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tDCS-Augmented Exposure Therapy for Pathological Fear

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ClinicalTrials.gov Identifier: NCT03095482
Recruitment Status : Unknown
Verified March 2017 by Michael J. Telch, University of Texas at Austin.
Recruitment status was:  Recruiting
First Posted : March 29, 2017
Last Update Posted : March 29, 2017
Sponsor:
Information provided by (Responsible Party):
Michael J. Telch, University of Texas at Austin

Brief 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, tightly enclosed spaces, 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.

Condition or disease Intervention/treatment Phase
Specific Phobias Device: Transcranial Direct Current Stimulation (tDCS) Behavioral: In vivo exposure therapy Not Applicable

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 (a) tDCS using the same electrode positioning, but reversed polarity, and (b) sham tDCS; (2) determine whether reversed polarity tDCS impedes extinction learning; 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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, (b) the same tDCS electrode positioning, but with reversed polarity, or (c) sham tDCS
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Participants, treatment administrators, and outcome assessors will be blind to tDCS condition.
Primary Purpose: Treatment
Official Title: tDCS-Augmented Exposure Therapy for Pathological Fear
Actual Study Start Date : January 1, 2017
Estimated Primary Completion Date : May 30, 2018
Estimated Study Completion Date : May 30, 2018

Arm Intervention/treatment
Active Comparator: tDCS (mPFC+) + In Vivo Exposure
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 2 mA, followed by 30 minutes of in vivo exposure therapy.
Device: Transcranial Direct Current Stimulation (tDCS)
Participants will receive 20 minutes of either active or sham tDCS prior to in vivo exposure to feared targets.

Behavioral: In vivo exposure therapy
Participants will receive 30 minutes of in vivo exposure to feared targets following either active or sham tDCS

Active Comparator: tDCS (mPFC-) + In Vivo Exposure
Participants assigned to this condition will receive inhibitory transcranial direct current stimulation (tDCS) of the left medial prefrontal cortex (lmPFC) and excitatory tDCS of right dorsolateral prefrontal cortex (rdlPFC). tDCS will be administered for 20 minutes at 2 mA. tDCS will be administered for 20 minutes at 2 mA, followed by 30 minutes of in vivo exposure therapy.
Device: Transcranial Direct Current Stimulation (tDCS)
Participants will receive 20 minutes of either active or sham tDCS prior to in vivo exposure to feared targets.

Behavioral: In vivo exposure therapy
Participants will receive 30 minutes of in vivo exposure to feared targets following either active or sham tDCS

Sham Comparator: sham tDCS + In Vivo Exposure
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.
Behavioral: In vivo exposure therapy
Participants will receive 30 minutes of in vivo exposure to feared targets following either active or sham tDCS




Primary Outcome Measures :
  1. 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

  2. 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.


Secondary Outcome Measures :
  1. 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) ]
    Total score on the Fear of Spiders Questionnaire

  2. 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) ]
    Total score on the Fear of Snakes Questionnaire

  3. Change in claustrophobia symptom severity across time points [ Time Frame: Pre-treatment (baseline), post-treatment (1 week later), and follow-up (1 month after treatment) ]
    Total score on the Claustrophobia Questionnaire

  4. 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) ]
    Total score on the Obsessive Compulsive Inventory - Revised.

  5. Threat vigilance task [ Time Frame: Before and after tDCS administration (1 week after baseline) ]
    Computer-based task that assesses attention biases towards and away from threatening images.

  6. Visuospatial working memory task [ Time Frame: Before and after tDCS administration (1 week after baseline) ]
    Delayed match to sample task assessing recognition of 4 x 4 arrays of colored blocks, after a brief delay.

  7. 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) ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Age 18-65.
  2. Fluent in English.
  3. A score on at least 1 fear domain-specific prescreen measure > 2 SDs above the subject pool prescreen mean. These measures include (a) the CLQ, (b) FSQ, and (c) OCI-R.
  4. Peak fear ≥ 50 on BATs 1 and 2.

Exclusion Criteria:

  1. Currently receiving treatment for the primary fear domain (based on clinical interview).
  2. Unstable dose of psychotropic medications within 6 weeks prior to baseline assessment (based on the DMQ; see measures).
  3. Medical condition that would contraindicate participation in treatment or assessment activities (e.g., cardiovascular problems; based on the DMQ; see measures).
  4. Pregnancy (based on the DMQ; see measures).
  5. Current major depressive disorder (based on MINI; see measures).
  6. Current, or history of bipolar disorder (based on MINI; see measures).
  7. Current, or history of psychotic symptoms (based on MINI; see measures).
  8. Serious suicidal risk, as determined by self-report (C-SSRS, BDI-II) and clinical interview (MINI; see measures).
  9. Active neurological conditions, including seizures, stroke, unexplained loss of consciousness or concussion (based on DMQ and tDCS Safety Screening Form; see measures)
  10. Contraindications for tDCS: Metal in the head or implanted brain medical devices.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03095482


Contacts
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Contact: Michael J Telch, PhD (512)-560-4100 telch@austin.utexas.edu
Contact: Adam R Cobb, MA (325)-201-4228 adamrcobb@utexas.edu

Locations
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United States, Texas
Laboratory for the Study of Anxiety Disorders Recruiting
Austin, Texas, United States, 78712
Contact: Michael J. Telch, Ph.D.    512-404-9118    Telch@austin.utexas.edu   
Contact: Adam R Cobb, MA    (325)-201-4228    adamrcobb@utexas.edu   
Sponsors and Collaborators
University of Texas at Austin
Investigators
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Principal Investigator: Adam R. Cobb, MA The University of Texas at Austin
Study Director: Michael J. Telch, PhD The University of Texas at Austin

Additional Information:
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Responsible Party: Michael J. Telch, Professor of Psychology, University of Texas at Austin
ClinicalTrials.gov Identifier: NCT03095482     History of Changes
Other Study ID Numbers: 2016-02-0024
First Posted: March 29, 2017    Key Record Dates
Last Update Posted: March 29, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Michael J. Telch, University of Texas at Austin:
Arachnophobia (fear of spiders)
Ophidophobia (fear of snakes)
Claustrophobia (fear of tightly enclosed spaces)
Germaphobia (fear of germs, dirtiness, and contamination)