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

NCT04096625 | Unknown DMC

• 1 other identifier: tDCS ATP
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Psychiatric Disorder

Keywords

Brain Stimulation, tDCS, Psychotherapy, Psychiatric Disorder

Outcome Measures

Primary Outcomes (1)

• Psychopathological Assessment

  Symptom Questionnaire

  Change: Baseline, 3, 6 weeks, 6 and 12 months

Secondary Outcomes (1)

• Insecurity- Self-confidence

  Change: Baseline, 3, 6 weeks, 6 and 12 months

Study Arms (2)

Active tDCS

EXPERIMENTAL

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

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

Sham tDCS

SHAM COMPARATOR

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

Interventions

Active tDCS DEVICE

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

Active tDCS; Sham tDCS

Assertiveness Training Program (ATP) BEHAVIORAL

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

Active tDCS; Sham tDCS

Sham tDCS DEVICE

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

Active tDCS; Sham tDCS

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Concomitant group psychotherapeutic intervention.
• Current neurological disorder.
• Current cardiovascular disorder.
• Current respiratory disorder.
• Current substance use or withdrawal.
• Epilepsy.

Sponsors & Collaborators

• Psychiatric University Hospital, Zurich: lead

Study Sites (1)

Psychiatrische Universitätsklinik Zürich

Zurich, 8032, Switzerland

RECRUITING

MeSH Terms

Conditions

Mental Disorders

Study Officials

• Stephan T. Egger, MD

  Psychiatric University Hospital of Zurich

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephan T. Egger, MD

CONTACT

+41523049340; stephan.egger@puk.zh.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Psychiatrists

Model Details: 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.

Study Record Dates

• First Submitted: September 18, 2019
• First Posted: September 20, 2019
• Study Start: September 1, 2023
• Primary Completion: November 30, 2025
• Study Completion: December 31, 2025
• Last Updated: September 28, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)