Randomized Controlled Trial of Cognitive-Behavioral and Mindfulness-Based Stress Reduction on the Quality of Life of Patients With Crohn Disease

Inflamm Bowel Dis. 2021 Apr 13;izab083. doi: 10.1093/ibd/izab083. Online ahead of print.

Ganit Goren 1, Doron Schwartz 2 3, Michael Friger 4, Hagar Banai 5 6, Ruslan Sergienko 3, Shirley Regev 1, Heba Abu-Kaf 2 3, Dan Greenberg 7, Anna Nemirovsky 6, Karny Ilan 8, Livnat Lerner 8, Alon Monsonego 8, Iris Dotan 5 6, Henit Yanai 5 6, Rami Eliakim 6 9, Shomron Ben Horin 6 9, Vered Slonim-Nevo 1, Shmuel Odes 3, Orly Sarid 1


Author information

  • 1Spitzer Department of Social Work, Ben-Gurion University of the Negev, Beer Sheva, Israel.
  • 2Department of Gastroenterology and Hepatology, Soroka Medical Center, Beer Sheva, Israel.
  • 3Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer Sheva, Israel.
  • 4Department of Public Health, Ben-Gurion University of the Negev, Beer Sheva, Israel.
  • 5Division of Gastroenterology, Rabin Medical Center, Petah Tikva, Israel.
  • 6Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
  • 7Department of Health Systems Management, School of Public Health, Guilford Glazer Faculty of Business and Management, Ben-Gurion University of the Negev, Beer Sheva, Israel.
  • 8The Shraga Segal Department of Microbiology and Immunology, Faculty of Health Sciences, The National Institute for Biotechnology in the Negev, Ben-Gurion University of the Negev, Beer-Sheva, Israel.
  • 9Department of Gastroenterology, Sheba Medical Center, Tel Hashomer, Israel.


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.

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