None listed
Conditions
Brief summary
The aim of this study is to investigate whether Mindfulness-based stress reduction (MBSR) can be used as an effective treatment option for people with restless legs syndrome (RLS). Specifically, the aim is to evaluate the effectiveness of the six-week MBSR group program in enhancing measures of RLS-specific quality of life, general health, sleep, RLS-specific symptom severity, depression and anxiety symptoms, and mindfulness skills. It is hypothesised that there will be a significant improvement in subjective measures of RLS symptom severity, RLS-related quality of life, general health, symptoms of psychopathology, including anxiety and depression, and subjective and objective measures of sleep, directly following the MBSR program and at three months post-intervention.
Interventions
Mindfulness-Based Stress Reduction (MBSR).
MBSR, developed by Jon Kabat-Zinn (1990) incorporates meditation practice together with mindfulness principles (i.e., the attitudinal foundations of mindfulness practice described by Kabat-Zinn (1990), non-striving, acceptance, non-judging, beginner's mind, trust, patience, letting go). It will be taught over a 6 week period, with 2 hour weekly sessions in a group setting of 8-10 participants. These sessions will be facilitated by a provisional psycholo
Mindfulness-Based Stress Reduction (MBSR). MBSR, developed by Jon Kabat-Zinn (1990) incorporates meditation practice together with mindfulness principles (i.e., the attitudinal foundations of mindfulness practice described by Kabat-Zinn (1990), non-striving, acceptance, non-judging, beginner's mind, trust, patience, letting go). It will be taught over a 6 week period, with 2 hour weekly sessions in a group setting of 8-10 participants. These sessions will be facilitated by a provisional psychologist who has specific training in MBSR and is supervised by a registered clinical psychologist and sleep physicians (the medical directors) from the Melbourne Sleep Disorders Centre. Adherence to MBSR intervention will be monitored by recording participant attendance to the weekly sessions, and also by asking participants to record their mindfulness practice, in terms of frequency, duration and type of mindfulness (formal or informal) practice in a daily log.
Sponsors
RMIT University
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
For inclusion in this study, men and women must be aged above 18 years and must present with restless legs syndrome (RLS), and significant psychosocial impairment or distress due to RLS according to the International Restless Legs Syndrome Study Group's (IRLSSG) diagnostic criteria, and determined via a diagnostic screening interview. Both unmedicated and medicated patients will be included in this study if treatment response has been stable for the past four weeks and there is no foreseeable medication change.
Exclusion criteria
Exclusion criteria are patients with neuropathic disorders; iron deficiency anaemia; uraemia (or renal failure); serious psychiatric disorders (i.e., severe major depressive disorder with suicidality, severe post-traumatic stress disorder or substance dependency); and, patients with severe cognitive deficits that would impair their ability to comply with research requirements or their ability to give consent.
Outcome results
None listed