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Clinical Trials/NCT07300410
NCT07300410
Completed
Not Applicable

Usability, Acceptance, and Effectiveness of a Coach-Guided, App-Based Mental Health Intervention: The beWell Tirol Pilot Study

Medical University Innsbruck1 site in 1 country25 target enrollmentStarted: January 13, 2024Last updated:
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Overview

Phase
Not Applicable
Status
Completed
Sponsor
Medical University Innsbruck
Enrollment
25
Locations
1
Primary Endpoint
Usability of the digital mental health program
OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief Summary

The goal of this clinical trial is to learn if a coach-guided, app-based mental health program can improve well-being and reduce psychological distress in adults experiencing elevated stress levels. The main questions it aims to answer are:

  • Does the beWell Tirol program show high usability and participant satisfaction?
  • Does participation in the program lead to improvements in psychological distress, resilience, self-efficacy, coping strategies, emotion regulation, and quality of life?

Participants will:

  • Complete a 4-month digital mental health program using the beWell Tirol app
  • Attend bi-weekly video coaching sessions with a trained psychologist
  • Choose individualized cognitive-behavioral exercises within the app
  • Complete questionnaires at baseline, post-intervention, and 3-month follow-up

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Adults (≥ 18 years)
  • •Living in Tyrol (Austria) or South Tyrol (Italy)
  • •Elevated psychological distress (Brief Symptom Inventory / BSCL Global Severity Index T-score \> 60 based on age and gender)
  • •Sufficient German language skills to use the app and complete questionnaires
  • •Access to a smartphone or tablet and the internet
  • •Willing and able to participate in the 4-month digital program and follow-up assessments
  • •Provided written informed consent

Exclusion Criteria

  • •Non-German-speaking individuals
  • •Acute psychiatric crisis or acute suicidality requiring immediate face-to-face treatment
  • •Any condition that, in the judgment of the investigators, would prevent safe participation or the completion of the app-based intervention (e.g., severe cognitive impairment)

Outcomes

Primary Outcomes

Usability of the digital mental health program

Time Frame: Right after the intervention ended

Usability will be assessed using the System Usability Scale (SUS), a 10-item validated questionnaire measuring perceived usability of digital systems. Scores range from 0 to 100, with higher scores indicating better usability.

Secondary Outcomes

  • Participant satisfaction(Right after the intervention ended)
  • Psychological distress(Baseline, right after the intervention ended, 3-month follow-up)
  • Resilience(Baseline, right after the intervention ended, 3-month follow-up)
  • Self-efficacy expectation(Baseline, right after the intervention ended, 3-month follow-up)
  • Emotion regulation(Baseline, right after the intervention ended, 3-month follow-up)
  • Quality of Life: WHOQOL-BREF Global Score(Baseline, right after the intervention ended, 3-month follow-up)
  • Coping strategies(Baseline, right after the intervention ended, 3-month follow-up)
  • Coach Evaluations(Right after the intervention ended)

Investigators

Sponsor
Medical University Innsbruck
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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