Personalized Digital Treatment for Adolescent Anxiety: A Feasibility Trial

NCT07145307 | Recruiting

• 2 other identifiers: Sidekick - A Feasibility TrialSøknadsid 39864
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Anxiety Disorders

Keywords

anxiety disorders; digital interventions; digital cognitive behavioral therapy; digital ad-on; digital adjunct; adolescents; feasibility trial; exposure therapy; mobile app

Outcome Measures

Primary Outcomes (12)

• 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.

  From pre-treatment/baseline to post-treatment (variable and participant-dependent, estimated range: 4-12 weeks)

• 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.

  At post-treatment (variable and participant-dependent, estimated range: 4-12 weeks post-baseline)

• 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.

  At post-treatment (variable and participant-dependent, estimated range: 4-12 weeks post-baseline)

• 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.

  At pre-treatment/baseline and post-treatment (variable and participant-dependent, estimated range: 4-12 weeks post-baseline)

• Level of anxiety before, during and after exposure tasks

  Participants will evaluate their level of anxiety on a sliding bar in the Sidekick app before, during and after every exposure task completed. User-data from the Sidekick app will be collected. Minimum score: 1. Maximum score: 10. Higher scores mean worse outcomes.

  From pre-treatment/baseline to post-treatment (variable and participant-dependent, estimated range: 4-12 weeks) after every completed exposure task (variable and participant-dependent, estimated range: 1-20 exposure tasks per month)

• Recruitment

  The investigators will assess recruitment capability and sample characteristics and provide a flow-chart to evaluate feasibility of completing the planned study.

  At pre-treatment/baseline.

• Adherence

  The investigators will assess retention and follow-up rates, and adherence to procedures to evaluate feasibility of completing the planned study.

  From pre-treatment/baseline to post-treatment (variable and participant-dependent, estimated range: 4-12 weeks post-baseline), and from post-treatment to 3-month follow-up.

• Qualitative interviews

  To evaluate user experiences from both patients and clinicians perspectives taking part in the study.

  At post-treatment (variable and participant-dependent, estimated range: 4-12 weeks post-baseline).

• Revised Child Anxiety and Depression Scale (RCADS 47)

  The Revised Child Anxiety and Depression Scale (RCADS) is a self-report measure of anxiety symptoms for children and adolescents aged 8-18 years old. It has 47 items, and results in subscales of separation anxiety, social phobia, generalized anxiety disorder, panic disorder, obsessive compulsive disorder and major depressive disorder. The scale provides a total anxiety scale (sum of the 5 anxiety subscales) and a total internalizing scale (sum of all 6 subscales). Minimum score: 10 Maximum score: 3. Higher scores mean worse outcomes.

  At pre-treatment/baseline, post-treatment (variable and participant-dependent, estimated range: 4-12 weeks post-baseline), and 3-month follow-up.

• General self-efficacy scale (GSES)

  The General self-efficacy scale (GSES) is a 10-item self-report questionnaire used to measure the respondents perceived self-efficacy. Minimum score: 1. Maximum score: 4. Higher scores mean better outcomes.

  At pre-treatment/baseline, post-treatment (variable and participant-dependent, estimated range: 4-12 weeks post-baseline), and 3-month follow-up.

• KIDSCREEN-10

  KIDSCREEN-10 is a 10-item self-report questionnaire for children and adolescents aged 8-18 years old. It measures general health-related quality of life (HRQoL). Minimum score: 1. Maximum score: 5. Higher scores mean better outcomes.

  At pre-treatment/baseline, post-treatment (variable and participant-dependent, estimated range: 4-12 weeks post-baseline), and 3-month follow-up.

• Patient Exposure and Response Prevention Adherence Scale (PEAS)

  The Patient Exposure and Response Prevention Adherence Scale (PEAS) is a 3-item self-report questionnaire designed to measure adherence of exposure and response prevention outside of therapy sessions. Minimum score: 0. Maximum score: 7. Higher scores mean better outcomes.

  From pre-treatment/baseline to post-treatment (variable and participant-dependent, estimated range: 4-12 weeks) after every completed exposure task (variable and participant-dependent, estimated range: 1-20 exposure tasks per month)

Study Arms (1)

Sidekick

EXPERIMENTAL

Use of the Sidekick app as an ad-on to regular outpatient treatment.

Device: Sidekick

Interventions

Sidekick DEVICE

An app for adolescents used to plan, complete and evaluate exposure exercises completed between sessions at a children and adolescent mental health clinic (BUP)

Also known as: App-facilitated exposure therapy, Digital cognitive behavioral therapy, Digital adjunct, Digital ad-on

Sidekick

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• to 18 years old
• Adequate Norwegian reading, writing and speaking skills
• Access to the internett and a smart-phone
• Diagnosed anxiety disorder
• Receiving outpatient treatment for their anxiety disorder
• Exposure therapy included in therapy during the study period
• Therapist agrees to incorporate the app as an ad-on to therapy

You may not qualify if:

• 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.

Sponsors & Collaborators

• Helse Stavanger HF: lead
• Alcohol and Drug Research Western Norway (KoRFor): collaborator
• Research Centre for Digital Mental Health Services (Forhelse): collaborator

Study Sites (2)

Children and Adolescent Mental Health Outpatient Clinics

Stavanger, Norway

RECRUITING

Stavanger Universitetssykehus

Stavanger, Norway

NOT YET RECRUITING

Related Links

• UngMeistring - About the project

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Aleksander H Erga, PhD

  KORFOR, Helse Stavanger

  STUDY DIRECTOR

• Torgeir G Lid, PhD

  KORFOR, Helse Stavanger

  STUDY CHAIR

• Emilie S Nordby, PhD

  Forhelse, Helse Bergen

  STUDY CHAIR

• Tine Nordgreen, PhD

  Forhelse, Helse Bergen

  STUDY CHAIR

• Pia R Hauge, Master

  Helse Stavanger HF

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pia R Hauge, Master

CONTACT

+47 92877830; pia.rygg.hauge@sus.no

Aleksander H Erga, PhD

CONTACT

+4751515684; aleksander.hagen.erga@sus.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 5, 2025
• First Posted: August 28, 2025
• Study Start: October 20, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: April 28, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

NO (2)