NCT05577338

ToM Psychotherapy and Brain Networks in EOS

Completed NA Last updated 13 September 2023

What this trial tests

NA trial testing Theory of Mind psychotherapy in Early-onset Schizophrenia in 30 participants. Completed in 30 September 2021.

Timeline

1 August 2018

Primary endpoint
30 August 2021

30 September 2021

Quick facts

Lead sponsor	The First Affiliated Hospital of Anhui Medical University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	30
Start date	1 August 2018
Primary completion	30 August 2021
Estimated completion	30 September 2021
Sites	1 location across China

Drugs / interventions tested

• Theory of Mind psychotherapy
• health education

Conditions studied

• Early-onset Schizophrenia — all drugs for Early-onset Schizophrenia →

Sponsor

The First Affiliated Hospital of Anhui Medical University

Who can join

Adults 13 to 18, any sex, with Early-onset Schizophrenia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Neural mechanism underlying the beneficial effect of Theory of Mind psychotherapy on early-onset schizophrenia: a randomized controlled trial.
   Liu S, Zhong H, Qian Y, Cai H, et al · · 2023 · cited 1× · PMID 37935475 · DOI 10.1503/jpn.230049