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A Mindfulness-Based Stress Reduction programme in at-risk mutation carriers of genetic frontotemporal dementia

A Mindfulness-Based Stress Reduction programme in at-risk mutation carriers of genetic frontotemporal dementia - MBSR in presymptomatic FTD

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON48354
Enrollment
26
Registered
2019-12-20
Start date
2020-11-10
Completion date
Unknown
Last updated
2026-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

frontotemporal dementia

Interventions

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

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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 outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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 (FFM

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Aug 15, 2026