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Completed

NCT Number: NCT05588596

Intervention Program to Address PTSD 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.

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Key information

Conditions

HIV AIDS Acquired Immunodeficiency Syndrome Blood-Borne Infections China Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Mental Disorders Mindfulness-based Stress Reduction PTSD RNA Virus Infections Resilience Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Hospital of Changsha

Changsha, Hunan, 0731, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Trauma Resiliency Mindfulness-Informed Intervention

Behavioral

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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

  4. 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.

  5. 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.

Other outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Central South University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 20, 2022
Registry last updated
Oct 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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