Anxiety DisorderstDCSplusUPNCT04453631
tDCS and Psychotherapy for the Treatment of Anxiety Disorders
A study testing active tDCS, CBT-UP and Psychoeducation in people with Anxiety Disorders, run by University of Coimbra.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anxiety Disorders
- What is being tested?
- active tDCS, CBT-UP and Psychoeducation
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 3 Jan 2023to Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of generalized anxiety disorder, specific phobia, panic disorder, agoraphobia, or social anxiety disorder.
- Willing to participate and to give written informed consent
Who cannot join
- 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
Show all 13Show fewer
- 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
About this study
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
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).
Read the 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.
- Conditions
- Anxiety Disorders
- Being tested
- active tDCS, sham tDCS, CBT-UP, Psychoeducation
- Keywords
- anxiety disorders, tDCS, Unified Protocol, RCT
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
active tDCSDevice
Also called Transcranial Direct Current Stimulation
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 tDCSDevice
tDCS is controlled in this intervention: sham mode.
CBT-UPBehavioural
15 psychotherapy sessions (1/week) following the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders developed by Barlow et al. 2018.
PsychoeducationBehavioural
To control for the cognitive-behavioral intervention we will use psychoeducation materials.
| Study group | Role | What they receive |
|---|---|---|
| active tDCS + CBT-UP | Experimental | Active tDCS combined with the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders. Receives: 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. Receives: Device: sham tDCS; Behavioral: CBT-UP |
| active tDCS + Psychoeducation | Active comparator | Active tDCS combined with psychoeducation (control condition for CBT-UP). Receives: Device: active tDCS; Behavioral: Psychoeducation |
| sham tDCS + Psychoeducation | Placebo comparator | Sham tDCS combined with psychoeducation (control conditions for active tDCS and CBT-UP). Receives: Device: sham tDCS; Behavioral: Psychoeducation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At week 8th, 15th (middle and end of treatment) and 6 months follow-up
Secondary outcomes (3)
Response to treatment
Defined as reduction of total Hamilton Anxiety Rating Scale (HARS; Hamilton, 1959) score by ≥ 50%.
Measured: At week 8th, 15th (middle and end of treatment) and 6 months follow-up.
Remission to treatment
Defined as reduction of total Hamilton Anxiety Rating Scale (HARS; Hamilton, 1959) to scores lower than 18 (indicating mild anxiety severity).
Measured: 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.
Measured: At week 8th, 15th (middle and end of treatment) and 6 months follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2020
- Study start3 Jan 2023 (estimated)
- Primary completionJan 2024 (estimated)
- Study completionJul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Anxiety DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Coimbra
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ana Ganho Ávila, University of Coimbra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04453631
- Sponsor's protocol ID
- tDCS-UP
- Acronym
- tDCSplusUP
- Status last verified
- May 2022
- First submitted
- 26 Jun 2020
- Last updated
- 20 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 13638508HAMILTON 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.
PubMed 14399272Bikson 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.
PubMed 27372845Barlow 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.
PubMed 28768327
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04453631
- Acronym / sponsor ID
- tDCSplusUP / tDCS-UP
- Conditions
- Anxiety Disorders
- Keywords
- anxiety disorders, tDCS, Unified Protocol, RCT
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of CoimbraUniversity, hospital or other
- Study start
- 3 Jan 2023 (estimated)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 1 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| active tDCS + CBT-UP | Experimental | Device: active tDCS, Behavioral: CBT-UPActive tDCS combined with the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders. |
| sham tDCS + CBT-UP | Active comparator | Device: sham tDCS, Behavioral: CBT-UPSham tDCS (control for active tDCS) combined with the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders. |
| active tDCS + Psychoeducation | Active comparator | Device: active tDCS, Behavioral: PsychoeducationActive tDCS combined with psychoeducation (control condition for CBT-UP). |
| sham tDCS + Psychoeducation | Placebo comparator | Device: sham tDCS, Behavioral: PsychoeducationSham tDCS combined with psychoeducation (control conditions for active tDCS and CBT-UP). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of generalized anxiety disorder, specific phobia, panic disorder, agoraphobia, or social anxiety disorder.
- Willing to participate and to give written informed consent
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| active tDCSAlso: Transcranial Direct Current Stimulation26 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. | Device | active tDCS + CBT-UP, active tDCS + Psychoeducation |
| sham tDCStDCS is controlled in this intervention: sham mode. | Device | sham tDCS + CBT-UP, sham tDCS + Psychoeducation |
| CBT-UP15 psychotherapy sessions (1/week) following the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders developed by Barlow et al. 2018. | Behavioural | active tDCS + CBT-UP, sham tDCS + CBT-UP |
| PsychoeducationTo control for the cognitive-behavioral intervention we will use psychoeducation materials. | Behavioural | active tDCS + Psychoeducation, sham tDCS + Psychoeducation |
Primary outcome
Hamilton Anxiety Rating Scale (HARS; Hamilton, 1959)
Time frame: At week 8th, 15th (middle and end of treatment) and 6 months follow-up
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.
3 secondary outcomes
Response to treatment
Time frame: At week 8th, 15th (middle and end of treatment) and 6 months follow-up.
Remission to treatment
Time frame: At week 8th, 15th (middle and end of treatment) and 6 months follow-up.
Hamilton Depression Rating Scale (HRSD; Hamilton, 1960)
Time frame: At week 8th, 15th (middle and end of treatment) and 6 months follow-up.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2022.
- Background: PubMed 13638508HAMILTON 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.
- Background: PubMed 14399272HAMILTON 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.
- Background: PubMed 27372845Bikson 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.
- Background: PubMed 28768327Barlow 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing active tDCS, CBT-UP and Psychoeducation in people with Anxiety Disorders, run by University of Coimbra.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 May 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hamilton Anxiety Rating Scale (HARS; Hamilton, 1959) (time frame: At week 8th, 15th (middle and end of treatment) and 6 months follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04453631, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2022.