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NCT Number: NCT07731568

Efficacy and Underlying Mechanisms of Group Natural Psychotherapy for Anxiety Symptoms

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.

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Key information

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tsinghua University

Beijing, Beijing Municipality, 100084, China

Location status: Recruiting

Location contact

Professor Zhang

CONTACT

[email protected]

+86 18513299860

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CBT-001 Multi-dose

Behavioral

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

Natural Psychotherapy

Behavioral

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Beck Depression Inventory(BDI)

    Time frame: Baseline, After 1 week, After 4 weeks, After 8 weeks

    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.

Other outcomes

  1. Insomnia Severity Index (ISI)

    Time frame: Baseline, After 1 week, After 4 weeks, After 8 weeks

    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.

  2. State-Trait Anxiety Inventory - State Anxiety (STAI-S)

    Time frame: Baseline, After 4 weeks, After 8 weeks

    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.

  3. State-Trait Anxiety Inventory - Trait Anxiety (STAI-T)

    Time frame: Baseline, After 4 weeks, After 8 weeks

    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.

  4. Intolerance of Uncertainty Scale (IUS-12)

    Time frame: Baseline, After 4 weeks, After 8 weeks

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Professor Zhang

CONTACT

[email protected]

+86 18513299860

Sponsors and collaborators

Lead sponsor

Beijing HuiLongGuan Hospital

Other

Collaborators

  • Tsinghua University

Registry information

Official study title

Efficacy and Underlying Mechanisms of Group Natural Psychotherapy for Anxiety Symptoms In Chinese University Students

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 28, 2026
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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