We want to examine whether a semi-acute mindfulness based stress reduction (MBSR) intervention, specifically tailored to fit the needs of the health care workers and crisis situation, in addition to support as usual (SAU) can prevent incident/…
ID
Source
Brief title
Condition
- Psychiatric disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome will be changes from baseline (pre-MBSR) to 4 and 7-months on
depression, anxiety and somatoform symptoms measured with the Patient Health
Questionnaire SADS (PHQ-SADS).
Secondary outcome
Secondary measures of psychopathology will be the change of post-traumatic
stress symptoms (PDS), insomnia (ISI) and substance abuse (AUDIT-C, SCID). In
addition, we will measure positive changes in post-traumatic growth (PTG-R),
positive mental health (MHC-SF) and general health (EQ-5D-5L). As possible
mediators we will measure perseverative thinking (PTQ), mindfulness skills
(FFMQ-SF) and self-compassion (SCS). After 7 months of follow-up, a structured
psychiatric interview (SCID) will determine whether (and which) or not
psychiatric disorders are present. At that time point, the costs arising from
any psychosocial problems of the participants (TIC-P) will also be measured.
In addition, at baseline we will collect demographic data as well as data on
negative life events (part of NLEQ).
Background summary
Frontline health care workers are exposed to extreme acute stress during this
COVID-19 pandemic. Data recently collected in China show that this might lead
to substantial burden of psychopathology in these health care workers, which
might represent both new (incident) and deteriorating (prevalent) cases. This
is in line with findings from previous (health care) crises.
Study objective
We want to examine whether a semi-acute mindfulness based stress reduction
(MBSR) intervention, specifically tailored to fit the needs of the health care
workers and crisis situation, in addition to support as usual (SAU) can prevent
incident/prevalent psychopathology. Our hypothesis is that it can diminish
depression, anxiety, stress, post-traumatic stress symptoms, insomnia and
substance abuse and improve post-traumatic growth and positive mental health.
Study design
A randomized, single-blind, controlled trial with a SAU (including access to a
YouTube channel offering daily mindfulness exercises) control group and a MBSR
+ SAU intervention group.
Intervention
The intervention is a adapted MBSR program. The training consists of eight 1.5
hour sessions twice per week. The sessions will be held via interactive
videostreaming and will be recorded. This will enable those who could not
attend (e.g. because of an evening-shift) to catch up with the program. In
addition, SAU will consist of the possibility we provide to join the daily
guided mindfulness exercise (30 min) on a live YouTube channel, amongst the
other interventions already available in the hospital (e.g. buddy system,
psychological debriefing).
Study burden and risks
The health care workers will follow the 4 week MBSR program with biweekly 1.5
hour sessions and are encouraged to practice MBSR inbetween. Furthermore, they
will be asked to fill in online questionnaires before and directly after the
intervention (1 month post-baseline), and at 4 and 7 months (3 and 6 months
after the end of the intervention) which will take approximately 30-60 minute
each. Time investment for the group receiving SAU this is 5 hours and for the
group receiving SAU+MBSR is 17 hours across 7 months. MBSR is not known to
cause any serious effects and no risks are associated with the intervention.
Reinier Postlaan 4
Nijmegen 6500 HB
NL
Reinier Postlaan 4
Nijmegen 6500 HB
NL
Listed location countries
Age
Inclusion criteria
Healthcare workers working/reallocated on/to COVID-19 wards
Exclusion criteria
Impossibility to obtain a valid informed consent
Insufficient comprehension of the Dutch language
Inability to access the interactive videostream
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 | NL73793.091.20 |