Development, Feasibility and Acceptability of an iCBT Intervention for Adolescents With Anxiety

Study Overview
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Brief Summary
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The aim of the feasibility study is twofold: 1) to test the feasibility of the study design, and 2) to test the preliminary efficacy and the acceptability of a new iCBT intervention when delivered with different levels of therapist support. The feasibility trial will provide important information on the initial participant responses, and on how to properly collect data in the subsequent RCT. The feasibility trial is conducted as a randomized study with 16 participants consisting of two conditions: 1) guided iCBT, and 2) on-demand iCBT, both to be completed over a 14-week period. Participants in the guided iCBT condition will receive the new iCBT intervention with planned feedback after each completed module. Participants in the on-demand iCBT condition will receive the intervention with on-demand feedback that is participant-initiated. In both conditions, the therapist may spend a max. of 15 minutes giving feedback per module. As there is no evidence on what amount of therapist support is sufficient for adolescents, the allowed time spent giving feedback will not differ between the two conditions in the feasibility trial. Thus, data on engagement will be collected to inform how the two treatment conditions differ. The trial includes data points at pre-treatment (T1) and post-treatment (T2) where the same measures will be administered as are planned in the RCT. Acceptability of the intervention will be investigated by conducting semi-structured interviews with the participants. The interview will include an evaluation of the intervention, client satisfaction and potential reasons for drop out. The results from the feasibility trial will be used to inform the subsequent RCT and to revise the intervention, procedures, and conditions if needed.

Official Title
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Development, Feasibility and Acceptability of an Internet-based Cognitive Behavioral (iCBT) Intervention for Adolescents With Anxiety Disorders

Conditions
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Anxiety Disorders

Intervention / Treatment
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* Behavioral: CoolMinds


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Between 12 and 17 years of age Primary anxiety diagnosis Must have the ability to read and write Danish Must have Internet access Must have a parent able to participate in the treatment alongside the adolescent Exclusion Criteria: Specific phobia of blood-injection-injury type An autism spectrum disorder Psychotic symptoms Bipolar disorder Current suicidal ideation or self-mutilating behavior Current alcohol or substance abuse Moderate to severe depression Current eating disorder

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Planned therapist feedback iCBT<br>Participants in the planned therapist feedback iCBT condition will receive the iCBT intervention with planned feedback after each completed module. The therapist may spend a max. of 15 minutes giving feedback per module. | Behavioral: CoolMinds<br>* CoolMinds consists of 11 adolescent sessions and 9 parent sessions to be completed simultaneously during a 14-week treatment period. The main components comprise psychoeducation, cognitive restructuring, exposure therapy, and relapse prevention. The parent program also comprises information on how to handle school absenteeism for parents and teachers or pedagogues. The intervention is mainly transdiagnostic within the anxiety disorders but also includes diagnosis specific modules and content allowing for more personalized treatment. The treatment is delivered via a telephone app but can also be accessed via computer.<br>* Other names: iCBT;|
| Experimental: On-demand therapist feedback iCBT<br>Participants in the on-demand therapist feedback iCBT condition will receive the intervention with on-demand feedback that is participant-initiated. The therapist may spend a max. of 15 minutes giving feedback per module. | Behavioral: CoolMinds<br>* CoolMinds consists of 11 adolescent sessions and 9 parent sessions to be completed simultaneously during a 14-week treatment period. The main components comprise psychoeducation, cognitive restructuring, exposure therapy, and relapse prevention. The parent program also comprises information on how to handle school absenteeism for parents and teachers or pedagogues. The intervention is mainly transdiagnostic within the anxiety disorders but also includes diagnosis specific modules and content allowing for more personalized treatment. The treatment is delivered via a telephone app but can also be accessed via computer.<br>* Other names: iCBT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Youth Online Diagnostic Assessment (YODA) | An online diagnostic assessment tool that assesses DSM-5 anxiety disorders and specific phobias. Each present diagnosis is assigned a clinician-rated severity score ranging from 0 (minimal/absent) to 4 (pervasive). Typically subclinical disorders would receive a rating of 0 or 1, and clinical disorders a rating of 1 to 4. | Pre-intervention, post-intervention (12 weeks after commencing treatment) | 
| Spence Children's Anxiety Scale (SCAS-C/P) | A 44-item self-report questionnaire assessing anxiety symptoms of six different anxiety disorders in DSM-IV: generalized anxiety, panic/agoraphobia, social phobia, separation anxiety, obsessive compulsive disorder and physical injury fears. Symptoms are rated on a 4-point frequency scale ranging from 0 (never) to 3 (always) (min. = 0; max. = 114). A higher score indicates increased symptom severity. The Danish version has demonstrated good psychometric properties | Pre-intervention, post-intervention (12 weeks after commencing treatment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Child Anxiety Life Interference Scale (CALIS) | CALIS measures the impact of youth anxiety on various areas of life functioning such as school, extracurricular activities, family life and friendships. Impact is reported on a 5-point severity scale ranging from 0 (not at all) to 4 (a lot) (min. = 0; max = 56). A summed score of all items is used to indicate level of impact, where a higher score indicates greater impairment. CALIS has shown satisfactory internal consistency and moderate test-retest reliability. | Pre-intervention, post-intervention (12 weeks after commencing treatment) | 
| The Patient Health Questionnaire (PHQ-9) | A 9-item questionnaire used to measure youth depressive symptoms and suicidal ideation within the past 2 weeks. Symptoms are rated on a frequency scale ranging from 0 (not at all) to 3 (nearly everyday). The symptoms are evaluated independently by adolescents. A summed score of all 9 items is used to indicate symptom severity (min. = 0; max. = 27), where a higher score indicates greater severity and possible presence of a depressive disorder. | Pre-intervention, post-intervention (12 weeks after commencing treatment) |