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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-01

Study Completion Date

2025-12-31

Brief Summary

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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

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Detailed Description

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Conditions

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Psychiatric Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Active tDCS

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

Group Type EXPERIMENTAL

Active tDCS

Intervention Type DEVICE

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

Assertiveness Training Program (ATP)

Intervention Type BEHAVIORAL

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

Sham tDCS

Intervention Type DEVICE

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

Sham tDCS

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

Group Type SHAM_COMPARATOR

Active tDCS

Intervention Type DEVICE

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

Assertiveness Training Program (ATP)

Intervention Type BEHAVIORAL

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

Sham tDCS

Intervention Type DEVICE

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

Interventions

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Active tDCS

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

Intervention Type DEVICE

Assertiveness Training Program (ATP)

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

Intervention Type BEHAVIORAL

Sham tDCS

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

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No