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

Primary Purpose

Psychiatric Disorder

Status

Recruiting

Phase

Not Applicable

Locations

Switzerland

Study Type

Interventional

Intervention

Active tDCS

Assertiveness Training Program (ATP)

Sham tDCS

About this trial

This is an interventional treatment trial for Psychiatric Disorder focused on measuring Brain Stimulation, tDCS, Psychotherapy, Psychiatric Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Psychiatrische Universitätsklinik ZürichRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Active tDCS

Sham tDCS

Arm Description

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

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

Outcomes

Primary Outcome Measures

Psychopathological Assessment

Symptom Questionnaire

Secondary Outcome Measures

Insecurity- Self-confidence

Symptom Questionnaire

Full Information

NCT ID

NCT04096625

First Posted

September 18, 2019

Last Updated

September 26, 2023

Sponsor

Psychiatric University Hospital, Zurich

1. Study Identification

Unique Protocol Identification Number

NCT04096625

Brief Title

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

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

September 1, 2023 (Actual)

Primary Completion Date

November 30, 2025 (Anticipated)

Study Completion Date

December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Psychiatric University Hospital, Zurich

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Psychiatric Disorder

Keywords

Brain Stimulation, tDCS, Psychotherapy, Psychiatric Disorder

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

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

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Active tDCS

Arm Type

Experimental

Arm Description

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

Arm Title

Sham tDCS

Arm Type

Sham Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Active tDCS

Intervention Description

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

Intervention Type

Behavioral

Intervention Name(s)

Assertiveness Training Program (ATP)

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

Sham tDCS

Intervention Description

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

Primary Outcome Measure Information:

Title

Psychopathological Assessment

Description

Symptom Questionnaire

Time Frame

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

Secondary Outcome Measure Information:

Title

Insecurity- Self-confidence

Description

Symptom Questionnaire

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Stephan T. Egger, MD

Phone

+41523049340

stephan.egger@puk.zh.ch

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Stephan T. Egger, MD

Organizational Affiliation

Psychiatric University Hospital of Zurich

Official's Role

Principal Investigator

Facility Information:

Facility Name

Psychiatrische Universitätsklinik Zürich

City

Zürich

ZIP/Postal Code

8032

Country

Switzerland

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Stephan T Egger, MD

Phone

+4152304940

stephan.egger@puk.zh.ch

First Name & Middle Initial & Last Name & Degree

Godehard Weniger, MD

Phone

+41523049341

godehard.weniger@puk.zh.ch

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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