Specific PhobiasNCT03095482
tDCS-Augmented Exposure Therapy for Pathological Fear
A study testing Transcranial Direct Current Stimulation (tDCS) and In vivo exposure therapy in people with Specific Phobias, run by University of Texas at Austin at 1 site in United States.
Trial summary
This double-blind randomized controlled clinical trial aims to test whether transcranial direct current stimulation (tDCS) can be used to modulate fear extinction learning during exposure therapy for pathological fear, including fear of spiders, snakes, or germs / contamination. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Specific Phobias
- What is being tested?
- Transcranial Direct Current Stimulation (tDCS) and In vivo exposure therapy
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2017to 6 Sep 2018
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18-65.
- Fluent in English.
- A score on at least 1 fear domain-specific prescreen measure > 2 SDs above the subject pool prescreen mean. These measures include (a) FSQ, and (b) OCI-R.
- Peak fear ≥ 50 on BATs 1 and 2.
Who cannot join
- Currently receiving treatment for the primary fear domain (based on clinical interview).
- Unstable dose of psychotropic medications within 6 weeks prior to baseline assessment (based on the DMQ; see measures).
- Medical condition that would contraindicate participation in treatment or assessment activities (e.g., cardiovascular problems; based on the DMQ; see measures).
- Pregnancy (based on the DMQ; see measures).
- Current major depressive disorder (based on MINI; see measures).
- Current, or history of bipolar disorder (based on MINI; see measures).
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- Current, or history of psychotic symptoms (based on MINI; see measures).
- Serious suicidal risk, as determined by self-report (C-SSRS, BDI-II) and clinical interview (MINI; see measures).
- Active neurological conditions, including seizures, stroke, unexplained loss of consciousness or concussion (based on DMQ and tDCS Safety Screening Form; see measures)
- Contraindications for tDCS: Metal in the head or implanted brain medical devices.
Trial locations and contacts
1 site in 1 country.
United States1 site
Laboratory for the Study of Anxiety Disorders
Austin, Texas, 78712
About this study
This double-blind randomized controlled clinical trial aims to test whether transcranial direct current stimulation (tDCS) can be used to modulate fear extinction learning during exposure therapy for pathological fear, including fear of spiders, snakes, or germs / contamination. Participation takes place over three laboratory visits, including (1) a pre-treatment visit, (2) a treatment and post-treatment visit, and (3) a 1 month follow-up visit. During treatment, participants will receive either 20 minutes of active or sham tDCS, followed by 30 minutes of in vivo exposure therapy.
Read the detailed description
In a trans-diagnostic sample with marked pathological fear and behavioral avoidance, this study aims to: (1) evaluate whether excitatory tDCS of the mPFC and inhibitory tDCS of right dlPFC enhances exposure therapy relative to sham tDCS; (2) determine whether tDCS effects are moderated by baseline negative prognostic indicators; and (3) determine whether tDCS effects are mediated by pre-post changes in vigilance to threat, in-session fear reduction, and contextual memory for the exposure context. If successful, the project may discover a potentially effective exposure therapy augmentation, and may enhance knowledge of the behavioral, cognitive, affective, and neurobiological factors that moderate and mediate acute treatment response and maintenance of treatment gains. This knowledge may inform treatment development efforts for more debilitating forms of pathological fear.
- Conditions
- Specific Phobias
- Being tested
- Transcranial Direct Current Stimulation (tDCS), In vivo exposure therapy
- Keywords
- Arachnophobia (fear of spiders), Ophidophobia (fear of snakes), Germaphobia (fear of germs, dirtiness, and contamination)
- Medical subject headings
- Phobia, Specific, Arachnophobia, Zoophobia, Mysophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Direct Current Stimulation (tDCS)Device
Participants will receive 20 minutes of either active or sham tDCS prior to in vivo exposure to feared targets.
In vivo exposure therapyBehavioural
Participants will receive 30 minutes of in vivo exposure to feared targets following either active or sham tDCS
| Study group | Role | What they receive |
|---|---|---|
| Active tDCS + In Vivo Exposure | Active comparator | Participants assigned to this condition will receive excitatory transcranial direct current stimulation (tDCS) of the left medial prefrontal cortex (lmPFC) and inhibitory tDCS of right dorsolateral prefrontal cortex (rdlPFC). tDCS will be administered for 20 minutes at 1.7 mA, followed by 30 minutes of in vivo exposure therapy. Receives: Device: Transcranial Direct Current Stimulation (tDCS); Behavioral: In vivo exposure therapy |
| sham tDCS + In Vivo Exposure | Sham comparator | Participants assigned to this condition will receive sham transcranial direct current stimulation (tDCS), which will consist of 30 seconds of stimulation at the beginning and end of tDCS administration. Electrode positioning will be counterbalanced across participants (i.e., either mPFC+ or mPFC-, with same electrode positioning as the active comparators). Sham tDCS will be administered for 20 minutes, followed by 30 minutes of in vivo exposure therapy. Receives: Behavioral: In vivo exposure therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in peak fear during two behavioral approach tasks across time-points.
Subjective units of distress from 0 = no fear, to 100 = extreme fear
Measured: Pre-treatment (baseline), post-treatment (1 week later), and follow-up (1 month after treatment)
Change in approach level during two behavioral approach tasks across time points.
Highest difficulty level achieved from 0 = least challenging to 10 = most challenging.
Measured: Pre-treatment (baseline), post-treatment (1 week later), and follow-up (1 month after treatment)
Secondary outcomes (6)
Change in arachnophobia symptom severity across time-points
Total score on the Fear of Spiders Questionnaire
Measured: Pre-treatment (baseline), post-treatment (1 week later), and follow-up (1 month after treatment)
Change in ophidophobia symptom severity across time-points
Total score on the Fear of Snakes Questionnaire
Measured: Pre-treatment (baseline), post-treatment (1 week later), and follow-up (1 month after treatment)
Change in germaphobia / contamination fear symptom severity across time points.
Total score on the Obsessive Compulsive Inventory - Revised.
Measured: Pre-treatment (baseline), post-treatment (1 week later), and follow-up (1 month after treatment)
Threat vigilance task
Computer-based task that assesses attention biases towards and away from threatening images.
Measured: Before and after tDCS administration (1 week after baseline)
Visuospatial working memory task
Delayed match to sample task assessing recognition of 4 x 4 arrays of colored blocks, after a brief delay.
Measured: Before and after tDCS administration (1 week after baseline)
Incidental contextual memory task
Assessment of incidental memory for a 4 x 4 array of line drawings from the Test of Memory Malingering, presented in the treatment context only during in vivo exposure.
Measured: Stimulus presented during in vivo exposure (1 week after baseline), and memory assessed at follow-up (1 month after treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2017
- Study start1 Jan 2017
- Primary completion6 Sep 2018
- Study completion6 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Specific PhobiasStudies 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
- Model description
- Participants will be randomly assigned to receive either (a) excitatory tDCS of the medial prefrontal cortex and inhibitory tDCS of right dorsolateral prefrontal cortex, or (b) sham tDCS
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael J. Telch, University of Texas at Austin
- Investigators
- Adam R. Cobb, Ph.D., Principal investigator, The University of Texas at AustinMichael J. Telch, PhD, Study director, The University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03095482
- Sponsor's protocol ID
- 2016-02-0024
- Status last verified
- Dec 2020
- First submitted
- 20 Mar 2017
- Last updated
- 8 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- tDCS-Augmented Exposure Therapy for Pathological Fear
- ClinicalTrials.gov ID
- NCT03095482
- Acronym / sponsor ID
- 2016-02-0024
- Conditions
- Specific Phobias
- Keywords
- Arachnophobia (fear of spiders), Ophidophobia (fear of snakes), Germaphobia (fear of germs, dirtiness, and contamination)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 6 Sep 2018 (actual)
- Study completion
- 6 Sep 2018 (actual)
- First posted
- 29 Mar 2017 (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.
This double-blind randomized controlled clinical trial aims to test whether transcranial direct current stimulation (tDCS) can be used to modulate fear extinction learning during exposure therapy for pathological fear, including fear of spiders, snakes, or germs / contamination. Participation takes place over three laboratory visits, including (1) a pre-treatment visit, (2) a treatment and post-treatment visit, and (3) a 1 month follow-up visit. During treatment, participants will receive either 20 minutes of active or sham tDCS, followed by 30 minutes of in vivo exposure therapy.
Detailed description
In a trans-diagnostic sample with marked pathological fear and behavioral avoidance, this study aims to: (1) evaluate whether excitatory tDCS of the mPFC and inhibitory tDCS of right dlPFC enhances exposure therapy relative to sham tDCS; (2) determine whether tDCS effects are moderated by baseline negative prognostic indicators; and (3) determine whether tDCS effects are mediated by pre-post changes in vigilance to threat, in-session fear reduction, and contextual memory for the exposure context. If successful, the project may discover a potentially effective exposure therapy augmentation, and may enhance knowledge of the behavioral, cognitive, affective, and neurobiological factors that moderate and mediate acute treatment response and maintenance of treatment gains. This knowledge may inform treatment development efforts for more debilitating forms of pathological fear.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to receive either (a) excitatory tDCS of the medial prefrontal cortex and inhibitory tDCS of right dorsolateral prefrontal cortex, or (b) sham tDCS
| Arm | Type | Receives |
|---|---|---|
| Active tDCS + In Vivo Exposure | Active comparator | Device: Transcranial Direct Current Stimulation (tDCS), Behavioral: In vivo exposure therapyParticipants assigned to this condition will receive excitatory transcranial direct current stimulation (tDCS) of the left medial prefrontal cortex (lmPFC) and inhibitory tDCS of right dorsolateral prefrontal cortex (rdlPFC). tDCS will be administered for 20 minutes at 1.7 mA, followed by 30 minutes of in vivo exposure therapy. |
| sham tDCS + In Vivo Exposure | Sham comparator | Behavioral: In vivo exposure therapyParticipants assigned to this condition will receive sham transcranial direct current stimulation (tDCS), which will consist of 30 seconds of stimulation at the beginning and end of tDCS administration. Electrode positioning will be counterbalanced across participants (i.e., either mPFC+ or mPFC-, with same electrode positioning as the active comparators). Sham tDCS will be administered for 20 minutes, followed by 30 minutes of in vivo exposure therapy. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18-65.
- Fluent in English.
- A score on at least 1 fear domain-specific prescreen measure > 2 SDs above the subject pool prescreen mean. These measures include (a) FSQ, and (b) OCI-R.
- Peak fear ≥ 50 on BATs 1 and 2.
Key exclusion criteria (10 listed)
- Currently receiving treatment for the primary fear domain (based on clinical interview).
- Unstable dose of psychotropic medications within 6 weeks prior to baseline assessment (based on the DMQ; see measures).
- Medical condition that would contraindicate participation in treatment or assessment activities (e.g., cardiovascular problems; based on the DMQ; see measures).
- Pregnancy (based on the DMQ; see measures).
- Current major depressive disorder (based on MINI; see measures).
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 |
|---|---|---|
| Transcranial Direct Current Stimulation (tDCS)Participants will receive 20 minutes of either active or sham tDCS prior to in vivo exposure to feared targets. | Device | Active tDCS + In Vivo Exposure |
| In vivo exposure therapyParticipants will receive 30 minutes of in vivo exposure to feared targets following either active or sham tDCS | Behavioural | Active tDCS + In Vivo Exposure, sham tDCS + In Vivo Exposure |
Primary outcome
Change in peak fear during two behavioral approach tasks across time-points.
Time frame: Pre-treatment (baseline), post-treatment (1 week later), and follow-up (1 month after treatment)
Subjective units of distress from 0 = no fear, to 100 = extreme fear
Change in approach level during two behavioral approach tasks across time points.
Time frame: Pre-treatment (baseline), post-treatment (1 week later), and follow-up (1 month after treatment)
Highest difficulty level achieved from 0 = least challenging to 10 = most challenging.
6 secondary outcomes
Change in arachnophobia symptom severity across time-points
Time frame: Pre-treatment (baseline), post-treatment (1 week later), and follow-up (1 month after treatment)
Change in ophidophobia symptom severity across time-points
Time frame: Pre-treatment (baseline), post-treatment (1 week later), and follow-up (1 month after treatment)
Change in germaphobia / contamination fear symptom severity across time points.
Time frame: Pre-treatment (baseline), post-treatment (1 week later), and follow-up (1 month after treatment)
Threat vigilance task
Time frame: Before and after tDCS administration (1 week after baseline)
Visuospatial working memory task
Time frame: Before and after tDCS administration (1 week after baseline)
Incidental contextual memory task
Time frame: Stimulus presented during in vivo exposure (1 week after baseline), and memory assessed at follow-up (1 month after treatment)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2020.
- Website for the Laboratory for the Study of Anxiety DisordersLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for Specific Phobias
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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.
Adam R. Cobb, Ph.D. principal investigator
The University of Texas at Austin
Michael J. Telch, PhD study director
The University of Texas at Austin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Direct Current Stimulation (tDCS) and In vivo exposure therapy in people with Specific Phobias, run by University of Texas at Austin at 1 site in United States.
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 4 inclusion and 10 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: finished, as of the sponsor's last update on 8 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in peak fear during two behavioral approach tasks across time-points. (time frame: Pre-treatment (baseline), post-treatment (1 week later), and follow-up (1 month after treatment)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Dec 2020.