- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07391072
Effectiveness of a Waitlist App "Stappvoorstap" During Mental Healthcare Waiting Times
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
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sevda Demirel, MSc
- Phone Number: +31 6 57511938
- Email: s.demirel@ggzcentraal.nl
Study Contact Backup
- Name: Yvette Roke, MD, PhD
- Phone Number: +31 36 538 3250
- Email: y.roke@ggzcentraal.nl
Study Locations
-
-
Flevoland
-
Almere Stad, Flevoland, Netherlands, 1326 AD
- Recruiting
- GGZ Centraal
-
Contact:
- Sevda Demirel, MSc
- Phone Number: +31 6 57511938
- Email: s.demirel@ggzcentraal.nl
-
Contact:
- Yvette Roke, MD, PhD
- Phone Number: +31 36 538 3250
- Email: y.roke@ggzcentraal.nl
-
Principal Investigator:
- Sevda Demirel, MSc
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- Currently enrolled in another medical-scientific research study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group 1: 3-week baseline
Participants receive 3 weeks of baseline measurements, 4 weeks of Stappvoorstap app intervention, and 3 weeks of follow-up (10 total measurements).
|
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.
|
|
Experimental: Group 2: 4-week baseline
Participants receive 4 weeks of baseline measurements, 4 weeks of Stappvoorstap app intervention, and 3 weeks of follow-up (11 total measurements).
|
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.
|
|
Experimental: Group 3: 5-week baseline
Participants receive 5 weeks of baseline measurements, 4 weeks of Stappvoorstap app intervention, and 3 weeks of follow-up (12 total measurements).
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Weekly measurements for 10-12 weeks (depending on group assignment)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Coping Self-Efficacy
Time Frame: Weekly measurements for 10-12 weeks (depending on group assignment)
|
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.
|
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)
|
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.
|
Weekly measurements for 10-12 weeks (depending on group assignment)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
User Experience and Perceived Usefulness
Time Frame: After completion of the 4-week intervention period
|
Semi-structured interview assessing participants' experiences with the Stappvoorstap app, including perceived usefulness, usability, barriers and facilitators, and suggestions for improvement.
Open-ended questions explore how participants integrated the app into daily life and their overall satisfaction.
|
After completion of the 4-week intervention period
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Stappvoorstap_N24.084
- KPO-79 (Other Grant/Funding Number: Zorgondersteuningsfonds)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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