Obsessive-Compulsive DisorderNCT06443125
Study on Therapeutic Mechanism of Natural Psychotherapy for Neurosis
A study testing Natural psychotherapy in people with Obsessive-Compulsive Disorder, run by Xiang Yang Zhang at 2 sites in China.
Trial summary
explore objective indicators of the efficacy of natural psychotherapy in the treatment of disorders such as obsessive-compulsive disorder Read more about this study
- Who is it for?
- Ages 15 to 60 years
- Conditions the study is for
- Obsessive-Compulsive Disorder
- What is being tested?
- Natural psychotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesChina
- Study dates
- 1 Aug 2023to 1 Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Have a diagnosis of obsessive-compulsive disorder or compulsive behavior
- Duration of symptoms for not less than 12 months
- Age 15-60 years old.
- You can participate in the whole experiment and offline assessment in Beijing
Who cannot join
- Documented disease of physical diseases including, but not limited to stroke, tumor, Parkinson's disease, Huntington's disease, seizure, epilepsy, history of brain trauma
- Subjects who suffered from alcohol or illegal drug abuse/dependence
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Institute of Psychology, Chinese Academy of Sciences
Beijing
Zhang X Yang
- Recruiting
Anhui Mental Health Center
Hefei, Anhui, 230022
Xiangyang Zhang, Ph.D, MD, +86-10-62710644, zhangxy@psych.ac.cn
About this study
explore objective indicators of the efficacy of natural psychotherapy in the treatment of disorders such as obsessive-compulsive disorder
Read the 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 electroencephalic graph/functional magnetic resonance imaging (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.
- Conditions
- Obsessive-Compulsive Disorder
- Being tested
- Natural psychotherapy
- Keywords
- obsessive-compulsive disorder, natural psychotherapy
- Medical subject headings
- Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Natural psychotherapyOther
Draw ideas from traditional Chinese culture, learn from the practice of Morita therapy in Japan, and create local practice experience. At the same time, a variety of research methods such as cognitive assessment and brain imaging were used to establish the scientific, professional and objective evaluation indexes of the therapy.
| Study group | Role | What they receive |
|---|---|---|
| Natural Psychotherapy intervention for obsessive-compulsive disorder | Experimental | Inpatient naturopathic treatment was performed once a day for 45 consecutive days Receives: Other: Natural psychotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Obsessive-compulsive symptoms
Obsessive-compulsive symptoms were assessed according to the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS), The total score ranges from 0 to 40, with higher scores indicating more severe symptoms.
Measured: Baseline, 12 weeks
Cognitive function
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.
Measured: Baseline, 12 weeks
Mood and behavior
Mood changes judged using gait and face recognition
Measured: Baseline, 12 weeks
ERP components associated with cognitive function
To explore the ERP component analysis related to cognitive inhibition and Behavioral inhibition in obsessive-compulsive disorder (OCD) by event related potential (ERP) analysis
Measured: Baseline, 12 weeks
rest fMRI in Obsessive-compulsive patients
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.
Measured: Baseline, 12 weeks
Behavioral inhibition
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.
Measured: Baseline, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2024
- Study start1 Aug 2023
- Primary completion1 Aug 2025 (estimated)
- Study completion1 Aug 2025 (estimated)
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
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiang Yang Zhang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xiang Yang Zhang, Beijing HuiLongGuan Hospital
- Investigators
- Xiang-Yang Zhang, M.D., Ph.D, Principal investigator, Institute of Psychology, Chinese Academy of Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06443125
- Sponsor's protocol ID
- CASPsy6
- Status last verified
- Dec 2024
- First submitted
- 26 Sep 2023
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data with be available on request
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Therapeutic Mechanism of Natural Psychotherapy for Neurosis
- ClinicalTrials.gov ID
- NCT06443125
- Acronym / sponsor ID
- CASPsy6
- Conditions
- Obsessive-Compulsive Disorder
- Keywords
- obsessive-compulsive disorder, natural psychotherapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Xiang Yang ZhangUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 5 Jun 2024 (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.
explore objective indicators of the efficacy of natural psychotherapy in the treatment of disorders such as obsessive-compulsive disorder
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 electroencephalic graph/functional magnetic resonance imaging (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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Natural Psychotherapy intervention for obsessive-compulsive disorder | Experimental | Other: Natural psychotherapyInpatient naturopathic treatment was performed once a day for 45 consecutive days |
Who may qualify
- Ages
- 15 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Have a diagnosis of obsessive-compulsive disorder or compulsive behavior
- Duration of symptoms for not less than 12 months
- Age 15-60 years old.
- You can participate in the whole experiment and offline assessment in Beijing
Key exclusion criteria (2 listed)
- Documented disease of physical diseases including, but not limited to stroke, tumor, Parkinson's disease, Huntington's disease, seizure, epilepsy, history of brain trauma
- Subjects who suffered from alcohol or illegal drug abuse/dependence
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 |
|---|---|---|
| Natural psychotherapyDraw ideas from traditional Chinese culture, learn from the practice of Morita therapy in Japan, and create local practice experience. At the same time, a variety of research methods such as cognitive assessment and brain imaging were used to establish the scientific, professional and objective evaluation indexes of the therapy. | Other | Natural Psychotherapy intervention for obsessive-compulsive disorder |
Primary outcome
Obsessive-compulsive symptoms
Time frame: Baseline, 12 weeks
Obsessive-compulsive symptoms were assessed according to the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS), The total score ranges from 0 to 40, with higher scores indicating more severe symptoms.
Cognitive function
Time frame: Baseline, 12 weeks
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.
Mood and behavior
Time frame: Baseline, 12 weeks
Mood changes judged using gait and face recognition
ERP components associated with cognitive function
Time frame: Baseline, 12 weeks
To explore the ERP component analysis related to cognitive inhibition and Behavioral inhibition in obsessive-compulsive disorder (OCD) by event related potential (ERP) analysis
rest fMRI in Obsessive-compulsive patients
Time frame: Baseline, 12 weeks
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.
Behavioral inhibition
Time frame: Baseline, 12 weeks
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- Individual participant dataSharing planned: No. Data with be available on request
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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.
Xiang-Yang Zhang, M.D., Ph.D principal investigator
Institute of Psychology, Chinese Academy of Science
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Natural psychotherapy in people with Obsessive-Compulsive Disorder, run by Xiang Yang Zhang at 2 sites 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 2 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: looking for participants now, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhang Y Xiang, M.D., Ph.D (+86-10-62710644, zhangxy@psych.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Obsessive-compulsive symptoms (time frame: Baseline, 12 weeks). The study lists 6 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 27 Dec 2024.