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Recruiting NCT07391072

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

No phase Interventional Psychological Stress Coping Ability Mental Health Quality of Life

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Stappvoorstap: mobile self-management waitlist intervention.
Who it may be relevant to
Registry conditions: Psychological Stress, Coping Ability, Mental Health, Quality of Life. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Netherlands
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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

Overview

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.

Interventions

  • Behavioral Stappvoorstap: mobile self-management waitlist intervention
    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 stori

Primary outcome measures

  • Change in Perceived Stress [Time frame: Weekly measurements for 10-12 weeks (depending on group assignment)]
Secondary outcome measures (2)
  • 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)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Single group
Masking
Open label
Primary purpose
Supportive care

Study locations

Netherlands · 1 center
  • GGZ Centraal — Almere Stad

Identifiers

NCT: NCT07391072 · Stappvoorstap_N24.084 · KPO-79

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗