Brief Cognitive Behaviour Therapy (CBT) for Adolescent OCD in Routine Clinical Practice

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:

1. 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. 2. 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). 3. Associated with significant improvements in OCD processes, functional interference, anxiety and depression symptoms.

The researchers will examine this across the whole sample and those with an autism diagnosis and/or high levels of autistic traits.

What does the study involve

The brief CBT consists of 5 sessions of 60 to 90-minutes, with the option of 2 additional booster sessions (also 60 to 90 minutes), spanning a total of 24 weeks.

Young people who meet diagnostic criteria for OCD via the Anxiety Disorders Interview Schedule for DSM-5 (ADIS-5) and all other inclusion criteria will be identified within the clinics, provided with written information about the study and invited to take part. Informed consent with be provided by young people aged 16 years or older. Young people under the age of 16 years will provide informed assent and their parent/carer will provide informed consent.

Self-report questionnaire measures will be administered to young people and parents/carers at baseline (1-2 weeks prior to treatment), post-treatment (at 12 weeks) and 3-month follow-up (at 24 weeks). The CY-BOCS-II clinical interview will also be conducted with the young person and parent/carer at baseline and a 3-month follow-up.

The young people receiving the treatment are expected to read and complete a total of six workbooks (an introduction workbook and five session-related workbooks) independently between sessions. As well as reading and completing the exercises in the workbooks, adolescents are also expected to complete tasks between sessions at home, or in the relevant context (e.g., school). Parents/carers may have some involvement in treatment sessions (depending on the preferences of the young person).

The research team will also conduct qualitative interviews with young people and clinicians/service providers and administer a measure of treatment satisfaction to explore the acceptability of treatment. Depending on the preference of the participant, interviews will take place at the clinical site they are receiving treatment (young person) or they work for (clinician/service provider), at the University of Oxford, or online via MS Teams.

What are the possible benefits and risks of participating?

The young people who are participating will receive an evidence-based treatment for OCD. Brief CBT for adolescent OCD has potential benefits that they can use the skills taught and resources provided to them to continue to support a self-guided progress when faced with remaining symptoms or a relapse of symptoms. The clinicians delivering the treatment will be trained in a new treatment approach. This trial includes discussing potentially sensitive information with young people and parents/carers as part of the diagnostic interviews, intervention and self-report measures. Assessments will be conducted by trained assessors who have had DBS checks, have received extensive training to undertake assessments, and receive regular supervision from experienced clinicians within the research team. If any participant becomes distressed, assessors are trained to be able to handle this in a sensitive way and there will always be a named trained clinician from the research team available to speak to as part of a risk rota. In addition, the lead researchers for this study (PW and PS) are Consultant Clinical Psychologists experienced at recognising and managing potential distress.

There will be a greater burden on all participants (young people, parents/carers and clinicians) than in routine clinical work in terms of their participation in assessment procedures. To minimise this burden, only measures that are strictly necessary are included. Clinician interviews will be carried out during the working day so that this does not create additional burden. Because qualitative interviews with young people are an additional time burden, they will be reimbursed for their time.

When is the study starting and how long is it expected to run for?

The study plans to run from 31/03/2025 to 31/03/2026.

Recruitment

All participants (young people, parents/carers, and clinicians) will be recruited from the Anxiety and Depression in Young People (AnDY) Research Clinics based in Oxford and Reading. The Oxford-based AnDY clinic is a collaboration with Oxford Health NHS Foundation Trust Child and Adolescent Mental Health Services (CAMHS). The Reading-based AnDY clinic is based in the School of Psychology and Clinical Language Sciences at the University of Reading and receives referrals through other local health and social care providers, including Berkshire Healthcare NHS Foundation Trust CAMHS. Both clinics provides assessment and brief psychological interventions to young people with anxiety disorders, depression or OCD and are informed by Children and Young People's Improving Access to Psychological Therapies (CYP IAPT) principles, enabling young people and their families to access high-quality, evidence-based treatments and research opportunities.

Young people and their parents/carers who meet eligibility criteria for the study will be identified by the clinical team following their initial assessment. They will be approached and provided with participant information sheets. If they are interested in taking part, their details will be passed to the research team, and a member of the research team will speak to them in-person or by video call (via MS Teams) to answer questions and check understanding of the study. If they agree to take part, written informed consent will be obtained.

Clinicians who meet eligibility criteria will be identified by the research team and trial site before the recruitment of young people with OCD. They will be approached and provided with participant information sheets. If they are interested in taking part, a member of the research team will speak to them in-person or by video call (via MS Teams) to answer questions and check understanding of the study. If they agree to take part, written informed consent will be obtained.

Screening and Eligibility Assessment

Eligibility for young people and their parent/carer to take part in the study is determined by the young person meeting criteria for a primary diagnosis of OCD, as assessed by the clinical team using the Anxiety Disorders Interview Schedule (ADIS-5-C/P; Silverman \& Albano, 2024). The ADIS C/P is a structured interview to determine whether the young person meets diagnosis for OCD and/or a range of anxiety and behavioural disorders. Each diagnosis is given a corresponding clinician severity rating (CSR); the primary diagnosis is the disorder with the highest CSR. This assessment is part of the routine clinical service in both clinics. It is completed by a suitably trained assessor, under the clinical supervision of an experienced clinician and typically lasts three to four hours. The maximum duration allowed between a diagnostic assessment and registration in the trial is 6 months. Protocol waivers are not permitted; each participant must satisfy all the approved inclusion and exclusion criteria of the protocol. The clinical team will review the outcome of the diagnostic interview and other information to determine if the young person and parent/carer is eligible to take part.

Eligibility for clinicians to take part in the study will be determined by evidence of adequate training, as outlined in the inclusion criteria.

The research team will then review this information to confirm eligibility. This will be done anonymously (i.e., clinicians will not reveal names or any personally identifying information about the young person until informed consent for data sharing from young people (and parents, where applicable), has been obtained).

Informed Consent

Informed consent form will be provided to eligible participants by a suitably trained member of the clinical or research team. It will be provided no less than 24 hours after the participant has received study information, which is presented to the participant after eligibility to the trial has been determined (i.e., after the initial assessment and supervision).

For young people and parent/carers, if they agree to participate in the trial, they both (regardless of age) must personally sign and date the latest approved version of the Informed Consent Form (or Assent Form for young people under 16 years of age) before any trial specific procedures are performed. This can be either the paper version, or the online version (worded the same as the paper version and administered via a secure online system such as Qualtrics). If consent is collected online, an appropriate electronic signature will be obtained (typing their full name). This will be done with a member of the research team (or a member of the clinical team acting on the behalf of the research team) either in person or on Microsoft Teams. As young people aged 16-18 years are providing their own informed consent, it will not be necessary for their parent/carer to be present. Signed informed consent will need to be obtained for any young people who turn 16 during participation within the study. A suitably trained member of the clinical or research team will share the Participant Information Sheet for 16-18 year olds and ask the young person to sign the Informed Consent Form prior to any further research activity.

For clinicians, if they agree to participate, they must personally sign and date the latest approved version of the Informed Consent Form before completing any research activities. If consent is collected online, an appropriate electronic signature will be obtained (typing their full name).

Written and verbal versions of the Participant Information Sheets and Informed Consent Forms will be presented to participants detailing the exact nature of the trial, what it will involve for the participant, the implications and constraints of the protocol, and any risks involved in taking part. For young people and parents/carers, it will be clearly stated that the participant is free to withdraw from the trial at any time for any reason withou

• Children's Yale-Brown Obsessive Compulsive Scale II (CY-BOCS-II; Abramovitch et al., 2022) [Срок оценки: Baseline and follow-up (week 24)]
• Obsessive-Compulsive Inventory - Child Version - Revised (OCI-CV-R; Abramovitch et al., 2022) [Срок оценки: From baseline to follow-up (week 24)]
• Child Responsibility Interpretations Questionnaire - CRIQ (Salkovskis & Williams, 2004a; Salkovskis & Williams, 2004b) [Срок оценки: From baseline to follow-up (week 24)]
• Child Responsibility Attitude Scale - CRAS (Salkovskis & Williams, 2004a; Salkovskis & Williams, 2004b) [Срок оценки: From baseline to follow-up (week 24)]
• Family Accommodation Scale-Parent Report (FAS-PR) (Peris et al., 2008; Storch et al., 2007) [Срок оценки: Baseline, end of treatment (week 12) and at follow-up (week 24).]
• Demographic information [Срок оценки: Baseline]
• Autism-Spectrum Quotient-Short (AQ-Short; Hoekstra et al., 2011) [Срок оценки: Baseline]
• Work and Social Adjustment Scale - Youth version (WSAS-Y; Jassi et al., 2020) [Срок оценки: Baseline, post-intervention (week 12) and follow up (week 24)]
• Revised Child Anxiety and Depression Scale (RCADS; Chorpita et al., 2000) [Срок оценки: From baseline to follow-up (week 24)]
• Vancouver Obsessive Compulsive Inventory - Mental Contamination (VOCI-MC; Radomsky, Rachman, Shafran, Coughtrey, & Barber, 2014) [Срок оценки: Baseline and follow-up (week 24)]