tDCS and Psychotherapy for the Treatment of Anxiety Disorders (tDCSplusUP)
Primary Purpose
Anxiety Disorders
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
active tDCS
sham tDCS
CBT-UP
Psychoeducation
Sponsored by
About this trial
This is an interventional treatment trial for Anxiety Disorders focused on measuring anxiety disorders, tDCS, Unified Protocol, RCT
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of generalized anxiety disorder, specific phobia, panic disorder, agoraphobia, or social anxiety disorder.
- Willing to participate and to give written informed consent
Exclusion Criteria:
Contra-indications to tDCS use:
- 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
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
active tDCS + CBT-UP
sham tDCS + CBT-UP
active tDCS + Psychoeducation
sham tDCS + Psychoeducation
Arm Description
Active tDCS combined with the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders.
Sham tDCS (control for active tDCS) combined with the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders.
Active tDCS combined with psychoeducation (control condition for CBT-UP).
Sham tDCS combined with psychoeducation (control conditions for active tDCS and CBT-UP).
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Response to treatment
Defined as reduction of total Hamilton Anxiety Rating Scale (HARS; Hamilton, 1959) score by ≥ 50%.
Remission to treatment
Defined as reduction of total Hamilton Anxiety Rating Scale (HARS; Hamilton, 1959) to scores lower than 18 (indicating mild anxiety severity).
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04453631
Brief Title
tDCS and Psychotherapy for the Treatment of Anxiety Disorders
Acronym
tDCSplusUP
Official Title
The Efficacy of Transcranial Direct Current Stimulation Combined With the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders: a Double Blind, Sham Controlled, Randomized Factorial Designed Study for Anxiety Disorders
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 3, 2023 (Anticipated)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Coimbra
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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).
Detailed Description
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
active tDCS + CBT-UP
sham tDCS + CBT-UP
active tDCS + Psychoeducation
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Disorders
Keywords
anxiety disorders, tDCS, Unified Protocol, RCT
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
active tDCS + CBT-UP
Arm Type
Experimental
Arm Description
Active tDCS combined with the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders.
Arm Title
sham tDCS + CBT-UP
Arm Type
Active Comparator
Arm Description
Sham tDCS (control for active tDCS) combined with the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders.
Arm Title
active tDCS + Psychoeducation
Arm Type
Active Comparator
Arm Description
Active tDCS combined with psychoeducation (control condition for CBT-UP).
Arm Title
sham tDCS + Psychoeducation
Arm Type
Placebo Comparator
Arm Description
Sham tDCS combined with psychoeducation (control conditions for active tDCS and CBT-UP).
Intervention Type
Device
Intervention Name(s)
active tDCS
Other Intervention Name(s)
Transcranial Direct Current Stimulation
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
sham tDCS
Intervention Description
tDCS is controlled in this intervention: sham mode.
Intervention Type
Behavioral
Intervention Name(s)
CBT-UP
Intervention Description
15 psychotherapy sessions (1/week) following the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders developed by Barlow et al. 2018.
Intervention Type
Behavioral
Intervention Name(s)
Psychoeducation
Intervention Description
To control for the cognitive-behavioral intervention we will use psychoeducation materials.
Primary Outcome Measure Information:
Title
Hamilton Anxiety Rating Scale (HARS; Hamilton, 1959)
Description
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.
Time Frame
At week 8th, 15th (middle and end of treatment) and 6 months follow-up
Secondary Outcome Measure Information:
Title
Response to treatment
Description
Defined as reduction of total Hamilton Anxiety Rating Scale (HARS; Hamilton, 1959) score by ≥ 50%.
Time Frame
At week 8th, 15th (middle and end of treatment) and 6 months follow-up.
Title
Remission to treatment
Description
Defined as reduction of total Hamilton Anxiety Rating Scale (HARS; Hamilton, 1959) to scores lower than 18 (indicating mild anxiety severity).
Time Frame
At week 8th, 15th (middle and end of treatment) and 6 months follow-up.
Title
Hamilton Depression Rating Scale (HRSD; Hamilton, 1960)
Description
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.
Time Frame
At week 8th, 15th (middle and end of treatment) and 6 months follow-up.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of generalized anxiety disorder, specific phobia, panic disorder, agoraphobia, or social anxiety disorder.
Willing to participate and to give written informed consent
Exclusion Criteria:
Contra-indications to tDCS use:
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
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
12. IPD Sharing Statement
Plan to Share IPD
Yes
Citations:
PubMed Identifier
13638508
Citation
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.
Results Reference
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PubMed Identifier
14399272
Citation
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.
Results Reference
background
PubMed Identifier
27372845
Citation
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.
Results Reference
background
PubMed Identifier
28768327
Citation
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.
Results Reference
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tDCS and Psychotherapy for the Treatment of Anxiety Disorders
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