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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04096625
Enrollment
100
Registered
2019-09-20
Start date
2023-09-01
Completion date
2025-12-31
Last updated
2023-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psychiatric Disorder

Keywords

Brain Stimulation, tDCS, Psychotherapy, Psychiatric Disorder

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

Interventions

DEVICEActive tDCS

Active tDCS will be delivered at 2mA for 20 minutes.

The Assertiveness Training Program (ATP) is a cognitive-behavioural therapy delivered in group sessions.

DEVICESham tDCS

Sham tDCS, after 40 seconds of stimulation (2mA), a small current pulse was delivered every 550 msec (110 muA over 15 msec).

Sponsors

Psychiatric University Hospital, Zurich
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Intervention model description

The investigators plan a double-blind, randomised, sham-controlled trial in a cross-over design to assess the efficacy and safety of tDCS as an add-on intervention to a psychotherapeutic treatment for patients with a severe psychiatric condition requiring hospitalization.

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Psychopathological AssessmentChange: Baseline, 3, 6 weeks, 6 and 12 monthsSymptom Questionnaire

Secondary

MeasureTime frameDescription
Insecurity- Self-confidenceChange: Baseline, 3, 6 weeks, 6 and 12 monthsSymptom Questionnaire

Countries

Switzerland

Contacts

Primary ContactStephan T. Egger, MD
stephan.egger@puk.zh.ch+41523049340

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026