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

NCT ID: NCT05010447

Last Updated: 2021-08-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-15
• Study Completion Date: 2021-12-31

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.

Conditions

Mental Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Virtual Coach App

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitäre Psychiatrische Kliniken (UPK) Basel

UNKNOWN

Sponsor Role: collaborator

Klinik Sonnenhalde AG Psychiatrie und Psychotherapie

UNKNOWN

Sponsor Role: collaborator

Swiss National Science Foundation

OTHER

Sponsor Role: collaborator

University of Basel

OTHER

Sponsor Role: lead

Responsible Party

Prof. Dr. Andrew Gloster

Prof. Dr., Division of Clinical Psychology & Intervention Science, University of Basel

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andrew T. Gloster, Prof. Dr.

Role: STUDY_CHAIR

University of Basel, Faculty of Psychology, Division for Clinical Psychology and Intevention Science

Locations

Universitäre Psychiatrische Kliniken (UPK) Basel

Basel, Canton of Basel-City, Switzerland

Klinik Sonnenhalde

Riehen, Canton of Basel-City, Switzerland

Countries

Switzerland

Central Contacts

Andrew T. Gloster, Prof. Dr.

Role: CONTACT

andrew.gloster@unibas.ch

+41 61 207 02 75

Victoria J. Block, MSc

Role: CONTACT

victoria.block@unibas.ch

+41 61 207 06 67

Facility Contacts

Victoria J Block, MSc

Role: primary

victoria.block@unibas.ch

+41 61 207 06 67

Julia Ruemmelein, MSc

Role: primary

julia.ruemmelein@unibas.ch

References

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.

Reference Type: BACKGROUND

PMID: 16300724 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21151705 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32383736 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19947780 (View on PubMed)

Other Identifiers

VC

Identifier Type: -

Identifier Source: org_study_id