Efficacy and Underlying Mechanisms of Group Natural Psychotherapy for Anxiety Symptoms
ConditionAnxiety Symptoms
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-30
SponsorBeijing HuiLongGuan Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
CBT-001 Multi-dose
BehavioralCBT-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 Psychotherapy
BehavioralNPT'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.
Treatment groups
55 Participants
are divided into 2 treatment groupsGroup A: Group Natural PsychotherapyExperimental treatment 1 intervention
Group B: Group Cognitive Behavioral TherapyActive comparator 1 intervention
Trial outcomes
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.
Time frame
Baseline, After 1 Week, After 4 weeks, After 8 weeksSecondary 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.
Time frame
Baseline, After 1 week, After 4 weeks, After 8 weeksOther outcomes
1
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.
Time frame
Baseline, After 1 week, After 4 weeks, After 8 weeks2
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.
Time frame
Baseline, After 4 weeks, After 8 weeks3
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.
Time frame
Baseline, After 4 weeks, After 8 weeks4
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.
Time frame
Baseline, After 4 weeks, After 8 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Beijing HuiLongGuan Hospital
Lead sponsor
Tsinghua University
Collaborator
Source ClinicalTrials.gov