tDCS and Psychotherapy for the Treatment of Anxiety Disorders

NCT04453631 | Unknown

• 1 other identifier: tDCS-UP
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Anxiety Disorders

Keywords

anxiety disorders; tDCS; Unified Protocol; RCT

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Response to treatment

  At week 8th, 15th (middle and end of treatment) and 6 months follow-up.

• Remission to treatment

  At week 8th, 15th (middle and end of treatment) and 6 months follow-up.

• Hamilton Depression Rating Scale (HRSD; Hamilton, 1960)

  At week 8th, 15th (middle and end of treatment) and 6 months follow-up.

Study Arms (4)

active tDCS + CBT-UP

EXPERIMENTAL

Active tDCS combined with the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders.

Device: active tDCS; Behavioral: CBT-UP

sham tDCS + CBT-UP

ACTIVE COMPARATOR

Sham tDCS (control for active tDCS) combined with the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders.

Device: sham tDCS; Behavioral: CBT-UP

active tDCS + Psychoeducation

ACTIVE COMPARATOR

Active tDCS combined with psychoeducation (control condition for CBT-UP).

Device: active tDCS; Behavioral: Psychoeducation

sham tDCS + Psychoeducation

PLACEBO COMPARATOR

Sham tDCS combined with psychoeducation (control conditions for active tDCS and CBT-UP).

Device: sham tDCS; Behavioral: Psychoeducation

Interventions

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.

Also known as: Transcranial Direct Current Stimulation

active tDCS + CBT-UP; active tDCS + Psychoeducation

sham tDCS DEVICE

tDCS is controlled in this intervention: sham mode.

sham tDCS + CBT-UP; sham tDCS + Psychoeducation

CBT-UP BEHAVIORAL

15 psychotherapy sessions (1/week) following the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders developed by Barlow et al. 2018.

active tDCS + CBT-UP; sham tDCS + CBT-UP

Psychoeducation BEHAVIORAL

To control for the cognitive-behavioral intervention we will use psychoeducation materials.

active tDCS + Psychoeducation; sham tDCS + Psychoeducation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of generalized anxiety disorder, specific phobia, panic disorder, agoraphobia, or social anxiety disorder.
• Willing to participate and to give written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Coimbra: lead

Related Publications (4)

• 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.

  PMID: 13638508 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.

  PMID: 14399272 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.

  PMID: 27372845 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.

  PMID: 28768327 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Integrated Researcher

Study Record Dates

• First Submitted: June 26, 2020
• First Posted: July 1, 2020
• Study Start: January 3, 2023
• Primary Completion: January 1, 2024
• Study Completion: July 1, 2024
• Last Updated: May 20, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share