Anxiety SymptomsNCT07731568
Efficacy and Underlying Mechanisms of Group Natural Psychotherapy for Anxiety Symptoms
A study testing CBT-001 Multi-dose and Natural Psychotherapy in people with Anxiety Symptoms, run by Beijing HuiLongGuan Hospital at 1 site in China.
Trial summary
The goal of this clinical trial is to learn if Natural Psychotherapy(NPT) works to treat anxiety symptoms in university students. It will also learn about the efficacy of Natural Psychotherapy in comparison to CBT. Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Anxiety Symptoms
- What is being tested?
- CBT-001 Multi-dose and Natural Psychotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteChina
- Study dates
- 10 Jul 2026to 31 Aug 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 18 to 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Voluntarily signed the informed consent form
- Generalized Anxiety Disorder-7 (GAD-7) total score≥4
- Chinese
- Aged 18-30 years, currently enrolled as an undergraduate or postgraduate student.
Who cannot join
- Severe depression or high risk of suicide
- History of substance abuse, drug dependence, or psychotic disorders
- Severe neurological diseases, severe somatic illnesses, or other conditions unsuitable for physical labor or physical activities
- History of electroconvulsive therapy (ECT) within the past 6 months, or currently undergoing other pharmacological or systematic psychological treatments.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Tsinghua University
Beijing, Beijing Municipality, 100084
Professor Zhang, +86 18513299860, zhangxy99@mail.tsinghua.edu.cn
About this study
Official title: Efficacy and Underlying Mechanisms of Group Natural Psychotherapy for Anxiety Symptoms In Chinese University Students
The goal of this clinical trial is to learn if Natural Psychotherapy(NPT) works to treat anxiety symptoms in university students. It will also learn about the efficacy of Natural Psychotherapy in comparison to CBT.
The main questions are: Does online group Natural Psychotherapy lower the participants' anxiety symptoms? Is there any difference between NPT and CBT? Researchers will compare online group Natural Psychotherapy to online group Cognitive Behavioral Therapy(CBT) to see if Natural Psychotherapy works better to lower anxiety symptoms.
Read more
Participants will:
Attend online groupNPT or group CBT once a week for 4 weeks; Complete online questionnaires before the intervention, after the first week, after four weeks and after eight weeks.
- Conditions
- Anxiety Symptoms
- Being tested
- CBT-001 Multi-dose, Natural Psychotherapy
- Keywords
- anxiety symptom, online group psychotherapy, university student
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBT-001 Multi-doseBehavioural
Also called Natural Psychotherapy
CBT-1 is a 4-week structured online group cognitive behavioral therapy program tailored for college students with subclinical anxiety. The protocol systematically guides participants to deconstruct anxiety into an interconnected loop of situations, automatic thoughts, and behaviors.
Natural PsychotherapyBehavioural
NPT's principle is fundamentally about fostering a proactive mindset. The participants are encouraged to actively seek out and engage with life's inherent challenges and discomforts as a path to growth. The emphasis is on cultivating courage and initiative as a characterological trait, transforming the individual's relationship with fear itself, rather than solely habituating to specific triggers. This represents a shift from a disorder-specific protocol to a life-oriented philosophy.
| Study group | Role | What they receive |
|---|---|---|
| Group Natural Psychotherapy | Experimental | NPT is a novel approach integrating Japanese Morita therapy and traditional Chinese culture. It proposes three core principles for treating anxiety.
* Week 1 Focuses on the first principle: endure the pain and do what you should do.
* Week 2: the second principle is accept the pain and avoid doing what you should not do.
* Week 3: the third principle is seek pain and do what you fear.
* Week 4 serves as a consolidation phase where participants synthesize their gains into a personalized coping plan for future relapse prevention. Receives: Behavioral: Natural Psychotherapy |
| Group Cognitive Behavioral Therapy | Active comparator | A 4-week structured online group CBT intervention will be delivered weekly (90 mins per session) via an online meeting app.
* Week 1 focuses on psychoeducation regarding anxiety mechanisms and establishing individual CBT loops (Situation-Thought-Emotion-Behavior).
* Week 2 introduces cognitive restructuring to help participants catch automatic thoughts, check cognitive distortions, and generate balanced thoughts.
* Week 3 targets behavioral modifications by helping participants recognize avoidance/safety behaviors and design manageable behavioral experiments ("mini-actions").
* Week 4 serves as a consolidation phase where participants synthesize their gains into a personalized coping plan for future relapse prevention.
Homework compliance (e.g., self-monitoring tables and behavioral logs) is required weekly. Receives: Behavioral: CBT-001 Multi-dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Generalized Anxiety Disorder Assessment (GAD-7)
The GAD-7 is a 7-item, self-reported Likert scale used to assess the severity of participants' anxiety symptoms over the past two weeks. Each item is scored from 0 (not at all) to 3 (nearly every day), yielding a total score ranging from 0 to 21, with higher scores indicating greater anxiety severity. The primary endpoint will evaluate the mean change in GAD-7 scores from baseline (Pre-intervention) to post-intervention (Week 4) to determine the efficacy of the intervention.
Measured: Baseline, After 1 Week, After 4 weeks, After 8 weeks
Secondary outcomes (1)
Beck Depression Inventory（BDI）
The Beck Depression Inventory (BDI) is a 21-item, self-reported Likert scale used to measure the severity of depressive symptoms. Each item is scored on a 4-point scale ranging from 0 to 3. The total score is calculated by summing the scores of all 21 items, yielding a total score range from 0 to 63. Higher total scores indicate more severe depressive symptoms.
Measured: Baseline, After 1 week, After 4 weeks, After 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2026
- Study start10 Jul 2026 (estimated)
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety SymptomsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing HuiLongGuan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Tsinghua University
- Responsible party
- Principal investigator, Xiang Yang Zhang, Beijing HuiLongGuan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07731568
- Sponsor's protocol ID
- ThuPsy-202601
- Status last verified
- Jul 2026
- First submitted
- 7 Jul 2026
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Underlying Mechanisms of Group Natural Psychotherapy for Anxiety Symptoms In Chinese University Students
- ClinicalTrials.gov ID
- NCT07731568
- Acronym / sponsor ID
- ThuPsy-202601
- Conditions
- Anxiety Symptoms
- Keywords
- anxiety symptom, online group psychotherapy, university student
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Beijing HuiLongGuan HospitalUniversity, hospital or other
- Collaborators
- Tsinghua University
- Study start
- 10 Jul 2026 (estimated)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 28 Jul 2026 (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 clinical trial is to learn if Natural Psychotherapy(NPT) works to treat anxiety symptoms in university students. It will also learn about the efficacy of Natural Psychotherapy in comparison to CBT.
The main questions are: Does online group Natural Psychotherapy lower the participants' anxiety symptoms? Is there any difference between NPT and CBT? Researchers will compare online group Natural Psychotherapy to online group Cognitive Behavioral Therapy(CBT) to see if Natural Psychotherapy works better to lower anxiety symptoms.
Participants will:
Attend online groupNPT or group CBT once a week for 4 weeks; Complete online questionnaires before the intervention, after the first week, after four weeks and after eight weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Natural Psychotherapy | Experimental | Behavioral: Natural PsychotherapyNPT is a novel approach integrating Japanese Morita therapy and traditional Chinese culture. It proposes three core principles for treating anxiety. * Week 1 Focuses on the first principle: endure the pain and do what you should do. * Week 2: the second principle is accept the pain and avoid doing what you should not do. * Week 3: the third principle is seek pain and do what you fear. * Week 4 serves as a consolidation phase where participants synthesize their gains into a personalized coping plan for future relapse prevention. |
| Group Cognitive Behavioral Therapy | Active comparator | Behavioral: CBT-001 Multi-doseA 4-week structured online group CBT intervention will be delivered weekly (90 mins per session) via an online meeting app. * Week 1 focuses on psychoeducation regarding anxiety mechanisms and establishing individual CBT loops (Situation-Thought-Emotion-Behavior). * Week 2 introduces cognitive restructuring to help participants catch automatic thoughts, check cognitive distortions, and generate balanced thoughts. * Week 3 targets behavioral modifications by helping participants recognize avoidance/safety behaviors and design manageable behavioral experiments ("mini-actions"). * Week 4 serves as a consolidation phase where participants synthesize their gains into a personalized coping plan for future relapse prevention. Homework compliance (e.g., self-monitoring tables and behavioral logs) is required weekly. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Voluntarily signed the informed consent form
- Generalized Anxiety Disorder-7 (GAD-7) total score≥4
- Chinese
- Aged 18-30 years, currently enrolled as an undergraduate or postgraduate student.
Key exclusion criteria (4 listed)
- Severe depression or high risk of suicide
- History of substance abuse, drug dependence, or psychotic disorders
- Severe neurological diseases, severe somatic illnesses, or other conditions unsuitable for physical labor or physical activities
- History of electroconvulsive therapy (ECT) within the past 6 months, or currently undergoing other pharmacological or systematic psychological treatments.
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 |
|---|---|---|
| CBT-001 Multi-doseAlso: Natural PsychotherapyCBT-1 is a 4-week structured online group cognitive behavioral therapy program tailored for college students with subclinical anxiety. The protocol systematically guides participants to deconstruct anxiety into an interconnected loop of situations, automatic thoughts, and behaviors. | Behavioural | Group Cognitive Behavioral Therapy |
| Natural PsychotherapyNPT's principle is fundamentally about fostering a proactive mindset. The participants are encouraged to actively seek out and engage with life's inherent challenges and discomforts as a path to growth. The emphasis is on cultivating courage and initiative as a characterological trait, transforming the individual's relationship with fear itself, rather than solely habituating to specific triggers. This represents a shift from a disorder-specific protocol to a life-oriented philosophy. | Behavioural | Group Natural Psychotherapy |
Primary outcome
Generalized Anxiety Disorder Assessment (GAD-7)
Time frame: Baseline, After 1 Week, After 4 weeks, After 8 weeks
The GAD-7 is a 7-item, self-reported Likert scale used to assess the severity of participants' anxiety symptoms over the past two weeks. Each item is scored from 0 (not at all) to 3 (nearly every day), yielding a total score ranging from 0 to 21, with higher scores indicating greater anxiety severity. The primary endpoint will evaluate the mean change in GAD-7 scores from baseline (Pre-intervention) to post-intervention (Week 4) to determine the efficacy of the intervention.
1 secondary outcome
Beck Depression Inventory（BDI）
Time frame: Baseline, After 1 week, After 4 weeks, After 8 weeks
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 28 Jul 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBT-001 Multi-dose and Natural Psychotherapy in people with Anxiety Symptoms, run by Beijing HuiLongGuan Hospital 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 4 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 28 Jul 2026. 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 Professor Zhang (+86 18513299860, zhangxy99@mail.tsinghua.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Generalized Anxiety Disorder Assessment (GAD-7) (time frame: Baseline, After 1 Week, After 4 weeks, After 8 weeks). 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 28 Jul 2026.