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Evaluation of a Mindfulness-Based program for people with Multiple Sclerosis

Randomized controlled trial of a Mindfulness-Based program for symptoms of depression in people with Multiple Sclerosis

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618001260213
Enrollment
125
Registered
2018-07-25
Start date
2018-08-01
Completion date
2020-03-31
Last updated
2019-07-15

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

Conditions

None listed

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.

Interventions

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-

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are based on the thematic analysis of 19 face-to-face interviews with people with MS by a registered psychologist in an unpublished qualitative study, examining the psychological experiences of people with MS (e.g. depressive symptoms, anxiety, fatigue, pain and low health-related quality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.

Sponsors

The University of Sydney
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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.

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).

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 2, 2026