Supportive Coaching Intervention in PLWHA

HIV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05481294
• Other study ID #: 683/UN4.6.4.5.31./PP36/2021
• Status: Recruiting
• Phase: N/A
• Start date: December 16, 2021
• Est. completion date: June 30, 2023

Study information

• Verified date: December 2022
• Source: Hasanuddin University
• Contact: Muh. Yusuf Tahir, PhD (Cand.)
• Phone: +628111885522
• Email: yusuf_0101[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: June 30, 2023
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 17 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• HIV

Intervention

Other:
• Transpersonal 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
Standard support is given for four months using a support system provided by Peer Support Foundation

Locations

Country	Name	City	State
Indonesia	Yayasan Kelompok Dukungan Sebaya (Peer Support Group Foundation)	Makassar	South Sulawesi

Sponsors (1)

Lead Sponsor	Collaborator
Muh. Yusuf Tahir

Country where clinical trial is conducted

Indonesia, 

References & Publications (19)

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Hui D. Definition of supportive care: does the semantic matter? Curr Opin Oncol. 2014 Jul;26(4):372-9. doi: 10.1097/CCO.0000000000000086. — View Citation

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* Note: There are 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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).