Skip to main content
Clinical Trials/NCT05588596
NCT05588596
Completed
N/A

Developing and Validating an Integrative Model Incorporating Mindfulness-based Resilience Intervention to Address Post-Traumatic Stress Disorder in People Living With HIV

Central South University1 site in 1 country82 target enrollmentMay 3, 2020

Overview

Phase
N/A
Intervention
Not specified
Conditions
HIV
Sponsor
Central South University
Enrollment
82
Locations
1
Primary Endpoint
Change of PTSD symptoms
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 3, 2020
End Date
March 30, 2021
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Central South University
Responsible Party
Principal Investigator
Principal Investigator

TANG Chulei

Principal investigator

Central South University

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

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

Outcomes

Primary Outcomes

Change of PTSD symptoms

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

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.

Secondary Outcomes

  • Change of depression symptoms(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 mindfulness(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 resilience(Outcomes were evaluated at baseline, immediately after the intervention, and 3 months follow-up after the intervention)

Study Sites (1)

Loading locations...

Similar Trials