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

Psychiatric Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04096625
• Other study ID #: tDCS ATP
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: September 2023
• Source: Psychiatric University Hospital, Zurich
• Contact: Stephan T. Egger, MD
• Phone: +41523049340
• Email: stephan.egger[@]puk.zh.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2025
• Est. primary completion date: November 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Mental Disorders
• Problem Behavior
• Psychiatric Disorder

Intervention

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).

Locations

Country	Name	City	State
Switzerland	Psychiatrische Universitätsklinik Zürich	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
Psychiatric University Hospital, Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Psychopathological Assessment	Symptom Questionnaire	Change: Baseline, 3, 6 weeks, 6 and 12 months
Secondary	Insecurity- Self-confidence	Symptom Questionnaire	Change: Baseline, 3, 6 weeks, 6 and 12 months