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NCT Number: NCT07518264

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.

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This study is active but is not currently recruiting participants.

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Key information

Age range

15 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Natural Psychotherapy

Hefei, Anhui, 230000, China

About this study

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:

  • 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.
  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Group-based Natural Psychotherapy

Behavioral

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

Primary outcomes

  1. Generalized Anxiety Disorder-7 (GAD-7)

    Time frame: week 0; week 4; week 8

    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).

  2. State-Trait Anxiety Inventory (STAI)

    Time frame: week 0; weeek 4; week 8

    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).

Secondary outcomes

  1. Intolerance of Uncertainty Scale (IUS)

    Time frame: week 0; weeek 4; week 8

    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).

  2. Quality of Life Scale (QOL)

    Time frame: week 0; weeek 4; week 8

    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.

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

Sponsors and collaborators

Lead sponsor

Beijing HuiLongGuan Hospital

Other

Collaborators

  • Fourth People's Hospital in Hefei
  • Institute of Psychology, Chinese Academy of Sciences

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 8, 2026
Registry last updated
Jul 1, 2026

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

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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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