Development, Feasibility and Acceptability of an iCBT Intervention for Adolescents With Anxiety
- Conditions
- Anxiety Disorders
- Interventions
- Behavioral: CoolMinds
- Registration Number
- NCT06076954
- Lead Sponsor
- University of Aarhus
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 16
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Planned therapist feedback iCBT CoolMinds 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. On-demand therapist feedback iCBT CoolMinds 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.
- Primary Outcome Measures
Name Time Method The Youth Online Diagnostic Assessment (YODA) Pre-intervention, post-intervention (12 weeks after commencing treatment) 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.
Spence Children's Anxiety Scale (SCAS-C/P) Pre-intervention, post-intervention (12 weeks after commencing treatment) 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
- Secondary Outcome Measures
Name Time Method Child Anxiety Life Interference Scale (CALIS) Pre-intervention, post-intervention (12 weeks after commencing treatment) 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.
The Patient Health Questionnaire (PHQ-9) Pre-intervention, post-intervention (12 weeks after commencing treatment) 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.
Trial Locations
- Locations (1)
University of Southern Denmark
🇩🇰Odense, Region Of Southern Denmark, Denmark