Efficacy and Underlying Mechanisms of Group-Based Natural Psychotherapy for Anxiety Disorder
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Beijing HuiLongGuan Hospital
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Generalized Anxiety Disorder-7 (GAD-7)
Study Overview
Brief 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.
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:
- 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
In the study, primary clinical outcomes were evaluated using self - rating scales.
Eligibility Criteria
- Ages
- 15 Years to 55 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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.
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).
Intervention: Group-based Natural Psychotherapy (Behavioral)
Outcomes
Primary Outcomes
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).
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
- Intolerance of Uncertainty Scale (IUS)(week 0; weeek 4; week 8)
- Quality of Life Scale (QOL)(week 0; weeek 4; week 8)
Investigators
Xiang Yang Zhang
Professor
Tsinghua University