Clinical trial NCT04096625: Enhancement of a Psychotherapeutic Intervention Through Transcranial Direct Current Stimulation (tDCS)
Official title: Enhancement of a Psychotherapeutic Intervention Through Transcranial Direct Current Stimulation (tDCS)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Psychiatric Disorder
Keywords: Brain Stimulation, tDCS, Psychotherapy, Psychiatric Disorder
Lead sponsor: Psychiatric University Hospital, Zurich
Sponsor class: OTHER
First posted: 2019-09-20
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Psychopathological Assessment
timeFrame: Change: Baseline, 3, 6 weeks, 6 and 12 months
Secondary outcomes:
measure: Insecurity- Self-confidence
timeFrame: Change: Baseline, 3, 6 weeks, 6 and 12 months
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: Psychiatrische Universitätsklinik Zürich
Study officials:
affiliation: Psychiatric University Hospital of Zurich
name: Stephan T. Egger, MD
role: PRINCIPAL_INVESTIGATOR
References: