Enhancement of a Psychotherapeutic Intervention Through Transcranial Direct Current Stimulation (tDCS)

Not Applicable

Recruiting

• Conditions: Psychiatric Disorder
• Interventions: Device: Active tDCS; Behavioral: Assertiveness Training Program (ATP); Device: Sham tDCS

• Registration Number: NCT04096625
• Lead Sponsor: Psychiatric University Hospital, Zurich

Brief Summary

Transcranial Direct Current Stimulation (tDCS), is a neuromodulatory technique, that is safe, well-tolerated, easy to administer and fairly inexpensive. Results from tDCS trials involving participants with several neuropsychiatric disorders, including major depression, bipolar disorder, schizophrenia and substance use disorder are encouraging. The clinical effects of tDCS are broad; the underlying condition, the areas stimulated together with the type and duration of stimulation are important factors. In patients with neuropsychiatric conditions, a reduction of symptoms, an enhancement of neurocognitive functions together with an overall improvement in functionality and wellbeing have been consistently reported. These effects emerge during the stimulation period, in the weeks after stimulation, the effects seem to peak and consolidate further. tDCS appears to enhance the effects of other interventions as well; however, to date, there have been no studies into the effects of using tDCS as an add-on intervention to psychotherapy on symptoms and wellbeing

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-09-18
• Study First Submitted QC: 2019-09-18
• Study First Posted: 2019-09-20
• Status Verified: 2023-09
• Study Start: 2023-09-01
• Last Update Submitted: 2023-09-26
• Last Update Posted: 2023-09-28
• Primary Completion: 2025-11-30
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Participants are competent to give informed consent, as determined by the referring physician or psychiatrist.
• German language proficiency as a native speaker or level B1
• A psychiatric diagnosis according to ICD-10;
• Three or more psychiatric hospitalizations in the past 12 months; or
• A cumulative length of stay over 40 days; or
• Referral for further treatment to our treatment unit.

Exclusion Criteria

• Concomitant group psychotherapeutic intervention.
• Current neurological disorder.
• Current cardiovascular disorder.
• Current respiratory disorder.
• Current substance use or withdrawal.
• Epilepsy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Active tDCS	Sham tDCS	Active tDCS will be delivered at 2mA for 20 minutes.
Active tDCS	Assertiveness Training Program (ATP)	Active tDCS will be delivered at 2mA for 20 minutes.
Active tDCS	Active tDCS	Active tDCS will be delivered at 2mA for 20 minutes.
Sham tDCS	Sham tDCS	Sham tDCS: after 40 seconds of stimulation (2mA), a small current pulse was delivered every 550 msec (110 muA over 15 msec).
Sham tDCS	Active tDCS	Sham tDCS: after 40 seconds of stimulation (2mA), a small current pulse was delivered every 550 msec (110 muA over 15 msec).
Sham tDCS	Assertiveness Training Program (ATP)	Sham tDCS: after 40 seconds of stimulation (2mA), a small current pulse was delivered every 550 msec (110 muA over 15 msec).

Primary Outcome Measures

Name	Time	Method
Psychopathological Assessment	Change: Baseline, 3, 6 weeks, 6 and 12 months	Symptom Questionnaire

Secondary Outcome Measures

Name	Time	Method
Insecurity- Self-confidence	Change: Baseline, 3, 6 weeks, 6 and 12 months	Symptom Questionnaire

Trial Locations

Locations (1)

Psychiatrische Universitätsklinik Zürich; 🇨🇭 Zürich, Switzerland