Obsessive - Compulsive DisorderNCT07518264
Efficacy and Underlying Mechanisms of Group-Based Natural Psychotherapy for Anxiety Disorder
A study testing Group-based Natural Psychotherapy in people with Obsessive - Compulsive Disorder, run by Beijing HuiLongGuan Hospital at 1 site in China.
Trial 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 more about this study
- Who is it for?
- Ages 15 to 55 years
- Conditions the study is for
- Obsessive - Compulsive Disorder
- What is being tested?
- Group-based Natural Psychotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2026to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 55 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
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.
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:
- 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.
- Conditions
- Obsessive - Compulsive Disorder
- Being tested
- Group-based Natural Psychotherapy
- Keywords
- Obsessive - Compulsive Disorder, Natural Psychotherapy
- Medical subject headings
- Compulsive Personality Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group-based Natural PsychotherapyBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: week 0; weeek 4; week 8
Secondary outcomes (2)
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).
Measured: week 0; weeek 4; week 8
Quality of Life (QOL)
A single-item visual analog scale scored from 0 to 100 was administered to evaluate participants' overall quality of life across the past month.
Measured: week 0; weeek 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2026
- Study start1 Mar 2026
- Primary completion1 Jun 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obsessive - Compulsive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing HuiLongGuan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Institute of Psychology, Chinese Academy of Sciences, Fourth People's Hospital in Hefei
- Responsible party
- Principal investigator, Xiang Yang Zhang, Tsinghua University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07518264
- Sponsor's protocol ID
- NPAD26
- Status last verified
- Jun 2026
- First submitted
- 2 Apr 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Underlying Mechanisms of Group-Based Natural Psychotherapy for Anxiety Disorder
- ClinicalTrials.gov ID
- NCT07518264
- Acronym / sponsor ID
- NPAD26
- Conditions
- Obsessive - Compulsive Disorder
- Keywords
- Obsessive - Compulsive Disorder, Natural Psychotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Beijing HuiLongGuan HospitalUniversity, hospital or other
- Collaborators
- Institute of Psychology, Chinese Academy of Sciences, Fourth People's Hospital in Hefei
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 1 Jun 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 8 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Group-based Natural PsychotherapyParticipants 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). |
| 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. |
Who may qualify
- Ages
- 15 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group-based Natural PsychotherapyPatients 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 | Behavioural | Intervention group |
Primary outcome
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).
2 secondary outcomes
Intolerance of Uncertainty Scale (IUS)
Time frame: week 0; weeek 4; week 8
Quality of Life (QOL)
Time frame: week 0; weeek 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group-based Natural Psychotherapy in people with Obsessive - Compulsive Disorder, run by Beijing HuiLongGuan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Generalized Anxiety Disorder-7 (GAD-7) (time frame: week 0; week 4; week 8). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.