Evaluation of a Modified Mindfulness-Based Stress Reduction Intervention for Adults with Cerebral Palsy and Anxiety and/or Emotion Regulation Difficulties—A Randomised Control Trial
Abstract
:1. Introduction
2. Materials and Methods
2.1. Study Design and Participants
- Adults with CP;
- Individuals 20–40 years of age;
- Individuals with the ability to speak conversational English, which could include the use of augmentative and alternative communication;
- Individuals self-identifying as having elevated anxiety or emotional regulation difficulties and one or more of the following scores on baseline assessment;
- DASS Anxiety raw score of four or higher;
- DERS total raw score of 99 or higher;
- Individuals that had not participated in active mindfulness training in the past year;
- Individuals with no reported moderate to severe intellectual impairment;
- Individuals identified as having functional hearing and vision;
- Individuals with access to the internet, a laptop, or a personal computer with a web camera and microphone for access to Microsoft Teams;
- Individuals committed to attending the 9-week course via telehealth on a Tuesday or Wednesday evening and to completing evaluations.
2.2. Randomisation and Blinding
2.3. Intervention
- Course overview and what is mindfulness?
- The mind–body connection—how our body responds physiologically to anxiety and stress.
- How to practice mindfulness meditation.
- How mindfulness works with respect to anxiety and stress.
- Mindfulness for the body.
- Deepening your practice—sitting meditation.
- Meditation for anxiety and stress.
- Loving kindness meditation.
- Interpersonal mindfulness and how to make mindfulness part of your everyday life.
2.4. Outcome Measures
- The mean between-group difference (MBSR vs Control) in CAMS-R scores from T1 to T3.
- The mean within-group difference in the CAMS-R total score from T1 to T2 and T1 to T3 for the MBSR intervention group.
- The mean within-group difference from T1 to T2 and T1 to T3 with regard to the following:
- Depression Anxiety and Stress Scale—21 (DASS-21);
- Depression;
- Anxiety;
- Stress;
- Difficulties in Emotion Regulation Scale (DERS) Total Raw Score.
- The mean within-group differences from T1 to T2 and T1 to T3 with regard to the following:
- Brief Pain Inventory (BPI) short-form pain intensity and interference scores;
- Point changes in ratings on a 10-point rating scale between baseline and follow-up time points across 5 individual specific anxiety-inducing situations.
2.5. Statistical Analysis
3. Results
3.1. Dose
3.2. Modifications to Course Content during the Study Period
3.3. Primary Outcome Measure
3.4. Secondary Outcome Measures
4. Discussion
5. Conclusions
Supplementary Materials
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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Variables | Measure | Description |
---|---|---|
Mindfulness behaviour and experiences | The Cognitive and Affective Mindfulness Scale-R (CAMS-R) [21] | A 12-item measure designed to capture a broad conceptualisation of mindfulness with language that is not specific to any particular type of meditation training. Respondents self-report their responses to the 12 items using a 4-point Likert scale (ranging from rarely/not at all to almost always). Items requiring reverse scoring are coded, and item scores are summed to obtain a total score, with higher CAMS-R scores indicating adequate sensitivity to self-reported changes [22]. |
Depression, anxiety, and stress | Depression Anxiety and Stress Scale—21 (DASS-21) [5] | DASS-21 is a valid and reliable categorical conception of depression, anxiety, and stress dimensions. DASS-21 scores indicate the degree to which someone is experiencing symptoms, but it is not a diagnostic tool. It has been used across a wide range of populations, including adolescents and adults with developmental disabilities (e.g., Down’s Syndrome). |
Emotion regulation | Difficulties in Emotion Regulation Scale (DERS) [23,24] | Widely used self-report measure of subjective emotion regulation ability. It has been used previously by the investigators in a study on adults with CP [6]. |
Pain | Brief Pain Inventory (BPI) pain intensity and interference scores [25,26] | The BPI is widely used to assess the severity and impact of pain on daily functions. It is a recommended outcome measure for clinical trials assessing chronic pain as per the IMMPACT guidelines (2005) [25,26]. |
Anxiety | Changes in ratings of 5 specific anxiety-inducing situations | Participants were asked to individually identify 5 anxiety-inducing situations and rate the level of anxiety induced by each situation on a 10-point rating scale. |
Co-variates | Measure | Description |
Socio-demographic and clinical characteristics | Survey | Self-report survey with a range of variables, including age, gender, employment, and accommodation. Participants were also asked to indicate their motor type and topography of CP (spastic hemiplegia/monoplegia, spastic diplegia, spastic tri/quadriplegia, ataxic, and/or dyskinetic). Gross motor limitations were classified using the Gross Motor Function Classification System (GMFCS) [27]. Speech and communication function were classified using the Communication Function Classification System [28] and Viking Speech Scale [29] and via the use of Augmentative and Alternative Communication. |
Perceived social support | The Multidimensional Scale of Perceived Social Support [30] | A 12-item self-report measure of perceived adequacy of social support from three sources: family, friends, and significant other. A total score on this measure ranging from 61–84 is indicative of high perceived support. |
Sense of community | Sense of Community Index-2 [31] | A 24-item self-report measure with responses recorded from a four-point Likert scale with scores ranging from 0 to 3 for a maximum score of 72 and a maximum subscale score of 18. Higher scores in this index suggest a greater sense of community. |
COVID-19-related well-being | Single survey question | A single survey question was included to ascertain whether COVID-19 had impacted participant well-being in the last week. |
Assessment/Procedure | Screening | Baseline T1 | Post MBSR Intervention T2 | Follow-Up T3 |
---|---|---|---|---|
Screening re-inclusion/exclusion criteria | ✓ | |||
Covariates | ||||
Socio-demographic and clinical characteristics | ✓ | |||
The Multidimensional Scale of Perceived Social Support | ✓ | |||
Sense of Community Index-2 | ✓ | |||
COVID-19-related well-being | ✓ | ✓ | ✓ | |
Outcomes | ||||
Cognitive and Affective Mindfulness Scale-R | ✓ | ✓ | ✓ | |
Depression, Anxiety, and Stress Scale—21 | ✓ | ✓ | ✓ | |
Difficulties in Emotion Regulation Scale | ✓ | ✓ | ✓ | |
BPI Pain interference score | ✓ | ✓ | ✓ | |
BPI Pain intensity score | ✓ | ✓ | ✓ | |
Scores regarding 5 anxiety-inducing situations | ✓ | ✓ | ✓ | |
Practice of mindfulness-based skills | ✓ | ✓ |
Total n = 31 | MBSR Intervention n = 16 | Control n = 15 | p-Value | |
---|---|---|---|---|
Age, years, mean (SD) | 25.3 (3.9) | 26.2 (4.3) | 24.2 (3.2) | 0.10 |
Years, n (%) | ||||
20–24 | 13 (41.9%) | 4 (25.0%) | 9 (60.0%) | 0.20 |
25–29 | 14 (45.2%) | 9 (56.2%) | 5 (33.3%) | |
30–35 | 4 (12.9%) | 3 (18.8%) | 1 (6.7%) | |
Gender, n (%) | ||||
Male | 8 (25.8%) | 5 (31.2%) | 3 (20.0%) | 0.40 |
Female | 21 (67.7%) | 11 (68.8%) | 10 (66.7%) | |
Non-binary | 2 (6.5%) | 0 (0.0%) | 2 (13.3%) | |
Employment, n (%) | ||||
Paid employment | 12 (38.7%) | 9 (56.3%) | 3 (20.0%) | 0.14 |
Student | 9 (29.0%) | 3 (18.8%) | 6 (40.0%) | |
Volunteer/not engaged in paid employment | 10 (32.3%) | 4 (25.0%) | 6 (40.0%) | |
Living situation, n (%) | ||||
With parents/family member | 21 (67.7%) | 11 (68.8%) | 10 (66.7%) | 0.49 |
Alone/with spouse | 6 (19.4%) | 4 (25.0%) | 2 (13.3%) | |
Share house/supported accommodation | 4 (12.9%) | 1 (6.2%) | 3 (20.0%) | |
Children, n (%) | ||||
Yes | 0 | |||
No | 31 (100.0%) | |||
Receive care support for daily living activities, n (%) | ||||
Yes | 20 (64.5%) | 11 (68.8%) | 9 (60.0%) | 0.70 |
No | 11 (35.5%) | 5 (31.2%) | 6 (40.0%) | 0 |
Support person, n (%) | ||||
Partner/spouse | 3 (9.7%) | 2 (12.5%) | 1 (6.7%) | 0.99 |
Parent | 22 (71.0%) | 11 (68.8%) | 11 (73.3%) | |
Friend | 1 (3.2%) | 1 (6.3% | ||
Sibling | 1 (3.2%) | 0 | 1 (6.7%) | |
Case worker/advocate | 1 (3.2%) | 0 | 1 (6.7%) | |
Other | 3 (9.7%) | 2 (12.5%) | 1 (6.7%) | |
The Multidimensional Scale of Perceived Social Support, mean (SD) | ||||
Total | 60.4 (17.1) | 56.6 (16.3) | 64.4 (17.6) | 0.20 |
Friends | 18.5 (6.4) | 16.6 (6.8) | 20.7 (5.3) | 0.07 |
Family | 21.2 (6.7) | 20.9 (6.2) | 21.6 (7.4) | 0.80 |
Significant Other | 20.6 (7.0) | 19.1 (6.6) | 22.1 (7.2) | 0.20 |
Sense of Community Index-2, mean (SD) | ||||
Total | 65.1 (19.8) | 65.1 (18.6) | 65.1 (21.6) | 0.99 |
Reinforcement of needs | 16.4 (4.8) | 16.4 (4.2) | 16.5 (5.5) | 0.96 |
Membership | 15.7 (5.3) | 15.6 (5.2) | 15.9 (5.6) | 0.88 |
Influence | 15.5 (5.1) | 15.6 (5.1) | 15.3 (5.2) | 0.90 |
Shared emotional connection | 17.5 (5.4) | 17.6 (5.0) | 17.4 (5.9) | 0.91 |
Total n = 31 | Intervention n = 16 | Control n = 15 | p-Value | |
---|---|---|---|---|
Gross Motor Function (GMFCS), n (%) | ||||
Level I–III | 24 (77.4%) | 12 (75.0%) | 12 (80.0%) | 0.99 |
Level IV–V | 7 (22.6%) | 4 (25.0%) | 3 (20.0%) | |
CP Motor Type, n (%) | 12 (38.7%) | 5 (31.2%) | 7 (46.7%) | 0.79 |
Spastic hemiplegia/monoplegia | ||||
Spastic diplegia | 9 (29.0%) | 6 (37.5%) | 3 (20.0%) | |
Spastic triplegia or quadriplegia | 6 (19.4%) | 3 (18.8%) | 3 (20.0%) | |
Other (Ataxia, mixed type, not stated) | 4 (12.9%) | 2 (12.5%) | 2 (13.3%) | |
Communication Function (CFCS), n (%) | ||||
Level I | 22 (71.0%) | 12 (75.0%) | 10 (66.7%) | 0.70 |
Level II–V | 9 (29.0%) | 4 (25.0%) | 5 (33.3%) | |
Viking Speech Scale (VSS) [29], n (%) | ||||
Level I | 20 (64.5%) | 11 (68.8%) | 9 (60.0%) | 0.70 |
Level II–IV | 11 (35.5%) | 5 (31.2%) | 6 (40.0%) | |
Augmentative/alternative communication system used, n (%) | ||||
Yes | 4 (12.9%) | 2 (12.5%) | 2 (13.3%) | 0.99 |
No | 27 (87.1%) | 14 (87.5%) | 13 (86.7%) | |
Cognitive and Affective Mindfulness Scale-R, mean (SD) | 27.9 (6.3) | 26.7 (6.2) | 29.3 (6.3) | 0.30 |
Depression, Anxiety and Stress Scale-21, mean (SD) | ||||
Total | 22.7 (10.3) | 22.7 (10.9) | 22.8 (10.0) | 0.99 |
Depression | 7.1 (4.9) | 7.3 (4.5) | 6.9 (5.5) | 0.80 |
Anxiety | 6.2 (3.7) | 6.4 (4.4) | 6.1 (3.0) | 0.80 |
Stress | 9.5 (3.7) | 9.1 (3.0) | 9.9 (4.6) | 0.60 |
Difficulties in Emotion Regulation Scale, mean (SD) | ||||
Total | 59.6 (14.9) | 60.4 (14.4) | 58.4 (16.2) | 0.70 |
Non-acceptance | 60.7 (10.1) | 62.7 (8.1) | 58.1 (12.1) | 0.20 |
Goals | 59.4 (11.4) | 61.7 (9.3) | 56.2 (13.6) | 0.20 |
Impulse | 56.2 (14.9) | 56.9 (14.6) | 55.3 (16.0) | 0.80 |
Awareness | 55.4 (14.7) | 54.1 (12.2) | 57.2 (18.0) | 0.60 |
Strategy | 56.4 (13.4) | 58.8 (14.2) | 53.3 (12.0) | 0.30 |
Clarity | 56.1 (13.3) | 55.7 (13.1) | 56.7 (14.0) | 0.80 |
Brief Pain Inventory, n (%) | ||||
Interference | 18.8 (19.5) | 17.9 (17.6) | 19.7 (21.9) | 0.80 |
Intensity | 4.0 (2.0) | 3.1 (2.0) | 4.9 (1.5) | 0.01 |
Situation Anxiety Ratings, mean (SD) | 6.7 (1.6) | 6.3 (1.8) | 7.2 (1.4) | 0.10 |
COVID impacted well-being in the last week, n (%) | ||||
No | 18 (60.0%) | 11 (68.8%) | 7 (50.0%) | 0.46 |
Yes | 12 (40.0%) | 5 (31.2%) | 7 (50.0%) |
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Share and Cite
Smithers-Sheedy, H.; Waight, E.; Swinburn, K.L.; Given, F.; Hooke, K.; Webb, A.; McIntyre, S.; Henry, G.; Honan, I. Evaluation of a Modified Mindfulness-Based Stress Reduction Intervention for Adults with Cerebral Palsy and Anxiety and/or Emotion Regulation Difficulties—A Randomised Control Trial. J. Clin. Med. 2024, 13, 1. https://doi.org/10.3390/jcm13010001
Smithers-Sheedy H, Waight E, Swinburn KL, Given F, Hooke K, Webb A, McIntyre S, Henry G, Honan I. Evaluation of a Modified Mindfulness-Based Stress Reduction Intervention for Adults with Cerebral Palsy and Anxiety and/or Emotion Regulation Difficulties—A Randomised Control Trial. Journal of Clinical Medicine. 2024; 13(1):1. https://doi.org/10.3390/jcm13010001
Chicago/Turabian StyleSmithers-Sheedy, Hayley, Emma Waight, Katherine L. Swinburn, Fiona Given, Kate Hooke, Annabel Webb, Sarah McIntyre, Georgina Henry, and Ingrid Honan. 2024. "Evaluation of a Modified Mindfulness-Based Stress Reduction Intervention for Adults with Cerebral Palsy and Anxiety and/or Emotion Regulation Difficulties—A Randomised Control Trial" Journal of Clinical Medicine 13, no. 1: 1. https://doi.org/10.3390/jcm13010001