HIVNCT05588596
Intervention Program to Address PTSD in People Living With HIV
A study testing Trauma Resiliency Mindfulness-Informed Intervention in people with HIV and AIDS, run by Central South University at 1 site in China.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV, AIDS, Mindfulness-based Stress Reduction
- What is being tested?
- Trauma Resiliency Mindfulness-Informed Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteChina
- Study dates
- 3 May 2020to 30 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- impaired Verbal Communication
- have received psychological treatment or related psychological intervention in the past three months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- HIV, AIDS, Mindfulness-based Stress Reduction, China, Resilience, PTSD
- Being tested
- Trauma Resiliency Mindfulness-Informed Intervention
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trauma Resiliency Mindfulness-Informed InterventionBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | 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. Receives: Behavioral: Trauma Resiliency Mindfulness-Informed Intervention |
| Waitlist group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Outcomes were evaluated at baseline, immediately after the intervention, and 3 months follow-up after the intervention
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: Outcomes were evaluated at baseline, immediately after the intervention, and 3 months follow-up after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2022
- Study start3 May 2020
- Primary completion30 Jan 2021
- Study completion30 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, TANG Chulei, Central South University
- Investigators
- Chulei TANG, Doctor, Principal investigator, Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05588596
- Sponsor's protocol ID
- 2018040
- Status last verified
- Oct 2022
- First submitted
- 14 Oct 2022
- Last updated
- 20 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing and Validating an Integrative Model Incorporating Mindfulness-based Resilience Intervention to Address Post-Traumatic Stress Disorder in People Living With HIV
- ClinicalTrials.gov ID
- NCT05588596
- Acronym / sponsor ID
- 2018040
- Conditions
- HIV, AIDS, Mindfulness-based Stress Reduction, China, Resilience, PTSD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Central South UniversityUniversity, hospital or other
- Study start
- 3 May 2020 (actual)
- Primary completion
- 30 Jan 2021 (actual)
- Study completion
- 30 Mar 2021 (actual)
- First posted
- 20 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Trauma Resiliency Mindfulness-Informed InterventionAccess 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. |
| Waitlist group | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- impaired Verbal Communication
- have received psychological treatment or related psychological intervention in the past three months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trauma Resiliency Mindfulness-Informed InterventionThe 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 | Behavioural | Intervention group |
Primary outcome
Change of PTSD symptoms
Time frame: 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.
5 secondary outcomes
Change of depression symptoms
Time frame: Outcomes were evaluated at baseline, immediately after the intervention, and 3 months follow-up after the intervention
Change of resilience
Time frame: Outcomes were evaluated at baseline, immediately after the intervention, and 3 months follow-up after the intervention
Change of rumination
Time frame: Outcomes were evaluated at baseline, immediately after the intervention, and 3 months follow-up after the intervention
Change of perceived social support
Time frame: Outcomes were evaluated at baseline, immediately after the intervention, and 3 months follow-up after the intervention
Change of mindfulness
Time frame: Outcomes were evaluated at baseline, immediately after the intervention, and 3 months follow-up after the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2022.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chulei TANG, Doctor principal investigator
Central South University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trauma Resiliency Mindfulness-Informed Intervention in people with HIV and AIDS, run by Central South University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of PTSD symptoms (time frame: Outcomes were evaluated at baseline, immediately after the intervention, and 3 months follow-up after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2022.