Evaluation of a Personalised Digital Treatment for Adolescents With Anxiety Disorders - A Feasibility Trial in Routine Care
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Helse Stavanger HF
- Enrollment
- 46
- Locations
- 2
- Primary Endpoint
- General self-efficacy scale (GSES)
Study Overview
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.
Detailed Description
- Study goals and objectives
This project will investigate the feasibility of an app-facilitated exposure therapy for adolescents with anxiety. The primary objective is to contribute to the development of an efficient and personalized digital treatment. To meet this objective, the project aims i) evaluate the feasibility of Sidekick, a personalized digital treatment tool for patients with anxiety disorders, and ii) evaluate the user experience of digitally assisted exposure therapy on patient-clinician dyads.
1.1 Short-term and long-term goals
In the short-term, this project will implement an open, explorative trial of Sidekick in specialized clinical practice. In the long-term, the project will report, communicate and implement findings in clinical and user settings. If results indicate that the blended intervention is feasible and acceptable, the next step is to seek funding and perform a large-scale, national randomized controlled trials (RCT) of a blended treatment protocol for anxiety in adolescents. 2. Feasibility
2.1 Study design, choice of methodology and analysis
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 13 Years to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •13 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
- •For patients receiving medication, inclusion requires a stable dose of medication for a psychiatric disorder for six weeks
Exclusion Criteria
- •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.
Arms & Interventions
Sidekick
Use of the Sidekick app as an ad-on to regular outpatient treatment.
Intervention: Sidekick (Device)
Outcomes
Primary Outcomes
General self-efficacy scale (GSES)
Time Frame: At pre-treatment/baseline, post-treatment (variable and participant-dependent, estimated range: 4-12 weeks post-baseline), and 3-month follow-up.
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.
KIDSCREEN-10
Time Frame: At pre-treatment/baseline, post-treatment (variable and participant-dependent, estimated range: 4-12 weeks post-baseline), and 3-month follow-up.
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.
Patient Exposure and Response Prevention Adherence Scale (PEAS)
Time Frame: 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)
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.
Sidekick app engagement and completion of tasks
Time Frame: From pre-treatment/baseline to post-treatment (variable and participant-dependent, estimated range: 4-12 weeks)
Sidekick app engagement and completion of tasks will be evaluated through assessment of user-data from the app.
Credibility and Expectancy Questionnaire (CEQ-1)
Time Frame: At post-treatment (variable and participant-dependent, estimated range: 4-12 weeks post-baseline)
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.
Client Satisfaction Questionnaire (CSQ-3)
Time Frame: At post-treatment (variable and participant-dependent, estimated range: 4-12 weeks post-baseline)
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.
EuroQoL 5D-5L (EQ-5D-5L)
Time Frame: At pre-treatment/baseline and post-treatment (variable and participant-dependent, estimated range: 4-12 weeks post-baseline)
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.
Level of anxiety before, during and after exposure tasks
Time Frame: 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)
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.
Recruitment
Time Frame: At pre-treatment/baseline.
The investigators will assess recruitment capability and sample characteristics and provide a flow-chart to evaluate feasibility of completing the planned study.
Adherence
Time Frame: 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.
The investigators will assess retention and follow-up rates, and adherence to procedures to evaluate feasibility of completing the planned study.
Qualitative interviews
Time Frame: At post-treatment (variable and participant-dependent, estimated range: 4-12 weeks post-baseline).
To evaluate user experiences from both patients and clinicians perspectives taking part in the study.
Revised Child Anxiety and Depression Scale (RCADS 47)
Time Frame: At pre-treatment/baseline, post-treatment (variable and participant-dependent, estimated range: 4-12 weeks post-baseline), and 3-month follow-up.
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Pia Rygg Hauge
Principal Investigator
Helse Stavanger HF