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

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

Study Overview

• Status: Recruiting
• Conditions: Psychiatric Disorder
• Intervention / Treatment: Device: Active tDCS; Behavioral: Assertiveness Training Program (ATP); Device: Sham tDCS

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stephan T. Egger, MD; Phone Number: +41523049340; Email: stephan.egger@puk.zh.ch

Study Locations

• Switzerland
  • Zürich, Switzerland, 8032
    • Recruiting
    • Psychiatrische Universitätsklinik Zürich
    • Contact: Stephan T Egger, MD; Phone Number: +4152304940; Email: stephan.egger@puk.zh.ch
    • Contact: Godehard Weniger, MD; Phone Number: +41523049341; Email: godehard.weniger@puk.zh.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active tDCS; Active tDCS will be delivered at 2mA for 20 minutes.	Device: Active tDCS; Active tDCS will be delivered at 2mA for 20 minutes.; Behavioral: Assertiveness Training Program (ATP); The Assertiveness Training Program (ATP) is a cognitive-behavioural therapy delivered in group sessions.; Device: 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 Comparator: Sham tDCS; Sham tDCS: after 40 seconds of stimulation (2mA), a small current pulse was delivered every 550 msec (110 muA over 15 msec).	Device: Active tDCS; Active tDCS will be delivered at 2mA for 20 minutes.; Behavioral: Assertiveness Training Program (ATP); The Assertiveness Training Program (ATP) is a cognitive-behavioural therapy delivered in group sessions.; Device: Sham tDCS; Sham tDCS, after 40 seconds of stimulation (2mA), a small current pulse was delivered every 550 msec (110 muA over 15 msec).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Psychopathological Assessment	Symptom Questionnaire	Change: Baseline, 3, 6 weeks, 6 and 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Insecurity- Self-confidence	Symptom Questionnaire	Change: Baseline, 3, 6 weeks, 6 and 12 months

Collaborators and Investigators

• Sponsor: Psychiatric University Hospital, Zurich
• Investigators: Principal Investigator: Stephan T. Egger, MD, Psychiatric University Hospital of Zurich

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2023
• Primary Completion (Estimated): November 30, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: September 18, 2019
• First Submitted That Met QC Criteria: September 18, 2019
• First Posted (Actual): September 20, 2019

Study Record Updates

• Last Update Posted (Actual): September 28, 2023
• Last Update Submitted That Met QC Criteria: September 26, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Brain Stimulation, tDCS, Psychotherapy, Psychiatric Disorder
• Additional Relevant MeSH Terms: Behavioral Symptoms; Problem Behavior; Mental Disorders
• Other Study ID Numbers: tDCS ATP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No