Crohn Disease
Conditions
Keywords
Crohn's Disease, Health related quality of life, Cognitive behavioral therapy, Mindfulness, Immune regulation, Healthcare cost
Brief summary
Psychological intervention by COBMINDEX application to reduce psychological stress among CD patients, fatigue and pain and improve the patients' well being, quality-of-life and disease-coping skills, as well as improvement of the patients' immunological profile and intestinal microbiome.
Detailed description
200 patients will be randomly divided into two groups - 100 patients will learn and practice COBMINDEX by a human therapist-social worker and 100 patients will learn and practice COBMINDEX by a digital therapist using the COBMINDEX application. In the first 3-months there will be an assessment of patient progress following randomization to human therapist or digital therapist using the application for learning and practicing. During this period, the group of the human social-worker will have a limited access to the application dedicated for daily exercises and assessment. In the following 9-month period, all patients will practice using the application, each group by it's permissions. There will be daily assessment of stress, pain, fatigue, well-being and frequent assessments of patients' medical, psychological, and immunological status. Throughout the trial, adverse events and concomitant medications will be collected.
Interventions
BEHAVIORALCOBMINDEX digital application
COBMINDEX is a Cognitive, behavioral and mindfulness-based stress reduction with daily self-exercise. The intervention comprises of 7 sessions in which stress reduction techniques are learned. In this arm the Patient learns techniques and practices using digital application.
BEHAVIORALHuman therapist (Control)
COBMINDEX is a Cognitive, behavioral and mindfulness-based stress reduction with daily self-exercise. The intervention comprises of 7 sessions in which stress reduction techniques are learned. In this arm the Patient learns techniques from a human therapist (the comperator for learning from the application) and practices using digital application.
Sponsors
Soroka University Medical Center
The Leona M. and Harry B. Helmsley Charitable Trust
Ben-Gurion University of the Negev
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
200 CD patients divided into two equal groups: Intervention and control.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Willingness to participate and signed informed consent * Hebrew-speaking * Age 18-75 * Proven diagnosis of Crohn's disease, at least 3 months post-diagnosis * Stable medical treatment for the last 3 months * Any Harvey Bradshaw Index score * Ability to operate a smartphone and cellular application
Exclusion criteria
* Diagnosis of ulcerative colitis or unclassified inflammatory bowel disease * Planned surgery for Crohn's disease * Surgery for Crohn's disease (excluding drainage of perianal abscess) in the last 3 months * Psychiatric disease (schizophrenia, major depression or bipolar disorder) * Alcohol or drug dependency (stable medical use of cannabinoids will be allowed) * Pregnancy or planned pregnancy during study period * Clinically significant comorbidity * Former participation in COBMINDEX trials
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness of application as compared to human therapist. | 12 months | Develop a smartphone application that will teach the patient COBMINDEX and to determine whether the application will be as effective as the psychological intervention delivered by the therapists. the primary end point is SIBDQ disease specific HRQOL. 10 questions each scale 1-7 with range 7-70. higher is better. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cost-effectiveness | 12 months | To determine the cost-effectiveness of the intervention as provided by application versus therapists by prospective monitoring of direct and indirect healthcare costs. A cost-effectiveness analysis to assess the value for money of the application versus therapist interventions will be performed using primary data collected from patients in the study. These data include information of utilization of healthcare services reported by patients. The cost of each service will be based on the Israel Ministry of Health List Price for health services. We will calculate indirect costs of lost productivity based on patient responses to the WPAI questionnaire. For each patient we will calculate the quality-adjusted life-year (QALY) based on responses to the SF-12 questionnaires |
| Effects of intervention on microbiome | 12 months | alpha + beta diversity |
| Psychological improvment | 12 months | Psychological self-report questionnaires WPAI- Work Productivity and Activity Impairment. four types of scores: 1. Absenteeism 2. Presenteesism 3. Work productivty loss 4. Activity Impairment all presented in presentage 0-100. higher is worse. |
| disease severity measurement | 12 months | C Reactive Protein mg/dl 0- 100 normal range 0-0.5 higher means more inflammation. |
Countries
Israel
Contacts
CONTACTDoron Schwartz, MD
CONTACTShmuel Odes, MD
STUDY_DIRECTORRuthie Bekore, MPH
Soroka University Medical Center
STUDY_DIRECTORGanit Goren, PhD
Ben-Gurion University of the Negev
Outcome results
None listed