tDCS-Augmented Exposure Therapy for Pathological Fear

NCT03095482 | Completed

• 1 other identifier: 2016-02-0024
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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, 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.

Conditions

Specific Phobias

Keywords

Arachnophobia (fear of spiders); Ophidophobia (fear of snakes); Germaphobia (fear of germs, dirtiness, and contamination)

Outcome Measures

Primary Outcomes (2)

• Change in peak fear during two behavioral approach tasks across time-points.

  Subjective units of distress from 0 = no fear, to 100 = extreme fear

  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.

  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

  Pre-treatment (baseline), post-treatment (1 week later), and follow-up (1 month after treatment)

• Change in ophidophobia symptom severity across time-points

  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.

  Pre-treatment (baseline), post-treatment (1 week later), and follow-up (1 month after treatment)

• Threat vigilance task

  Before and after tDCS administration (1 week after baseline)

• Visuospatial working memory task

  Before and after tDCS administration (1 week after baseline)

Study Arms (2)

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.

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.

Behavioral: In vivo exposure therapy

Interventions

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.

Active tDCS + In Vivo Exposure

In vivo exposure therapy BEHAVIORAL

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

Active tDCS + In Vivo Exposure; sham tDCS + In Vivo Exposure

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• University of Texas at Austin: lead

Study Sites (1)

Laboratory for the Study of Anxiety Disorders

Austin, Texas, 78712, United States

Location

Related Links

• Website for the Laboratory for the Study of Anxiety Disorders

MeSH Terms

Conditions

Phobia, Specific; Arachnophobia; Zoophobia; Mysophobia

Interventions

Transcranial Direct Current Stimulation

Intervention Hierarchy (Ancestors)

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

Study Officials

• Adam R. Cobb, Ph.D.

  The University of Texas at Austin

  PRINCIPAL INVESTIGATOR

• Michael J. Telch, PhD

  The University of Texas at Austin

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants, treatment administrators, and outcome assessors will be blind to tDCS condition.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychology

Model Details: 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

Study Record Dates

• First Submitted: March 20, 2017
• First Posted: March 29, 2017
• Study Start: January 1, 2017
• Primary Completion: September 6, 2018
• Study Completion: September 6, 2018
• Last Updated: December 8, 2020

Record last verified: 2020-12

Locations

US (1)