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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
60
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
Natural Psychotherapy
Hefei, Anhui, China
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
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
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).
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Time frame: 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.
Time frame: week 0; weeek 4; week 8