Dataset Information

Intensive Mindfulness Meditation Reduces Frequency and Burden of Migraine: An Unblinded Single-Arm Trial.

ABSTRACT:

Objectives

Preventing migraine headaches and improving the quality of life for patients with migraine remains a challenge. We hypothesized intensive meditation training would reduce the disease burden of migraine.

Method

An unblinded trial was analyzed as a single cohort exposed to a silent 10-day Vipassana meditation retreat that included 100 hr of sitting meditation. Participants with chronic or episodic migraine were enrolled and followed for 1 year. The primary outcome was a change in mean monthly migraine days at 12 months from baseline. Secondary outcomes included headache frequency and intensity, acute medication use, work days missed, home meditation, sleep quality, general health, quality of life, migraine impact, positive and negative affect, perceived stress, mindfulness, and pain catastrophizing.

Results

Three hundred people were screened and 58 (19%) agreed to participate and enrolled in the intensive meditation training. Forty-six participants with chronic migraine (≥ 15 headaches/month of which ≥ 8 were migraines) and 12 with episodic migraine (< 15 and ≥ 4 migraines/month) attended and 45 (78%) completed the retreat. At 12 months, the average migraine frequency was reduced by 2.7 days (from 16.6 at baseline) per 28 days (95%CI - 4.3, - 1.3) and headaches by 3.4 (20.1 at baseline) per 28 days (- 4.9, - 1.9). Fifty percent responder rate was 29% for migraine. Acute medication use dropped by an average of 2.2 days (- 3.9, - 0.5) per 28 days, and participants reported 2.3 fewer days (- 4.0, - 0.5) on which they reduced their activity due to migraines. The most striking and promising effects were in several secondary outcomes, including migraine-specific quality of life, pain catastrophizing, and perceived stress. The significant improvements observed immediately following the intervention were sustained at 12 months follow-up.

Conclusions

Training in Vipassana meditation via a 10-day retreat may reduce the frequency and burden of migraine.

Preregistration

ClinicalTrials.gov: NCT00663585.

SUBMITTER: Goyal M

PROVIDER: S-EPMC10810247 | biostudies-literature | 2023 Feb

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Intensive Mindfulness Meditation Reduces Frequency and Burden of Migraine: An Unblinded Single-Arm Trial.

Goyal Madhav M Haythornthwaite Jennifer A JA Jain Sharat S Peterlin Barbara Lee BL Mehrotra Megha M Levine David D Rosenberg Jason D JD Minges Mary M Seminowicz David A DA Ford Daniel E DE

Mindfulness 20230124 2

<h4>Objectives</h4>Preventing migraine headaches and improving the quality of life for patients with migraine remains a challenge. We hypothesized intensive meditation training would reduce the disease burden of migraine.<h4>Method</h4>An unblinded trial was analyzed as a single cohort exposed to a silent 10-day Vipassana meditation retreat that included 100 hr of sitting meditation. Participants with chronic or episodic migraine were enrolled and followed for 1 year. The primary outcome was a c ...[more]

PMID: 38282695

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Project description:A metastatic cancer diagnosis is associated with high levels of distress in patients and caregivers. Mindfulness interventions can reduce distress and improve quality of life in cancer patients. However, standard mindfulness training relies on in-person instruction, which is often not practical for either patients receiving chemotherapy or their caregivers. In the Being Present single arm pilot study, we designed and tested an 8-week audio-based mindfulness meditation program for patients with metastatic colorectal cancer receiving chemotherapy with or without a participating caregiver. The study accrued 33 of 74 (45%) eligible patients consenting together with 20 family caregivers (53 participants total) within nine months. Forty-one participants were evaluable (77%); 10 of 12 cases of attrition were attributable to hospitalization or death. Median participant age was 51 (range 21-78 years); 38% were men. Baseline levels of distress were similar in patients and caregivers. The top reasons for participation cited in pre-intervention interviews were to increase relaxation/calm, improve mood/emotions, and reduce stress/anxiety. In measures of adherence, 59% of responses to weekly texts asking: "Have you practiced today?" were "Yes" and 59% of interviewees reported practicing >50% of the time. Compared to baseline, post-intervention surveys demonstrated significantly reduced distress (p = 0.01) and anxiety (p = 0.03); as well as increased non-reactivity (p<0.01), and feeling at peace (p<0.01). Post-intervention qualitative interviews, where 71% of participants reported benefit, were consistent with quantitative findings. In the interviews, participants spontaneously described reduced stress/anxiety and increased relaxation/calm. Benefits appeared to be accentuated in patient-caregiver pairs as compared to unpaired patients. Seventy-nine percent of participants reported plans for continued practice after study completion. We conclude that the Being Present audio-based mindfulness meditation program is of interest to, feasible, and acceptable for patients with metastatic colorectal cancer and caregivers, with initial evidence of efficacy. These results will guide plans for a follow-up study.Trial registrationClinicalTrials.gov NCT02423720.

Project description:ImportanceMigraine is the second leading cause of disability worldwide. Most patients with migraine discontinue medications due to inefficacy or adverse effects. Mindfulness-based stress reduction (MBSR) may provide benefit.ObjectiveTo determine if MBSR improves migraine outcomes and affective/cognitive processes compared with headache education.Design, setting, and participantsThis randomized clinical trial of MBSR vs headache education included 89 adults who experienced between 4 and 20 migraine days per month. There was blinding of participants (to active vs comparator group assignments) and principal investigators/data analysts (to group assignment).InterventionsParticipants underwent MBSR (standardized training in mindfulness/yoga) or headache education (migraine information) delivered in groups that met for 2 hours each week for 8 weeks.Main outcomes and measuresThe primary outcome was change in migraine day frequency (baseline to 12 weeks). Secondary outcomes were changes in disability, quality of life, self-efficacy, pain catastrophizing, depression scores, and experimentally induced pain intensity and unpleasantness (baseline to 12, 24, and 36 weeks).ResultsMost participants were female (n = 82, 92%), with a mean (SD) age of 43.9 (13.0) years, and had a mean (SD) of 7.3 (2.7) migraine days per month and high disability (Headache Impact Test-6: 63.5 [5.7]), attended class (median attendance, 7 of 8 classes), and followed up through 36 weeks (33 of 45 [73%] of the MBSR group and 32 of 44 [73%] of the headache education group). Participants in both groups had fewer migraine days at 12 weeks (MBSR: -1.6 migraine days per month; 95% CI, -0.7 to -2.5; headache education: -2.0 migraine days per month; 95% CI, -1.1 to -2.9), without group differences (P = .50). Compared with those who participated in headache education, those who participated in MBSR had improvements from baseline at all follow-up time points (reported in terms of point estimates of effect differences between groups) on measures of disability (5.92; 95% CI, 2.8-9.0; P < .001), quality of life (5.1; 95% CI, 1.2-8.9; P = .01), self-efficacy (8.2; 95% CI, 0.3-16.1; P = .04), pain catastrophizing (5.8; 95% CI, 2.9-8.8; P < .001), depression scores (1.6; 95% CI, 0.4-2.7; P = .008), and decreased experimentally induced pain intensity and unpleasantness (MBSR group: 36.3% [95% CI, 12.3% to 60.3%] decrease in intensity and 30.4% [95% CI, 9.9% to 49.4%] decrease in unpleasantness; headache education group: 13.5% [95% CI, -9.9% to 36.8%] increase in intensity and an 11.2% [95% CI, -8.9% to 31.2%] increase in unpleasantness; P = .004 for intensity and .005 for unpleasantness, at 36 weeks). One reported adverse event was deemed unrelated to study protocol.Conclusions and relevanceMindfulness-based stress reduction did not improve migraine frequency more than headache education, as both groups had similar decreases; however, MBSR improved disability, quality of life, self-efficacy, pain catastrophizing, and depression out to 36 weeks, with decreased experimentally induced pain suggesting a potential shift in pain appraisal. In conclusion, MBSR may help treat total migraine burden, but a larger, more definitive study is needed to further investigate these results.Trial registrationClinicalTrials.gov Identifier: NCT02695498.

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Dataset Information

Intensive Mindfulness Meditation Reduces Frequency and Burden of Migraine: An Unblinded Single-Arm Trial.

Objectives

Method

Results

Conclusions

Preregistration

Publications

Intensive Mindfulness Meditation Reduces Frequency and Burden of Migraine: An Unblinded Single-Arm Trial.

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