Feasibility of an Avatar-Led and ACT-Based Smartphone Application for Adjunctive Psychotherapy in In- and Outpatients: Virtual Coach App
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- University of Basel
- Enrollment
- 40
- Locations
- 2
- Primary Endpoint
- User Experience Questionnaire
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Current undergoing inpatient or outpatient psychotherapy;
- •ability to speak German or English;
- •giving informed consent.
Exclusion Criteria
- •not able to take part as assessed by the clinic's medical/therapeutic staff
Arms & Interventions
Study Group
Participants receive the Virtual Coach App for one week at the beginning of their therapy and one week towards the end of their therapy.
Intervention: Virtual Coach App (Device)
Outcomes
Primary Outcomes
User Experience Questionnaire
Time Frame: once at Baseline (beginning of therapy/week 1)
User Experience Questionnaire (UEQ; Laugwitz, B., Schrepp, M. \& Held, T., 2008). The UEQ is a short questionnaire using semantic differentials (word pairs with opposite meanings) to allow for fast and intuitive responses. An example item would be "attractive - unattractive". Items are scored on a 7-point Likert scale and range from full agreement with the negative term (-3) to the full agreement with the positive term (+3). Half of the items start with the positive term, the rest with the negative term. Higher sum scores indicate more positive evaluation of the app.
System Usability Scale
Time Frame: up to 3 months (from Baseline/beginning of treatment to Post/end of treatment)
System Usability Scale (SUS; adapted from Brooke, 1996) embedded. SUS scores have a range of 0 to 100. A high score indicates a high system usability; and where 1 = strongly disagree and 5 = strongly agree.
Semi-structured User Experience Questionnaire
Time Frame: up to 3 months (from Baseline/beginning of treatment to Post/end of treatment)
Self-designed questionnaire with closed and open questions regarding the user's experience with the app. Questions were tested in a pilot and then adapted in a feedback round. They include items such as "How was your week with Virtual Coach?", "What about Virtual Coach did you like best?", "What about Virtual Coach did you like least?", etc. The Interview also includes space for open comments from the user.
User Adherence Meta-Variables
Time Frame: up to 3 months (from Baseline/beginning of treatment to Post/end of treatment)
Metavariables and app-usage of participants are collected automatically while the app is being used by the study participant, such as: * Number of prompts responded (where a higher number equals more adherence) * Number of prompts finished (where a higher number equals more adherence) * Number of exercises completed (where a higher number equals more adherence) * Number of additional exercises completed (where a higher number equals more adherence) * Time to complete prompts (where the average time of the sample should represent an adequate time for an adherent user to complete the prompt) * An answers typed in by the participant in the app during its usage
Secondary Outcomes
- Therapy Expectancy(up to 3 months (from Baseline/beginning of treatment to Post/end of treatment))
- Psychological Flexibility(up to 3 months (from Baseline/beginning of treatment to Post/end of treatment))
- Social Interaction(up to 3 months (from Baseline/beginning of treatment to Post/end of treatment))
- Disability(up to 3 months (from Baseline/beginning of treatment to Post/end of treatment))
- Emotion Dysregulation(up to 3 months (from Baseline/beginning of treatment to Post/end of treatment))
- Wellbeing(up to 3 months (from Baseline/beginning of treatment to Post/end of treatment))
- Symptomatology(up to 3 months (from Baseline/beginning of treatment to Post/end of treatment))
- Perceived Stress(up to 3 months (from Baseline/beginning of treatment to Post/end of treatment))
- Prosocial Behavior(up to 3 months (from Baseline/beginning of treatment to Post/end of treatment))
- Self-efficacy(up to 3 months (from Baseline/beginning of treatment to Post/end of treatment))
- Media and Technology Usage and Attitudes(up to 3 months (from Baseline/beginning of treatment to Post/end of treatment))
- Trusting Beliefs towards the Avatar(up to 3 months (from Baseline/beginning of treatment to Post/end of treatment))
- Perceived Social Presence of the Avatar(up to 3 months (from Baseline/beginning of treatment to Post/end of treatment))
Investigators
Prof. Dr. Andrew Gloster
Prof. Dr., Division of Clinical Psychology & Intervention Science, University of Basel
University of Basel