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Active, not recruitingNCT07518264Updated Jul 1, 2026

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

An interventional study of Group-based Natural Psychotherapy in Obsessive - Compulsive Disorder, sponsored by Beijing HuiLongGuan Hospital. Active, not recruiting at 1 site in China. Open to participants aged 15 Years to 55 Years. Per ClinicalTrials.gov, last updated 2026-07-01.

Sponsored by Beijing HuiLongGuan Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
15 Years to 55 Years
Sex
All
01

Study summary

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.

Read the 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.
02

Conditions studied

  • Obsessive - Compulsive Disorder

Keywords

  • Obsessive - Compulsive Disorder
  • Natural Psychotherapy
03

Who can participate

Ages eligible
15 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • 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

  • 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.

Interventions

  • BehavioralGroup-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

05

What researchers measure

Primary outcomes

  1. 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).

    Time frame: week 0; week 4; week 8

  2. 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).

    Time frame: week 0; weeek 4; week 8

Secondary outcomes

  1. 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).

    Time frame: week 0; weeek 4; week 8

  2. 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.

    Time frame: week 0; weeek 4; week 8

Other outcomes

  1. Revised Beads Task

    Time frame: week 0; weeek 4

  2. Emotional Color-word Stroop

    Time frame: week 0; weeek 4

  3. Resting-state functional Magnetic Resonance Imaging (fMRI)

    Time frame: week 0; week 4

06

Study locations

1 site
  • Natural Psychotherapy
    Hefei, Anhui 230000, China
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07518264
Lead sponsor
Beijing HuiLongGuan Hospital
Collaborators
Institute of Psychology, Chinese Academy of Sciences, Fourth People's Hospital in Hefei
Responsible party
Xiang Yang Zhang (Professor, Tsinghua University) — Principal investigator
First posted
Apr 8, 2026
Start date
Mar 1, 2026
Primary completion
Jun 1, 2026
Completion
Jul 1, 2026 (estimated)
Last update
Jul 1, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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