NCT06443125

Brief Summary

explore objective indicators of the efficacy of natural psychotherapy in the treatment of disorders such as obsessive-compulsive disorder

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2023

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 26, 2023

Completed
8 months until next milestone

First Posted

Study publicly available on registry

June 5, 2024

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

December 27, 2024

Status Verified

December 1, 2024

Enrollment Period

2 years

First QC Date

September 26, 2023

Last Update Submit

December 24, 2024

Conditions

Keywords

obsessive-compulsive disordernatural psychotherapy

Outcome Measures

Primary Outcomes (6)

  • 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.

    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.

    Baseline, 12 weeks

  • Mood and behavior

    Mood changes judged using gait and face recognition

    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

    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.

    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.

    Baseline, 12 weeks

Study Arms (1)

Natural Psychotherapy intervention for obsessive-compulsive disorder

EXPERIMENTAL

Inpatient naturopathic treatment was performed once a day for 45 consecutive days

Other: Natural psychotherapy

Interventions

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.

Natural Psychotherapy intervention for obsessive-compulsive disorder

Eligibility Criteria

Age15 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Anhui Mental Health Center

Hefei, Anhui, 230022, China

RECRUITING

Institute of Psychology, Chinese Academy of Sciences

Beijing, China

RECRUITING

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Study Officials

  • Xiang-Yang Zhang, M.D., Ph.D

    Institute of Psychology, Chinese Academy of Science

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhang Y Xiang, M.D., Ph.D

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 26, 2023

First Posted

June 5, 2024

Study Start

August 1, 2023

Primary Completion

August 1, 2025

Study Completion

August 1, 2025

Last Updated

December 27, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Data with be available on request

Locations