The proposed study is guided by DBT and combined with the actual needs and unique characteristics of young people living with HIV to develop a specialized psychological intervention system suitable for the characteristics of this population.

The actual needs of mental health among young people living with HIV were collected based on literature and qualitative interviews with young people living with HIV. The outline of the qualitative interview mainly included (1) basic information and (2) The main source of stress (infection, drug side-effect, income, life expectancy).

Study subjects in the experimental group received 2 modules of psychological intervention. Module 1 was the basic intervention module, mainly the DBT treatment course, which covers 4 parts: mindfulness, distress tolerance, emotional regulation, and interpersonal effectiveness. The second module is a flexible intervention module applicable to the actual needs of young people living with HIV. As shown in Figure 1.

We set up a user management platform as the support for the intervention. The function of the platform included (1) information management: a complete record with a unique number is generated when each research object is enrolled. The researcher is the system administrator and can add and modify the relevant information of the patient, such as fixed number, basic personal information (deprivatized), clinical and therapeutic information, psychological assessment scale, etc. The system is associated with the VR intervention software, which can record and synchronize the completion of the intervention course of the research object, and the administrator can view and export the corresponding data through the number.

(2) Upload and update intervention resources: the intervention content involved in VR software forms a “resource library” in the management system, and the user portrait is generated when the subject is enrolled in the corresponding intervention content. The user portrait is the virtualization of real users and the category of research objects extracted; that is, the entire psychological intervention system is a big picture. Against this background, different types of subjects receive psychological intervention corresponding to their characteristics to achieve personalized customization. In the course of the experiment, the researchers continuously improved and updated the intervention resources.

(3) The intervention goal setting and process supervision: researchers use motivation type interview (motivational interviewing [MI]) to help subjects set up goals, regularly to supervise the completion of the intervention for subjects, and set a message to remind, intervention to ensure compliance.

VR application development mainly includes 3 stages. First, Scene design is a virtual scene in which the participants experience psychological intervention therapy. This study mainly includes 2 scenes: natural landscape and indoor landscape. The natural landscape was used as the environment for participants to immerse in mindfulness and other skills training. The indoor landscape, including the home environment and the consultation environment, was used for the explanation and learning of psychological intervention courses. Second, regarding interface design, this study follows the principle of consistency of interface structure and style, choosing simple graphical design language and interface style with comfort and color sense. The icon uses a simple 2-dimensional graphic simulation to represent the functional form, which is convenient for the participant to identify and quickly associate the icon function, reducing the possibility of wrong selection. Third, interaction design refers to the use of VR hardware devices such as glasses and gamepads to realize the interaction of subjects in the scene. For example, when the participant enters the “family scene,” he or she can move freely and roam in panorama; through the button control of indoor lighting and curtains, choose the bedroom, living room, consulting room, etc, to carry out the study of psychological courses. As shown in Figure 2.

A 1:1 RCT will be conducted to verify the effectiveness of VR psychological intervention in reducing depression and anxiety in young people living with HIV. The RCT was not possible to blind the participants. The study lasted for 12 months. According to the inclusion and exclusion criteria, the participants are randomly divided into an experimental group and a control group. The experimental group received VR psychological intervention for 3 months, and the control group received non-VR mobile phone intervention for the same period. Data will be collected at 5 time points: baseline, postintervention, 3 months, 6 months, and 9 months after intervention, as shown in Figure 3.

Depression score was measured by the Patient Health Questionnaire-9 (PHQ-9). PHQ-9 is shorter but has demonstrated both good reliability and validity in the Chinese populations [23,24]. The scale consists of 9 items, such as “Little interest or pleasure in doing things” and “Feeling down, depressed, or hopeless,” to measure the depressive status of the participants over the previous 2 weeks. Each item was rated on a 4-point Likert scale ranging from 0 (not at all) to 3 (nearly every day), providing a 0 to 27 total severity score, with higher scores indicating increased depressive symptoms [25].

Anxiety was measured by the Self-rating Anxiety Scale (SAS) that assesses anxiety in the last week with the Chinese version [26,27]. SAS has 20 items with responses of a 4-point Likert scale (1=“never or rarely,” 2=“sometimes,” 3=“most of the time,” 4=“almost every day”). The total score ranges from 20-80, with 50 as a cutoff point, 50-59 being considered mild anxiety, 60-69 as moderate anxiety, and ≥70 as severe anxiety.

Inclusion criteria were a positive HIV test, age 15-24 years, depression score (PHQ-9)≥10 (with depressive symptoms), accepting and being able to use VR devices or mobile apps. Exclusion criteria were taking antipsychotic drugs or, for physical or other reasons, being unable to complete surveys or questionnaires independently, or being unable to accept psychological intervention courses.

The recruitment location is mainly based on Beijing Ditan Hospital Capital Medical University, which is treating 11,735 people in 2023. After clinic doctors have completed all the treatment procedures, researchers will distribute research leaflets to them to introduce the research project and invite them to participate. If the young people living with HIV agree to participate, the program’s researchers will invite the participants to a separate room to be screened for enrollment conditions.

The staff will present the informed consent form of this study and inform the content of the informed consent form, including the introduction of the project, the benefits and possible risks of participating in this study, and the voluntary principle. The research subjects will be asked to sign the informed consent form after they have fully understood it.

The collection of baseline information in this study included 2 items: filling out questionnaires and retaining biological samples. A self-designed questionnaire was used to collect baseline information, including sociodemographic characteristics, medication and treatment information, clinical indicators, and mental health scale evaluation. The electronic questionnaire data can be downloaded directly, which is convenient to timely grasp or correct the information of infected people enrolled on the same day, and ensure the quality of data. To facilitate data collection, improve work efficiency, and improve data collection quality, electronic questionnaires were used at baseline and 3 follow-up visits.

The sample size was calculated according to depression, the main outcome indicator of this study. Participants with PHQ-9 depression scale score ≥10 were classified as having depressive symptoms. It is expected that after intervention, the proportion of depression in the intervention group will be reduced by 20% compared with that in the control group. A bilateral test with a sample size ratio of the test group and control group as 1:1, test efficacy (1-β) as 0.9, and α as .05 was adopted, and a loss rate of 20% is expected. Through the calculation of PASS software (NCSS), 145 study subjects need to be included, and finally, 160 study subjects are rounded up, including 80 in the experimental group and 80 in the control group.

To ensure the balance between the experimental group and the control group, the block randomization method was adopted, code was written in R (R Foundation for Statistical Computing), random numbers were generated according to random seeds, and randomization was carried out to make the allocation of each treatment group more balanced and meet the research requirements. According to the order in which the subjects were enrolled, each participant was given a random number generated by the above random scheme. According to the group corresponding to the random number, the subjects were randomly assigned to the experimental group and the control group.

To improve the compliance of young people living with HIV, this study conducted regular telephone communication with the permission of the study subjects based on unified management through the user management platform to understand the intervention and treatment of the study subjects and give more humanistic care.

To ensure privacy and reduce reporting bias, this study was conducted anonymously, and the VR intervention was free during the study. The fixed and unique number assigned to each research subject when they were enrolled was used as the basis for information matching. After each collection of questionnaires, data was downloaded and backed up on the same day, and the questionnaire platform data was deleted in time. The downloaded questionnaires were formed into a special database and stored encrypted in an unconnected computer for safekeeping by the project leader. At the same time, the VR intervention software and the intervention program of the control group are regularly maintained, network security is regularly checked, user information is protected in many aspects, and security information is set in the application, such as adding mobile phone number association, email association, secret security issues, and the relevant computer professionals are supervised.

Quantitative data were analyzed using SD or demographic characteristics of composition comparison baseline. The t test, ANOVA, or rank sum test were used for hypothesis testing of quantitative data. The chi-square test or Fisher exact probability method was used to test the hypothesis of qualitative data. The effect size would also be calculated. In this study, the intervention effect of the VR psychological intervention system was analyzed using generalized estimating equations (GEE). During the follow-up, the attrition diagram in each group would be plotted over time. In this study, binary classification PHQ-9 is used as the outcome variable, which belongs to longitudinal data, and there is a certain correlation between the data. When conducting statistical analysis of such data, the data correlation should be fully considered. Therefore, GEE was used to analyze the intervention effect to correct for the correlation between data caused by repeated measurements at multiple time points.

The clinical cohort supported by this study is a long-term antiviral treatment cohort, which can ensure the sample size and representativeness of the enrolled participants. The research team includes experts and scholars from various disciplines, including epidemiology and health statistics, clinical medicine, psychology, computer science, technology, etc, to provide professional guidance for the design of a psychological intervention department and the implementation of mental health intervention. The case managers in the research team are from Beijing Red Ribbon Home and have rich experience in providing psychological support for people living with HIV. The Home of Red Ribbon was previously known as the Home of Red Ribbon of Beijing Ditan Hospital, which was established in 1999. On January 5, 2005, the Home of Red Ribbon was registered with the Beijing Municipal Civil Affairs Bureau as the first civil society organization in China specializing in comprehensive HIV/AIDS care. It has 6 independent branches focusing on medical support, self-help of HIV-positive people, volunteer service, social assistance, online publicity, and legal aid. Its purpose is to provide comprehensive support and services for people living with HIV by pooling strength from all social strata, carrying out a variety of HIV prevention and control measures, and health awareness campaigns for enhanced public understanding of HIV.

This study innovatively applied modern VR technology to psychological intervention for young people living with HIV, which provides a new idea for our country to carry out psychological treatment. As a special group, people living with HIV are in urgent need of effective psychological guidance and sensitivity for privacy. This study combines VR technology with psychological intervention, uses an immersive 3D virtual environment to overcome the disadvantages of 2D mobile phone intervention, and avoids the privacy exposure that may be caused by offline medical treatment. It can provide data support and a scientific basis for solving the mental health problems of young people living with HIV in the future.