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The main goal of the study is to test the efficacy of tDCS in combination with the Unified Protocol for transdiagnostic treatment of emotional disorders, to reduce anxiety symptoms in a mixed anxiety disorders sample, as assessed by the Hamilton Anxiety Rating Scale (HARS; Hamilton, 1959).
Participants will be randomly allocated to one of four parallel experimental arms, within a 2X2 factorial design in which two interventions (tDCS and CBT-UP) will be delivered, and assessed according to two levels (e.g., intervention vs. no intervention).
Each study participant will assigned to one factor level. Four intervention groups are defined
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| active tDCS + CBT-UP | Experimental | Active tDCS combined with the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders. |
|
| sham tDCS + CBT-UP | Active Comparator | Sham tDCS (control for active tDCS) combined with the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders. |
|
| active tDCS + Psychoeducation | Active Comparator | Active tDCS combined with psychoeducation (control condition for CBT-UP). |
|
| sham tDCS + Psychoeducation | Placebo Comparator | Sham tDCS combined with psychoeducation (control conditions for active tDCS and CBT-UP). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| active tDCS | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Hamilton Anxiety Rating Scale (HARS; Hamilton, 1959) | The mean change in the Hamilton Anxiety Rating Scale (HARS; Hamilton, 1959) score, from baseline. HARS total score ranges from 0 to 56, where higher values indicate higher anxiety symptom's severity. | At week 8th, 15th (middle and end of treatment) and 6 months follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Response to treatment | Defined as reduction of total Hamilton Anxiety Rating Scale (HARS; Hamilton, 1959) score by ≥ 50%. | At week 8th, 15th (middle and end of treatment) and 6 months follow-up. |
| Remission to treatment |
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Inclusion Criteria:
Exclusion Criteria:
Contra-indications to tDCS use:
Current diagnosis of another psychiatric disorder (except for depression, as long as secondary diagnosis), psychoactive medication or psychological treatment
Left-handedness
Pregnancy
Skin condition on the stimulation target area
Recreational drug use
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 13638508 | Background | 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. | |
| 14399272 | Background | 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. |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
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|
| sham tDCS | Device | tDCS is controlled in this intervention: sham mode. |
|
| CBT-UP | Behavioral | 15 psychotherapy sessions (1/week) following the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders developed by Barlow et al. 2018. |
|
| Psychoeducation | Behavioral | To control for the cognitive-behavioral intervention we will use psychoeducation materials. |
|
Defined as reduction of total Hamilton Anxiety Rating Scale (HARS; Hamilton, 1959) to scores lower than 18 (indicating mild anxiety severity).
| At week 8th, 15th (middle and end of treatment) and 6 months follow-up. |
| Hamilton Depression Rating Scale (HRSD; Hamilton, 1960) | The mean change in the Hamilton Depression Rating Scale (HRSD; Hamilton, 1960) score, from baseline. HDRS total score ranges from 0 to 75, where higher values indicate higher depressive symptoms' severity. | At week 8th, 15th (middle and end of treatment) and 6 months follow-up. |
| 27372845 | Background | 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. |
| 28768327 | Background | 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. |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |