Integrating Exposure and Response Prevention and Habit Reversal Techniques to Treat a Tourettic Subtype of Obsessive-Compulsive Disorder (Tourettic OCD) (TORCH)
調査の概要
状態
詳細な説明
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前:Dipesh Patel, MPhil / PhD
- 電話番号:+44 (0)20 3456 7890
- メール:dipesh.patel.23@ucl.ac.uk
研究場所
-
-
London
-
London、London、イギリス、WC1N 3BG
- 募集
- University College London Queen Square Institute of Neurology
-
コンタクト:
- Dipesh Patel, MPhil / PhD
- 電話番号:+44 (0)20 3456 7890
- メール:dipesh.patel.23@ucl.ac.uk
-
主任研究者:
- Himanshu Tyagi, PhD
-
London、London、イギリス、WC1N 3BG
- 募集
- University College London Hospitals NHS Foundation Trust
-
コンタクト:
- Dipesh Patel, MPhil / PhD
- 電話番号:+44 (0)20 3456 7890
- メール:dipesh.patel.23@ucl.ac.uk
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Age 18 years or older
- All genders
- Confirmation of a primary diagnosis of either:
a. Tourettes Disorder / Tourette Syndrome b. Persistent Motor or Vocal Tic Disorder / Chronic Motor or Vocal Tic Disorder c. Provisional Tic Disorder / Transient Motor Tics d. Other Specified Tic Disorder e. Unspecified Tic Disorder f. Obsessive-Compulsive Disorder [d] Participants taking psychotropic medication are eligible provided medication type and dose remain stable throughout the intervention period [e] Ability to provide sustained informed consent [f] A minimum score of 16 on YBOCS [g] A minimum score of 5 on the Premonitory Urge for Tics Scale (PUTS)
Exclusion Criteria:
- Substance misuse
- Current diagnosis of a personality disorder
- Schizophrenia
- Bipolar disorder
- Contraindications to participation in a trial (i.e., active suicidal ideations and/or requirement of an interpreter)
- Any psychiatric or neurological condition that, in the opinion of the investigators, would interfere with participation or interpretation of study outcomes.
研究計画
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:独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的:Combined Exposure and Response Prevention and Habit Reversal
Participants allocated to this arm will receive a 12-week individual psychological intervention integrating Exposure and Response Prevention (ERP) and Habit Reversal Training (HRT).
ERP will involve planned exposure to obsessional fears, distress, sensory discomfort, premonitory urges, and "not-just-right" experiences while reducing compulsions, avoidance, reassurance seeking, and other safety behaviours.
HRT will include awareness training, identification of premonitory urges and tic-related cues, development and practice of competing responses, and strategies to support generalisation.
Sessions will last approximately 50 minutes and will be delivered face-to-face or remotely.
|
Exposure and Response Prevention (ERP) is a behavioural intervention that involves gradual and systematic exposure to obsessional fears, distress, sensory discomfort, premonitory urges, and "not-just-right" experiences while refraining from compulsions, avoidance, reassurance seeking, and other safety behaviours.
Treatment is delivered individually over 12 weekly 50-minute sessions, either face-to-face or remotely.
Habit Reversal Training (HbRT) is a behavioural intervention that includes awareness training, identification of premonitory urges and antecedents to tic expression, development and practice of competing responses, and strategies to generalise skills across settings.
Treatment is delivered individually over 12 weekly 50-minute sessions, either face-to-face or remotely.
|
|
アクティブコンパレータ:Psychoeducation / Supportive Intervention
Participants allocated to this arm will receive a 12-week individual psychological intervention consisting of psychoeducation and supportive therapy.
Sessions will provide information about obsessive-compulsive disorder, tic disorders, Tourettic obsessive-compulsive disorder, stress, and wellbeing, together with supportive discussion and general problem-solving.
This intervention will not include structured Exposure and Response Prevention, Habit Reversal Training, or other targeted behavioural techniques.
Sessions will last approximately 50 minutes and will be delivered face-to-face or remotely.
|
Psychoeducation and Supportive Therapy consists of structured education about obsessive-compulsive disorder, tic disorders, Tourettic obsessive-compulsive disorder, stress, and wellbeing, together with supportive discussion and general problem-solving.
The intervention does not include Exposure and Response Prevention, Habit Reversal Training, or other targeted behavioural techniques.
Treatment is delivered individually over 12 weekly 50-minute sessions, either face-to-face or remotely.
|
|
アクティブコンパレータ:Standardised Exposure and Response Prevention
Participants allocated to this arm will receive a 12-week individual psychological intervention based on Exposure and Response Prevention (ERP).
Treatment will involve gradual and systematic exposure to obsessional fears, distress, sensory discomfort, premonitory urges, and "not-just-right" experiences while refraining from compulsions, avoidance, reassurance seeking, and other safety behaviours.
The intervention aims to reduce obsessive-compulsive symptoms by promoting inhibitory learning and increasing tolerance of uncertainty and internal experiences.
Sessions will last approximately 50 minutes and will be delivered face-to-face or remotely.
|
Exposure and Response Prevention (ERP) is a behavioural intervention that involves gradual and systematic exposure to obsessional fears, distress, sensory discomfort, premonitory urges, and "not-just-right" experiences while refraining from compulsions, avoidance, reassurance seeking, and other safety behaviours.
Treatment is delivered individually over 12 weekly 50-minute sessions, either face-to-face or remotely.
|
|
アクティブコンパレータ:Standardised Habit Reversal
Participants allocated to this arm will receive a 12-week individual psychological intervention based on Habit Reversal Training (HbRT).
Treatment will include awareness training to improve recognition of tics and premonitory urges, identification of antecedents and contextual triggers, development and practice of competing responses, and strategies to promote generalisation of skills to everyday settings.
The intervention aims to reduce tic severity and improve voluntary tic management.
Sessions will last approximately 50 minutes and will be delivered face-to-face or remotely.
|
Habit Reversal Training (HbRT) is a behavioural intervention that includes awareness training, identification of premonitory urges and antecedents to tic expression, development and practice of competing responses, and strategies to generalise skills across settings.
Treatment is delivered individually over 12 weekly 50-minute sessions, either face-to-face or remotely.
|
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 |
|---|---|---|
|
Change From Baseline in Yale-Brown Obsessive Compulsive Scale Total Score
時間枠:Baseline, Week 12 and Week 24
|
Obsessive-compulsive symptom severity will be assessed using the Yale-Brown Obsessive Compulsive Scale (Y-BOCS).
Total scores range from 0 to 40, with higher scores indicating greater obsessive-compulsive symptom severity.
Change from baseline will be assessed at Week 12 and Week 24.
|
Baseline, Week 12 and Week 24
|
|
Change From Baseline in Yale Global Tic Severity Scale Total Tic Severity Score
時間枠:Baseline, Week 12 and Week 24
|
Tic symptom severity will be assessed using the Yale Global Tic Severity Scale (YGTSS) Total Tic Severity Score.
Scores range from 0 to 50, with higher scores indicating greater tic symptom severity.
Change from baseline will be assessed at Week 12 and Week 24.
|
Baseline, Week 12 and Week 24
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change From Baseline in Yale Global Tic Severity Scale Global Severity Score
時間枠:Baseline, Week 12 and Week 24
|
Overall tic symptom severity and tic-related impairment will be assessed using the Yale Global Tic Severity Scale (YGTSS) Total Score.
The Global Score is calculated by summing the Total Tic Severity Score (0-50) and the Impairment Score (0-50), resulting in a global score ranging from 0 to 100.
Higher scores indicate greater overall tic severity and impairment.
Change from baseline will be assessed at Week 12 and Week 24.
|
Baseline, Week 12 and Week 24
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- ERP/HR TOCD RTC - 177187
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?
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
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。