Brain Stimulation And Group Therapy to Improve Gesture and Social Skills in Psychosis (BrAGG-SoS)

University of Bern

Status: Completed

Conditions: Schizophrenia

Treatments: Behavioral: Sham group therapy; Behavioral: social cognitive remediation therapy (SCRT); Device: continuous theta burst stimulation (cTBS); Device: placebo cTBS

Study type: Interventional

Funder types: Other

Identifiers

NCT04106427

2019-00798

Details and patient eligibility

About

Randomized, double-blind, placebo-controlled clinical trial testing the effects of 10 sessions of continuous theta burst stimulation and the effects of 16 sessions of social cognitive remediation therapy on gesture performance and nonverbal communication skills in schizophrenia

Full description

The study focuses on nonverbal communication skills in schizophrenia. The trial will test, whether the combination of noninvasive brain stimulation and group psychotherapy will improve gesture performance and thus nonverbal communication in schizophrenia

Enrollment: 73 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Right-handed subjects
• Ability and willingness to participate in the study
• Ability to provide written informed consent
• Informed Consent as documented by signature
• schizophrenia spectrum disorders according to Diagnostic and statistical manual version 5 (DSM-5)

Exclusion criteria

• Substance abuse or dependence other than nicotine
• Past or current medical or neurological condition associated with impaired or aberrant movement, such as brain tumors, stroke, M. Parkinson, M. Huntington, dystonia, or severe head trauma with subsequent loss of consciousness.
• Epilepsy or other convulsions
• History of any hearing problems or ringing in the ears
• Standard exclusion criteria for cerebral magnetic resonance imaging scanning and transcranial magnetic stimulation (TMS); e.g. metal implants, claustrophobia
• Patients only: any transcranial magnetic stimulation (TMS) treatment in the past 3 months
• Patients only: any cognitive remediation therapy in the past 2 years
• Women who are pregnant or breast feeding,
• Intention to become pregnant during the course of the study,
• Female participants who are surgically sterilised / hysterectomised or post-menopausal for longer than 2 years are not considered as being of child bearing potential.
• Previous enrolment into the current study,
• Enrolment of the investigator, his/her family members, employees and other dependent persons

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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73 participants in 3 patient groups, including a placebo group

cTBS plus SCRT

Experimental group

Description:

10 daily sessions of continous theta burst (cTBS) on the right inferior parietal cortex for two weeks together with 16 sessions of social cognitive remediation therapy (SCRT) twice per week over an eight week period according to the manual

Treatment:

Device: continuous theta burst stimulation (cTBS)

Behavioral: social cognitive remediation therapy (SCRT)

Placebo plus SCRT

Placebo Comparator group

Description:

10 daily sessions of placebo continous theta burst (cTBS) on the right inferior parietal cortex for two weeks together with 16 sessions of social cognitive remediation therapy (SCRT) twice per week over an eight week period according to the manual

Treatment:

Device: placebo cTBS

Behavioral: social cognitive remediation therapy (SCRT)

Sham SCRT

Sham Comparator group

Description:

16 sessions of sham social cognitive remediation therapy (SCRT) twice per week over an eight week period. Participants will engage in non-effective group activities

Treatment:

Behavioral: Sham group therapy