Psychological StressNCT07391072
Effectiveness of a Waitlist App "Stappvoorstap" During Mental Healthcare Waiting Times
A study testing Stappvoorstap: mobile self-management waitlist intervention in people with Psychological Stress and Coping Ability, run by GGZ Centraal at 1 site in Netherlands.
Trial summary
This study evaluates the effectiveness of Stappvoorstap, a mobile self-management application designed for adults on mental health waiting lists in the Netherlands. The app helps users monitor daily stress levels, recognize personal stress patterns, and provides coping strategies, relaxation exercises, and supportive… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psychological Stress, Coping Ability, Mental Health
- What is being tested?
- Stappvoorstap: mobile self-management waitlist intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteNetherlands
- Study dates
- 17 Mar 2025to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Currently on a waiting list at a mental health organization in the Netherlands.
- Aged 18 years or older
- Owns a smartphone and has the ability to operate it
- Sufficient proficiency in Dutch or English language (at least B1 level)
Who cannot join
- Currently enrolled in another medical-scientific research study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
GGZ Centraal
Almere Stad, Flevoland, 1326 AD
Yvette Roke, MD, PhD, +31 36 538 3250, y.roke@ggzcentraal.nl
Sevda Demirel, MSc, +31 6 57511938, s.demirel@ggzcentraal.nl
About this study
Official title: Bridging the Gap: A Multiple Baseline Design Study on the Effectiveness of a Mobile-based Stress Management Intervention in Adults on Waiting Lists for Mental Healthcare
This study evaluates the effectiveness of Stappvoorstap, a mobile self-management application designed for adults on mental health waiting lists in the Netherlands. The app helps users monitor daily stress levels, recognize personal stress patterns, and provides coping strategies, relaxation exercises, and supportive resources. Using a multiple baseline single-case experimental design, participants use the app for 4 weeks while completing weekly questionnaires measuring perceived stress, coping self-efficacy, and quality of life. The study aims to determine whether the app can reduce stress and improve wellbeing during the waiting period before mental healthcare treatment begins.
Read the detailed description
Prolonged waiting times for mental healthcare pose significant challenges, with nearly 100,000 people on waiting lists in the Netherlands as of December 2023. During this period, symptoms can worsen, daily functioning may decline, and quality of life decreases. Stappvoorstap was developed in co-creation with waitlist clients and experts-by-experience to address this gap. The app is based on stress-signaling plans used in Dutch mental healthcare and functions as an ecological momentary intervention. It measures perceived stress 2-4 times daily, creates visual overviews of stress patterns, and provides real-time coping suggestions, mindfulness exercises, informational articles, and personal stories from other clients. This study uses a nonconcurrent multiple baseline design with A-B-A design. Participants are randomly assigned to 3, 4, or 5-week baseline phases, followed by 4 weeks of app use, and 3 weeks of follow-up. Weekly assessments include the Perceived Stress Scale (PSS-10), Coping Self-Efficacy Scale (CSES-13), and WHOQOL-BREF. Both group-level and individual case analyses will be conducted using mixed-effects modeling and Tau-(BC) effect size measures.
Participants are recruited from mental health waiting lists across the Netherlands. As this is a mobile app-based intervention, participation is location-independent and takes place remotely.
- Being tested
- Stappvoorstap: mobile self-management waitlist intervention
- Keywords
- waiting list, mental health, stress management, mobile health, self-management, mHealth, ecological momentary intervention, single-case experimental design, perceived stress
- Medical subject headings
- Stress, Psychological, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stappvoorstap: mobile self-management waitlist interventionBehavioural
Stappvoorstap is a free mobile self-management application developed in co-creation with mental health waitlist clients. The app measures daily stress levels 2-4 times per day through short questionnaires, creates visual overviews of personal stress patterns on daily and weekly scales, provides real-time coping suggestions, offers mindfulness and relaxation exercises (breathing exercises, meditation, nature sounds, calming music), and includes informational articles and personal experience stories.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: 3-week baseline | Experimental | Participants receive 3 weeks of baseline measurements, 4 weeks of Stappvoorstap app intervention, and 3 weeks of follow-up (10 total measurements). Receives: Behavioral: Stappvoorstap: mobile self-management waitlist intervention |
| Group 2: 4-week baseline | Experimental | Participants receive 4 weeks of baseline measurements, 4 weeks of Stappvoorstap app intervention, and 3 weeks of follow-up (11 total measurements). Receives: Behavioral: Stappvoorstap: mobile self-management waitlist intervention |
| Group 3: 5-week baseline | Experimental | Participants receive 5 weeks of baseline measurements, 4 weeks of Stappvoorstap app intervention, and 3 weeks of follow-up (12 total measurements). Receives: Behavioral: Stappvoorstap: mobile self-management waitlist intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Perceived Stress
Measured using the Perceived Stress Scale with 10 items (PSS-10). The PSS-10 is a validated self-report questionnaire assessing how stressful situations were perceived in the past week. Items are rated on a 5-point scale (1=never to 5=very often). Higher scores indicate higher perceived stress. Change from baseline phase to intervention phase, and to follow-up will be assessed.
Measured: Weekly measurements for 10-12 weeks (depending on group assignment)
Secondary outcomes (2)
Change in Coping Self-Efficacy
Measured using the Coping Self-Efficacy Scale with 13 items (CSES-13). The CSES-13 measures confidence in coping behaviors across three subscales: problem-focused coping, emotion-focused coping, and social support coping. Items are rated on a 10-point scale (0=cannot do at all to 10=certainly can do). Higher scores indicate greater coping self-efficacy.
Measured: Weekly measurements for 10-12 weeks (depending on group assignment)
Change in Quality of Life
Measured using selected domains of the World Health Organization Quality of Life Brief version (WHOQOL-BREF): physical health (7 items), psychological health (6 items), and social relationships (3 items), plus 2 items on overall quality of life and general health. Items rated on 5-point Likert scales. Higher scores indicate better quality of life.
Measured: Weekly measurements for 10-12 weeks (depending on group assignment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2026
- Study start17 Mar 2025
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychological StressStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GGZ Centraal
- Sponsor type
- University, hospital or other
- Collaborators
- Leiden University Medical Center
- Responsible party
- Principal investigator, Sevda Demirel, GGZ Centraal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07391072
- Sponsor's protocol ID
- Stappvoorstap_N24.084
- Other IDs
- KPO-79
- Status last verified
- Jan 2026
- First submitted
- 29 Jan 2026
- Last updated
- 5 Feb 2026
- 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. Anonymized group-level data may be made available upon reasonable request to the principal investigator, in accordance with institutional and ethical guidelines.
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bridging the Gap: A Multiple Baseline Design Study on the Effectiveness of a Mobile-based Stress Management Intervention in Adults on Waiting Lists for Mental Healthcare
- ClinicalTrials.gov ID
- NCT07391072
- Acronym / sponsor ID
- Stappvoorstap_N24.084
- Keywords
- waiting list, mental health, stress management, mobile health, self-management, mHealth, ecological momentary intervention, single-case experimental design
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- GGZ CentraalUniversity, hospital or other
- Collaborators
- Leiden University Medical Center
- Study start
- 17 Mar 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 5 Feb 2026 (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.
This study evaluates the effectiveness of Stappvoorstap, a mobile self-management application designed for adults on mental health waiting lists in the Netherlands. The app helps users monitor daily stress levels, recognize personal stress patterns, and provides coping strategies, relaxation exercises, and supportive resources. Using a multiple baseline single-case experimental design, participants use the app for 4 weeks while completing weekly questionnaires measuring perceived stress, coping self-efficacy, and quality of life. The study aims to determine whether the app can reduce stress and improve wellbeing during the waiting period before mental healthcare treatment begins.
Detailed description
Prolonged waiting times for mental healthcare pose significant challenges, with nearly 100,000 people on waiting lists in the Netherlands as of December 2023. During this period, symptoms can worsen, daily functioning may decline, and quality of life decreases. Stappvoorstap was developed in co-creation with waitlist clients and experts-by-experience to address this gap. The app is based on stress-signaling plans used in Dutch mental healthcare and functions as an ecological momentary intervention. It measures perceived stress 2-4 times daily, creates visual overviews of stress patterns, and provides real-time coping suggestions, mindfulness exercises, informational articles, and personal stories from other clients. This study uses a nonconcurrent multiple baseline design with A-B-A design. Participants are randomly assigned to 3, 4, or 5-week baseline phases, followed by 4 weeks of app use, and 3 weeks of follow-up. Weekly assessments include the Perceived Stress Scale (PSS-10), Coping Self-Efficacy Scale (CSES-13), and WHOQOL-BREF. Both group-level and individual case analyses will be conducted using mixed-effects modeling and Tau-(BC) effect size measures.
Participants are recruited from mental health waiting lists across the Netherlands. As this is a mobile app-based intervention, participation is location-independent and takes place remotely.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1: 3-week baseline | Experimental | Behavioral: Stappvoorstap: mobile self-management waitlist interventionParticipants receive 3 weeks of baseline measurements, 4 weeks of Stappvoorstap app intervention, and 3 weeks of follow-up (10 total measurements). |
| Group 2: 4-week baseline | Experimental | Behavioral: Stappvoorstap: mobile self-management waitlist interventionParticipants receive 4 weeks of baseline measurements, 4 weeks of Stappvoorstap app intervention, and 3 weeks of follow-up (11 total measurements). |
| Group 3: 5-week baseline | Experimental | Behavioral: Stappvoorstap: mobile self-management waitlist interventionParticipants receive 5 weeks of baseline measurements, 4 weeks of Stappvoorstap app intervention, and 3 weeks of follow-up (12 total measurements). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Currently on a waiting list at a mental health organization in the Netherlands.
- Aged 18 years or older
- Owns a smartphone and has the ability to operate it
- Sufficient proficiency in Dutch or English language (at least B1 level)
Key exclusion criteria (1 listed)
- Currently enrolled in another medical-scientific research study
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 |
|---|---|---|
| Stappvoorstap: mobile self-management waitlist interventionStappvoorstap is a free mobile self-management application developed in co-creation with mental health waitlist clients. The app measures daily stress levels 2-4 times per day through short questionnaires, creates visual overviews of personal stress patterns on daily and weekly scales, provides real-time coping suggestions, offers mindfulness and relaxation exercises (breathing exercises, meditation, nature sounds, calming music), and includes informational articles and personal experience stories. | Behavioural | Group 1: 3-week baseline, Group 2: 4-week baseline, Group 3: 5-week baseline |
Primary outcome
Change in Perceived Stress
Time frame: Weekly measurements for 10-12 weeks (depending on group assignment)
Measured using the Perceived Stress Scale with 10 items (PSS-10). The PSS-10 is a validated self-report questionnaire assessing how stressful situations were perceived in the past week. Items are rated on a 5-point scale (1=never to 5=very often). Higher scores indicate higher perceived stress. Change from baseline phase to intervention phase, and to follow-up will be assessed.
2 secondary outcomes
Change in Coping Self-Efficacy
Time frame: Weekly measurements for 10-12 weeks (depending on group assignment)
Change in Quality of Life
Time frame: Weekly measurements for 10-12 weeks (depending on group assignment)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- Official website with information about the Stappvoorstap app, and resources for people on mental health waiting lists.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Individual participant data will not be shared. Anonymized group-level data may be made available upon reasonable request to the principal investigator, in accordance with institutional and ethical guidelines.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stappvoorstap: mobile self-management waitlist intervention in people with Psychological Stress and Coping Ability, run by GGZ Centraal at 1 site in Netherlands.
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 4 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 5 Feb 2026. 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 Netherlands. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sevda Demirel, MSc (+31 6 57511938, s.demirel@ggzcentraal.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Perceived Stress (time frame: Weekly measurements for 10-12 weeks (depending on group assignment)). 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 5 Feb 2026.