Stress Autism Mate (SAM) App for Stress Management in Adults With Borderline Personality Disorder Traits

March 6, 2026 updated by: Sevda Demirel, GGZ Centraal

The Effects of a Stress Management App on Enhancing Insight and Coping With Daily Stress in Adults With Borderline Personality Disorder Traits

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:

  1. Does using the SAM app change daily stress levels measured within the app during four weeks of use?
  2. Does app use reduce perceived stress and improve coping self-efficacy and resilience after the intervention?

Participants will:

  • 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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
16

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Amersfoort, Netherlands, 3811MG
        • GGZ Centraal

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • inability to understand Dutch
  • inability to use a smartphone

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Stress Autism Mate App Intervention
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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in Daily Stress Scores as Measured by In-App Assessments During the Intervention Period
Time Frame: From baseline (day 1-7) to the end of the intervention period (day 8-30).
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in Perceived Stress as Measured by the Perceived Stress Scale (PSS)
Time Frame: From baseline to pre-intervention (week 4), to post-intervention (week 8) and 4-week follow-up (week 12).
Perceived stress was assessed using the 10-item Perceived Stress Scale (PSS), a self-report questionnaire measuring the extent to which situations in life are experienced as stressful. Change in perceived stress was evaluated by comparing scores at post-intervention and follow-up to baseline.
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)
Time Frame: From baseline to pre-intervention (week 4), to post-intervention (week 8) and 4-week follow-up (week 12).
Coping self-efficacy was assessed using the Coping Self-Efficacy Scale (CSES), which measures confidence in the ability to cope with stressful situations. Changes were evaluated by comparing post-intervention and follow-up scores to baseline.
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)
Time Frame: From baseline to pre-intervention (week 4), to post-intervention (week 8) and 4-week follow-up (week 12).
Resilience was assessed using the Dutch version of the Resilience Scale (RS-NL), which measures personal competence and acceptance of self and life. Change in resilience was evaluated by comparing post-intervention and follow-up scores to baseline.
From baseline to pre-intervention (week 4), to post-intervention (week 8) and 4-week follow-up (week 12).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
GGZ Centraal

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Yvette Roke, MD, PhD, GGZ Centraal

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 16, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 15, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 12, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 6, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 6, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 11, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 11, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 6, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SAM_BPD_240102

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

At this time, no public individual participant data sharing is planned, but data may be made available upon reasonable request from the corresponding author, in accordance with institutional and ethical guidelines.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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