A RANDOMIZED CONTROLLED TRIAL OF THE EFFECTIVENESS OF INDIVIDUALIZED COGNITIVE BEHAVIORAL MINDFULNESS INTERVENTION ON DISEASE SYMPTOMS AND PSYCHO-SOCIAL OUTCOMES IN PATIENTS WITH CROHN'S DISEASE

Shirley Reggev, Ganit Goren, Doron Schwartz, Ruslan Sergienko, Michael Friger, Dan Greenberg, Anna Nemirovsky, Ekaterina Vinogradov, Alon Monsonego, Vered Slonim-Nevo, Orly Sarid, Selwyn H. Odes

Research output: Contribution to journalMeeting Abstractpeer-review

Abstract

INTRODUCTION: Individuals living with Crohn's disease are known to experience high levels of psychological distress. Moreover, there is evidence that elevated stress may contribute to increased risk of inflammation in Crohn's disease. We sought to determine whether individualized cognitive behavioral mindfulness intervention (CBMI) would have a beneficial effect on disease activity and psychological wellbeing in patients with Crohn's disease.
METHODS: In a prospective randomized controlled trial, patients with diagnosed Crohn's disease were allocated in a 1:1 ratio to either a CBMI treatment group or a wait-list control group. Patients in the CBMI group received eight sessions of CBMI tailored to individuals with Crohn's disease over 12 consecutive weeks; these sessions were delivered by trained social workers using SKYPETM. Outcome measures included the Harvey-Bradshaw Index (HBI) of disease activity, the Short Inflammatory Bowel Disease Questionnaire (SIBDQ) for disease-related quality-of-life, and the Brief Symptom Inventory (BSI) for somatization (somatic distress). The Freiburg Mindfulness Inventory (FMI) was used as a manipulation
check for mindfulness. Analyses of covariance were employed to test for differences in posttreatment outcomes between CBMI and control groups, after controlling for baseline level by including pre-treatment values as a covariate. RESULTS: One-hundred patients with mildly or moderately active disease (4<HBI<16) were enrolled, of which 86 patients completed the 12-week follow-up (40 CBMI arm, 46 control arm). Of the CBMI and control patients, 70% and 61% were female, their mean age ± SD was 33.8 ± 12.3) and 32.3 ± 10.7 years, and their mean disease duration was 8.4 ± 8.5 and 8.7 ± 8.4 years, respectively. All demographics and baseline characteristics were similar in both groups (Table 1). At 12 weeks, disease activity scores were significantly lower in the CBMI group (4.2 ± 2.7) compared to the control group (6.5 ± 3.5; F(1,83) = 12.51, p = .001, partial effect size = .13). The CBMI group also exhibited reduced levels of post-intervention somatization (0.9 ± 0.6), differing significantly from the control group (1.3 ± 0.8; F(1,83) = 5.53, p = .021, partial effect size =
.06). Moreover, after treatment, the CBMI group had significantly higher scores than the control group on measures of disease-related quality of life (47.7 ± 8.8 vs. 43.2 ± 10.3; F(1,83) = 4.69, p = .033, partial effect size = .05), and mindfulness (39.7 ± 7.3 vs. 33.1 ± 7.8; F(1,83) = 20.05, p < .001, partial effect size = .19) CONCLUSION: These data support the efficacy of CBMI intervention as a complementary treatment for disease symptomology, somatization and impaired quality-of-life associated with active Crohn’s disease.
Original languageEnglish GB
Pages (from-to)S424-S425
JournalGastroenterology
Volume158
Issue number6
DOIs
StatePublished - May 2020

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