NCT04278027

Cognitive Remediation Therapy in Schizophrenia: Effects on Epigenetics

Epigenetic Regulation of Brain-Derived Neurotrophic Factor (BDNF) Gene Expression According to Response to Cognitive Remediation in Schizophrenia

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Hospital Clinic of Barcelona · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

This study is a randomised and controlled trial that aims to investigate whether Cognitive Remediation Therapy (CRT) can modulate epigenetic mechanisms by changing methylation levels of BDNF gene in patients with Schizophrenia.

Detailed description

OBJECTIVES: To investigate whether Cognitive Remediation Therapy (CRT) can modulate epigenetic mechanisms by changing methylation levels of BDNF gene. It also aims to test whether BDNF valine-66-methionine (Val66Met) polymorphism influences CRT treatment outcome among people with schizophrenia. SAMPLE AND METHODS: A randomized and controlled study will be carried out with two groups: patients receiving CRT and patients in control condition without any cognitive intervention and receiving Treatment as Usual (TAU). Methylation levels of BDNF gene at different sites will be contrasted before and after treatment. Additionally, neurocognition profile, level of symptoms and psychosocial functioning will also be tested. CRT outcomes will be investigated in a mixed model for repeated measures.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
BEHAVIORAL	Cognitive Remediation Therapy	"CIRCuiTS is a web-based computerised CR therapy, delivered by a therapist but supplemented with independent sessions to facilitate massed practice. It targets metacognition, particularly strategy use, in addition to providing massed practice of basic cognitive functions. The therapist facilitates motivation, metacognitive and strategy development and generalisation of learning by encouraging the participant to learn about and regulate their cognitive performance and to transfer this learning to meet real-world goals. Therapists provide additional scaffolding for CR tasks to ensure consistent successful performance. Independent sessions involve carrying out cognitive tasks allocated by the therapist to ensure scaffolded learning" (Reeder et al.2017)

Timeline

• Start date: 2017-01-03
• Primary completion: 2020-05-05
• Completion: 2020-06-15
• First posted: 2020-02-20
• Last updated: 2020-02-20

Locations

1 site across 1 country: Spain