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Supportive Coaching Intervention in PLWHA

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05481294
Enrollment
80
Registered
2022-08-01
Start date
2021-12-16
Completion date
2023-06-30
Last updated
2022-12-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV

Keywords

Serotonin, Quality of Life, Supportive Coaching, PLWHA

Brief summary

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: 1. There is a difference in serotonin levels before and after Transpersonal Supportive Coaching on PLWHA. 2. There is a difference in the quality of life before and after Transpersonal Supportive Coaching on PLWHA

Detailed description

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: 1. 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. 2. Control group I: A group was given only basic support for 4 months and taking ARV therapy. 3. Control group II: A group only taking ARV therapy without any support was given. Statistical analysis: 1. Qualitative analysis using thematic and content analysis with N-Vivo software 2. Quantitative analysis: 1. Univariate analysis using Mean and Standard deviation and percentage with 95% Confidence interval 2. Bivariate analysis using Anova or Kruskal Wallis tests. 3. Multivariate analysis using logistic regression for main effect test and Process version 5.3.5. for mediation test with bootstrapping method 4. Data will analysis using SPSS version 26

Interventions

OTHERTranspersonal Supportive Coaching

Coaching is given for four months (two times a month) with a 45-minute duration per coaching by a professional coach

Standard support is given for four months using a support system provided by Peer Support Foundation

Sponsors

Muh. Yusuf Tahir
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
17 Years to 45 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The change in blood serotonin levelThe 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)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 change in Quality of life (QoL) of PLWHAThe 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).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.

Countries

Indonesia

Contacts

Primary ContactMuh. Yusuf Tahir, PhD (Cand.)
yusuf_0101@yahoo.com+628111885522
Backup ContactFirdaus Hamid, PhD
firdaus.hamid@gmail.com+6281343788836

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026