AIDS, China, HIV, Mindfulness-based Stress Reduction, PTSD, Resilience
Conditions
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.
Interventions
BEHAVIORALTrauma 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
Sponsors
Central South University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of PTSD symptoms | 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
| Measure | Time frame | Description |
|---|---|---|
| Change of depression symptoms | Outcomes were evaluated at baseline, immediately after the intervention, and 3 months follow-up after the intervention | 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. |
| Change of resilience | Outcomes were evaluated at baseline, immediately after the intervention, and 3 months follow-up after the intervention | 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. |
| Change of perceived social support | Outcomes were evaluated at baseline, immediately after the intervention, and 3 months follow-up after the intervention | 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. |
| Change of mindfulness | Outcomes were evaluated at baseline, immediately after the intervention, and 3 months follow-up after the intervention | 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. |
| Change of rumination | Outcomes were evaluated at baseline, immediately after the intervention, and 3 months follow-up after the intervention | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change of medication adherence | Outcomes were evaluated at baseline, immediately after the intervention, and 3 months follow-up after the intervention | 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 |
Countries
China
Outcome results
None listed