco MJ, Fresán-Orellana A, Vite-Sierra A, Sánchez-Sosa JJ, Robles-García R. Escala de apreciación cognitiva del VIH/SIDA: Adaptación y evaluación psicométrica en población mexicana. Psicología Iberoamericana, 14; 55-60, 2015.
Pakenham K, Rinaldis M. Development of the HIV/AIDS Stress Scale. Psychology and Health, 17(2):203-219, 2002
Pakenham KI, Rinaldis M. The role of illness, resources, appraisal, and coping strategies in adjustment to HIV/AIDS: the direct and buffering effects. J Behav Med. 2001 Jun;24(3):259-79. doi: 10.1023/a:1010718823753.
Meade CS, Wang J, Lin X, Wu H, Poppen PJ. Stress and coping in HIV-positive former plasma/blood donors in China: a test of cognitive appraisal theory. AIDS Behav. 2010 Apr;14(2):328-38. doi: 10.1007/s10461-008-9494-x. Epub 2009 Jan 6.
Robles R, Páez F. Estudio sobre la traducción al español y las propiedades psicométricas de las escalas de afecto positivo y negativo (PANAS). Salud mental, 26(1): 69-75, 2003.
Remor E. Valoración de la adhesión al tratamiento antirretroviral en pacientes VIH positivo. Psicothema,14 (2): 262-267, 2002.
Pena de Leon E, Aguilar Gaytan SS, Suarez Mendoza AA, Reyes Teran G. [A validation of the MOS-HIV quality of life measure in HIV-infected patients in Mexico]. Rev Panam Salud Publica. 2007 May;21(5):313-9. doi: 10.1590/s1020-49892007000400007. Spanish.
Lopez-Alvarenga JC, Vazquez-Velazquez V, Arcila-Martinez D, Sierra-Ovando AE, Gonzalez-Barranco J, Salin-Pascual RJ. [Accuracy and diagnostic utility of the Hospital Anxiety and Depression Scale (HAD) in a sample of obese Mexican patients]. Rev Invest Clin. 2002 Sep-Oct;54(5):403-9. Spanish.
Robles R, Morales M, Jimenez LM, Morales J. Depresión y ansiedad en mujeres con cáncer de mama: el papel de la afectividad y el soporte social. Psicooncología, 6:191-201, 2009.
Molina-Lopez A, Cruz-Islas JB, Palma-Cortes M, Guizar-Sanchez DP, Garfias-Rau CY, Ontiveros-Uribe MP, Fresan-Orellana A. Validity and reliability of a novel Color-Risk Psychiatric Triage in a psychiatric emergency department. BMC Psychiatry. 2016 Feb 10;16:30. doi: 10.1186/s12888-016-0727-7.
Mejia-Castrejon J, Sierra-Madero JG, Belaunzaran-Zamudio PF, Fresan-Orellana A, Molina-Lopez A, Alvarez-Mota AB, Robles-Garcia R. Development and content validity of EVAD: A novel tool for evaluating and classifying the severity of adverse events for psychotherapeutic clinical trials. Psychother Res. 2024 Apr;34(4):475-489. doi: 10.1080/10503307.2023.2239448. Epub 2023 Aug 8.
Other Identifiers
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REF. 2695
Identifier Type: -
Identifier Source: org_study_id
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