Primary objectives:1) Investigate the effectivity of PRIMARY on BPD related problems (especially self-harm, emotion regulation and social relationships)Secondary objectives:1) Understanding the underlying mechanisms (especially social relationships…
ID
Source
Brief title
Condition
- Personality disorders and disturbances in behaviour
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
(Thoughts about) Self-harm
Emotion regulation
Social relationships
Secondary outcome
Social relationships (support and conflict)
Emotions (positive and negative)
(thoughts about) self-harm
Quality of life
Usability of the online monitor
Satisfaction with PRIMARY
Background summary
Borderline personality disorder (BPD) is a disorder with serious symptoms as
well as negative consequences in the long term, especially for mental health.
Although the first symptoms of BPD usually develop during adolescence,
therapists mainly diagnose patients with BPD in adulthood. For a long time,
also research mainly focused on adulthood, but more research is now focusing on
adolescents at risk for BPD as well. Besides, early intervention programs for
this target group are rising. However, these programs are still limited, which
means that many adolescents are on waiting lists for a suitable intervention.
With our research project, we aim to test a new intervention (PRIMARY) for
adolescents at risk for BPD. PRIMARY works through an online monitor and aims
to help adolescents with BPD symptoms - while they are on the waiting list - to
gain more insight in their emotions and hazardous situations.
Study objective
Primary objectives:
1) Investigate the effectivity of PRIMARY on BPD related problems (especially
self-harm, emotion regulation and social relationships)
Secondary objectives:
1) Understanding the underlying mechanisms (especially social relationships) of
the development of BPD symptoms
2) Investigate the effect of PRIMARY on the treatment program called HYPE
3) Investigate the satisfaction with PRIMARY
Study design
The study is a randomized controlled trial (RCT) with control group. We use the
Experience Sampling Method (ESM): patients fill out a short questionnaire on
their smartphone 5 times a day, for 4 weeks long. Furthermore, they fill out
questionnaires three times: at start (T1), at the end (T2) and a couple of
weeks after PRIMARY (T3).
Intervention
PRIMARY is an online monitor which asks participants to register their
emotions, social relationships and behavior (5 times a day, for 4 weeks). Once
a week, a researcher discusses the data from the past week with the
participant, using graphs. We expect that this enlarges the understanding of
emotions, improves emotion regulation and social relationships, and diminishes
self-harm.
Study burden and risks
The intervention group fills out a short questionnaire (2-3 minutes) 5 times a
day, for 4 weeks. Once a week, they will have an appointment with a researcher
to discuss the data on a secure online platform; this takes 15 minutes. The
intervention* and control group fill out questionnaires three times (T1-T3),
which takes 45-60 minutes each time. The risks associated with the research are
negligible.
Westsingel 41
Amersfoort 3811BB
NL
Westsingel 41
Amersfoort 3811BB
NL
Listed location countries
Age
Inclusion criteria
- Age between 12 and 25 years
- Sufficient skills in the Dutch language
- Self-harm in the past 4 weeks
- At risk for borderline personality disorder
Exclusion criteria
Not applicable.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL73936.041.20 |