- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07464301
Stress Autism Mate (SAM) App for Stress Management in Adults With Borderline Personality Disorder Traits
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:
- 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 Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Amersfoort, Netherlands, 3811MG
- GGZ Centraal
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
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 |
Intervention / Treatment |
|---|---|
|
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.
|
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
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.
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From baseline (day 1-7) to the end of the intervention period (day 8-30).
|
Secondary Outcome Measures
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.
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From baseline to pre-intervention (week 4), to post-intervention (week 8) and 4-week follow-up (week 12).
|
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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).
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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.
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From baseline to pre-intervention (week 4), to post-intervention (week 8) and 4-week follow-up (week 12).
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Yvette Roke, MD, PhD, GGZ Centraal
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SAM_BPD_240102
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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