A non-inferiority randomised controlled trial comparing the clinical and cost-effectiveness of one session treatment (OST) with multi-session cognitive behavioural therapy (CBT) in children with specific phobias

eeds and York Partnership NHS Foundation Trust0 个研究点目标入组 274 人开始时间: 2016年11月30日最近更新: 2023年1月30日

试验速览

2018 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/30121618 protocol (added 23/10/2019) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35962334/ Cost-effectiveness (added 15/08/2022) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35915056/ Primary data (added 15/08/2022) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/36318050/ Primary data Health Technol Assess (added 02/11/2022) 2022 Other publications in https://pubmed.ncbi.nlm.nih.gov/36107883/ Qualitative paper (added 19/01/2023)

•1. Aged between 7 and 16 years
•2. Experience at least one specific phobia as defined by DSM-IV criteria, which will be assessed using the Anxiety Disorder Interview Schedule (ADIS). These criteria are:
•2.1. Marked and out of proportion fear to a specific object or situation
•2.2. Exposure provokes immediate anxiety
•2.3. The phobic situation(s) is avoided where possible
•2.4. The avoidance or distress interferes with the person's routine or functioning (e.g. learning, sleep, social activities)
•2.5. Present for 6 months or more

•1. Specific phobias where exposure to the stimulus has the potential to cause harm to the participants, providing the stimulus cannot be safely simulated
•2. Specific phobias where exposure therapy is not feasible for the individual child in the context of the study
•3. Specific phobias where exposure therapy is not the best first line / available therapy for the individual child'
•4. ASPECT will not exclude primarily on the basis of comorbidity; however, as per standard practice, comorbidity will be assessed and monitored by the clinicians and therapists responsible for delivering the therapies. Where comorbidity is likely to impact negatively on the wellbeing of the participants, the participant will be withdrawn from the trial.

发起方

eeds and York Partnership NHS Foundation Trust