Intervention Program to Address PTSD in People Living With HIV

HIV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05588596
• Other study ID #: 2018040
• Status: Completed
• Phase: N/A
• Start date: May 3, 2020
• Est. completion date: March 30, 2021

Study information

• Verified date: October 2022
• Source: Central South University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: March 30, 2021
• Est. primary completion date: January 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
China	The First Hospital of Changsha	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Central South University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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