Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001260213
Ethics application status
Approved
Date submitted
18/07/2018
Date registered
25/07/2018
Date last updated
25/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of a Mindfulness-Based program for people with Multiple Sclerosis
Scientific title
Randomized controlled trial of a Mindfulness-Based program for symptoms of depression in people with Multiple Sclerosis
Secondary ID [1] 295553 0
n/a
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Sclerosis 308818 0
Depression 308819 0
Anxiety 308820 0
Fatigue 308821 0
Pain 308822 0
Condition category
Condition code
Neurological 307750 307750 0 0
Multiple sclerosis
Mental Health 307836 307836 0 0
Depression
Mental Health 307837 307837 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Brief Name: Mindfulness-Based Program for People with MS
Description of Trial: The program is adapted from Dr John Kabat Zinn’s Mindfulness-Based Stress Reduction program (Kabat-Zinn, 2013), using meditation audio-guides to supplement the program material. The program consists of five modules, each containing case examples illustrating how mindfulness meditation techniques can be used and applied to people with MS. These fictional case examples are based on the thematic analysis of 19 face-to-face interviews with people with MS by a registered psychologist in an unpublished qualitative study, examining the psychological experiences of people with MS (e.g. depressive symptoms, anxiety, fatigue, pain and low health-related quality of life).
Content: The five main topics areas broadly cover: 1) An Introduction to Mindfulness Meditation and Simple Awareness, 2) Dealing with Stress, 3) Dealing with Difficult Emotions and Pain 4) Dealing with Thoughts 5) Mindful Communication, Compassion and Relapse Prevention.
Duration: Each module is approximately 15-20 minutes in length and will be delivered over the course of eight weeks (one module every 1-2 weeks).
Procedures: In addition to watching these online modules, participants will be asked to practice 30 minutes of mindfulness meditation every day, using guided audio tapes. Participants will also be encouraged to complete informal mindfulness practice and will be provided with Mindfulness Logs which they can use to help record the type, frequency and duration of mindfulness practice each week. Adherence will be assessed by asking questions about the type, frequency, and duration of mindfulness meditation practice at the end of each week.
Delivery: The program and telephone calls will be delivered individually. Participants will be guided through the online program with 5-8 telephone calls (approx. 1 x 5-10 minutes per week) by a registered psychologist (supervised by a clinical psychologist) to (1) encourage participation (2) normalize challenges to treatment (3) help resolve any technological difficulties. It is hoped that these guided telephone calls will help to improve fidelity and decrease drop-out rates.
Location: As the program is online, participants will be able to participate in the trial from any location as long as they have access to a computer device and the Internet.
Intervention code [1] 301851 0
Behaviour
Comparator / control treatment
The control is a wait-list control group. Participants in the control group will be offered the mindfulness-based intervention after the 6-month follow-up (if the program is found to be effective).
Control group
Active

Outcomes
Primary outcome [1] 306739 0
Depressive symptoms (Centre for Epidemiological Studies of Depression; CES-D; Radloff, 1977)
Timepoint [1] 306739 0
• Baseline
• Post-intervention, beginning of week 9 (PRIMARY ENDPOINT)
• 3-month follow-up, beginning of week 21
• 6-month follow-up, beginning of week 33.
Secondary outcome [1] 349400 0
Anxiety (Generalized Anxiety Disorder Scale; GAD-7; Spitzer, Kroenke, Williams, & Löwe, 2006)
Timepoint [1] 349400 0
• Baseline
• Post-intervention, beginning of week 9
• 3-month follow-up, beginning of week 21
• 6-month follow-up, beginning of week 33.
Secondary outcome [2] 349401 0
Fatigue (Fatigue Severity Scale (FSS) (Spitzer et al., 2006)
Timepoint [2] 349401 0
• Baseline
• Post-intervention, beginning of week 9
• 3-month follow-up, beginning of week 21
• 6-month follow-up, beginning of week 33.
Secondary outcome [3] 349402 0
Pain (Pain intensity and interference (Brief Pain Inventory- Short Form; Cleeland, 1989)
Timepoint [3] 349402 0
• Baseline
• Post-intervention, beginning of week 9
• 3-month follow-up, beginning of week 21
• 6-month follow-up, beginning of week 33.
Secondary outcome [4] 349403 0
MS-related Quality of Life (Multiple Sclerosis Impact Scale; MSIS-29; Krupp, LaRocca, Muir-Nash, & Steinberg, 1989)
Timepoint [4] 349403 0
• Baseline
• Post-intervention, beginning of week 9
• 3-month follow-up, beginning of week 21
• 6-month follow-up, beginning of week 33.
Secondary outcome [5] 349405 0
Mindfulness (Cognitive and Affective Mindfulness Scale- Revised; CAMS-R; Hobart, Lamping, Fitzpatrick, Riazi, & Thompson, 2001)
Timepoint [5] 349405 0
• Baseline
• Post-intervention, beginning of week 9
• 3-month follow-up, beginning of week 21
• 6-month follow-up, beginning of week 33.
Secondary outcome [6] 349406 0
Working Alliance (Working Alliance Inventory Short Form; WAIRSF-R; Hatcher & Gillaspy, 2006)
Timepoint [6] 349406 0
Week 8 post-enrolment
Secondary outcome [7] 349407 0
Meditation adherence: Questions regarding adherence to type, frequency, and duration of mindfulness meditation exercises will be assessed via online survey specifically designed for the study.
Timepoint [7] 349407 0
Week 1 (1 week after baseline), 2, 3, 4, 5, 6,7 ,8, 9, 21, 33
Secondary outcome [8] 349408 0
Treatment satisfaction: Questions regarding participants’ satisfaction with the program will be asked via online survey specifically designed for the study.
Timepoint [8] 349408 0
Week 8 post-enrolment

Eligibility
Key inclusion criteria
Participants will be included if they:
1. Have a neurologist-confirmed diagnosis of MS
2. 18 years old or older
3. Currently live in Australia
4. Have regular access to the Internet.
5. Have sufficient English to complete questionnaires and understand program content in English.
6. If taking MS treatment, be on a consistent MS regimen for more than one month with no plans to change this.
7. If taking anti-depressant medication, a stable dose for > 8 weeks.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded if they:
1. Have a comorbid medical condition known to impact on cognition or physical ability
2. Have moderate- severe cognitive deficits (<25 on the Telephone Interview for Cognitive Status; TICS).
3. Have suicidal intent requiring emergency care
4. Have alcohol or drug abuse or dependence
5. A psychotic illness or history of bipolar disorder
6. Have received consistent psychotherapy within the last 6 months
7 . Are pregnant. (Please note that if a participant becomes pregnant during the trial, this will not preclude them from continuing to participate).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The person that determines if a potential participant is eligible for inclusion in the trial will not be aware, when this decision is made, to which group the participant will be allocated.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be stratified according to history of major depression using clinical interviews and will be randomized by an independent statistician, using a computer-generated randomization system.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Participants will be stratified according to history of major depression in order to determine whether people with MS with a history of chronic depressive symptoms will benefit significantly more from the program than those without.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample size calculation is based on Sesel, Sharpe, and Naismith (2018)’s meta-analysis that found effect sizes of psychosocial interventions ranging from (d= 0.2- 0.3). According to G*Power, we would need a total sample of 125 to get 80% power with an alpha of .05 including an expected 20% drop-out rate.

Data will be analysed via intention-to-treat analysis. Linear mixed models will be generated with group as the fixed factor and baseline level of each treatment outcome as the covariate. Multiple linear regression analyses will also be used to predict change in outcomes over treatment and to investigate the predictive value of potential moderators (i.e. type of MS, depression, fatigue and pain status). Missing data will be minimized using a forced online completion format and will be imputed using linear mixed modelling.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2018
Actual
Date of last participant enrolment
Anticipated
31/03/2020
Actual
Date of last data collection
Anticipated
30/09/2020
Actual
Sample size
Target
125
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment postcode(s) [1] 23454 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 300133 0
Self funded/Unfunded
Name [1] 300133 0
Study is Unfunded
Country [1] 300133 0
Primary sponsor type
University
Name
The University of Sydney
Address
Brennan MacCallum A18
The University of Sydney
NSW 2006
Australia
Country
Australia
Secondary sponsor category [1] 299534 0
None
Name [1] 299534 0
Address [1] 299534 0
Country [1] 299534 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300967 0
The University of Sydney Human Research Ethics Committee (HREC)
Ethics committee address [1] 300967 0
Margaret Telfer Building (K07)
University of Sydney
NSW 2006
Ethics committee country [1] 300967 0
Australia
Date submitted for ethics approval [1] 300967 0
Approval date [1] 300967 0
09/07/2018
Ethics approval number [1] 300967 0
2018/402

Summary
Brief summary
The aim of this research project is to evaluate an online mindfulness-based program for people with Multiple Sclerosis. The eight-week program involves five online modules, and mindfulness meditation practice, which will be supplemented by meditation audio-guides and weekly telephone calls with a psychologist. We hypothesize that people with MS who complete this program will improve in symptoms of depression (primary outcome), anxiety, fatigue, and health-related quality of life.

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 85450 0
Prof Louise Sharpe
Address 85450 0
Brennan MacCallum A18
The University of Sydney
NSW 2006
Australia
Country 85450 0
Australia
Phone 85450 0
+61 2 93514558
Fax 85450 0
Email 85450 0
louise.sharpe@sydney.edu.au
Contact person for public queries
Name 85451 0
Ms Amy-Lee Sesel
Address 85451 0
Level 3 Building F (M02F)
94 Mallett St Camperdown NSW 2050
Country 85451 0
Australia
Phone 85451 0
+61 417061710
Fax 85451 0
Email 85451 0
ases5680@uni.sydney.edu.au
Contact person for scientific queries
Name 85452 0
Prof Louise Sharpe
Address 85452 0
Room 450, Brennan MacCallum (A18)
The University of Sydney
NSW 2006 Australia
Country 85452 0
Australia
Phone 85452 0
+61 2 9351 4558
Fax 85452 0
Email 85452 0
louise.sharpe@sydney.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

Current supporting documents:


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23665Ethical approval-999999  
23666Informed consent form-999999  

Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseA randomized controlled trial of a web-based mindfulness programme for people with MS with and without a history of recurrent depression.2022https://dx.doi.org/10.1177/13524585211068002
EmbaseThe evaluation of an online mindfulness program for people with multiple sclerosis: Study protocol.2019https://dx.doi.org/10.1186/s12883-019-1356-9
N.B. These documents automatically identified may not have been verified by the study sponsor.