A Feasibility Study of Brief Cognitive Behaviour Therapy for Adolescent OCD in Routine Clinical Practice
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 25
- 试验地点
- 6
- 主要终点
- Credibility and Expectation of Treatment Questionnaire (CEQ; Borkovec & Nau, 1972)
研究概览
简要总结
Obsessive-Compulsive Disorder (OCD) is a common and often disabling condition in young people, characterised by distressing, intrusive thoughts, images or urges, and repetitive behaviours intended to reduce discomfort or prevent harm. Around 1% of adolescents in the UK experience OCD, with many cases beginning in childhood or adolescence. Cognitive Behavioural Therapy (CBT) is the recommended treatment for OCD in young people, but access to treatment is limited due to high demand, long waiting lists, and lack of trained clinicians.
A brief form of CBT for OCD, supported by workbooks, has previously shown promising results in research settings. However, it remains unclear whether this approach is feasible, acceptable, and effective when delivered within routine NHS child and adolescent mental health services (CAMHS), especially for young people with co-occurring autism.
This single-arm feasibility trial aims to explore whether brief CBT can be delivered effectively in routine NHS and NHS-commissioned services to young people aged 11-18 years with OCD as their main presenting problem. The trial will also assess whether the intervention is acceptable to young people, their parents/carers, and clinicians, and whether outcomes are comparable to existing evidence.
Intervention Overview: The brief CBT intervention consists of five core sessions, with the option of two additional booster sessions, delivered over 24 weeks. Sessions are delivered face-to-face by trained clinicians and last between 60 to 90 minutes. The intervention is supported by a series of co-designed workbooks to be completed by the young person between sessions. Parents/carers are also provided with a workbook and encouraged to support the young person's progress where appropriate. Sessions may take place in the clinic or in other agreed settings, such as at home or school. The frequency of sessions decreases over time, with the first four sessions delivered weekly and later sessions spaced further apart.
The intervention includes psychoeducation, developing a cognitive-behavioural understanding of OCD, goal setting, and techniques to support motivation and engagement. A key focus is helping young people develop cognitive flexibility by testing and challenging unhelpful beliefs that drive OCD behaviours, supported by behavioural experiments. Parents/carers and other adults in the young person's life may also be involved to help generalise learning and promote progress.
Trial Aims: The trial has two primary aims:
To establish whether brief CBT for OCD can be delivered with fidelity and acceptability by clinicians in NHS services, and is acceptable to young people and their families.
To explore whether the intervention is associated with significant improvements in OCD symptoms for young people, including those with autism or high levels of autistic traits.
Trial Design: The study is a single-arm feasibility trial. Between 20-30 young people aged 11-18 years will be recruited alongside their parents/carers. Approximately 8-10 clinicians will be trained to deliver the intervention. OCD symptoms, treatment processes, and acceptability will be assessed at baseline, post-treatment (12 weeks), and at 3-month follow-up (24 weeks). Additional measures will be collected before each therapy session.
Qualitative interviews will be conducted with young people, parents/carers, and clinicians to understand their experiences of the intervention. Acceptability will also be measured using standardised questionnaires completed during and after treatment.
Outcomes: The primary outcomes are feasibility and acceptability of the intervention, assessed through session attendance, participant engagement, clinician adherence, and feedback from young people, parents/carers, and clinicians.
Secondary outcomes include changes in OCD symptoms, responsibility beliefs, family accommodation, and overall functioning, as well as measures of anxiety and depression. Data will be analysed to assess changes from baseline to post-treatment and follow-up, including for young people with and without autistic traits. Treatment adherence and clinician competence will also be evaluated.
详细描述
Background and Study Aims
Obsessive-Compulsive Disorder (OCD) is characterised by persistent, distressing intrusive thoughts, urges or images (i.e., intrusions) and behaviours aimed at preventing harm and reducing associated discomfort (e.g., compulsions or avoidance) (American Psychiatric Association, 2013). It affects around 1% of adolescents aged 11-19 years in the UK (Sadler et al., 2018), with up to 36% of OCD cases having an onset in adolescence across the globe (Dell'Osso et al., 2016).
The research team developed a brief 5 session CBT intervention (therapist supported, involving workbooks) for adolescent Obsessive Compulsive Disorder (OCD) which was evaluated through a large randomised control trial (RCT; Bolton et al., 2011, https://doi.org/10.1111/j.1469-7610.2011.02419.x) and found to be effective. In this trial, clinicians were all highly trained clinical psychologists and young people with 'marked symptoms of autistic spectrum disorder' were not included. The research team recently updated the materials (e.g., workbooks, treatment manual, training materials) with PPI and stakeholder involvement (https://doi.org/10.31234/osf.io/tcqm8).
This study aims to explore the feasibility of adopting brief CBT within NHS and NHS-commissioned child and adolescent mental health services. Specifically, we aim to ascertain whether brief CBT for adolescent OCD is:
- Deliverable within services (i.e. whether clinicians show high levels of treatment adherence) and is acceptable to adolescents, their parents/carers and clinicians/service providers.
- Associated with significant improvements in OCD symptoms and outcomes equivalent to outcomes for adolescent OCD within meta-analyses for all young people in the trial (including those with an autistic diagnosis and/or high levels of autistic traits).
- Associated with significant improvements in OCD processes, functional interference, anxiety and depression symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 11 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Young people:
- •Willing and able to give informed assent (if aged 11-15 years, and parent/carer consent is provided) or consent (if aged 16-18 years) for participation in the study.
- •Aged 11 to 18 years at the time of recruitment.
- •Diagnosed with OCD using the Anxiety Disorders Interview Schedule (ADIS) and OCD has been identified as the primary problem.
- •If on pharmacotherapy for OCD, then stable dose for at least 6 weeks prior to trial entry.
- •Able to speak and read English at a sufficient level to be able to read and understand the workbooks and materials and complete exercises in the workbooks.
- •Willing to engage in the treatment.
- •In the Investigator's opinion, is able and willing to comply with all trial requirements.
- •Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the trial.
- •Parents/carers:
- •Able and willing to provide written informed consent for their child's participation in the study.
- •Able to read the parent/carer workbook and materials.
- •Willing and able to participate.
- •Clinicians:
- •Working within a participating NHS or NHS-commissioned service.
- •Have a professional qualification in psychological therapy that includes training in CBT at or above post-graduate certificate level.
- •Willing to participate.
- •Clinical capacity and managerial approval to participate
排除标准
- •Young people:
- •The clinical assessment indicates that risk/safeguarding cannot be safely managed within the service.
- •Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.
- •Evidence of learning difficulties identified by schools or evident at interview that would inhibit participation in cognitive components of therapy.
- •Currently receiving a psychological intervention for OCD.
- •Parents/carers:
- •No exclusion criteria.
- •Clinicians:
- •No exclusion criteria
结局指标
主要结局
Credibility and Expectation of Treatment Questionnaire (CEQ; Borkovec & Nau, 1972)
时间窗: Baseline and follow-up (week 24)
The Credibility and Expectation of Treatment Questionnaire (CEQ; Borkovec \& Nau, 1972) will be collected at baseline and used to establish treatment acceptability. Score range 0-30. Higher scores represent a better outcome.
Experience of Service Questionnaire (ESQ; Astride-Stirling, 2002)
时间窗: End of treatment (week 12) and follow-up (week 24)
The Experience of Service Questionnaire (ESQ; Astride-Stirling, 2002) will be used at the end of treatment (Week 12) and follow-up (Week 24) to measure young peoples' and parent/carers' expectations and views on the acceptability of the treatment and service.
Attrition Rate
时间窗: From enrolment to the end of follow-up (week 24)
Feasibility will also be established by the number and rate of participants who drop-out of treatment (attrition rate).
Therapist Adherence
时间窗: From enrolment to the end of treatment (week 12)
Recordings of therapy sessions will be rated by the research team to assess therapist competency and intervention adherence.
Semi-structured interviews
时间窗: At follow-up (week 24)
Semi-structured one-to-one/joint interviews at follow-up (Week 24) exploring experiences of receiving/delivering the treatment will be conducted with participants (young people and clinicians).
Session Rating Scale (SRS; Miller, Duncan & Johnson, 2002)
时间窗: From first intervention session (week 1) to the end of follow-up (week 24)
The Session Rating Scale is a brief, four-item measure developed to assess the therapeutic alliance from the client's perspective in real-time. Higher scores indicate a better outcome.
Therapist Experience of Training and Treatment Delivery Questionnaire
时间窗: Follow-up (week 24)
The Therapist Experience of Training and Treatment Delivery Questionnaire will be given to clinicians at follow-up (Week 24) in order to establish their perceived competence, acceptability and feasibility in delivering the intervention. Score range 19-95. Higher scores represent a better outcome.
Participant Engagement with Materials
时间窗: From first intervention session (week 1) to the end of treatment (week 12)
A brief questionnaire for clinicians to rate whether the workbooks were not completed, partially completed or fully completed by the young person. To be completed following each clinical session with workbooks.
次要结局
- Children's Yale-Brown Obsessive Compulsive Scale II (CY-BOCS-II; Abramovitch et al., 2022)(Baseline and follow-up (week 24))
- Obsessive-Compulsive Inventory - Child Version - Revised (OCI-CV-R; Abramovitch et al., 2022)(From baseline to follow-up (week 24))
- Child Responsibility Interpretations Questionnaire - CRIQ (Salkovskis & Williams, 2004a; Salkovskis & Williams, 2004b)(From baseline to follow-up (week 24))
- Child Responsibility Attitude Scale - CRAS (Salkovskis & Williams, 2004a; Salkovskis & Williams, 2004b)(From baseline to follow-up (week 24))
- Family Accommodation Scale-Parent Report (FAS-PR) (Peris et al., 2008; Storch et al., 2007)(Baseline, end of treatment (week 12) and at follow-up (week 24).)
- Work and Social Adjustment Scale - Youth version (WSAS-Y; Jassi et al., 2020)(Baseline, post-intervention (week 12) and follow up (week 24))
- Revised Child Anxiety and Depression Scale (RCADS; Chorpita et al., 2000)(From baseline to follow-up (week 24))
- Vancouver Obsessive Compulsive Inventory - Mental Contamination (VOCI-MC; Radomsky, Rachman, Shafran, Coughtrey, & Barber, 2014)(Baseline and follow-up (week 24))
- Demographic information(Baseline)
- Autism-Spectrum Quotient-Short (AQ-Short; Hoekstra et al., 2011)(Baseline)