Stress, EmotionalEASYNCT07115186
School-Based Intervention to Enhance Resilience and Stress Coping in Rural Chinese Adolescents
A study testing Psychoeducation, guided written therapy and wait-list condition in people with Stress, Emotional and Stress-related Mental Disorders, run by Peking University at 1 site in China.
Trial summary
This study aims to evaluate the effectiveness of school-based psychological interventions in improving stress resilience and coping skills among adolescents in rural China. The intervention seeks to reduce stress-related mental health symptoms, including depression, anxiety, and post-traumatic stress, measured using… Read more about this study
- Who is it for?
- Ages 10 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress, Emotional, Stress-related Mental Disorders
- What is being tested?
- Psychoeducation, guided written therapy and wait-list condition
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 850 participants
- Where
- 1 siteChina
- Study dates
- 12 May 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 10 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Currently enrolled middle school students attending regular school classes
- Sufficient functional capacity in hearing, speaking, reading, and writing to participate in intervention activities and assessments.
Who cannot join
- Individuals assessed to be at high risk of suicide, based on screening or clinical judgment
- Diagnosis of severe mental disorders (e.g., psychotic disorders, severe mood disorders) that would interfere with participation or require more intensive clinical care
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Feng Junkai, MSc contact
China1 site, 1 recruiting
- Recruiting
Biancun middle school
Hebei, Baoding, 071603
Liang Yachai, 86+ 03125217599
About this study
Official title: Enhancing Stress Resilience and Coping Skills Among Adolescents in Rural China Through School-Based Psychological Interventions: A Cluster Randomized Controlled Trial
This study aims to evaluate the effectiveness of school-based psychological interventions in improving stress resilience and coping skills among adolescents in rural China. The intervention seeks to reduce stress-related mental health symptoms, including depression, anxiety, and post-traumatic stress, measured using validated instruments such as the Patient Health Questionnaire-9 (PHQ-9), the Generalized Anxiety Disorder 7-item scale (GAD-7), and the Child PTSD Symptom Scale for DSM-5 (CPSS-5). (See Appendix for full scale descriptions.)
Participants will be recruited from rural middle schools and randomly assigned to either an intervention group or a wait-list control group. The intervention consists of four sessions delivered over one week. Assessments will be conducted at baseline, immediately after the intervention, and again at a 3-month and 6-month follow-ups.
Researchers will use multilevel modeling (MLM) and structural equation modeling (SEM) to examine potential mediators and moderators of intervention effects, including emotion recognition, alexithymia, and coping strategies. indings are expected to provide evidence on the effectiveness and mechanisms of an existing, school-based psychological intervention tailored to the needs of adolescents in underserved rural settings.
- Conditions
- Stress, Emotional, Stress-related Mental Disorders
- Being tested
- Psychoeducation, guided written therapy, wait-list condition
- Keywords
- adolescents, randomized controlled trial, PTSD, depression, anxiety, stress-related mental disorders, rural area
- Medical subject headings
- Stress, Psychological, Stress Disorders, Post-Traumatic, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsychoeducationBehavioural
Psychoeducation sessions for adolescents focus on essential topics like stress, emotional distress, and mental disorders, offering foundational knowledge to enhance their understanding and ability to manage these challenges effectively.
guided written therapyBehavioural
In the guided writing intervention, students are asked to write about a recent event that triggered strong emotions on paper and, based on the requirements of each session, attempt to regulate their emotions. This approach aims to enhance students' abilities in emotional identification and emotion regulation.
wait-list conditionBehavioural
Participants will engage in their regular school activities, and after the intervention group completes the program, they will receive the same intervention content as the intervention group.
| Study group | Role | What they receive |
|---|---|---|
| TAU + delayed intervention | Active comparator | Participants in this group will receive treatment as usual (TAU), which includes standard school-based support services. They will not receive the study intervention during the trial period but will be offered the full intervention after final outcome assessments. This design enables comparison between the intervention and existing standard care, while ensuring ethical access to the intervention for all participants. Receives: Behavioral: wait-list condition |
| intervention group | Experimental | Participants in the intervention group will receive a structured psychological program consisting of four sessions delivered over the course of one week. Each session is 40 minutes in duration and includes approximately 20 minutes of psychoeducation followed by 20 minutes of a guided writing intervention.
The sessions will cover the following core themes: ① chronic stress and emotional regulation, ② emotional identification and acceptance, ③ cognitive emotion regulation, and ④ the cognitive triangle. Interventions will be administered by trained graduate students in clinical psychology from Peking University. These facilitators will receive specialized training on the intervention protocol, and will conduct pre-intervention assessments and participate in regular supervision. All sessions will be audio and video recorded to monitor treatment fidelity, ensure adherence to the intervention manual, and support supervision and quality assurance procedures. Receives: Behavioral: Psychoeducation; Behavioral: guided written therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
PTSD for adolescents
The Child PTSD Symptom Scale for DSM-5 (CPSS-5) for adolescents and children (scores from 0 to 4, and total scores vary from 0 to 80). A higher score represents worse PTSD symptoms.
Measured: baseline, post treatment (2 weeks after baseline), 3 month after post treatment
Depression
The 9-item patient health questionnaire (PHQ-9) for adults (score ranges from 0 to 3, and the total score varies from 0 to 27). A higher score indicates worse depression symptoms.
Measured: baseline, post treatment (2 weeks after baseline), 3 month after post treatment
Insomnia Severity
The severity of insomnia symptoms will be assessed using the Insomnia Severity Index (ISI). This 7-item self-report measurement evaluates the severity of insomnia symptoms, the level of satisfaction with sleep, interference with daily functioning, noticeability of impairment attributed to sleep problems, and the level of distress caused by sleep disturbance (score from 0 to 4, and total score vary from 0 to 32). Each item is rated on a 5-point scale, providing a comprehensive measure of insomnia severity.
Measured: baseline, post treatment (2 weeks after baseline), 3 month after post treatment
Generalized anxiety disorder
The Generalized Anxiety Disorder-7 scale (GAD-7) for adults, adolescents, and children (scored from 0 to 3, and total score from 0 to 21). A higher score represents worse anxiety symptoms.
Measured: baseline, post treatment (2 weeks after baseline), 3 month after post treatment
Alexithymia
A 22-item Peking alexithymia scale measures thoughts and behaviors that prevent people from feeling or recognizing negative emotions on a 5-point Likert scale (1 to 5, and total scores vary from 22 to 110). A higher score represents more severe alexithymia.
Measured: baseline, post treatment (2 weeks after baseline), 3 month after post treatment
Emotion awareness
A 30-item Emotion awareness questionnaire measures emotion awareness on a 3-point Likert scale (1 to 3, with total scores ranging from 30 to 90). A higher score indicates better emotion awareness.
Measured: baseline, post treatment (2 weeks after baseline), 3 month after post treatment
Secondary outcomes (7)
Resilience
The Connor-Davidson resilience scale is a 10-item resilience measurement scale that measures resilience on a 5-point Likert scale (scores range from 0 to 4, and the total score varies from 0 to 40). A higher score represents better resilience.
Measured: baseline, post treatment (2 weeks after baseline), 3 month after post treatment
Self-esteem
A 10-item self-esteem measurement scale, Rosenberg self-esteem scale, measures self-esteem on a 4-point Likert scale (score from 0 to 3, and total score varies from 0 to 30), with higher scores indicating greater self-esteem.
Measured: baseline, post treatment (2 weeks after baseline), 3 month after post treatment
Subjective Happiness Scale
A 4-item subjective happiness scale measures happiness (score from 1 to 7, and total score vary from 4 to 28). A higher score represents a happier state.
Measured: baseline, post treatment (2 weeks after baseline), 3 month after post treatment
Frustration
The 25-item frustration scale (score from 1 to 5, and total score varies from 24 to 120). A higher score represents less frustration.
Measured: baseline, post treatment (2 weeks after baseline), 3 month after post treatment
Irritability
A 17-item irritability measurement scale, the Peking irritability scale, measures impulsive emotions, thoughts, and behaviors on a 5-point Likert scale (score from 1 to 5, and total score varies from 17 to 85). A higher score represents higher irritability.
Measured: baseline, post treatment (2 weeks after baseline), 3 month after post treatment
Cognitive emotion regulation
An 18-item cognitive emotion regulation questionnaire measures the ability of emotion regulation on a 5-point Likert scale (1 to 5, and total scores vary from 18 to 90). A higher score represents more emotion regulation.
Measured: baseline, post treatment (2 weeks after baseline), 3 month after post treatment
Game Addiction Scale
A 7-item game addiction scale measures game addiction on a 5-point Likert scale (score from 1 to 5, and total score varies from 7 to 35), with higher scores indicating worse game addiction.
Measured: baseline, post treatment (2 weeks after baseline), 3 month after post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2025
- Study start12 May 2025
- Primary completion1 Jun 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress, EmotionalStudies of the same condition, open and under way.
- More trials run by Peking UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 850 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yinyin Zang, PhD, Peking University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07115186
- Sponsor's protocol ID
- School interv. rural Adolscent
- Acronym
- EASY
- Status last verified
- Aug 2025
- First submitted
- 12 May 2025
- Last updated
- 11 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Stress Resilience and Coping Skills Among Adolescents in Rural China Through School-Based Psychological Interventions: A Cluster Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07115186
- Acronym / sponsor ID
- EASY / School interv. rural Adolscent
- Conditions
- Stress, Emotional, Stress-related Mental Disorders
- Keywords
- adolescents, randomized controlled trial, PTSD, depression, anxiety, stress-related mental disorders, rural area
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 850 participants (estimated)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- 12 May 2025 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 11 Aug 2025 (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.
This study aims to evaluate the effectiveness of school-based psychological interventions in improving stress resilience and coping skills among adolescents in rural China. The intervention seeks to reduce stress-related mental health symptoms, including depression, anxiety, and post-traumatic stress, measured using validated instruments such as the Patient Health Questionnaire-9 (PHQ-9), the Generalized Anxiety Disorder 7-item scale (GAD-7), and the Child PTSD Symptom Scale for DSM-5 (CPSS-5). (See Appendix for full scale descriptions.)
Participants will be recruited from rural middle schools and randomly assigned to either an intervention group or a wait-list control group. The intervention consists of four sessions delivered over one week. Assessments will be conducted at baseline, immediately after the intervention, and again at a 3-month and 6-month follow-ups.
Researchers will use multilevel modeling (MLM) and structural equation modeling (SEM) to examine potential mediators and moderators of intervention effects, including emotion recognition, alexithymia, and coping strategies. indings are expected to provide evidence on the effectiveness and mechanisms of an existing, school-based psychological intervention tailored to the needs of adolescents in underserved rural settings.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAU + delayed intervention | Active comparator | Behavioral: wait-list conditionParticipants in this group will receive treatment as usual (TAU), which includes standard school-based support services. They will not receive the study intervention during the trial period but will be offered the full intervention after final outcome assessments. This design enables comparison between the intervention and existing standard care, while ensuring ethical access to the intervention for all participants. |
| intervention group | Experimental | Behavioral: Psychoeducation, Behavioral: guided written therapyParticipants in the intervention group will receive a structured psychological program consisting of four sessions delivered over the course of one week. Each session is 40 minutes in duration and includes approximately 20 minutes of psychoeducation followed by 20 minutes of a guided writing intervention. The sessions will cover the following core themes: ① chronic stress and emotional regulation, ② emotional identification and acceptance, ③ cognitive emotion regulation, and ④ the cognitive triangle. Interventions will be administered by trained graduate students in clinical psychology from Peking University. These facilitators will receive specialized training on the intervention protocol, and will conduct pre-intervention assessments and participate in regular supervision. All sessions will be audio and video recorded to monitor treatment fidelity, ensure adherence to the intervention manual, and support supervision and quality assurance procedures. |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Currently enrolled middle school students attending regular school classes
- Sufficient functional capacity in hearing, speaking, reading, and writing to participate in intervention activities and assessments.
Key exclusion criteria (2 listed)
- Individuals assessed to be at high risk of suicide, based on screening or clinical judgment
- Diagnosis of severe mental disorders (e.g., psychotic disorders, severe mood disorders) that would interfere with participation or require more intensive clinical care
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 |
|---|---|---|
| PsychoeducationPsychoeducation sessions for adolescents focus on essential topics like stress, emotional distress, and mental disorders, offering foundational knowledge to enhance their understanding and ability to manage these challenges effectively. | Behavioural | intervention group |
| guided written therapyIn the guided writing intervention, students are asked to write about a recent event that triggered strong emotions on paper and, based on the requirements of each session, attempt to regulate their emotions. This approach aims to enhance students' abilities in emotional identification and emotion regulation. | Behavioural | intervention group |
| wait-list conditionParticipants will engage in their regular school activities, and after the intervention group completes the program, they will receive the same intervention content as the intervention group. | Behavioural | TAU + delayed intervention |
Primary outcome
PTSD for adolescents
Time frame: baseline, post treatment (2 weeks after baseline), 3 month after post treatment
The Child PTSD Symptom Scale for DSM-5 (CPSS-5) for adolescents and children (scores from 0 to 4, and total scores vary from 0 to 80). A higher score represents worse PTSD symptoms.
Depression
Time frame: baseline, post treatment (2 weeks after baseline), 3 month after post treatment
The 9-item patient health questionnaire (PHQ-9) for adults (score ranges from 0 to 3, and the total score varies from 0 to 27). A higher score indicates worse depression symptoms.
Insomnia Severity
Time frame: baseline, post treatment (2 weeks after baseline), 3 month after post treatment
The severity of insomnia symptoms will be assessed using the Insomnia Severity Index (ISI). This 7-item self-report measurement evaluates the severity of insomnia symptoms, the level of satisfaction with sleep, interference with daily functioning, noticeability of impairment attributed to sleep problems, and the level of distress caused by sleep disturbance (score from 0 to 4, and total score vary from 0 to 32). Each item is rated on a 5-point scale, providing a comprehensive measure of insomnia severity.
Generalized anxiety disorder
Time frame: baseline, post treatment (2 weeks after baseline), 3 month after post treatment
The Generalized Anxiety Disorder-7 scale (GAD-7) for adults, adolescents, and children (scored from 0 to 3, and total score from 0 to 21). A higher score represents worse anxiety symptoms.
Alexithymia
Time frame: baseline, post treatment (2 weeks after baseline), 3 month after post treatment
A 22-item Peking alexithymia scale measures thoughts and behaviors that prevent people from feeling or recognizing negative emotions on a 5-point Likert scale (1 to 5, and total scores vary from 22 to 110). A higher score represents more severe alexithymia.
Emotion awareness
Time frame: baseline, post treatment (2 weeks after baseline), 3 month after post treatment
A 30-item Emotion awareness questionnaire measures emotion awareness on a 3-point Likert scale (1 to 3, with total scores ranging from 30 to 90). A higher score indicates better emotion awareness.
7 secondary outcomes
Resilience
Time frame: baseline, post treatment (2 weeks after baseline), 3 month after post treatment
Self-esteem
Time frame: baseline, post treatment (2 weeks after baseline), 3 month after post treatment
Subjective Happiness Scale
Time frame: baseline, post treatment (2 weeks after baseline), 3 month after post treatment
Frustration
Time frame: baseline, post treatment (2 weeks after baseline), 3 month after post treatment
Irritability
Time frame: baseline, post treatment (2 weeks after baseline), 3 month after post treatment
Cognitive emotion regulation
Time frame: baseline, post treatment (2 weeks after baseline), 3 month after post treatment
Game Addiction Scale
Time frame: baseline, post treatment (2 weeks after baseline), 3 month after post treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2025.
- Individual participant dataSharing planned: Undecided
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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.
Feng Junkai, MSc contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychoeducation, guided written therapy and wait-list condition in people with Stress, Emotional and Stress-related Mental Disorders, run by Peking 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 2 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: looking for participants now, as of the sponsor's last update on 11 Aug 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zang Yinyin, PhD (+86 15553201610, yinyin.zang@pku.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PTSD for adolescents (time frame: baseline, post treatment (2 weeks after baseline), 3 month after post treatment). The study lists 6 primary outcomes in all. 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 11 Aug 2025.