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

NCT04106427 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 73

Last updated 2025-08-08

No results posted yet for this study

Summary

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

Conditions

Interventions

DEVICE

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

DEVICE

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

BEHAVIORAL

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

BEHAVIORAL

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.

Sponsors & Collaborators

  • University of Bern

    lead OTHER

Principal Investigators

  • Sebastian Walther, MD · University of Bern

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-12-01
Primary Completion
2024-04-24
Completion
2024-04-24

Countries

  • Switzerland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04106427 on ClinicalTrials.gov