Intervention Program to Address PTSD in People Living With HIV

Study 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.

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

Conditions
-----------------
HIV, AIDS, Mindfulness-based Stress Reduction, China, Resilience, PTSD

Intervention / Treatment
-----------------
* Behavioral: Trauma Resiliency Mindfulness-Informed Intervention


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>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<br>* 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<br>|
| No Intervention: Waitlist group<br>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 |