A randomized controlled trial is currently evaluating the effectiveness of internet-based cognitive behavioral therapy (iCBT) for adolescents experiencing anxiety disorders. The study, conducted in Denmark, aims to determine whether planned therapist feedback is superior to on-demand support in improving anxiety symptoms among adolescents aged 12-17.
The trial utilizes the CoolMinds program, an iCBT intervention based on the work of Kendall and further developed by Rapee, Lyneham and Cunningham. This program delivers therapy through online modules, allowing adolescents to progress at their own pace. Key components include psychoeducation, cognitive restructuring, exposure therapy, and relapse prevention. The program consists of eleven sessions for adolescents and ten separate sessions for parents, to be completed over a 14-week period, including a booster session.
Trial Design and Methods
The study includes three arms: iCBT with planned feedback, iCBT with on-demand feedback, and a waitlist control group. Participants in the planned feedback group receive weekly written feedback from a therapist on their assignments and can contact their therapist via a built-in messaging system for asynchronous support. Those in the on-demand feedback group only have the option to contact the therapist as needed. Therapists in both conditions are limited to a maximum of 15 minutes of feedback per week per participant.
Participants in the waitlist group will wait for 14 weeks before being offered iCBT treatment with planned therapist feedback. All participants are monitored for depression and suicidal ideation using in-session questionnaires. If an adolescent shows an increase in co-morbid depressive symptoms or signs of suicidal ideation, the clinician will contact the participant and their guardians to discuss potential discontinuation from the study and alternative treatment options.
To improve adherence, therapists actively monitor the adolescent’s engagement with the treatment program. If an adolescent fails to engage with the program for 10 consecutive days, both the adolescent and the parents are offered a motivational video call to address any barriers to participation.
Outcome Measures
The primary outcome of the trial is the point difference in anxiety diagnosis and severity, as measured by the Spence Children’s Anxiety Scale (SCAS). Secondary outcomes include point differences in anxiety diagnosis and severity measured by clinician-reviewed Youth Online Diagnostic Assessment-Child and Parent Versions (YODA), anxiety symptoms interference on daily life measured by the self- and parent-reported questionnaire Child Anxiety Life Interference Scale (CALIS), depressive symptoms measured by The mood and Feelings Questionnaire (MFQ), and Quality of life measured by EuroQol-5 Dimension Youth (EQ-5D-5L).
Other secondary outcomes include participant satisfaction with treatment and with system usability, measured by Working Alliance Inventory applied to Internet (WAI-TECH-SF), Working Alliance Inventory – Short Form (WAI-SF), Client Satisfaction Questionnaire-8 (CSQ-8), System Usability scale (SUS), Negative Effect Questionnaire (NEQ).
Sample Size and Recruitment
The trial aims to recruit 168 adolescents aged 12-17 with anxiety disorders. Participants are recruited through self-referral and referrals from health specialists within Denmark. The sample size calculation is based on detecting a difference of 10 points between the waiting list and the (combined) treatment groups in change in SCAS score from baseline to 3 months’ follow-up.
Implications
This trial will provide valuable insights into the optimal delivery of iCBT for adolescents with anxiety disorders. By comparing planned versus on-demand therapist feedback, the study seeks to identify the most effective and efficient approach to providing support within an internet-based intervention. The results could inform the design and implementation of future iCBT programs, potentially improving access to mental health care for adolescents struggling with anxiety.
