Integrating Exposure and Response Prevention and Habit Reversal Techniques to Treat a Tourettic Subtype of Obsessive-Compulsive Disorder (Tourettic OCD)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change From Baseline in Yale-Brown Obsessive Compulsive Scale Total Score
研究概览
简要总结
Obsessive-Compulsive Disorder and Tic Disorders frequently co-occur, and a subgroup of patients - those with a Tourettic Subtype of OCD (TOCD) - present with concurrent obsessive-compulsive and tic symptoms. Existing psychological interventions typically target one condition or the other, but rarely both together. This study aims to test whether a combined psychological therapy integrating Exposure and Response Prevention (ERP) and Habit Reversal (HbRT) is more effective at reducing symptoms than either therapy delivered alone, in adults with TOCD.
详细描述
Participants are randomly allocated to one of four groups: (1) combined ERP and HbRT, (2) ERP alone, (3) HbRT alone, or (4) a supportive psychoeducation control. All participants receive 12 weekly one-to-one sessions (either in-person or remotely) of approximately fifty minutes. Symptoms will be assessed using the Yale Global Tic Severity Scale (YGTSS) and Yale-Brown Obsessive Compulsive Scale (Y-BOCS) by an independent clinician at the start of treatment, at Week 12, and again at Week 24.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Exposure and Response Prevention (ERP) (Behavioral)
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.
干预措施: Habit Reversal Training (HbRT (Behavioral)
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.
干预措施: Psychoeducation and Supportive Intervention (Behavioral)
结局指标
主要结局
Change From Baseline in Yale-Brown Obsessive Compulsive Scale Total Score
时间窗: 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.
Change From Baseline in Yale Global Tic Severity Scale Total Tic Severity Score
时间窗: 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.
次要结局
- Change From Baseline in Yale-Brown Obsessive Compulsive Scale Impairment Score(Baseline, Week 12 and Week 24)
- Change From Baseline in Yale Global Tic Severity Scale Impairment Score(Baseline, Week 12 and Week 24)
- Change From Baseline in Yale Global Tic Severity Scale Global Severity Score(Baseline, Week 12 and Week 24)
研究者
Dipesh Patel
Dr
University College London Hospitals