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

NCT07518264 | Active Not Recruiting

• 1 other identifier: NPAD26
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Obsessive - Compulsive Disorder

Keywords

Obsessive - Compulsive Disorder; Natural Psychotherapy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Intolerance of Uncertainty Scale (IUS)

  week 0; weeek 4; week 8

• Quality of Life Scale (QOL)

  week 0; weeek 4; week 8

Other Outcomes (3)

• 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

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Waiting-list control group

NO INTERVENTION

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

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

Intervention group

Eligibility Criteria

• Age: 15 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing HuiLongGuan Hospital: lead
• Institute of Psychology, Chinese Academy of Sciences: collaborator
• Fourth People's Hospital in Hefei: collaborator

Study Sites (1)

Natural Psychotherapy

Hefei, Anhui, 230000, China

Location

MeSH Terms

Conditions

Compulsive Personality Disorder

Condition Hierarchy (Ancestors)

Personality Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: In the study, primary clinical outcomes were evaluated using self - rating scales.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 2, 2026
• First Posted: April 8, 2026
• Study Start: March 1, 2026
• Primary Completion: June 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: April 8, 2026

Record last verified: 2026-03

Locations

CN (1)