tDCS-Augmented Exposure Therapy for Pathological Fear
4 décembre 2020 mis à jour par: Michael J. Telch, University of Texas at Austin
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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Réel)
49
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Texas
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Austin, Texas, États-Unis, 78712
- Laboratory for the Study of Anxiety Disorders
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans à 65 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Comparateur actif: Active tDCS + 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 1.7 mA, followed by 30 minutes of in vivo exposure therapy.
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Participants will receive 20 minutes of either active or sham tDCS prior to in vivo exposure to feared targets.
Participants will receive 30 minutes of in vivo exposure to feared targets following either active or sham tDCS
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Comparateur factice: 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.
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Participants will receive 30 minutes of in vivo exposure to feared targets following either active or sham tDCS
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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Change in peak fear during two behavioral approach tasks across time-points.
Délai: Pre-treatment (baseline), post-treatment (1 week later), and follow-up (1 month after treatment)
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Subjective units of distress from 0 = no fear, to 100 = extreme fear
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Pre-treatment (baseline), post-treatment (1 week later), and follow-up (1 month after treatment)
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Change in approach level during two behavioral approach tasks across time points.
Délai: Pre-treatment (baseline), post-treatment (1 week later), and follow-up (1 month after treatment)
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Highest difficulty level achieved from 0 = least challenging to 10 = most challenging.
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Pre-treatment (baseline), post-treatment (1 week later), and follow-up (1 month after treatment)
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in arachnophobia symptom severity across time-points
Délai: Pre-treatment (baseline), post-treatment (1 week later), and follow-up (1 month after treatment)
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Total score on the Fear of Spiders Questionnaire
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Pre-treatment (baseline), post-treatment (1 week later), and follow-up (1 month after treatment)
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Change in ophidophobia symptom severity across time-points
Délai: Pre-treatment (baseline), post-treatment (1 week later), and follow-up (1 month after treatment)
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Total score on the Fear of Snakes Questionnaire
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Pre-treatment (baseline), post-treatment (1 week later), and follow-up (1 month after treatment)
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Change in germaphobia / contamination fear symptom severity across time points.
Délai: Pre-treatment (baseline), post-treatment (1 week later), and follow-up (1 month after treatment)
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Total score on the Obsessive Compulsive Inventory - Revised.
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Pre-treatment (baseline), post-treatment (1 week later), and follow-up (1 month after treatment)
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Threat vigilance task
Délai: Before and after tDCS administration (1 week after baseline)
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Computer-based task that assesses attention biases towards and away from threatening images.
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Before and after tDCS administration (1 week after baseline)
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Visuospatial working memory task
Délai: Before and after tDCS administration (1 week after baseline)
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Delayed match to sample task assessing recognition of 4 x 4 arrays of colored blocks, after a brief delay.
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Before and after tDCS administration (1 week after baseline)
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Incidental contextual memory task
Délai: Stimulus presented during in vivo exposure (1 week after baseline), and memory assessed at follow-up (1 month after treatment)
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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.
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Stimulus presented during in vivo exposure (1 week after baseline), and memory assessed at follow-up (1 month after treatment)
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Adam R. Cobb, Ph.D., The University of Texas at Austin
- Directeur d'études: Michael J. Telch, PhD, The University of Texas at Austin
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
1 janvier 2017
Achèvement primaire (Réel)
6 septembre 2018
Achèvement de l'étude (Réel)
6 septembre 2018
Dates d'inscription aux études
Première soumission
20 mars 2017
Première soumission répondant aux critères de contrôle qualité
23 mars 2017
Première publication (Réel)
29 mars 2017
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
8 décembre 2020
Dernière mise à jour soumise répondant aux critères de contrôle qualité
4 décembre 2020
Dernière vérification
1 décembre 2020
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- 2016-02-0024
Plan pour les données individuelles des participants (IPD)
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Indécis
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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