Supportive Coaching Intervention in PLWHA

NCT05481294 | Unknown

• 1 other identifier: 683/UN4.6.4.5.31./PP36/2021
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Conditions

HIV

Keywords

Serotonin; Quality of Life; Supportive Coaching; PLWHA

Outcome Measures

Primary Outcomes (2)

• 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).

Study Arms (3)

Intervention with Transpersonal Supportive Coaching

EXPERIMENTAL

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

Intervention with Standard Support

ACTIVE COMPARATOR

PLWHA is given standard support provided by peer support foundations

Other: Standard Support

No Support

NO INTERVENTION

PLWHA is not given any kind of support

Interventions

Transpersonal Supportive Coaching OTHER

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

Intervention with Transpersonal Supportive Coaching

Standard Support OTHER

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

Intervention with Standard Support

Eligibility Criteria

• Age: 17 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• newly diagnosed with HIV maximum 2 months
• Stadium I, II

You may not qualify if:

• 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

Sponsors & Collaborators

• Muh. Yusuf Tahir: lead

Study Sites (1)

Yayasan Kelompok Dukungan Sebaya (Peer Support Group Foundation)

Makassar, South Sulawesi, 90231, Indonesia

RECRUITING

Related Publications (19)

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Study Officials

• Yusuf Tahir, PhD (Cand.)

  Hasanudddin University

  PRINCIPAL INVESTIGATOR

• Firdaus Hamid, PhD

  Hasanudddin University

  STUDY CHAIR

• Risna Halim, PhD

  Hasanudddin University

  STUDY CHAIR

• Kusrini S. Kadar, PhD

  Hasanudddin University

  STUDY CHAIR

Central Study Contacts

Muh. Yusuf Tahir, PhD (Cand.)

CONTACT

+628111885522; yusuf_0101@yahoo.com

Firdaus Hamid, PhD

CONTACT

+6281343788836; firdaus.hamid@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecture

Model Details: 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.

Study Record Dates

• First Submitted: July 28, 2022
• First Posted: August 1, 2022
• Study Start: December 16, 2021
• Primary Completion: April 30, 2023
• Study Completion: June 30, 2023
• Last Updated: December 28, 2022

Record last verified: 2022-12

Locations

ID (1)