The primary objective is pilot-implementation of smartphone-based safety planning and real-time self-monitoring for patients with recurrent depression and suicide risk in mental health care. For the secondary objectives we will analyse the real-timeā¦
ID
Source
Brief title
Condition
- Suicidal and self-injurious behaviours NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary objective is to test the feasibility of the safety planning and
self-monitoring tools. Feasibility endpoints are defined in terms of uptake,
patient satisfaction and usability.
Secondary outcome
Secondary outcomes are the mental health variables measured by the EMA items.
These variables include anxiety, belongingness, (brooding) rumination,
burdensomeness, fear of dying, coping, defeat, depression, entrapment, future
thinking, impulsiveness, resilience and suicidal ideation (see also
attachment).
Background summary
Suicidal behaviour often occurs outside treatment hours, resulting in completed
suicides, crisis interventions and hospital admissions. Smartphone-based safety
planning and self-monitoring could provide tools for patients to avoid
situations of high risk, organise support in times of suicidal crisis, and
avoid relapse.
Study objective
The primary objective is pilot-implementation of smartphone-based safety
planning and real-time self-monitoring for patients with recurrent depression
and suicide risk in mental health care.
For the secondary objectives we will analyse the real-time monitoring data, in
order to (a) empirically validate hypothesised psychological processes and
stages of suicide pathways, (b) identify individual pathways to suicidal
behaviour, and (c) profile types of suicidal individuals.
Study design
This feasibility study is a single cohort design among patients of three mental
health centres. There will be three measurement points: T0 (baseline), T1 (1
month after T0) and T2 (3 months after T0). We consider this study to be an
adaptive design, which means that the apps that we investigate will be improved
based on patient feedback when possible and, therefore, may slightly change
during the study.
Intervention
We will add two mobile apps to the regular treatment of patients. We will only
look at the feasibility of the implementation and we do not have a therapeutic
meaning. The CASPAR study is therefore a feasibility study and not a standard
implementation study.
- Electronic safety planning is the electronic form of the existing, regular
safety plan.
- Electronic self-monitoring is the electronic form of registration of symptoms
of patients.
Study burden and risks
This study will point out whether mobile safety planning and self-monitoring
are useful additions to treating depressed patients with suicidal ideation. It
can be expected that at least some patients will benefit from these tools.
Furthermore, the secondary analyses might provide valuable data on the
psychological processes that coincide with suicidality. The added risk can be
considered to be minimal. Our study protocol interferes minimally with the
normal treatment. Dutch suicide prevention guidelines recommend safety planning
with mental health care patients who are at risk of engaging in suicidal
behaviour. Many participating patients will already have a safety plan and the
only difference is that it will be electronic instead of on paper.
Self-monitoring is comparable with keeping a mood diary, which is often used in
treatment. An extensive literature review shows that there is no evidence that
intensive assessment of suicidal ideation could lead to more suicidal ideation
or suicidal behaviour. Moreover, previous studies on EMA of suicidal ideation
have also shown no adverse effects.
Van der Boechorststraat 1
Amsterdam 1081BT
NL
Van der Boechorststraat 1
Amsterdam 1081BT
NL
Listed location countries
Age
Inclusion criteria
- Age * 18 years
- Outpatients or day-care patients
- Recurrent depressive disorder or dysthymia
- Severe suicidal ideation
- Understanding written Dutch
- Smartphone that runs either Android or iOS
Exclusion criteria
- Severe psychotic symptoms
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 | NL62795.029.17 |