NCT07391072

Brief 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 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
19mo left

Started Mar 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress42%
Mar 2025Dec 2027

Study Start

First participant enrolled

March 17, 2025

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

January 29, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 5, 2026

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

February 5, 2026

Status Verified

January 1, 2026

Enrollment Period

2.7 years

First QC Date

January 29, 2026

Last Update Submit

January 29, 2026

Conditions

Keywords

waiting listmental healthstress managementmobile healthself-managementmHealthecological momentary interventionsingle-case experimental designperceived stress

Outcome Measures

Primary Outcomes (1)

  • 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.

    Weekly measurements for 10-12 weeks (depending on group assignment)

Secondary Outcomes (2)

  • Change in Coping Self-Efficacy

    Weekly measurements for 10-12 weeks (depending on group assignment)

  • Change in Quality of Life

    Weekly measurements for 10-12 weeks (depending on group assignment)

Other Outcomes (1)

  • User Experience and Perceived Usefulness

    After completion of the 4-week intervention period

Study Arms (3)

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).

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).

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).

Behavioral: Stappvoorstap: mobile self-management waitlist intervention

Interventions

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.

Group 1: 3-week baselineGroup 2: 4-week baselineGroup 3: 5-week baseline

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • Currently enrolled in another medical-scientific research study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GGZ Centraal

Almere Stad, Flevoland, 1326 AD, Netherlands

RECRUITING

Related Links

MeSH Terms

Conditions

Stress, PsychologicalPsychological Well-Being

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorPersonal Satisfaction

Central Study Contacts

Yvette Roke, MD, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Candidate

Study Record Dates

First Submitted

January 29, 2026

First Posted

February 5, 2026

Study Start

March 17, 2025

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

February 5, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

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.

Locations