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

NCT05010447 | Unknown

• 1 other identifier: VC
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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.

Conditions

Mental Disorder

Keywords

Avatar-guided smartphone application; Acceptance and Commitment Therapy; Mental disorders; Device feasibility; Application feasibility

Outcome Measures

Primary Outcomes (4)

• User Experience Questionnaire

  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.

  once at Baseline (beginning of therapy/week 1)

• System Usability Scale

  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.

  up to 3 months (from Baseline/beginning of treatment to Post/end of treatment)

• Semi-structured User Experience Questionnaire

  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.

  up to 3 months (from Baseline/beginning of treatment to Post/end of treatment)

• User Adherence Meta-Variables

  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

  up to 3 months (from Baseline/beginning of treatment to Post/end of treatment)

Secondary Outcomes (13)

• 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)

Study Arms (1)

Study Group

EXPERIMENTAL

Participants receive the Virtual Coach App for one week at the beginning of their therapy and one week towards the end of their therapy.

Device: Virtual Coach App

Interventions

Virtual Coach App 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.

Study Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Current undergoing inpatient or outpatient psychotherapy;
• ability to speak German or English;
• giving informed consent.

You may not qualify if:

• not able to take part as assessed by the clinic's medical/therapeutic staff

Sponsors & Collaborators

• University of Basel: lead
• Universitäre Psychiatrische Kliniken (UPK) Basel: collaborator
• Klinik Sonnenhalde AG Psychiatrie und Psychotherapie: collaborator
• Swiss National Science Foundation: collaborator

Study Sites (2)

Universitäre Psychiatrische Kliniken (UPK) Basel

Basel, Canton of Basel-City, 4055, Switzerland

Location

Klinik Sonnenhalde

Riehen, Canton of Basel-City, 4125, Switzerland

Location

Related Publications (4)

• 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.

  PMID: 16300724 BACKGROUND

• 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.

  PMID: 21151705 BACKGROUND

• 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.

  PMID: 32383736 BACKGROUND

• 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.

  PMID: 19947780 BACKGROUND

MeSH Terms

Conditions

Mental Disorders

Study Officials

• Andrew T. Gloster, Prof. Dr.

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

  STUDY CHAIR

Central Study Contacts

Andrew T. Gloster, Prof. Dr.

CONTACT

+41 61 207 02 75; andrew.gloster@unibas.ch

Victoria J. Block, MSc

CONTACT

+41 61 207 06 67; victoria.block@unibas.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr., Division of Clinical Psychology & Intervention Science, University of Basel

Model Details: Micro-Randomized Trial

Study Record Dates

• First Submitted: July 7, 2021
• First Posted: August 18, 2021
• Study Start: August 15, 2021
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: August 18, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

CH (2)