Clinical trial NCT05010447: Feasibility of an Avatar-Led and ACT-Based App for Adjunctive Psychotherapy in In- and Outpatients: Virtual Coach App
Official title: Feasibility of an Avatar-Led and ACT-Based Smartphone Application for Adjunctive Psychotherapy in In- and Outpatients: Virtual Coach App
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mental Disorder
Keywords: Avatar-guided smartphone application
Acceptance and Commitment Therapy
Mental disorders
Device feasibility
Application feasibility
Lead sponsor: University of Basel
Sponsor class: OTHER
Collaborators: name: Universitäre Psychiatrische Kliniken (UPK) Basel
name: Klinik Sonnenhalde AG Psychiatrie und Psychotherapie
name: Swiss National Science Foundation
First posted: 2021-08-18
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Micro-Randomized Trial
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: User Experience Questionnaire
timeFrame: once at Baseline (beginning of therapy/week 1)
measure: System Usability Scale
timeFrame: up to 3 months (from Baseline/beginning of treatment to Post/end of treatment)
measure: Semi-structured User Experience Questionnaire
timeFrame: up to 3 months (from Baseline/beginning of treatment to Post/end of treatment)
measure: User Adherence Meta-Variables
timeFrame: up to 3 months (from Baseline/beginning of treatment to Post/end of treatment)
Secondary outcomes:
measure: Therapy Expectancy
timeFrame: up to 3 months (from Baseline/beginning of treatment to Post/end of treatment)
measure: Psychological Flexibility
timeFrame: up to 3 months (from Baseline/beginning of treatment to Post/end of treatment)
measure: Social Interaction
timeFrame: up to 3 months (from Baseline/beginning of treatment to Post/end of treatment)
measure: Disability
timeFrame: up to 3 months (from Baseline/beginning of treatment to Post/end of treatment)
measure: Emotion Dysregulation
timeFrame: up to 3 months (from Baseline/beginning of treatment to Post/end of treatment)
measure: Wellbeing
timeFrame: up to 3 months (from Baseline/beginning of treatment to Post/end of treatment)
measure: Symptomatology
timeFrame: up to 3 months (from Baseline/beginning of treatment to Post/end of treatment)
measure: Perceived Stress
timeFrame: up to 3 months (from Baseline/beginning of treatment to Post/end of treatment)
measure: Prosocial Behavior
timeFrame: up to 3 months (from Baseline/beginning of treatment to Post/end of treatment)
measure: Self-efficacy
timeFrame: up to 3 months (from Baseline/beginning of treatment to Post/end of treatment)
measure: Media and Technology Usage and Attitudes
timeFrame: up to 3 months (from Baseline/beginning of treatment to Post/end of treatment)
measure: Trusting Beliefs towards the Avatar
timeFrame: up to 3 months (from Baseline/beginning of treatment to Post/end of treatment)
measure: Perceived Social Presence of the Avatar
timeFrame: up to 3 months (from Baseline/beginning of treatment to Post/end of treatment)
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Universitäre Psychiatrische Kliniken (UPK) Basel
state: Basel-Stadt
city: Riehen
country: Switzerland
facility: Klinik Sonnenhalde
state: Basel-Stadt
Study officials:
affiliation: University of Basel, Faculty of Psychology, Division for Clinical Psychology and Intevention Science
name: Andrew T. Gloster, Prof. Dr.
role: STUDY_CHAIR
References:
citation: Hayes SC, Luoma JB, Bond FW, Masuda A, Lillis J. Acceptance and commitment therapy: model, processes and outcomes. Behav Res Ther. 2006 Jan;44(1):1-25. doi: 10.1016/j.brat.2005.06.006.
citation: Kashdan TB, Rottenberg J. Psychological flexibility as a fundamental aspect of health. Clin Psychol Rev. 2010 Nov;30(7):865-78. doi: 10.1016/j.cpr.2010.03.001. Epub 2010 Mar 12.
citation: Karekla M, Savvides SN, Gloster A. An Avatar-Led Intervention Promotes Smoking Cessation in Young Adults: A Pilot Randomized Clinical Trial. Ann Behav Med. 2020 Oct 1;54(10):747-760. doi: 10.1093/abm/kaaa013.
citation: Trull TJ, Ebner-Priemer UW. Using experience sampling methods/ecological momentary assessment (ESM/EMA) in clinical assessment and clinical research: introduction to the special section. Psychol Assess. 2009 Dec;21(4):457-62. doi: 10.1037/a0017653.