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NCT Number: NCT07391072

Effectiveness of a Waitlist App "Stappvoorstap" During Mental Healthcare Waiting Times

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.

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Key information

Conditions

Psychological Stress Behavior Behavioral Symptoms Coping Ability Coping Skills Mental Health Personal Satisfaction Psychological Well-Being Quality of Life Stress, Psychological

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Stappvoorstap: mobile self-management waitlist intervention

Behavioral

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Other outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sevda Demirel, MSc

CONTACT

[email protected]

+31 6 57511938

Yvette Roke, MD, PhD

CONTACT

[email protected]

+31 36 538 3250

Sponsors and collaborators

Lead sponsor

GGZ Centraal

Other

Collaborators

  • Leiden University Medical Center

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Feb 5, 2026
Registry last updated
Feb 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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