- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05552014
Study on the Efficacy Mechanism of Natural Psychotherapy for Neurosis
May 13, 2026 updated by: Xiang Yang Zhang, Beijing HuiLongGuan Hospital
Research on the Efficacy Mechanism of Natural Psychotherapy for Neurosis
explore objective indicators of the efficacy of natural psychotherapy in the treatment of disorders such as obsessive-compulsive disorder
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
- To evaluate the cognitive function, Cognitive control, emotion and other aspects of neurosis patients, and to understand and master the cognitive behavior indicators of this population.
- Investigate the pathological mechanism of neurotic patients from the aspects of EEG/fMRI and biology.
- To investigate the therapeutic effect of natural psychotherapy on cognitive impairment and related mood, sleep and symptom intervention in neurotic patients. In order to achieve the symptoms of neurosis patients, cognitive impairment and related mood and sleep intervention and promotion, while providing a scientific basis for neurosis rehabilitation.
Study Type
Interventional
Enrollment (Actual)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Anhui
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Hefei, Anhui, China, 230022
- Anhui Mental Health Center
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China
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Beijing, China, China, 100096
- Institute of Psychology, Chinese Academy of Sciences
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
15 years to 50 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- were between 16 and 55 years old;
- were diagnosed with OCD by an experienced psychiatrist utilizing the Structured Clinical Interview for DSM-5 (SCID);
- had an illness duration of at least 12 months;
- were able to participate in the entire trial and face-to-face on-site assessment
Exclusion Criteria:
- pregnant or breastfeeding;
- suffered from organic brain diseases or severe physical illness;
- had a history of substance or alcohol abuse
- were at high risk of suicide
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Natural Psychotherapy
Intervention using natural psychotherapy for OCD patients for two to three hours once a week for eight weeks
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Natural psychotherapy is based on "Morita therapy" and is a psychotherapy that fully reflects the characteristics of Chinese culture, taking into account the Chinese cultural background and actual clinical characteristics.
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Placebo Comparator: Mental Health Education
Mental health education was given to another group of OCD patients for two hours once a week for eight weeks
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Mental Health Education Seminar
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Obsessive-compulsive symptoms
Time Frame: Baseline, week 4, week 8
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Using the score of Yale-Brown Obsessive-Compulsive Scale as the primary outcome, a decrease in score of ≥35% was considered a 'response to treatment', also referred to as a 'full response', and a decrease in score of ≥25% was considered a 'partial response'
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Baseline, week 4, week 8
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Self-reported obsessive-compulsive symptoms
Time Frame: Baseline, week 4, week 8
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The reduction rate of the score of Obsessive-Compulsive Inventory-Revised (OCI-R), a self-rating scale of OCD symptoms severity, was employed as a secondary outcome
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Baseline, week 4, week 8
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Cognitive inhibition
Time Frame: Baseline, week 8
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Cognitive inhibition was assessed using the emotional color-word Stroop task.
The emotional Stroop task is a type of being Widely used cognitive inhibition assessment tools.
The longer the reaction time, the worse the cognitive inhibition ability.
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Baseline, week 8
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Behavioral inhibition
Time Frame: Baseline, week 8
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Behavioral inhibition was assessed using the emotional stop signal task (SST).
The emotional SST task is a type of being Widely used behavioral inhibition assessment tools.
Among them, the greater the SSRT, the worse the behavioral inhibition ability.
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Baseline, week 8
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ERP components associated with cognitive function
Time Frame: Baseline, week 8
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To explore the ERP component analysis related to cognitive inhibition and Behavioral inhibition in obsessive-compulsive disorder (OCD) by event related potential (ERP) analysis
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Baseline, week 8
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rest fMRI in Obsessive-compulsive patients
Time Frame: Baseline, week 8
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The changes of resting-state functional connectivity were analyzed in patients with OCD before and after intervention.
Resting-state functional connectivity:FC(Functional connectivity).
Resting-state functional brain imaging data were collected using a GE 3.0T magnetic resonance scanner (GE Discovery MR750) at the Brain Imaging Center, Institute of Psychology, Chinese Academy of Sciences.
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Baseline, week 8
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Xiang Y Zhang, M.D, Ph.D, Institute of Psychology, Chinese Academy of Science
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2022
Primary Completion (Actual)
December 1, 2025
Study Completion (Actual)
December 1, 2025
Study Registration Dates
First Submitted
September 21, 2022
First Submitted That Met QC Criteria
September 21, 2022
First Posted (Actual)
September 23, 2022
Study Record Updates
Last Update Posted (Actual)
May 15, 2026
Last Update Submitted That Met QC Criteria
May 13, 2026
Last Verified
December 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CASPsy5
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Data with be available on request
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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