Brain Stimulation And Group Therapy to Improve Gesture and Social Skills in Psychosis (BrAGG-SoS)
NCT ID: NCT04106427
Last Updated: 2025-08-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
73 participants
INTERVENTIONAL
2019-12-01
2024-04-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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cTBS plus SCRT
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
continuous theta burst stimulation (cTBS)
cTBS stimulation of 17 mins over right inferior parietal lobe (IPL) with two 44 s stimulations separated by 15 mins, 10 sessions in total (5 per week). intensity will be 100% of resting motor threshold at 30 Hz.
administered in weeks 1 and 2 of the trial
social cognitive remediation therapy (SCRT)
16 sessions of group SCRT will be scheduled within 8 weeks, comprising 6-8 participants per group with 2 therapists. Duration of group sessions will be 60-90 mins. The content will follow the manual of SCRT and we will add a short intervention to practice the use of co-speech gestures at each session
Placebo plus SCRT
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
placebo cTBS
Placebo stimulation of 17 mins over right IPL with two 44 s stimulations separated by 15 mins, 10 sessions in total (5 per week). intensity will be 0% of resting motor threshold at 30 Hz.
administered in weeks 1 and 2 of the trial
social cognitive remediation therapy (SCRT)
16 sessions of group SCRT will be scheduled within 8 weeks, comprising 6-8 participants per group with 2 therapists. Duration of group sessions will be 60-90 mins. The content will follow the manual of SCRT and we will add a short intervention to practice the use of co-speech gestures at each session
Sham SCRT
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
Sham group therapy
Group activities in closed groups of 6 participants. Schedule of two sessions per week for 8 weeks. Two therapists are guiding different leisure activities, e.g. group walks, going to museums/movies, games.
Interventions
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continuous theta burst stimulation (cTBS)
cTBS stimulation of 17 mins over right inferior parietal lobe (IPL) with two 44 s stimulations separated by 15 mins, 10 sessions in total (5 per week). intensity will be 100% of resting motor threshold at 30 Hz.
administered in weeks 1 and 2 of the trial
placebo cTBS
Placebo stimulation of 17 mins over right IPL with two 44 s stimulations separated by 15 mins, 10 sessions in total (5 per week). intensity will be 0% of resting motor threshold at 30 Hz.
administered in weeks 1 and 2 of the trial
social cognitive remediation therapy (SCRT)
16 sessions of group SCRT will be scheduled within 8 weeks, comprising 6-8 participants per group with 2 therapists. Duration of group sessions will be 60-90 mins. The content will follow the manual of SCRT and we will add a short intervention to practice the use of co-speech gestures at each session
Sham group therapy
Group activities in closed groups of 6 participants. Schedule of two sessions per week for 8 weeks. Two therapists are guiding different leisure activities, e.g. group walks, going to museums/movies, games.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
* 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
18 Years
65 Years
ALL
Yes
Sponsors
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University of Bern
OTHER
Responsible Party
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Principal Investigators
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Sebastian Walther, MD
Role: PRINCIPAL_INVESTIGATOR
University of Bern
Locations
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University of Bern, Translational Research Center, University Hospital of Psychiatry
Bern, , Switzerland
Countries
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References
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Chapellier V, Pavlidou A, Mueller DR, Walther S. Brain Stimulation and Group Therapy to Improve Gesture and Social Skills in Schizophrenia-The Study Protocol of a Randomized, Sham-Controlled, Three-Arm, Double-Blind Trial. Front Psychiatry. 2022 Jul 7;13:909703. doi: 10.3389/fpsyt.2022.909703. eCollection 2022.
Other Identifiers
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2019-00798
Identifier Type: -
Identifier Source: org_study_id
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