Intervention Program to Address PTSD in People Living With HIV

NCT05588596 | Completed

• 1 other identifier: 2018040
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this randomised controlled trial is to evaluate the efficacy of an integrated intervention program on post-traumatic stress disorder (PTSD) symptoms and related physiological and psychological indicators of people living with HIV (PLWH). The main question it aims to answer are:

• to evaluate the efficacy of the intervention program on PTSD symptoms and related physiological and psychological indicators of PLWH through empirical research.
• to analyze the mechanism of the intervention. Eligible PLWH were recruited and randomly divided as intervention group and control group. The efficacy of Trauma Resiliency Mindfulness-Informed Intervention on PTSD symptoms and related physiological and psychological indicators in PLWH was evaluated at baseline, after intervention, and 3 months after intervention through this randomized controlled trial. Researchers compared the intervention group and control group to see if it was feasible and had potential clinical value to introduce the Trauma Resiliency Mindfulness-Informed intervention program into the management of PLWH in China.

Conditions

HIV; AIDS; Mindfulness-based Stress Reduction; China; Resilience; PTSD

Outcome Measures

Primary Outcomes (1)

• Change of PTSD symptoms

  PTSD CheckList - Civilian Version (PCL-C) was used. The scale consists of 17 items divided into 3 dimensions. Each dimension is scored from 1 to 5. The total score of PCL-C ranges from 17 to 85, with higher scores indicating severer PTSD symptoms.

  Outcomes were evaluated at baseline, immediately after the intervention, and 3 months follow-up after the intervention

Secondary Outcomes (5)

• Change of depression symptoms

  Outcomes were evaluated at baseline, immediately after the intervention, and 3 months follow-up after the intervention

• Change of resilience

  Outcomes were evaluated at baseline, immediately after the intervention, and 3 months follow-up after the intervention

• Change of rumination

  Outcomes were evaluated at baseline, immediately after the intervention, and 3 months follow-up after the intervention

• Change of perceived social support

  Outcomes were evaluated at baseline, immediately after the intervention, and 3 months follow-up after the intervention

• Change of mindfulness

  Outcomes were evaluated at baseline, immediately after the intervention, and 3 months follow-up after the intervention

Other Outcomes (1)

• Change of medication adherence

  Outcomes were evaluated at baseline, immediately after the intervention, and 3 months follow-up after the intervention

Study Arms (2)

Intervention group

EXPERIMENTAL

Access to routine hospital care and outpatient services. Patients received relevant health counseling provided by the investigator. In addition, Patients received Trauma Resiliency Mindfulness-Informed Intervention, including Mindfulness awareness, body scanning, walking awareness, mindful breathing, etc.

Behavioral: Trauma Resiliency Mindfulness-Informed Intervention

Waitlist group

NO INTERVENTION

Access to routine hospital care and outpatient services. In addition, the patient received relevant health counseling provided by the investigator, including AIDS related knowledge counseling, diet advice, etc. At the end of the study, patients in the waitlist group were provided with intervention.

Interventions

Trauma Resiliency Mindfulness-Informed Intervention BEHAVIORAL

The total duration of the intervention was once a week for eight weeks. The aim of the intervention was to teach patients a range of trauma recovery mindfulness skills

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• aged 18 years or older
• been diagnosed with HIV for more than 1 month
• screened positive with PTSD CheckList - Civilian Version (PCL-C)
• voluntary participation

You may not qualify if:

• impaired Verbal Communication
• have received psychological treatment or related psychological intervention in the past three months

Sponsors & Collaborators

• Central South University: lead

Study Sites (1)

The First Hospital of Changsha

Changsha, Hunan, 0731, China

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Chulei TANG, Doctor

  Central South University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: October 14, 2022
• First Posted: October 20, 2022
• Study Start: May 3, 2020
• Primary Completion: January 30, 2021
• Study Completion: March 30, 2021
• Last Updated: October 20, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

CN (1)