tDCS and Psychotherapy for the Treatment of Anxiety Disorders
NCT ID: NCT04453631
Last Updated: 2022-05-20
Study Results
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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UNKNOWN
NA
60 participants
INTERVENTIONAL
2023-01-03
2024-07-31
Brief Summary
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Detailed Description
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Each study participant will assigned to one factor level. Four intervention groups are defined
1. active tDCS + CBT-UP
2. sham tDCS + CBT-UP
3. active tDCS + Psychoeducation
4. sham tDCS + Psychoeducation
The four arms allow to experimentally control the two active therapeutic interventions: active tDCS and CBT-UP. Sham tDCS is the control for active tDCS and psychoeducation is the control condition for CBT-UP.
The intervention will last for 15 weeks, and all groups will comply with the same intervention structure according to the examination plan established in the protocol:
* week 1-2: 1 CBT-UP session/week
* week 3-4: 5 tDCS sessions and 1 CBT-UP session/week
* week 5-8: 2 tDCS sessions and 1 CBT-UP session/week
* week 9-14: 1 tDCS session and 1 CBT-UP session/week
* week 15: 1 CBT-UP session
The treatment will consist of 26 transcranial direct current stimulation sessions, each lasting 20 minutes, with a current intensity of 2 mA, the cathode placed over the right dorsolateral prefrontal cortex and the anode placed over the left deltoid muscle. tDCS will be combined with cognitive-behavioral therapy, in particular following the unified protocol for transdiagnostic treatment of emotional disorders (Barlow et al. 2018).
Safety:
No serious adverse effects are expected with conventional tDCS protocols in humans (≤40 min, ≤4 mA; conclusions from a meta-analysis observing \>33200 sessions, \>1000 subjects with repeated sessions; Bikson et al., 2016).
Plans for treatment or care after the subject has ended his/her participation in the trial:
Patients will be recommended and offered the best treatment as evidenced by the trial results. For patients that already completed that intervention further standard psychological/psychiatric treatment will be recommended according to patients' status.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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active tDCS + CBT-UP
Active tDCS combined with the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders.
active tDCS
26 transcranial direct current stimulation sessions, each lasting 20 minutes, with a current intensity of 2 mA, the cathode placed over the right dorsolateral prefrontal cortex and the anode placed over the left deltoid muscle.
CBT-UP
15 psychotherapy sessions (1/week) following the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders developed by Barlow et al. 2018.
sham tDCS + CBT-UP
Sham tDCS (control for active tDCS) combined with the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders.
sham tDCS
tDCS is controlled in this intervention: sham mode.
CBT-UP
15 psychotherapy sessions (1/week) following the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders developed by Barlow et al. 2018.
active tDCS + Psychoeducation
Active tDCS combined with psychoeducation (control condition for CBT-UP).
active tDCS
26 transcranial direct current stimulation sessions, each lasting 20 minutes, with a current intensity of 2 mA, the cathode placed over the right dorsolateral prefrontal cortex and the anode placed over the left deltoid muscle.
Psychoeducation
To control for the cognitive-behavioral intervention we will use psychoeducation materials.
sham tDCS + Psychoeducation
Sham tDCS combined with psychoeducation (control conditions for active tDCS and CBT-UP).
sham tDCS
tDCS is controlled in this intervention: sham mode.
Psychoeducation
To control for the cognitive-behavioral intervention we will use psychoeducation materials.
Interventions
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active tDCS
26 transcranial direct current stimulation sessions, each lasting 20 minutes, with a current intensity of 2 mA, the cathode placed over the right dorsolateral prefrontal cortex and the anode placed over the left deltoid muscle.
sham tDCS
tDCS is controlled in this intervention: sham mode.
CBT-UP
15 psychotherapy sessions (1/week) following the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders developed by Barlow et al. 2018.
Psychoeducation
To control for the cognitive-behavioral intervention we will use psychoeducation materials.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Willing to participate and to give written informed consent
Exclusion Criteria
* Presence of a cardiac or neurological condition
* Metallic implants
* If contact with scalp is not possible
* Have had a head injury resulting in a loss of consciousness that has required further investigation
* History of seizures
* Epilepsy or a history of epilepsy
* Past adverse effects with non-invasive stimulation treatments
2. Current diagnosis of another psychiatric disorder (except for depression, as long as secondary diagnosis), psychoactive medication or psychological treatment
3. Left-handedness
4. Pregnancy
5. Skin condition on the stimulation target area
6. Recreational drug use
18 Years
65 Years
ALL
No
Sponsors
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University of Coimbra
OTHER
Responsible Party
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Ana Ganho Ávila
Integrated Researcher
References
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HAMILTON M. The assessment of anxiety states by rating. Br J Med Psychol. 1959;32(1):50-5. doi: 10.1111/j.2044-8341.1959.tb00467.x. No abstract available.
HAMILTON M. A rating scale for depression. J Neurol Neurosurg Psychiatry. 1960 Feb;23(1):56-62. doi: 10.1136/jnnp.23.1.56. No abstract available.
Bikson M, Grossman P, Thomas C, Zannou AL, Jiang J, Adnan T, Mourdoukoutas AP, Kronberg G, Truong D, Boggio P, Brunoni AR, Charvet L, Fregni F, Fritsch B, Gillick B, Hamilton RH, Hampstead BM, Jankord R, Kirton A, Knotkova H, Liebetanz D, Liu A, Loo C, Nitsche MA, Reis J, Richardson JD, Rotenberg A, Turkeltaub PE, Woods AJ. Safety of Transcranial Direct Current Stimulation: Evidence Based Update 2016. Brain Stimul. 2016 Sep-Oct;9(5):641-661. doi: 10.1016/j.brs.2016.06.004. Epub 2016 Jun 15.
Barlow DH, Farchione TJ, Bullis JR, Gallagher MW, Murray-Latin H, Sauer-Zavala S, Bentley KH, Thompson-Hollands J, Conklin LR, Boswell JF, Ametaj A, Carl JR, Boettcher HT, Cassiello-Robbins C. The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders Compared With Diagnosis-Specific Protocols for Anxiety Disorders: A Randomized Clinical Trial. JAMA Psychiatry. 2017 Sep 1;74(9):875-884. doi: 10.1001/jamapsychiatry.2017.2164.
Other Identifiers
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tDCS-UP
Identifier Type: -
Identifier Source: org_study_id
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