Intervention Program to Address PTSD in People Living With HIV

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

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.

Study Overview

• Status: Completed
• Conditions: PTSD; HIV; Resilience; AIDS; Mindfulness-based Stress Reduction; China
• Intervention / Treatment: Behavioral: Trauma Resiliency Mindfulness-Informed Intervention

• Study Type: Interventional
• Enrollment (Actual): 82
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China, 0731
      • The First Hospital of Changsha

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Intervention group; 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; 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
NO_INTERVENTION: Waitlist group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of depression symptoms	The Zung Self-Rating Depression Scale (SDS) was used. The scale consists of 20 items. Each dimension is scored from 1 to 4. The total score ranges from 20 to 80, with higher scores indicating severer depression symptoms.	Outcomes were evaluated at baseline, immediately after the intervention, and 3 months follow-up after the intervention
Change of resilience	The Connor-Davidson Resilience Scale (CD-RISC) was used. The scale consists of 25 items. Each dimension is scored from 0 to 4. The total score ranges from 0 to 100, with higher scores indicating higher resilience.	Outcomes were evaluated at baseline, immediately after the intervention, and 3 months follow-up after the intervention
Change of rumination	The Ruminative Responses Scale (RRS) was used. The scale consists of 22 items. Each dimension is scored from 1 to 4. The total score ranges from 22 to 88, with higher scores indicating higher rumination	Outcomes were evaluated at baseline, immediately after the intervention, and 3 months follow-up after the intervention
Change of perceived social support	The Multidimensional Scale of Perceived Social Support (MSPSS) was used. The scale consists of 12 items. Each dimension is scored from 1 to 7. The total score ranges from 12 to 84, with higher scores indicating higher perceived social support.	Outcomes were evaluated at baseline, immediately after the intervention, and 3 months follow-up after the intervention
Change of mindfulness	The Short Inventory of Mindfulness Capability (SIM-C) was used. The scale consists of 12 items. Each dimension is scored from 1 to 5. The total score ranges from 12 to 60, with higher scores indicating higher mindfulness.	Outcomes were evaluated at baseline, immediately after the intervention, and 3 months follow-up after the intervention

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of medication adherence	0 (0%)~10 (100%) grade was adopted for scoring. Evaluate the condition of patients taking antiretroviral drugs according to doctor's orders in the past month	Outcomes were evaluated at baseline, immediately after the intervention, and 3 months follow-up after the intervention

Collaborators and Investigators

• Sponsor: Central South University
• Investigators: Principal Investigator: Chulei TANG, Doctor, Central South University

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 3, 2020
• Primary Completion (ACTUAL): January 30, 2021
• Study Completion (ACTUAL): March 30, 2021

Study Registration Dates

• First Submitted: October 14, 2022
• First Submitted That Met QC Criteria: October 17, 2022
• First Posted (ACTUAL): October 20, 2022

Study Record Updates

• Last Update Posted (ACTUAL): October 20, 2022
• Last Update Submitted That Met QC Criteria: October 17, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 2018040

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No