Efficacy and Underlying Mechanisms of Group-Based Natural Psychotherapy for Anxiety Disorder

This study aims to preliminarily explore the intervention effect and feasibility of group natural psychotherapy (a new Eastern culture-based psychotherapy method) for patients with anxiety disorder through a randomized controlled trial.

Study Overview

• Status: Active, not recruiting
• Conditions: Obsessive - Compulsive Disorder
• Intervention / Treatment: Behavioral: Group-based Natural Psychotherapy

Detailed Description

This study aims to preliminarily explore the intervention effect and feasibility of group natural psychotherapy (a new Eastern culture-based psychotherapy method) for patients with anxiety disorder through a randomized controlled trial. The specific objectives include:

1. Verify the efficacy of group natural psychotherapy: Compare the differences between group natural psychotherapy and conventional treatment in alleviating anxiety and improving the quality of life of patients with anxiety disorder.
2. Evaluate the feasibility of the intervention program: Examine the operability, patient acceptance, and compliance of implementing group natural psychotherapy intervention in a real - clinical environment.
3. Combine cognitive paradigms and functional magnetic resonance imaging (fMRI) technology to explore the cognitive - neural mechanisms of natural psychotherapy in the intervention of anxiety disorder.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China, 230000
      • Natural Psychotherapy

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. Meet the diagnostic criteria for anxiety disorders in the DSM - 5;
2. Aged between 15 and 55 years old;
3. Have a junior high school education or above;
4. The patient agrees to participate in this project and signs the informed consent form.

Exclusion Criteria:

1. Have comorbidities of other severe mental disorders (including schizophrenia, bipolar disorder, and major depressive disorder);
2. Have a lifetime history of substance abuse;
3. Patients with severe neurological diseases, mental retardation, and cognitive impairment;
4. At high risk of suicide or have suicidal behavior;
5. Pregnant or breastfeeding;
6. Have severe physical diseases and infectious diseases.

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: Intervention group; Participants will undergo baseline assessment (T0) prior to the intervention, followed by a 4 week Natural Psychotherapy treatment in group setting. The group therapy will be delivered once per week, with each session lasting 2-3 hours. Post-intervention assessment (T1) will be conducted immediately after the completion of the intervention, and a follow-up assessment will be carried out 1 month after treatment termination (T2).	Behavioral: Group-based Natural Psychotherapy; Patients will be divided into 3-4 groups, with each group comprising 8-10 patients, led by one psychotherapist. The intervention will last 4 weeks, with all patients required to participate in weekly face-to-face group sessions, each lasting 2-3 hours. The weekly group sessions are the core of the treatment and consists of two parts: (1) phase-specific psychoeducation on the theoretical principles of Natural Psychotherapy; (2) experiential learning through carefully designed activities to facilitate personal experience and understanding of the theoretical content. Homework is assigned after each group session, such as writing treatment diaries and daily exercise plans. The psychotherapists review patients' treatment diaries daily according to guiding principles and provide feedback, offering key guidance and support. Exercise is emphasized as a core component of active action within the Natural Psychotherapy; participants will develop personalized weekly exercise plans during group ses
No Intervention: Waiting-list control group; Participants in the control group will receive baseline assessments prior to the waiting period and will continue their treatment-as-usual (TAU) while being placed on a waiting list for 4 weeks. Post-waiting assessment (T1) will be conducted at the end of the waiting period. After T1, the control group patients will receive the same group therapy as the intervention group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Generalized Anxiety Disorder-7 (GAD-7)	The GAD-7 is a brief self-report questionnaire designed to assess the severity of generalized anxiety symptoms (Spitzer et al., 2006). It consists of seven items, with higher scores indicating greater severity of anxiety. Clinical cut-off scores are: 0-4 (minimal/no clinical anxiety), 5-9 (mild), 10-14 (moderate), and ≥ 15 (severe). The Chinese version of the GAD-7 has demonstrated good reliability and validity, with high internal consistency (Cronbach's α = 0.93) and satisfactory test-retest reliability (ICC = 0.71-0.87; Zhang et al., 2021).	week 0; week 4; week 8
State-Trait Anxiety Inventory (STAI)	The STAI consists of two subscales (Spielberger et al., 1970): the State Anxiety Inventory (S-Anxiety, Items 1-20) and the Trait Anxiety Inventory (T-Anxiety, Items 21-40). The S-Anxiety subscale reflects transient feelings of tension, apprehension and nervousness in response to stressors, while the T-Anxiety subscale assesses relatively stable individual differences in anxiety proneness. Both subscales use a 4-point Likert scale (total scores 20-80), with higher scores indicating higher levels of anxiety; certain items are reverse-scored. The Chinese version shows robust reliability and validity, with high internal consistency (Cronbach's α = 0.91-0.92), strong test-retest reliability (0.76-0.91), and significant correlations with the HAMA (r = 0.69-0.74; Ma et al., 2012).	week 0; weeek 4; week 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intolerance of Uncertainty Scale (IUS)	The IUS is a standard self-report measure for evaluating intolerance of uncertainty (IU). This study uses the 12-item short-form (IUS-12) (Carleton, Sharpe, et al., 2007), which has been validated in Chinese populations (Zhang Y. et al., 2017). Items are rated on a 5-point scale from 0 (not at all characteristic) to 4 (entirely characteristic), with higher total scores indicating higher IU. IUS-12 includes two factors: Prospective IU (Items 1-7) and Inhibitory IU (Items 8-12), though research suggests the total score is a psychometrically sound representation of the construct (Hale et al., 2016; Shihata et al., 2018).	week 0; weeek 4; week 8
Quality of Life Scale (QOL)	The QOL is a concise self-report tool for assessing individuals' overall quality of life over the past month, emphasizing subjective perceptions across key life domains. The scale comprises 7 items, with the first 6 items evaluating quality of life in physical health, mental and psychological state, economic status, work (or study) situation and interpersonal relationships with family and others, using a 5-point scoring system from "very poor" to "very good" (scored 1-5); these 6 items are summed to obtain the QOL total score. Item 7 is a self-rating of overall quality of life on a 0-100 scale, denoted as QOL score, reflecting individuals' comprehensive evaluation of their overall quality of life.	week 0; weeek 4; week 8

Other Outcome Measures

Outcome Measure	Time Frame
Revised Beads Task	week 0; weeek 4
Emotional Color-word Stroop	week 0; weeek 4
Resting-state functional Magnetic Resonance Imaging (fMRI)	week 0; week 4

Collaborators and Investigators

• Sponsor: Beijing HuiLongGuan Hospital
• Collaborators: Institute of Psychology, Chinese Academy of Sciences; Fourth People's Hospital in Hefei

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: April 2, 2026
• First Submitted That Met QC Criteria: April 2, 2026
• First Posted (Actual): April 8, 2026

Study Record Updates

• Last Update Posted (Actual): April 8, 2026
• Last Update Submitted That Met QC Criteria: April 2, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Obsessive - Compulsive Disorder; Natural Psychotherapy
• Additional Relevant MeSH Terms: Mental Disorders; Personality Disorders; Compulsive Personality Disorder
• Other Study ID Numbers: NPAD26

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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