NCT07731568

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
1mo left

Started Jul 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress44%
Jul 2026Aug 2026

First Submitted

Initial submission to the registry

July 7, 2026

Completed
3 days until next milestone

Study Start

First participant enrolled

July 10, 2026

Completed
18 days until next milestone

First Posted

Study publicly available on registry

July 28, 2026

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2026

Expected
Last Updated

July 28, 2026

Status Verified

July 1, 2026

Enrollment Period

21 days

First QC Date

July 7, 2026

Last Update Submit

July 25, 2026

Conditions

Anxiety Symptoms

Keywords

anxiety symptomonline group psychotherapyuniversity student

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Beck Depression Inventory（BDI）

    Baseline, After 1 week, After 4 weeks, After 8 weeks

Other Outcomes (4)

  • Insomnia Severity Index (ISI)

    Baseline, After 1 week, After 4 weeks, After 8 weeks

  • State-Trait Anxiety Inventory - State Anxiety (STAI-S)

    Baseline, After 4 weeks, After 8 weeks

  • State-Trait Anxiety Inventory - Trait Anxiety (STAI-T)

    Baseline, After 4 weeks, After 8 weeks

  • +1 more other outcomes

Study Arms (2)

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.

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.

Behavioral: CBT-001 Multi-dose

Interventions

CBT-001 Multi-doseBEHAVIORAL

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.

Also known as: Natural Psychotherapy
Group Cognitive Behavioral Therapy
Natural PsychotherapyBEHAVIORAL

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.

Group Natural Psychotherapy

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tsinghua University

Beijing, Beijing Municipality, 100084, China

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Central Study Contacts

Professor Zhang

CONTACT

+86 18513299860zhangxy99@mail.tsinghua.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 7, 2026

First Posted

July 28, 2026

Study Start

July 10, 2026

Primary Completion

July 31, 2026

Study Completion (Estimated)

August 31, 2026

Last Updated

July 28, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)