NCT07464301

Brief Summary

The goal of this intervention study is to learn whether a stress management app (Stress Autism Mate, SAM) can help reduce stress and support coping in adults with borderline personality disorder traits receiving outpatient mental health care. The SAM app is a self-monitoring app designed in co-creation with and for individuals with autism, that supports users in recognizing, understanding, and managing daily stress. The app measures stress levels multiple times per day by asking what you were doing, how you were feeling and your stress signals. It offers real-time feedback and a visual overview of stress levels at both the daily and weekly level, and connecting to your activities. This allows users to recognize their own stress triggers and patterns. In addition, the app provides practical stress-reducing tips. The study focuses on changes in daily stress levels and self-reported perceived stress, coping self-efficacy, and resilience during and after use of the app. The main questions this study aims to answer are:

  • Use the SAM app on their smartphone for four weeks
  • Complete short in-app stress questionnaires multiple times per day
  • Complete online questionnaires about stress, coping, and resilience at several time points
  • Continue their regular outpatient treatment during the study

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

April 16, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2024

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 12, 2024

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

March 6, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 11, 2026

Completed
Last Updated

March 11, 2026

Status Verified

December 1, 2025

Enrollment Period

6 months

First QC Date

March 6, 2026

Last Update Submit

March 6, 2026

Conditions

Keywords

Borderline Personality DisorderPsychological StressStress monitoringStress managementMobile health interventionSmartphone applicationEcological momentary assessmentCoping self-efficacyResilienceOutpatient mental health careSingle-case experimental design

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline in Daily Stress Scores as Measured by In-App Assessments During the Intervention Period

    Daily stress was assessed using brief self-report stress questions embedded in the mobile application. Participants were prompted multiple times per day to rate their current level of stress. Stress scores reflect momentary perceived stress experiences and were aggregated over time for each participant. Change in daily stress was evaluated by comparing stress scores during the intervention period to the baseline phase.

    From baseline (day 1-7) to the end of the intervention period (day 8-30).

Secondary Outcomes (3)

  • Change From Baseline in Perceived Stress as Measured by the Perceived Stress Scale (PSS)

    From baseline to pre-intervention (week 4), to post-intervention (week 8) and 4-week follow-up (week 12).

  • Change From Baseline in Coping Self-Efficacy as Measured by the Coping Self-Efficacy Scale (CSES)

    From baseline to pre-intervention (week 4), to post-intervention (week 8) and 4-week follow-up (week 12).

  • Change From Baseline in Resilience as Measured by the Resilience Scale (RS-NL)

    From baseline to pre-intervention (week 4), to post-intervention (week 8) and 4-week follow-up (week 12).

Study Arms (1)

Stress Autism Mate App Intervention

EXPERIMENTAL

Participants in this single study arm use the Stress Autism Mate mobile application during a four-week intervention period. The app prompts participants to complete brief stress questionnaires multiple times per day and provides visual feedback on stress patterns and personalized coping suggestions. The intervention is used alongside treatment as usual in outpatient mental health care. Participants serve as their own control through within-subject comparisons over time.

Behavioral: Mobile Application for Stress Monitoring and Coping

Interventions

This intervention consists of a smartphone-based stress monitoring and coping application designed to support daily self-management of stress. The application uses ecological momentary assessment to prompt users multiple times per day to report stress-related experiences in their own environment. Based on these inputs, the app provides visual feedback on individual stress patterns over time and offers personalized coping suggestions. The intervention is low risk and self-guided.

Stress Autism Mate App Intervention

Eligibility Criteria

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

You may qualify if:

  • Presence of at least one borderline personality disorder (BPD) trait, as assessed according to DSM-5 criteria and the diagnostic guidelines of the Dutch Association of Psychiatry (NVVP)
  • Age 18 years or older

You may not qualify if:

  • inability to understand Dutch
  • inability to use a smartphone

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GGZ Centraal

Amersfoort, 3811MG, Netherlands

Location

MeSH Terms

Conditions

Borderline Personality DisorderStress, Psychological

Interventions

Coping Skills

Condition Hierarchy (Ancestors)

Personality DisordersMental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Yvette Roke, MD, PhD

    GGZ Centraal

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
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

March 6, 2026

First Posted

March 11, 2026

Study Start

April 16, 2024

Primary Completion

October 15, 2024

Study Completion

November 12, 2024

Last Updated

March 11, 2026

Record last verified: 2025-12

Locations