Personalized Digital Treatment for Adolescent Anxiety: A Feasibility Trial
ConditionAnxiety Disorders
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age13-18
SponsorHelse Stavanger HF
About this trial
The goal of this feasibility study is to test whether a new blended digital intervention for adolescents with anxiety disorders is feasible and acceptable for use, and to help plan future larger scale studies. The main questions it aims to answer are:
* A: Can the investigators recruit appropriate participants? * B: How appropriate are the data collection procedures and outcome measures? * C: Are the study procedures and interventions suitable for and acceptable to the participants? * D: Does the research team have the resources and ability to manage the study and intervention? * E: Does the intervention show promise of being successful for adolescents with anxiety disorders?
Participants will:
* Receive outpatient anxiety treatment, typically every other week or weekly. * Use the Sidekick app as a homework supplement to plan, carry out, and evaluate exposure exercises between treatment sessions. * Complete questionnaires before, during, after, and three months after using the app. * Some participants and therapists will be invited to take part in qualitative interviews following the intervention.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
13 to 18 years old
Adequate Norwegian reading, writing and speaking skills
Access to the internett and a smart-phone
Diagnosed anxiety disorder
Disqualifiers
Participants with serious mental illness, such as suicidality or poor general functioning may be excluded if participation is considered unfeasible or potentially harmful. Decision will be based on collaborative evaluation by the participants therapist and the research-team.
Trial design
Design model
Single group
Treatments tested in this trial
Sidekick
DeviceAn app for adolescents used to plan, complete and evaluate exposure exercises completed between sessions at a children and adolescent mental health clinic (BUP)
Treatment groups
46 Participants
are divided into 1 treatment groupGroup A: SidekickExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Sidekick app engagement and completion of tasks
Sidekick app engagement and completion of tasks will be evaluated through assessment of user-data from the app.
Time frame
From pre-treatment/baseline to post-treatment (variable and participant-dependent, estimated range: 4-12 weeks)2
Credibility and Expectancy Questionnaire (CEQ-1)
The Credibility and Expectancy Questionnaire (CEQ-1) is a 1-item self-report questionnaire used to assess treatment credibility and treatment expectancy. Minimum score: 1. Maximum score: 9. Higher scores mean better outcomes.
Time frame
At post-treatment (variable and participant-dependent, estimated range: 4-12 weeks post-baseline)3
Client Satisfaction Questionnaire (CSQ-3)
The Client Satisfaction Questionnaire (CSQ-3) is a 3-item self-report measure used clients satisfaction with a service. Minimum score: 1. Maximum score: 4. Higher scores mean better outcomes.
Time frame
At post-treatment (variable and participant-dependent, estimated range: 4-12 weeks post-baseline)4
EuroQoL 5D-5L (EQ-5D-5L)
EuroQoL 5D-5L (EQ-5D-5L) is a self-report questionnaire assessing health-related quality of life and cost-effectiveness analysis. It assesses health on five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Question 1-25: Minimum score: 1. Maximum score: 5. Higher scores mean worse outcomes. Question 26: Minimum score: 0. Maximum score: 100. Higher scores mean better outcomes.
Time frame
At pre-treatment/baseline and post-treatment (variable and participant-dependent, estimated range: 4-12 weeks post-baseline)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Helse Stavanger HF
Lead sponsor
Alcohol and Drug Research Western Norway (KoRFor)
Collaborator
Research Centre for Digital Mental Health Services (Forhelse)
Collaborator
Source ClinicalTrials.gov