Borderline Personality DisorderNCT07464301
Stress Autism Mate (SAM) App for Stress Management in Adults With Borderline Personality Disorder Traits
A study testing Mobile Application for Stress Monitoring and Coping in people with Borderline Personality Disorder and Stress (Psychology), run by GGZ Centraal at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Borderline Personality Disorder, Stress (Psychology), Perceived Stress
- What is being tested?
- Mobile Application for Stress Monitoring and Coping
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteNetherlands
- Study dates
- 16 Apr 2024to 12 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- inability to understand Dutch
- inability to use a smartphone
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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:
Read more
- Does using the SAM app change daily stress levels measured within the app during four weeks of use?
- 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
- Being tested
- Mobile Application for Stress Monitoring and Coping
- Keywords
- Borderline Personality Disorder, Psychological Stress, Stress monitoring, Stress management, Mobile health intervention, Smartphone application, Ecological momentary assessment, Coping self-efficacy, Resilience, Outpatient mental health care, Single-case experimental design
- Medical subject headings
- Borderline Personality Disorder, Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile Application for Stress Monitoring and CopingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Mobile Application for Stress Monitoring and Coping |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: From baseline to pre-intervention (week 4), to post-intervention (week 8) and 4-week follow-up (week 12).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2026
- Study start16 Apr 2024
- Primary completion15 Oct 2024
- Study completion12 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Borderline Personality DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- GGZ Centraal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sevda Demirel, GGZ Centraal
- Investigators
- Yvette Roke, MD, PhD, Study director, GGZ Centraal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07464301
- Sponsor's protocol ID
- SAM_BPD_240102
- Status last verified
- Dec 2025
- First submitted
- 6 Mar 2026
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a Stress Management App on Enhancing Insight and Coping With Daily Stress in Adults With Borderline Personality Disorder Traits
- ClinicalTrials.gov ID
- NCT07464301
- Acronym / sponsor ID
- SAM_BPD_240102
- Keywords
- Borderline Personality Disorder, Psychological Stress, Stress monitoring, Stress management, Mobile health intervention, Smartphone application, Ecological momentary assessment, Coping self-efficacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- GGZ CentraalUniversity, hospital or other
- Study start
- 16 Apr 2024 (actual)
- Primary completion
- 15 Oct 2024 (actual)
- Study completion
- 12 Nov 2024 (actual)
- First posted
- 11 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does using the SAM app change daily stress levels measured within the app during four weeks of use?
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stress Autism Mate App Intervention | Experimental | Behavioral: Mobile Application for Stress Monitoring and CopingParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- inability to understand Dutch
- inability to use a smartphone
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile Application for Stress Monitoring and CopingThis 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. | Behavioural | Stress Autism Mate App Intervention |
Primary outcome
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.
3 secondary outcomes
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).
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).
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
- Individual participant dataSharing planned: Undecided. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yvette Roke, MD, PhD study director
GGZ Centraal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile Application for Stress Monitoring and Coping in people with Borderline Personality Disorder and Stress (Psychology), run by GGZ Centraal at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2026.