ToM Psychotherapy and Brain Networks in EOS

NCT05577338 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-09-13

No results posted yet for this study

Summary

Background: Presence of a series of typical physical symptoms is an enduring and functionally relevant feature of early-onset schizophrenia (EOS). Psychotherapy improves clinical symptoms in adults with schizophrenia, although data in adolescents with EOS remain scarce. The purpose of this study is to examine the efficacy of the adapted group psychotherapy in improving clinical symptoms from a perspective of neuroimaging in a sample of symptomatically stable adolescents with EOS.

Methods: Investigators conducted a double-blind randomized controlled trial using multidomain, adaptive, group psychotherapy in 28 EOS patients, who were randomly allocated into either training (group psychotherapy) or active control (health education) groups. Data of diffusion tensor imaging, and clinical symptoms were obtained at baseline and after an average of 2 hours/day, 2 days/week for 4 weeks of intervention.

Conditions

  • Early-onset Schizophrenia

Interventions

BEHAVIORAL

Theory of Mind psychotherapy

a semi-structured, multidomain, tailored group psychotherapy

BEHAVIORAL

health education

disease-related health knowledge

Sponsors & Collaborators

  • The First Affiliated Hospital of Anhui Medical University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
13 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-01
Primary Completion
2021-08-30
Completion
2021-09-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05577338 on ClinicalTrials.gov