Randomized Controlled Trial of Cognitive-Behavioral and Mindfulness-Based Stress Reduction on the Quality of Life of Patients With Crohn Disease.
Study Goal
The researchers aimed to determine whether cognitive-behavioral and mindfulness-based stress reduction (COBMINDEX) could improve quality of life and reduce psychological symptoms in adults with mild-moderate Crohn disease.
Results Summary
COBMINDEX significantly improved quality of life, reduced psychological symptoms and fatigue, and increased mindfulness disposition in patients with Crohn disease, with those having severe baseline symptoms benefiting the most. Waitlist controls showed minimal improvements.
Population
Adults with mild-moderate Crohn disease (mean age 33 years, 65% women).
Effective Dosage
Not specified (one-on-one video conferences over 3 months with mandated daily home practice).
Duration
3 months
Interactions
None mentioned
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
cognitive-behavioral and mindfulness-based stress reduction (COBMINDEX) | decrease | disease activity (per Harvey-Bradshaw Index score, C-reactive protein level, and calprotectin level) | adults with mild-moderate Crohn disease | - | significantly reduced | #1 |
cognitive-behavioral and mindfulness-based stress reduction (COBMINDEX) | increase | quality of life (Short Inflammatory Bowel Disease Questionnaire [SIBDQ] score) | adults with mild-moderate Crohn disease | from baseline 41 to 50 | increased | #2 |
cognitive-behavioral and mindfulness-based stress reduction (COBMINDEX) | decrease | psychological symptoms (Global Severity Index [GSI]) | adults with mild-moderate Crohn disease | 0.98-0.70 | decreased | #3 |
cognitive-behavioral and mindfulness-based stress reduction (COBMINDEX) | decrease | fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue) | adults with mild-moderate Crohn disease | 26-33 | reduced | #4 |
cognitive-behavioral and mindfulness-based stress reduction (COBMINDEX) | increase | mindfulness disposition (Freiburg Mindfulness Inventory) | adults with mild-moderate Crohn disease | 33-38 | increased | #5 |
waitlist control | no change | Harvey-Bradshaw Index, SIBDQ, and GSI scores | adults with mild-moderate Crohn disease | - | had a significant but small change | #6 |
waitlist control | no change | fatigue or mindfulness | adults with mild-moderate Crohn disease | - | without improvement | #7 |
cognitive-behavioral and mindfulness-based stress reduction (COBMINDEX) | increase | patients' quality of life | patients with Crohn disease | - | was effective in increasing | #8 |
cognitive-behavioral and mindfulness-based stress reduction (COBMINDEX) | decrease | psychological symptoms and fatigue | patients with Crohn disease | - | reducing | #9 |
BACKGROUND: Patients with Crohn disease have debilitating psychological symptoms, mental fatigue, and poor quality of life. Psychological intervention may improve these symptoms. METHODS: We performed a randomized parallel-group physician-blinded trial of cognitive-behavioral and mindfulness-based stress reduction (COBMINDEX) on quality of life and psychological symptoms in adults with mild-moderate Crohn disease. COBMINDEX was taught by social workers in one-on-one video conferences over 3 months; quotidian home practice was mandated. RESULTS: Fifty-five COBMINDEX and 61 waitlist control patients completed the study; mean age was 33 years and 65% of participants were women. At 3 months, COBMINDEX patients had significantly reduced disease activity (per Harvey-Bradshaw Index score, C-reactive protein level, and calprotectin level), increased quality of life (Short Inflammatory Bowel Disease Questionnaire [SIBDQ] score increased from baseline 41 to 50; P < 0.001), decreased psychological symptoms (Global Severity Index [GSI], 0.98-0.70; P < 0.001), reduced fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue, 26-33; P < 0.001), and increased mindfulness disposition (Freiburg Mindfulness Inventory, 33-38; P < 0.001). Waitlist patients had a significant but small change in Harvey-Bradshaw Index, SIBDQ, and GSI scores, without improvement in fatigue or mindfulness. There were significant correlations (0.02 > P < 0.002) in COBMINDEX patients between baseline SIBDQ, GSI, Freiburg Mindfulness Inventory, and Functional Assessment of Chronic Illness Therapy-Fatigue scores with a relative change (baseline to 3 months) of the SIBDQ score, but none among waitlist patients. Predictors of relative change of the SIBDQ score in COBMINDEX patients included the GSI score (90% quantile; coefficient 0.52; P < 0.001), somatization (90%; 0.20; P = 0.001), depression (75%; 0.16; P = 0.03), and phobic anxiety (75%; 0.31; P = 0.008). CONCLUSIONS: COBMINDEX was effective in increasing patients' quality of life and reducing psychological symptoms and fatigue. Patients with severe baseline psychological symptoms benefited the most from COBMINDEX.