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

Study Overview
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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

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

Conditions
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Psychiatric Disorder

Intervention / Treatment
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* Device: Active tDCS
* Behavioral: Assertiveness Training Program (ATP)
* Device: Sham tDCS


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active tDCS<br>Active tDCS will be delivered at 2mA for 20 minutes. | Device: Active tDCS<br>* Active tDCS will be delivered at 2mA for 20 minutes.<br>Behavioral: Assertiveness Training Program (ATP)<br>* The Assertiveness Training Program (ATP) is a cognitive-behavioural therapy delivered in group sessions.<br>Device: Sham tDCS<br>* Sham tDCS, after 40 seconds of stimulation (2mA), a small current pulse was delivered every 550 msec (110 muA over 15 msec).<br>|
| Sham Comparator: Sham tDCS<br>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<br>* Active tDCS will be delivered at 2mA for 20 minutes.<br>Behavioral: Assertiveness Training Program (ATP)<br>* The Assertiveness Training Program (ATP) is a cognitive-behavioural therapy delivered in group sessions.<br>Device: Sham tDCS<br>* Sham tDCS, after 40 seconds of stimulation (2mA), a small current pulse was delivered every 550 msec (110 muA over 15 msec).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psychopathological Assessment | Symptom Questionnaire | Change: Baseline, 3, 6 weeks, 6 and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insecurity- Self-confidence | Symptom Questionnaire | Change: Baseline, 3, 6 weeks, 6 and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Brain Stimulation, tDCS, Psychotherapy, Psychiatric Disorder