Efficacy and Underlying Mechanisms of Group Natural Psychotherapy for Anxiety Symptoms

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.

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 Overview

• Status: Recruiting
• Conditions: Anxiety Symptoms
• Intervention / Treatment: Behavioral: Natural Psychotherapy; Behavioral: CBT-001 Multi-dose

• Study Type: Interventional
• Enrollment (Estimated): 55
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Professor Zhang; Phone Number: +86 18513299860; Email: zhangxy99@mail.tsinghua.edu.cn

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100084
      • Recruiting
      • Tsinghua University
      • Contact: Professor Zhang; Phone Number: +86 18513299860; Email: zhangxy99@mail.tsinghua.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group Natural Psychotherapy; 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.	Behavioral: Natural Psychotherapy; 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.
Active Comparator: Group Cognitive Behavioral Therapy; 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.	Behavioral: CBT-001 Multi-dose; 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.; Other Names: Natural Psychotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, After 1 Week, After 4 weeks, After 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, After 1 week, After 4 weeks, After 8 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Insomnia Severity Index (ISI)	The Insomnia Severity Index (ISI) is a 7-item self-report instrument assessing the nature, severity, and impact of insomnia over the past two weeks. Each item is rated on a 5-point Likert scale from 0 to 4. The total score is obtained by summing all 7 items, ranging from 0 to 28. Higher total scores reflect a higher severity of insomnia symptoms and greater perceived impairment.	Baseline, After 1 week, After 4 weeks, After 8 weeks
State-Trait Anxiety Inventory - State Anxiety (STAI-S)	The State-Trait Anxiety Inventory for State Anxiety (STAI-S) is a 20-item self-report scale evaluating a person's current, transient state of anxiety (how they feel "right now"). Items are scored on a 4-point Likert scale from 1 (not at all) to 4 (very much so). After reverse-scoring appropriate items, the total score ranges from 20 to 80. Higher total scores indicate greater levels of current, situational anxiety.	Baseline, After 4 weeks, After 8 weeks
State-Trait Anxiety Inventory - Trait Anxiety (STAI-T)	The State-Trait Anxiety Inventory for Trait Anxiety (STAI-T) is a 20-item self-report scale assessing relatively stable, long-term personality traits related to anxiety proneness (how they "generally" feel). Items are scored on a 4-point Likert scale from 1 (almost never) to 4 (almost always). After reverse-scoring appropriate items, the total score ranges from 20 to 80. Higher total scores indicate a greater propensity to experience anxiety as a personality trait.	Baseline, After 4 weeks, After 8 weeks
Intolerance of Uncertainty Scale (IUS-12)	The Intolerance of Uncertainty Scale (IUS-12) is a 12-item self-report scale measuring negative emotional, cognitive, and behavioral reactions to uncertainty. Each item is rated on a 5-point Likert scale from 1 (not at all characteristic of me) to 5 (entirely characteristic of me). The total score is computed by summing all items, ranging from 12 to 60. Higher total scores represent a lower tolerance for uncertainty and greater anxiety regarding future events.	Baseline, After 4 weeks, After 8 weeks

Collaborators and Investigators

• Sponsor: Beijing HuiLongGuan Hospital
• Collaborators: Tsinghua University

Study record dates

Study Major Dates

• Study Start (Estimated): July 10, 2026
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): August 31, 2026

Study Registration Dates

• First Submitted: July 7, 2026
• First Submitted That Met QC Criteria: July 25, 2026
• First Posted (Actual): July 28, 2026

Study Record Updates

• Last Update Posted (Actual): July 28, 2026
• Last Update Submitted That Met QC Criteria: July 25, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: university student; anxiety symptom; online group psychotherapy
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: ThuPsy-202601

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No