Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000797774
Ethics application status
Approved
Date submitted
15/07/2013
Date registered
17/07/2013
Date last updated
19/07/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Mindfulness-based Stress Reduction for Restless Legs Syndrome: A Single Arm Pilot Study
Scientific title
The Effect of Mindfulness-based Stress Reduction on Severity of Symptoms in People with Restless Legs Syndrome: A Single Arm Pilot Study
Secondary ID [1] 282824 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Restless Legs Syndrome
 289607 0
Condition category
Condition code
Neurological 289944 289944 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 287509 0
Treatment: Other
Intervention code [2] 287510 0
Lifestyle
Comparator / control treatment
The design of this research is a repeated measures design, using standard treatment for control, as it is currently prescribed by their treating physician.
Control group
Active

Outcomes
Primary outcome [1] 289997 0
The 10-item International Restless Legs Severity Scale (IRLS; The International Restless Legs Syndrome Study Group [IRLSSG], 2003) will be used in this study to assess RLS-specific symptom severity and psychosocial impairment due to RLS.
Timepoint [1] 289997 0
Baseline (week 0), Pre-intervention (week 4), post-intervention (week 10), 3 months follow up (3 months post-intervention)
Primary outcome [2] 289998 0
The 25-item Restless Legs Cognitions Questionnaire (RLSCQ; Sim, Greenwood, Cunnington, & Swieca, 2012) is a newly developed measure assessing the cognitive content related to symptoms of RLS across five subscales: 1) Psychosocial impairment on social life (e.g., I think that having RLS has limited my social activities); 2) Perseverance (e.g., I think that I am able to put up with the symptoms); 3) Medication persistence (e.g., I think that I will be unable to cope with RLS without the medication); 4) Helplessness (e.g., I think about the things that I did today to cause this episode); and, 5) Unbearable cognitions (e.g., I think that the symptoms will never end).
Timepoint [2] 289998 0
Baseline (week 0), Pre-intervention (week 4), post-intervention (week 10), 3 months follow up (3 months post-intervention)
Primary outcome [3] 289999 0
The self-report, 18-item, Restless Legs Syndrome Quality of Life scale (RLS-QoL; Abetz, Vallow, et al., 2005) will be used to assess the impact of RLS on daily living, morning and evening activity, concentration, sexual activity, and work over the past four weeks
Timepoint [3] 289999 0
baseline (week 0), Pre-intervention (week 4), post-intervention (week 10), 3 months follow up (3 months post-intervention)
Secondary outcome [1] 303748 0
The Medical Outcomes Study, 36-item, Short Form Health Survey (SF-36) will be used to assess general health status across eight components: 1) physical functioning; 2) role-physical functioning (i.e., physical health limitations in usual role activities); 3) bodily pain; 4) general health perceptions; 5) vitality (energy and fatigue); 6) social functioning (i.e., health limitations or interference with normal social activities); 7) role-emotional (i.e., problems with daily activities as a result of emotional issues); and, 8) mental health and psychological wellbeing (Ware, 2000; Ware & Sherbourne, 1992).
Timepoint [1] 303748 0
Baseline (week 0), Pre-intervention (week 4), post-intervention (week 10), 3 months follow up (3 months post-intervention)
Secondary outcome [2] 303749 0
The Symptom Checklist-90-Revised (SCL-90-R; Derogatis, 1994) will be used to evaluate a broad range of symptoms of psychopathology, and to measure progress and change due to the intervention. The SCL-90-R is a 90-item questionnaire that is designed to measure overall psychological distress, the number of self-reported symptoms and the intensity of symptoms of psychopathology.
Timepoint [2] 303749 0
Baseline (week 0), Pre-intervention (week 4), post-intervention (week 10), 3 months follow up (3 months post-intervention)
Secondary outcome [3] 303750 0
The Hospital Anxiety and Depression Scale (HADS; Zigmond & Snaith, 1983) was developed as a valid and reliable self-assessment measure in identifying anxiety and depression psychopathology in nonpsychiatric hospital and medical settings. The HADS consists of 14 items evenly divided into depression (HADS-D), and anxiety (HADS-A) subscales
Timepoint [3] 303750 0
Baseline (week 0), Pre-intervention (week 4), post-intervention (week 10), 3 months follow up (3 months post-intervention)
Secondary outcome [4] 303751 0
The 19-item, self-rated, Pittsburgh Sleep Quality Index (PSQI; Buysse, Reynolds III, Monk, Berman, & Kupfer, 1988) will be used to measure sleep quality across seven components of subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction.
Timepoint [4] 303751 0
Baseline (week 0), Pre-intervention (week 4), post-intervention (week 10), 3 months follow up (3 months post-intervention)
Secondary outcome [5] 303752 0
The 8-item,self-rated, Epworth Sleepiness Scale (ESS) will be used to assess daytime sleepiness, as a large negative impact on quality of life for RLS sufferers is daytime tiredness and sleepiness. Each itemis rated on 4-point scale ranging from 0 (would never doze) to 3 (high chance of dozing).
Timepoint [5] 303752 0
Baseline (week 0), Pre-intervention (week 4), post-intervention (week 10), 3 months follow up (3 months post-intervention)
Secondary outcome [6] 303753 0
The Five-Facet Mindfulness Questionnaire (FFMQ; Baer, Smith, Hopkins, Krietemeyer, & Toney, 2006) will be used in this study as it is based on a factor analytic study of five independent and well established mindfulness questionnaires which yielded five factors representing mindfulness. These are observing, describing, acting with awareness, non-judging and non-reacting. The FFMQ consists of 39 items which are self-rated on a 5-point scale from 1 (never or very rarely true)to 5 (very often, or always true).
Timepoint [6] 303753 0
Baseline (week 0), Pre-intervention (week 4), post-intervention (week 10), 3 months follow up (3 months post-intervention)

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
repeated measures design
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
10/07/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 7163 0
3002 - East Melbourne

Funding & Sponsors
Funding source category [1] 287605 0
Other Collaborative groups
Name [1] 287605 0
Melbourne Sleep Disorders Centre
Country [1] 287605 0
Australia
Funding source category [2] 287606 0
University
Name [2] 287606 0
RMIT University
Country [2] 287606 0
Australia
Primary sponsor type
University
Name
RMIT University
Address
Plenty Road, Bundoora, VIC, 3083
Country
Australia
Secondary sponsor category [1] 286355 0
Other Collaborative groups
Name [1] 286355 0
Melbourne Sleep Disorders Centre
Address [1] 286355 0
100 Victoria Parade, East Melbourne, VIC, 3002
Country [1] 286355 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289581 0
RMIT Human Research Ethics Committee
Ethics committee address [1] 289581 0
Level 2, Building 91
110 Swanston St, Carlton
VIC, 3053
Ethics committee country [1] 289581 0
Australia
Date submitted for ethics approval [1] 289581 0
Approval date [1] 289581 0
21/02/2013
Ethics approval number [1] 289581 0
project number 45/12

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 41410 0
Miss Vicky Bablas
Address 41410 0
Division of Psychology
School of Health Sciences
RMIT University
Plenty Road, Bundoora
VIC 3083
Country 41410 0
Australia
Phone 41410 0
+61 3 4976 7311
Fax 41410 0
Email 41410 0
[email protected]
Contact person for public queries
Name 41411 0
Miss Vicky Bablas
Address 41411 0
Division of Psychology
School of Health Sciences
RMIT University
Plenty Road, Bundoora
VIC 3083
Country 41411 0
Australia
Phone 41411 0
+61 3 4976 7311
Fax 41411 0
Email 41411 0
[email protected]
Contact person for scientific queries
Name 41412 0
Miss Vicky Bablas
Address 41412 0
Division of Psychology
School of Health Sciences
RMIT University
Plenty Road, Bundoora
VIC 3083
Country 41412 0
Australia
Phone 41412 0
+61 3 4976 7311
Fax 41412 0
Email 41412 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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