Supportive Coaching Intervention in PLWHA

Study Overview
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Brief Summary
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Introduction: Coaching is a process of self-exploration, thoughts, and feelings followed by actions within the coachee, through the relationship between the coachee and the coach. This process will help discover potencies in oneself as part of psychological and emotional support. Objective: To investigate the effectiveness of Transpersonal Supportive Coaching on Serotonin Levels and Quality of Life PLWHA. Method: This research was conducted using an intervention mixed-methods design which is the integration of quantitative and qualitative approaches to study designs, data collections, and analyses. Alternative hypothesis: There is a difference in serotonin levels before and after Transpersonal Supportive Coaching on PLWHA. There is a difference in the quality of life before and after Transpersonal Supportive Coaching on PLWHA

Detailed Description
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Sampling technique: Purposive sampling Sample Size : The estimation of sample size was calculated using the Slovin formula: n = N / (1 + (N x e²)) n = sample N = population e = margin error (0.05) n = 100/(1+100 x 0.0025) = 80 The sample will be divided into 3 groups (each group = 26.67 or 27). Detailed Intervention: Intervention group: A group was given supportive coaching for 4 months with a 45-minute duration per coaching. It was given two times a month and also taking an antiretroviral (ARV) therapy. Control group I: A group was given only basic support for 4 months and taking ARV therapy. Control group II: A group only taking ARV therapy without any support was given. Statistical analysis: Qualitative analysis using thematic and content analysis with N-Vivo software Quantitative analysis: Univariate analysis using Mean and Standard deviation and percentage with 95% Confidence interval Bivariate analysis using Anova or Kruskal Wallis tests. Multivariate analysis using logistic regression for main effect test and Process version 5.3.5. for mediation test with bootstrapping method Data will analysis using SPSS version 26

Official Title
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The Effectivity of Transpersonal Supportive Coaching Intervention on Serotonin Level and Quality of Life in People Living With HIV/AIDS (PLWHA)

Conditions
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HIV

Intervention / Treatment
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* Other: Transpersonal Supportive Coaching
* Other: Standard Support


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: newly diagnosed with HIV maximum 2 months Stadium I, II Exclusion Criteria: Stadium III and IV Opportunistic infection Drop Out (DO) criteria: Not participating in Supportive Coaching for consecutive 3 times Not taking ARV for 1 week

Ages Eligible for Study
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Minimum Age: 17 Years
Maximum Age: 45 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: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The intervention group was given transpersonal supportive coaching and ARV therapy. Meanwhile, comparison group 1 was given basic support and ARV therapy, and comparison group 2 was only given ARV therapy without any support.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention with Transpersonal Supportive Coaching<br>PLWHA is given coaching using standard operating procedures (SOP) for Transpersonal Supportive Coaching to encourage or guide patients in obtaining support. The necessary tool is a representative room for two people with two chairs. | Other: Transpersonal Supportive Coaching<br>* Coaching is given for four months (two times a month) with a 45-minute duration per coaching by a professional coach<br>|
| Active Comparator: Intervention with Standard Support<br>PLWHA is given standard support provided by peer support foundations | Other: Standard Support<br>* Standard support is given for four months using a support system provided by Peer Support Foundation<br>|
| No Intervention: No Support<br>PLWHA is not given any kind of support | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change in blood serotonin level | Serotonin (5-hydroxytryptamine, 5-HT) is one of the main neurotransmitters in the human brain that could be affected by psychotherapy (i.e., change the serotonin levels). Total serotonin levels in the blood are measured using the Enzyme-linked Immunoassay (ELISA) method with a standard curve range of 70 ng/L-270 ng/L. The change in serotonin level (i.e., mean score) before and after intervention will be statistically assessed. | The baseline level of serotonin in blood is measured on the first day before intervention (pre-intervention) and then compared after 4-months of intervention (post-intervention) | 
| The change in Quality of life (QoL) of PLWHA | Quality of life is defined as individuals' perception of their position in life in the context of the culture and value system in which they live and in relation to their goals, expectations, standards, and concern which measure using the modified World Health Organization's Quality of Life Questionnaire (WHOQOL-BREF) questionnaire in Indonesian version to measure the QoL patients with HIV/AIDS. it is a 31-item instrument consisting of six domains: physical health (4 items), psychological/emotional well-being (5 items), functional/independence (4 items), social (4 items), environmental (8 items) and spiritual satisfaction (4 items). Further, it also contains overall quality of life and general health perception (2 items). Each item's scores range between 1 (very bad) and 5 (very good). A total score and total of each domain at baseline and after the intervention will be statistically assessed. A positive score change indicates good QoL, while a negative indicates worse QoL. | The baseline score of total and each domain of Quality of Life on PLWHA is measured on the first day before intervention (pre-intervention) and then compared after 4-months of intervention (post-intervention). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Serotonin, Quality of Life, Supportive Coaching, PLWHA