tDCS-Augmented Exposure Therapy for Pathological Fear
2020年12月4日 更新者：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.
調査の概要
状態
完了
条件
詳細な説明
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.
研究の種類
介入
入学 (実際)
49
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Texas
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Austin、Texas、アメリカ、78712
- Laboratory for the Study of Anxiety Disorders
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年～65年 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
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アクティブコンパレータ：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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偽コンパレータ：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in peak fear during two behavioral approach tasks across time-points.
時間枠：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.
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in arachnophobia symptom severity across time-points
時間枠：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
時間枠：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.
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Adam R. Cobb, Ph.D.、The University of Texas at Austin
- スタディディレクター：Michael J. Telch, PhD、The University of Texas at Austin
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2017年1月1日
一次修了 (実際)
2018年9月6日
研究の完了 (実際)
2018年9月6日
試験登録日
最初に提出
2017年3月20日
QC基準を満たした最初の提出物
2017年3月23日
最初の投稿 (実際)
2017年3月29日
学習記録の更新
投稿された最後の更新 (実際)
2020年12月8日
QC基準を満たした最後の更新が送信されました
2020年12月4日
最終確認日
2020年12月1日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- 2016-02-0024
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
未定
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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Transcranial Direct Current Stimulation (tDCS)の臨床試験
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University of North Carolina, Chapel HillNational Institute of Mental Health (NIMH)完了