Clinical trial NCT05588596: Intervention Program to Address PTSD in People Living With HIV
Official title: Developing and Validating an Integrative Model Incorporating Mindfulness-based Resilience Intervention to Address Post-Traumatic Stress Disorder in People Living With HIV
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
AIDS
Mindfulness-based Stress Reduction
China
Resilience
PTSD
Lead sponsor: Central South University
Sponsor class: OTHER
First posted: 2022-10-20
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Change of PTSD symptoms
timeFrame: Outcomes were evaluated at baseline, immediately after the intervention, and 3 months follow-up after the intervention
Secondary outcomes:
measure: Change of depression symptoms
timeFrame: Outcomes were evaluated at baseline, immediately after the intervention, and 3 months follow-up after the intervention
measure: Change of resilience
timeFrame: Outcomes were evaluated at baseline, immediately after the intervention, and 3 months follow-up after the intervention
measure: Change of rumination
timeFrame: Outcomes were evaluated at baseline, immediately after the intervention, and 3 months follow-up after the intervention
measure: Change of perceived social support
timeFrame: Outcomes were evaluated at baseline, immediately after the intervention, and 3 months follow-up after the intervention
measure: Change of mindfulness
timeFrame: Outcomes were evaluated at baseline, immediately after the intervention, and 3 months follow-up after the intervention
Other outcomes:
measure: Change of medication adherence
timeFrame: Outcomes were evaluated at baseline, immediately after the intervention, and 3 months follow-up after the intervention
Locations:
city: Changsha
country: China
facility: The First Hospital of Changsha
state: Hunan
Study officials:
affiliation: Central South University
name: Chulei TANG, Doctor
role: PRINCIPAL_INVESTIGATOR
References: