The present study aims to investigate whether a standardized 8-week group MBSR treatment can significantly reduce symptoms of stress, anxiety and depression, and improve quality of life in at-risk mutation carriers for FTD. The primary objective is…
ID
Source
Brief title
Condition
- Neurological disorders congenital
- Dementia and amnestic conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome measure is the total, depression subscore (HADS-D) and
anxiety subscore (HADS-A) of the HADS, developed to measure psychological
distress in somatic patient populations (Zigmond & Snaith, 1983; Spinhoven et
al., 1997; Norton et al., 2013). In short, it consists of a 7-item depression
(HADS-D) and a 7-item anxiety (HADS-A) subscale. The HADS has good psychometric
qualities in the general medical population (Bjelland et al., 2002). Internal
consistency (Cronbach*s *) ranged between 0.84-0.90 (Spinhoven et al., 1997;
Bjelland et al., 2002). Test-retest reliability was good (Pearson*s r >0.80)
(Spinhoven et al., 1997).
Secondary outcome
The 36-item Short Form Health Survey (SF-36) assesses (health-related) quality
of life across eight scaled domains: vitality, physical functioning, bodily
pain, general health perceptions, physical role functioning, emotional role
functioning, social role functioning and mental health (Ware & Sherbourne,
1992). The internal consistency (Cronbach*s *) (>0.85) as well as the
test-retest reliability were good (Brazier et al., 1992).
The Utrecht Coping List (UCL) is a Dutch coping questionnaire, consisting of 47
items across seven subscales: seeking distraction, expression emotions, seeking
social support, avoiding, fostering reassuring thoughts, passive coping, and
active coping (Schreurs et al., 1984). The internal consistency (Cronbach*s *)
ranged between 0.43-0.89 (Schreurs & van de Willige, 1988). The test-retest
reliability ranged between 0.37 and 0.85 (Schreurs et al., 1993).
The Symptom Checklist 90 Revised (SCL-90-R) is a self-report questionnaire
measuring a broad range of psychological problems and symptoms of
psychopathology, including depression, anxiety, interpersonal sensitivity and
somatization. It is also used in measuring the progress and outcome of
psychiatric and psychological treatments or for research purposes (Arrindell &
Ettema, 2005). Reliability and validity of this instrument were good (Derogatis
& Savitz, 2000).
The Perceived Stress Scale (PSS) is one of the most widely used psychological
instruments for measuring the perception of stress, both of stressful life
events and current levels of experienced stress (Cohen et al., 1983). It has
been used in previous studies assessing the effectiveness of stress-reducing
interventions, including mindfulness (e.g. Marcus et al., 2003). The PSS showed
adequate reliability and was correlated with life-event scores, depressive and
physical symptomology, utilization of health services, and social anxiety
(Cohen et al., 1983).
The 39-item Five Facet Mindfulness Questionnaire (FFMQ) measures mindfulness
skills across five subscales: observing, describing, acting with awareness,
non-judging of inner experience, and non-reactivity to inner experience (Baer
et al., 2008). The internal consistency (Cronbach*s *) ranged between 0.72 and
0.93, and the FFMQ proved to be sensitive to change in prior mindfulness-based
interventions (Carmody et al., 2008).
Background summary
Frontotemporal dementia (FTD) is a young-onset type of dementia, with a
clinically heterogeneous presentation of either behavioural disturbances
(behavioural variant [bvFTD]) and/or language deterioration (Snowden, 2006).
Because FTD has an autosomal dominant inheritance pattern in up to 40% we can
define mutation carriers in the presymptomatic phase (Rabinovici, 2013).
Mutations in the MAPT, GRN, and C9orf72 genes constitute the three most common
causes of familial FTD (Warren, 2013). Familial forms constitute the ideal
disease-model for FTD, as we can identify pathogenic mutation carriers in their
presymptomatic stage and follow them longitudinally to develop sensitive
biomarkers for e.g. pinpointing disease onset, tracking disease progression,
and evaluating the effects of future disease-modifying treatments.
Started in 2009, a large cohort of at-risk mutation carriers are being followed
in the Erasmus MC, called the FTD Risk Cohort (FTD-RisC). At present, only a
minority of these persons have converted to the symptomatic phase. This means
that a large number of persons lives with the knowledge of a 50% risk of
carrying the pathogenic mutation for FTD. Moreover, these persons experience
the onset and progression of FTD in at least one of their close relatives.
Multiple participants have expressed feelings of distress, anxiety and
depression related to the risk of developing FTD, and psychological treatment
of these symptoms is therefore needed.
Some of the most promising clinical treatments for improving the quality of
life for people with chronic illnesses are based on the concept of mindfulness.
Mindfulness-Based Stress Reduction (MBSR) is defined as intentionally paying
interceptive attention in the present moment in a non-judgmental way
(Kabat-Zinn et al., 2004). MBSR has a variety of positive effects on both
physical and psychological health, and has a beneficial effect on emotion
regulation, with a significant improvement of symptoms of stress and mood
disturbance in people with anxiety. There is increasing research evidence to
support the application of MBSR in patients with chronic diseases such as ALS
(Pagnini et al., 2014), Parkinson*s Disease (Pickut et al., 2015) and epilepsy
(Walker et al., 2010), however its effectiveness in (presymptomatic) FTD is so
far unknown.
Study objective
The present study aims to investigate whether a standardized 8-week group MBSR
treatment can significantly reduce symptoms of stress, anxiety and depression,
and improve quality of life in at-risk mutation carriers for FTD. The primary
objective is to investigate whether the MBSR programme is able to lower
symptoms of anxiety and depression. The secondary objective is to investigate
whether the MBSR programme is able to improve health-related quality of life
and coping, and to decrease psychological problems, symptoms of psychopathology
and stress.
Study design
The design of the study is a parallel group randomized controlled design.
Participants are randomized between MBSR group and waitlist group.
Randomization will be computerized using a randomization website. The waitlist
group will get the opportunity to participate in the MBSR training afterwards
as we would like to offer this programme to each at-risk participant. Baseline
measurements will be administered after study inclusion, followed by
randomization. After the MBSR programme in the intervention group or after 8
weeks in the waitlist group, post-measurements will take place, as well as a
2-months follow-up measurement. One year post-training, adherence to the
programme will be investigated by means of a telephone follow-up. The exact
setting of the study is to be determined, but will most likely take place
outside of the hospital at a venue that is both centrally located and easily
reachable by the study participants.
Intervention
A standardized 8-week group MBSR programme will be given to at-risk mutation
carriers for FTD, in which participants are randomized between the intervention
(MBSR) and waitlist (control) group. The control group can participate in the
programme afterwards. The MBSR training is based on the 8-week programme
developed by Kabat-Zinn (Kabat-Zinn et al, 2004) and is modified to fit our
specific population of at-risk mutation carriers. The programme consists of 8
weekly 2.5 hour sessions, and home practice assignments of about 45 minutes, 6
days per week. Participants are provided with multimedia materials to guide
their at home exercises and a folder with information and practice
instructions. The MBSR training is taught by certified neuropsychologists with
experience in (presymptomatic) FTD.
Study burden and risks
There are no known risks of undergoing a MBSR programme. The only burden to be
expected is that from the relatively high time investment from each individual
(8 times 2.5 hours programme, filling out questionnaires before and after the
programme, and at 2-months follow-up). However, this potential burden is
outweighed by the likely benefits of the programme in reducing anxiety,
depression and distress in relation to FTD mutation carriership.
Dr. Molenwaterplein 40
Rotterdam 3015 GD
NL
Dr. Molenwaterplein 40
Rotterdam 3015 GD
NL
Listed location countries
Age
Inclusion criteria
Asymptomatic, first-degree relatives of FTD patients due to genetic mutations (MAPT, GRN or C9orf72 genes). They have 50% chance of having the mutation and therefore developing FTD. Age of 18 years and over.
Exclusion criteria
Symptomatic or participants suspect for developing FTD (Clinical Dementia Rating Scale > 0.5).
Persons with a previous or other (neurological) condition (e.g. stroke, brain tumour, MS) that may affect cognitive functioning to such a degree that it hampers study participation.
Current severe psychiatric conditions (e.g. clinical depression or anxiety disorders).
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 | NL68725.078.19 |