Intervention Program to Address PTSD in People Living With HIV

October 17, 2022 updated by: TANG Chulei, Central South University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
82

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hunan
      • Changsha, Hunan, China, 0731
        • The First Hospital of Changsha

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Intervention group
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
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
NO_INTERVENTION: Waitlist group
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Outcomes were evaluated at baseline, immediately after the intervention, and 3 months follow-up after the intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change of depression symptoms
Time Frame: 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.
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
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
Time Frame: 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
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
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
Time Frame: 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.
Outcomes were evaluated at baseline, immediately after the intervention, and 3 months follow-up after the intervention

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change of medication adherence
Time Frame: 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
Outcomes were evaluated at baseline, immediately after the intervention, and 3 months follow-up after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Central South University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Chulei TANG, Doctor, Central South University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 3, 2020

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 30, 2021

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 30, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 14, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 17, 2022

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 20, 2022

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 20, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 17, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2018040

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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