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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04096625
Recruitment Status : Not yet recruiting
First Posted : September 20, 2019
Last Update Posted : March 3, 2020
Sponsor:
Information provided by (Responsible Party):
Stephan T. Egger, Psychiatric University Hospital, Zurich

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

Condition or disease Intervention/treatment Phase
Psychiatric Disorder Device: Active tDCS Behavioral: Assertiveness Training Program (ATP) Device: Sham tDCS Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
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.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Enhancement of a Psychotherapeutic Intervention Through Transcranial Direct Current Stimulation (tDCS)
Estimated Study Start Date : May 1, 2020
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : April 30, 2021

Arm Intervention/treatment
Experimental: Active tDCS
Active tDCS will be delivered at 2mA for 20 minutes.
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).

Sham Comparator: Sham tDCS
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
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).




Primary Outcome Measures :
  1. Psychopathological Assessment [ Time Frame: Change: Baseline, 3, 6 weeks, 6 and 12 months ]
    Symptom Questionnaire


Secondary Outcome Measures :
  1. Insecurity- Self-confidence [ Time Frame: Change: Baseline, 3, 6 weeks, 6 and 12 months ]
    Symptom Questionnaire



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04096625


Contacts
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Contact: Stephan T. Egger, MD +41523049340 stephan.egger@puk.zh.ch

Locations
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Switzerland
Psychiatrische Universitätsklinik Zürich
Zürich, Switzerland, 8032
Sponsors and Collaborators
Psychiatric University Hospital, Zurich
Investigators
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Principal Investigator: Stephan T. Egger, MD Psychiatric University Hospital of Zurich
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Responsible Party: Stephan T. Egger, Senior Psychiatrists, Psychiatric University Hospital, Zurich
ClinicalTrials.gov Identifier: NCT04096625    
Other Study ID Numbers: tDCS ATP
First Posted: September 20, 2019    Key Record Dates
Last Update Posted: March 3, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Stephan T. Egger, Psychiatric University Hospital, Zurich:
Brain Stimulation, tDCS, Psychotherapy, Psychiatric Disorder
Additional relevant MeSH terms:
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Mental Disorders
Problem Behavior
Behavioral Symptoms