Study on the Efficacy Mechanism of Natural Psychotherapy for Neurosis

NCT05552014 | Recruiting DMC

• 1 other identifier: CASPsy5
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Obsessive-Compulsive Disorder

Keywords

obsessive-compulsive disorder; natural psychotherapy

Outcome Measures

Primary Outcomes (1)

• Obsessive-compulsive symptoms

  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'

  Baseline, week 4, week 8

Secondary Outcomes (5)

• Self-reported obsessive-compulsive symptoms

  Baseline, week 4, week 8

• Cognitive inhibition

  Baseline, week 8

• Behavioral inhibition

  Baseline, week 8

• ERP components associated with cognitive function

  Baseline, week 8

• rest fMRI in Obsessive-compulsive patients

  Baseline, week 8

Study Arms (2)

Natural Psychotherapy

ACTIVE COMPARATOR

Intervention using natural psychotherapy for OCD patients for two to three hours once a week for eight weeks

Behavioral: Natural Psychotherapy

Mental Health Education

PLACEBO COMPARATOR

Mental health education was given to another group of OCD patients for two hours once a week for eight weeks

Behavioral: Mental Health Education

Interventions

Natural Psychotherapy BEHAVIORAL

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.

Natural Psychotherapy

Mental Health Education BEHAVIORAL

Mental Health Education Seminar

Mental Health Education

Eligibility Criteria

• Age: 15 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing HuiLongGuan Hospital: lead

Study Sites (2)

Anhui Mental Health Center

Hefei, Anhui, 230022, China

RECRUITING

Institute of Psychology, Chinese Academy of Sciences

Beijing, China, 100096, China

RECRUITING

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Study Officials

• Xiang Y Zhang, M.D, Ph.D

  Institute of Psychology, Chinese Academy of Science

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

+86-10-62710644; zhangxy@psych.ac.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The patient was assigned to either the intervention group or the control group, but the control group would also receive treatment after a two-month waiting period. Therefore, the patient was only informed whether they would be participating in the first or second intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 21, 2022
• First Posted: September 23, 2022
• Study Start: May 1, 2022
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: December 30, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)