App-Based Coaching Program to Improve Mental Well-Being

NCT07300410 | Completed

• 1 other identifier: BeWell271125
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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

Conditions

Psychological Distress

Keywords

Digital Mental Health; App-Based Intervention; Cognitive Behavioral Therapy (CBT); Psychological Distress; Coaching

Outcome Measures

Primary Outcomes (1)

• Usability of the digital mental health program

  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.

  Right after the intervention ended

Secondary Outcomes (9)

• 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

Study Arms (1)

beWell Tirol Intervention

EXPERIMENTAL

A 4-month digital mental health program delivered via the beWell Tirol app. The intervention includes psychoeducation, cognitive-behavioral exercises, interactive tools, digital diaries, and bi-weekly video coaching.

Device: Digital Mental Health Program with Coaching

Interventions

Digital Mental Health Program with Coaching DEVICE

This intervention is a 4-month digital mental health program with coaching. Participants use a mobile app that provides access to psychoeducational content, interactive cognitive-behavioral exercises, digital diaries, and self-monitoring tools. The program includes individualized exercise selection, where participants choose exercises every two weeks in collaboration with a trained coach. The intervention also incorporates bi-weekly 20-30 minute video coaching sessions, delivered within the app, to support motivation, clarify questions, and tailor the training plan. Exercises include relaxation techniques, mindfulness exercises, positive psychology activities, journaling tools, daily structuring tasks, and problem-solving strategies.

beWell Tirol Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Medical University Innsbruck: lead

Study Sites (1)

Medical University Innsbruck

Innsbruck, 6020, Austria

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2025
• First Posted: December 23, 2025
• Study Start: January 13, 2024
• Primary Completion: August 29, 2024
• Study Completion: November 29, 2024
• Last Updated: December 23, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)