Supportive Coaching Intervention in PLWHA

December 24, 2022 updated by: Muh. Yusuf Tahir

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Indonesia
    • South Sulawesi
      • Makassar, South Sulawesi, Indonesia, 90231
        • Recruiting
        • Yayasan Kelompok Dukungan Sebaya (Peer Support Group Foundation)
        • Contact:
          • Rahman Rahim
          • Phone Number: +6281342122955
        • Principal Investigator:
          • Muh.Yusuf Tahir, PhD (Cand.)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years to 45 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention with Transpersonal Supportive Coaching
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
Coaching is given for four months (two times a month) with a 45-minute duration per coaching by a professional coach
Active Comparator: Intervention with Standard Support
PLWHA is given standard support provided by peer support foundations
Other: Standard Support
Standard support is given for four months using a support system provided by Peer Support Foundation
No Intervention: No Support
PLWHA is not given any kind of support

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The change in blood serotonin level
Time Frame: 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)
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
Time Frame: 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).
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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Muh. Yusuf Tahir

Investigators

  • Principal Investigator: Yusuf Tahir, PhD (Cand.), Hasanudddin University
  • Study Chair: Firdaus Hamid, PhD, Hasanudddin University
  • Study Chair: Risna Halim, PhD, Hasanudddin University
  • Study Chair: Kusrini S. Kadar, PhD, Hasanudddin University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 16, 2021

Primary Completion (Anticipated)

April 30, 2023

Study Completion (Anticipated)

June 30, 2023

Study Registration Dates

First Submitted

July 28, 2022

First Submitted That Met QC Criteria

July 29, 2022

First Posted (Actual)

August 1, 2022

Study Record Updates

Last Update Posted (Actual)

December 28, 2022

Last Update Submitted That Met QC Criteria

December 24, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 683/UN4.6.4.5.31./PP36/2021

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe