Psychological DistressNCT07300410
App-Based Coaching Program to Improve Mental Well-Being
A study testing Digital Mental Health Program with Coaching in people with Psychological Distress, run by Medical University Innsbruck at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Psychological Distress
- What is being tested?
- Digital Mental Health Program with Coaching
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteAustria
- Study dates
- 13 Jan 2024to 29 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Usability, Acceptance, and Effectiveness of a Coach-Guided, App-Based Mental Health Intervention: The beWell Tirol Pilot Study
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?
Read more
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
- Being tested
- Digital Mental Health Program with Coaching
- Keywords
- Digital Mental Health, App-Based Intervention, Cognitive Behavioral Therapy (CBT), Psychological Distress, Coaching
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Mental Health Program with CoachingDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Digital Mental Health Program with Coaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Right after the intervention ended
Secondary outcomes (9)
Participant satisfaction
Satisfaction will be measured using a 10-item participant satisfaction questionnaire assessing overall satisfaction, perceived usefulness, impact on well-being, and coach satisfaction. Items are rated on a 4-point Likert scale (strongly disagree to strongly agree). Higher scores indicate greater satisfaction.
Measured: Right after the intervention ended
Psychological distress
Psychological distress will be measured with the Perceived Stress Scale (PSS-10), which assesses whether individuals perceive situations in their lives as excessively uncontrollable and overwhelming. Scores ranging from 0 to 13 indicate low stress, scores ranging from 14 to 26 indicate moderate stress, and scores ranging from 27 to 40 indicate high perceived stress.
Measured: Baseline, right after the intervention ended, 3-month follow-up
Resilience
Resilience will be assessed using the RS-13 Resilience Scale, a 13-item measure with scores ranging from 13-91. Higher values reflect greater resilience.
Measured: Baseline, right after the intervention ended, 3-month follow-up
Self-efficacy expectation
Self-efficacy will be measured using the General Self-Efficacy Scale (SWE), consisting of 10 items rated on a 4-point Likert scale. Higher scores indicate greater perceived self-efficacy.
Measured: Baseline, right after the intervention ended, 3-month follow-up
Emotion regulation
Emotion regulation will be measured using the Emotion Regulation Questionnaire (ERQ), including the subscales Cognitive Reappraisal (6 items) and Expressive Suppression (4 items). Higher scores reflect greater use of the respective strategy.
Measured: Baseline, right after the intervention ended, 3-month follow-up
Quality of Life: WHOQOL-BREF Global Score
Quality of life will be assessed using the WHOQOL-BREF, comprising four domains: physical health, psychological health, social relationships, and environment. Higher scores reflect better quality of life.
Measured: Baseline, right after the intervention ended, 3-month follow-up
Coping strategies
Coping will be assessed using the SVF-ak 42, measuring positive and negative coping responses. Subscale scores range from 0-6. Higher scores indicate more frequent use of the respective strategies.
Measured: Baseline, right after the intervention ended, 3-month follow-up
Coach Evaluations
Goal attainment will be assessed by the coach using portions of the Goal Attainment Scaling (GAS) and therapy process scales (STEP-SV). Higher scores indicate higher goal achievement and better engagement.
Measured: Right after the intervention ended
Psychological distress
Somatization, depression, and anxiety syndromes will be assessed using the short version of the Brief Symptom Inventory (BSI-18). The total score on the BSI-18 is referred to as the Global Severity Index (GSI) and reflects the general psychological distress.
Measured: Baseline, right after the intervention ended, 3-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2025
- Study start13 Jan 2024
- Primary completion29 Aug 2024
- Study completion29 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychological DistressStudies of the same condition, open and under way.
- More trials run by Medical University InnsbruckThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University Innsbruck
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07300410
- Sponsor's protocol ID
- BeWell271125
- Status last verified
- Nov 2025
- First submitted
- 27 Nov 2025
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because the dataset contains sensitive health information and cannot be sufficiently de-identified to ensure participant privacy. Data sharing is restricted by ethical approval and local data protection regulations.
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usability, Acceptance, and Effectiveness of a Coach-Guided, App-Based Mental Health Intervention: The beWell Tirol Pilot Study
- ClinicalTrials.gov ID
- NCT07300410
- Acronym / sponsor ID
- BeWell271125
- Conditions
- Psychological Distress
- Keywords
- Digital Mental Health, App-Based Intervention, Cognitive Behavioral Therapy (CBT), Psychological Distress, Coaching
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Medical University InnsbruckUniversity, hospital or other
- Study start
- 13 Jan 2024 (actual)
- Primary completion
- 29 Aug 2024 (actual)
- Study completion
- 29 Nov 2024 (actual)
- First posted
- 23 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| beWell Tirol Intervention | Experimental | Device: Digital Mental Health Program with CoachingA 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital Mental Health Program with CoachingThis 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. | Device | beWell Tirol Intervention |
Primary outcome
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.
9 secondary outcomes
Participant satisfaction
Time frame: Right after the intervention ended
Psychological distress
Time frame: Baseline, right after the intervention ended, 3-month follow-up
Resilience
Time frame: Baseline, right after the intervention ended, 3-month follow-up
Self-efficacy expectation
Time frame: Baseline, right after the intervention ended, 3-month follow-up
Emotion regulation
Time frame: Baseline, right after the intervention ended, 3-month follow-up
Quality of Life: WHOQOL-BREF Global Score
Time frame: Baseline, right after the intervention ended, 3-month follow-up
Coping strategies
Time frame: Baseline, right after the intervention ended, 3-month follow-up
Coach Evaluations
Time frame: Right after the intervention ended
Psychological distress
Time frame: Baseline, right after the intervention ended, 3-month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because the dataset contains sensitive health information and cannot be sufficiently de-identified to ensure participant privacy. Data sharing is restricted by ethical approval and local data protection regulations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital Mental Health Program with Coaching in people with Psychological Distress, run by Medical University Innsbruck at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Usability of the digital mental health program (time frame: Right after the intervention ended). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025.