Mindfulness Intervention Decreases Frequency and Severity of Flares in Inactive Ulcerative Colitis Patients: Results of a Phase II, Randomized, Placebo-Controlled Trial.
Study Goal
The researchers aimed to determine whether an 8-week mindfulness intervention (MI) could improve disease course, inflammatory markers, mindfulness, perceived stress, and psychological outcomes in inactive ulcerative colitis (UC) patients with limited or no prior exposure to MI.
Results Summary
The MI significantly increased mindfulness and mindfulness skills, reduced perceived stress and stress response, and decreased the incidence of UC flares over 12 months (0% in MI group vs. 22% in controls).
Population
Inactive ulcerative colitis patients with high perceived stress and low mindfulness.
Effective Dosage
Not specified
Duration
8 weeks
Interactions
None mentioned
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
mindfulness intervention | increase | state of mindfulness | patients with inactive UC | - | increased | #1 |
mindfulness intervention | increase | mindfulness skills | patients with inactive UC | - | increased | #2 |
mindfulness intervention | decrease | perceived stress | patients with inactive UC | - | decreased | #3 |
mindfulness intervention | decrease | stress response | patients with inactive UC | - | decreased | #4 |
mindfulness intervention | decrease | incidence of flare | inactive ulcerative colitis patients | - | significantly decreased | #5 |
mindfulness intervention | no change | flare incidence | UC patients in the MI | 0% | flared | #6 |
- | increase | flare incidence | control group participants | 22% | flared | #7 |
BACKGROUND: Ulcerative Colitis (UC) is a chronic, inflammatory disease, characterized by symptomatic periods (flare) interspersed with asymptomatic periods (remission). Evidence suggests that psychological stress can trigger flare. Studies have shown that mindfulness interventions (MI) reduce stress, foster more adaptive coping, and improve quality of life, but have been minimally used for UC patients. The objective of this study was to determine whether participation in an MI results in improvements in UC disease course and inflammatory cascades, mindfulness, perceived stress, and other psychological outcomes in inactive UC patients with limited or no exposure to past MI. METHODS: Participants were randomized to an 8-week MI or control group. Biological and psychological assessments were performed at baseline, post 8-week course, and at 6- and 12-months. RESULTS: Forty-three participants enrolled. The MI increased the state of mindfulness and mindfulness skills, decreased perceived stress and stress response in patients with inactive UC. The MI intervention significantly decreased the incidence of flare over 12 months (P < .05). None of the UC patients in the MI flared during 12 months, while 5 of 23 (22%) control group participants flared during the same period. CONCLUSIONS: MIs could be considered as adjuvant treatment for a subset of UC patients with high perceived stress and low state of mindfulness.The trial was registered at clinicaltrials.gov as NCT01491997. Inactive ulcerative colitis patients were randomized to a mindfulness intervention or control group. Biological and psychological assessments were performed over 12 months. The intervention significantly decreased the incidence of flares, increased the state of mindfulness and mindfulness skills, and decreased perceived stress and the stress response.