NCT05010447

Feasibility of an Avatar-Led and ACT-Based App for Adjunctive Psychotherapy in In- and Outpatients: Virtual Coach App

Feasibility of an Avatar-Led and ACT-Based Smartphone Application for Adjunctive Psychotherapy in In- and Outpatients: Virtual Coach App

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: University of Basel · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to test the feasibility of an application for smartphones based on Acceptance and Commitment Therapy (ACT) that was designed to increase treatment adaptation (i.e. learning therapy skills) and treatment utility (i.e. feedback for the patient). The use of this avatar- led application will be tested by patients with mental disorders adjunctive to their therapy. Patients will be given a smartphone for one week with the application developed specifically for this purpose. The study will be a single group design and patients will be assessed two times: before and after having tested the application. Measurements will include acceptability (adherence, utilization, utility, satisfaction) of the application, as well as patients characteristics, such as diagnostic interviews, questionnaires about symptomatology, well-being, social interactions, and an exit questionnaire when leaving the study to assess what was learned.

Detailed description

This study will use a digital tool with the aim to test whether a "Virtual Coach" can increase treatment adaptation (i.e., learning of therapy skills, prevent drop-out), treatment utility (i.e., via direct feedback to the patient and therapist), and increase adherence. The digital tool will be an avatar-led application for smartphones and be based on the Acceptance and Commitment Therapy. The "Virtual Coach" will be used adjunctive to therapy and help patients initiate behavioral changes and accelerate the learning of new therapy skills. The questions addressed will be the following: a) adherence to and utilization of the Virtual Coach itself ; b) application of therapy skills; c) perceived usefulness of the Virtual Coach by patients and therapists, and d) the frequency of prosocial behaviors and their impact on well-being. The main purpose of this study is the feasibility of using the Virtual Coach adjunctively to a therapy. However, it also will be explored how outcomes may be related to the severity of symptoms and other factors. The study contains a pilot test in a single-arm trial to evaluate the main outcomes of acceptability (adherence, utilization, utility, satisfaction) with n = 40. Patients will be assessed at baseline and again after the course of their psychotherapy (post-assessment). Patients will complete informed consent, undergo a short diagnostic assessment, then receive a smartphone with the application to carry for one week. They will be asked to use the application at least three times per day in order to practice skills involved in the treatment. The assessment targets will include intentions, activities, and goals of the patient, interpersonal activities, and health behaviors. Subjective reports (e.g., emotions, thoughts, reactions, plans) and objective data (response times, adherence to prompts, etc.) will be tracked. In addition to the main acceptability outcomes, additional assessments will be used to measure patient characteristics. This will include a diagnostic interview, questionnaires about symptomatology, well-being, social interactions, and an exit questionnaire when leaving the study to assess what was learned.

Conditions

• Mental Disorder

Interventions

Type	Name	Description
DEVICE	Virtual Coach App	The avatar-guided app aims to deepen the user's understanding of Acceptance and Commitment Therapy (ACT) and promote application of ACT skills in every-day-life. Event-Sampling-Methodology (ESM) is used to capture the user's progress as it unfolds.

Timeline

• Start date: 2021-08-15
• Primary completion: 2021-12-31
• Completion: 2021-12-31
• First posted: 2021-08-18
• Last updated: 2021-08-18

Locations

2 sites across 1 country: Switzerland