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

Psychiatric University Hospital, Zurich

Status: Enrolling

Conditions: Psychiatric Disorder

Treatments: Device: Active tDCS; Behavioral: Assertiveness Training Program (ATP); Device: Sham tDCS

Study type: Interventional

Funder types: Other

Identifiers

NCT04096625

tDCS ATP

Details and patient eligibility

About

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

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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100 participants in 2 patient groups

Active tDCS

Experimental group

Description:

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

Treatment:

Behavioral: Assertiveness Training Program (ATP)

Device: Sham tDCS

Device: Active tDCS

Sham tDCS

Sham Comparator group

Description:

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

Treatment:

Behavioral: Assertiveness Training Program (ATP)

Device: Sham tDCS

Device: Active tDCS