Brief Mindfulness Intervention vs. Health Enhancement Program for Patients Undergoing Dialysis: A Randomized Controlled Trial
Abstract
:1. Introduction
2. Methods
2.1. Study Design
2.2. Participants
2.3. Randomization and Methods to Reduce Bias
2.4. Sample Size
2.5. Treatment: Brief Mindfulness Intervention (BMI)
2.6. Active Control: Health Enhancement Program (HEP)
2.7. Interventionists
2.8. Feasibility Outcome Measures
2.9. Efficacy Outcome Measures
2.10. Qualitative Evaluation
2.11. Analyses
3. Results
3.1. Participant Flow
3.2. Baseline Characteristics
3.3. Feasibility
3.4. Efficacy Outcomes
3.5. Qualitative Evaluation
4. Discussion
4.1. Strengths and Limitations
4.2. Future Directions
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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Participant Data | Total Sample (n = 55) | Treatment Group (n = 25) | Active Control Group (n = 30) |
---|---|---|---|
Demographic information | |||
Female | 58.2% (n = 32) | 65.4% (n = 17) | 51.7% (n = 15) |
Age, yr | 62.2 ± 12.0 | 58.7 ± 12.2 | 64.9 ± 11.2 |
Married/common law | 38.2% (n = 21) | 46.2% (n = 12) | 30.0% (n = 9) |
Level of education | |||
Elementary School | 9.1% (n = 5) | 8.0% (n = 2) | 10.3% (n = 3) |
High school | 38.2% (n = 21) | 30.1% (n = 8) | 44.8% (n = 13) |
CEGEP (pre-university in Quebec) | 18.2% (n = 10) | 23.1% (n = 6) | 13.8% (n = 4) |
University | 29.1% (n = 16) | 30.1% (n = 8) | 27.6% (n = 8) |
Currently living alone | 38.2% (n = 21) | 26.9% (n = 7) | 48.3% (n = 14) |
Medical History | |||
Number of medical problems | 7.0 (IQR 5.0–8.0) | 7.0 (IQR 5.0–8.0) | 7.0 (IQR 5.0–9.0) |
Number of years on dialysis | 3.0 (IQR 1.0–7.0) | 2.0 (IQR 1.0–5.0) | 6.0 (IQR 1.0–9.0) |
Number of current medications | 10.0 (IQR 8.0–13.0) | 9.0 (IQR 7.0–12.0) | 11.0 (IQR 9.0–13.0) |
Mental health information | |||
History of psychiatric diagnosis | 29.1% (n = 16) | 32.0% (n = 8) | 26.7% (n = 8) |
Depression | 18.2% (n = 10) | 24.0% (n = 6) | 13.3% (n = 4) |
Anxiety | 7.3% (n = 4) | 4.0% (n = 1) | 10.0% (n = 3) |
Other | 3.6% (n = 2) | 4.0% (n = 1) | 3.3% (n = 1) |
Number of years since first diagnosis | 15.0 (IQR 3.0–20.0) | 4.0 (IQR 3.0–15.0) | 17.0 (IQR 1.0–35.0) |
Psychotropic medications | 30.1% (n = 17) | 28.0% (n = 7) | 33.3% (n = 10) |
Anti-depressant | 25.5% (n = 14) | 28.0% (n = 7) | 23.3% (n = 7) |
Anti-anxiety | 9.1% (n = 5) | 4.0% (n = 1) | 13.3% (n = 4) |
Currently receiving mental health follow-up | 7.3% (n = 4) | 11.5% (n = 3) | 3.4% (n = 1) |
Other | |||
Habits (yes/no) | |||
Smoking | 14.5% (n = 8) | 19.2% (n = 5) | 10.3% (n = 3) |
Alcohol consumption | 23.6% (n = 13) | 15.4% (n = 4) | 30.0% (n = 9) |
Recreational drugs | 16.4% (n = 9) | 19.2% (n = 5) | 13.8% (n = 4) |
Meditated before | 18.2% (n = 10) | 23.1% (n = 6) | 13.8% (n = 4) |
Meditates currently | 10.9% (n = 6) | 11.5% (n = 3) | 10.3% (n = 3) |
PHQ-9 (n = 19) | Treatment (BMI) (n = 9) | Active Control (HEP) (n = 10) |
Baseline | 12.8 (±4.2) | 14.7 (±5.2) |
Follow-up | 5.8 (±3.3) | 8.6 (±4.7) |
8-week Change | −7.0 pts (±2.6) | −6.1 pts (±4.4) |
Between-group Change | p = 0.62 95% CI [−4.7, 2.9] | |
GAD-7 (n = 11) | Treatment (n = 6) | Active Control (n = 7) |
Baseline | 13.8 (±3.3) | 12.8 (±2.0) |
Follow-up | 5.2 (±4.6) | 11.4 (±4.6) |
8-week Change | −8.7 pts (±2.1) | −1.4 pts (±5.4) |
Between-group Change | p = 0.01 * 95% CI [−12.6, −1.9] |
PHQ-9 | Treatment (BMI) (n = 21) | Active Control (HEP) (n = 26) |
Baseline | 9.3 (±3.2) | 10.0 (±4.8) |
Follow-up | 5.2 (±3.3) | 6.9 (±4.1) |
8-week Change | −5 pts (−7–−1) | −3 pts (−5–0) |
Between-group Change | p = 0.23 95% CI = [−4, 1] | |
GAD-7 | Treatment (BMI) (n = 21) | Active Control (HEP) (n = 26) |
Baseline | 7.0 (±5.4) | 6.8 (±3.8) |
Follow-up | 3.9 (±4.0) | 5.8 (±4.8) |
8-week Change | −3.1 pts (±4.7) | −1 pts (±3.9) |
Between-group Change | p = 0.1 95% CI = [−4.61, 0.4] |
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Nassim, M.; Park, H.; Dikaios, E.; Potes, A.; Elbaz, S.; Mc Veigh, C.; Lipman, M.; Novak, M.; Trinh, E.; Alam, A.; et al. Brief Mindfulness Intervention vs. Health Enhancement Program for Patients Undergoing Dialysis: A Randomized Controlled Trial. Healthcare 2021, 9, 659. https://doi.org/10.3390/healthcare9060659
Nassim M, Park H, Dikaios E, Potes A, Elbaz S, Mc Veigh C, Lipman M, Novak M, Trinh E, Alam A, et al. Brief Mindfulness Intervention vs. Health Enhancement Program for Patients Undergoing Dialysis: A Randomized Controlled Trial. Healthcare. 2021; 9(6):659. https://doi.org/10.3390/healthcare9060659
Chicago/Turabian StyleNassim, Marouane, Haley Park, Elena Dikaios, Angela Potes, Sasha Elbaz, Clare Mc Veigh, Mark Lipman, Marta Novak, Emilie Trinh, Ahsan Alam, and et al. 2021. "Brief Mindfulness Intervention vs. Health Enhancement Program for Patients Undergoing Dialysis: A Randomized Controlled Trial" Healthcare 9, no. 6: 659. https://doi.org/10.3390/healthcare9060659