None listed
Conditions
Brief summary
Anxiety affects 7% of young people & only 50% receive help. This project aims to test the feasibility of a new, stepped care, internet based Cognitive behavioural treatment (iCBT) model for youth anxiety utilising the BRAVE Program. Therapist supported iCBT demonstrates equivalent efficacy with face to face CBT, but cost and insufficient numbers of clinicians means therapist guided iCBT is often not available or unsuitable to reach large numbers of anxious youth. Self help iCBT (no therapist) offers one solution. A national trial of BRAVE Self Help (>16,000 registrations in 2 years) showed meaningful anxiety reductions for youth completing the program. Many children failed to complete the treatment without support and not all were successfully treated. There is a need to identify models of care that can reach large numbers and provide appropriate support; such as a Stepped Care Model (SCM). Within a SCM, all young people would first receive the less intensive treatment. Those who have not responded well to the first step then receive a more intensive intervention. In this project, all participants would first receive 5 sessions of self help iCBT (step 1; psychoeducation, skills acquisition). Those who respond will receive 5 more self help sessions (skill rehearsal & maintenance). Those who fail to respond after step 1 would `step up' to receive their remaining 5 iCBT sessions with therapist guidance (step 2). Pilot evidence supports the use of a SCM in high intensity face to face CBT for childhood anxiety. To date, no studies of SCMs for iCBT exist. If a SCM approach, using self help plus therapist guided iCBT is as effective as therapist guided iCBT alone, we will have identified a scalable, easily disseminated model that can produce clinical outcomes similar to standard clinical therapy. This particular project utilises a very simple form of therapist support, primarily delivered via emails from the therapist, which can be conducted anywhere, anytime. Therefore, a stepped care model of intervention where people step up to email therapist support presents a model of care that can be easily distributed and is not intrusive to young people.
Interventions
Both conditions will receive the BRAVE-ONLINE program, which includes 10 online sessions of approximately 45-minute duration, completed once per week. BRAVE includes evidence-based anxiety management strategies such as recognition of physiological symptoms, relaxation, coping self-talk, cognitive restructuring, graded exposure, and self-reinforcement. Sessions comprise visually appealing pages, reading material, question/answer exercises, games, quizzes and homework. There are different versions of the program for children (aged 8-12 years) and adolescents (aged 13-17 years). Participants receive automated email reminders of session availability, reminding of overdue sessions and reinforcing progress. Intervention Arm 1- Stepped-Care Internet-Cognitive Behavioural Therapy (SC-iCBT) with email therapist assistance. Participants in this intervention arm will receive BRAVE-ONLINE as above, using a stepped-care version of the program. SC-iCBT will include all BRAVE-ONLINE components but incorporates 2 steps, namely (i) self-help iCBT and (ii) therapist guided iCBT. Step 1 (self-help) will be delivered to all SC participants and will include 5 sessions of low-intensity, self-directed iCBT (low intensity = no therapist support, participants complete program on their own). ‘Non-responders’ after Step 1 will progress to step 2, therapist-guided iCBT. Therapist support will include a brief phone introduction to their therapist (max 10 minutes) after session five, and one 30-minute phone call after session 5 (children) and 6 (adolescents) where the therapist assists the participant to refine their exposure hierarchy (developed in the previous session) and assist in planning the implementation of this exposure hierarchy. It will also include weekly emails from the therapist to the participant after completion of each of the remaining 5 sessions. In these one-way emails, the therapist will review participant responses, provide reinforcement of effort and correct misdirected responses. All therapists will be provided with template email responses to guide their responses and are asked to focus only on key elements of the treatment program. These have been generated by the lead investigator for each of the programs. Therapists will be asked to spend a maximum of 15 minutes per week on generating email responses. In this study, therapists will hold a minimum of 4-years training in Psychology. In terms of treatment fidelity, therapists are required to keep a record of the number of minutes spent each week on sending emails and the phone calls, to provide a check of the treatment provided. Further, a random sample of 10% of email responses will be examined by the lead investigator to check adherence to template email responses. Step 1 ‘responders’ will continue to receive the remaining five sessions of the self-help program (no therapist support provided) until the post-intervention assessment. ‘Responders’ will continue to be monitored, receiving automatic email alerts with referral recommendations if they demonstrate a return to clinical levels of anxiety, but will not receive additional therapist contact. ‘Non-responders’ will be defined as any participant who has not demonstrated a reduction into the non-elevated range, based on sex-standardised means (based on a large normative youth sample; and our previous large self-help trial) on the CAS-8 at mid-intervention. ‘Responders’ will be identified as participants who have demonstrated a reduction in anxiety by mid-intervention, to within the non-elevated range. This ‘step-up’ point was determined based on empirical evidence from our trial of BRAVE Self-Help which indicated that changes of this nature on the CAS-8 by Session 5 are representative of a positive response to the program and achieved by a significant proportion of the participants. Participants will be able to access the online program beyond post-treatment, although no therapist support will be provided beyond this point.
Sponsors
University of Southern Queensland
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
8 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
Children and adolescents will be included in the study if they meet diagnostic criteria for a primary diagnosis of anxiety (social anxiety disorder, specific phobia, separation anxiety disorder, generalised anxiety disorder) with a clinical severity rating (CSR) of at least 4 (on a 0-8 scale). Comorbidity with other disorders will be permissible as long as the anxiety disorder is considered primary. Participants with comorbid depression will be excluded if the depression is severe (rated 6 or higher on an 8-point scale). Families must have access to a suitable computer and the internet, and be willing to participate in the study.
Exclusion criteria
As the internet program requires a minimum reading age of 8 years, children with an identified intellectual handicap or learning disability will not be included. Children with a pervasive developmental disorder will also be excluded. For ethical reasons pertaining to the danger of potential self-harm, youngsters with clinical levels of depression (Clinician Severity Rating of 6 or higher on a 0-8 scale on the ADIS-C/P) will not be included in the program and will be referred elsewhere for assistance.
Outcome results
None listed