ToM Psychotherapy and Brain Networks in EOS

NCT05577338 | Completed

• 1 other identifier: PJ2022-10-37
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• changes in positive and negative scale score (PANSS)

  A standardized rating scale of clinical questionnaires without units designed to assess the severity of symptoms of different types of schizophrenia.

  Change from Baseline PANSS at 1 month

• changes in binary betweenness centrality

  One of the brain structural network properties computed via the software packages Brain functional Magnetic Resonance Imaging (FMRIB) Software Library (FSL3) and Diffusion Toolkit (DTK4) without units and captures the extent to which a node is in-between several other nodes in a network.

  Change from Baseline binary betweenness centrality at 1 month

Study Arms (2)

training group

EXPERIMENTAL

Theory of Mind psychotherapy psychotherapy

Behavioral: Theory of Mind psychotherapy

active control group

ACTIVE COMPARATOR

receive disease-related health knowledge

Behavioral: health education

Interventions

Theory of Mind psychotherapy BEHAVIORAL

a semi-structured, multidomain, tailored group psychotherapy

training group

health education BEHAVIORAL

disease-related health knowledge

active control group

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Clinical diagnosis of EOS
• Right-handed subjects
• Aged 13 - 18 years old
• Capable of understanding, judgments and expression

You may not qualify if:

• The presence of other psychiatric disorders such as substance-induced mood disorder, bipolar disorders, anxiety disorders, substance abuse, or dependence
• A history of significant physical or neurological disease
• A history of head injury with loss of consciousness
• A history of electroconvulsive therapy
• Contraindications for MRI such as claustrophobia
• Mental retardation.

Sponsors & Collaborators

• The First Affiliated Hospital of Anhui Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, 230022, China

Location

Related Publications (5)

• Kumra S, Charles Schulz S. Editorial: research progress in early-onset schizophrenia. Schizophr Bull. 2008 Jan;34(1):15-7. doi: 10.1093/schbul/sbm123. Epub 2007 Nov 28.

  PMID: 18048380 BACKGROUND

• Vernal DL, Boldsen SK, Lauritsen MB, Correll CU, Nielsen RE. Long-term outcome of early-onset compared to adult-onset schizophrenia: A nationwide Danish register study. Schizophr Res. 2020 Jun;220:123-129. doi: 10.1016/j.schres.2020.03.045. Epub 2020 Apr 13.

  PMID: 32299717 BACKGROUND

• Armando M, Pontillo M, Vicari S. Psychosocial interventions for very early and early-onset schizophrenia: a review of treatment efficacy. Curr Opin Psychiatry. 2015 Jul;28(4):312-23. doi: 10.1097/YCO.0000000000000165.

  PMID: 26001923 BACKGROUND

• Puig O, Penades R, Baeza I, De la Serna E, Sanchez-Gistau V, Bernardo M, Castro-Fornieles J. Cognitive remediation therapy in adolescents with early-onset schizophrenia: a randomized controlled trial. J Am Acad Child Adolesc Psychiatry. 2014 Aug;53(8):859-68. doi: 10.1016/j.jaac.2014.05.012. Epub 2014 Jun 21.

  PMID: 25062593 BACKGROUND

• Liu S, Zhong H, Qian Y, Cai H, Jia YB, Zhu J. Neural mechanism underlying the beneficial effect of Theory of Mind psychotherapy on early-onset schizophrenia: a randomized controlled trial. J Psychiatry Neurosci. 2023 Nov 7;48(6):E421-E430. doi: 10.1503/jpn.230049. Print 2023 Nov-Dec.

  PMID: 37935475 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2022
• First Posted: October 13, 2022
• Study Start: August 1, 2018
• Primary Completion: August 30, 2021
• Study Completion: September 30, 2021
• Last Updated: September 13, 2023

Record last verified: 2021-08

Locations

CN (1)