Health TrialsbyHealthPanel

A Smartphone Application for Added Psychological Wellbeing in Crohn's Disease

ConditionCrohn Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSoroka University Medical Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Willingness to participate and signed informed consent

Hebrew-speaking

Age 18-75

Proven diagnosis of Crohn's disease, at least 3 months post-diagnosis

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • COBMINDEX digital application

    Behavioral

    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.

  • Human therapist (Control)

    Behavioral

    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.

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Intervention- COBMINDEX applicationExperimental treatment 1 intervention
Group B: Control- COBMINDEX with Human therapistActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Effectiveness of application as compared to human therapist.

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.

Time frame
12 months

Secondary outcomes

1

Cost-effectiveness

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

Time frame
12 months
2

Effects of intervention on microbiome

alpha + beta diversity

Time frame
12 months
3

Psychological improvment

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.

Time frame
12 months
4

Psychological improvment

Psychological self-report questionnaires SWLS -The 5-item scale 0-7 "satisfaction with life scale" range 0-35 higher is better.

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Soroka University Medical Center

Lead sponsor

The Leona M. and Harry B. Helmsley Charitable Trust

Collaborator

Ben-Gurion University of the Negev

Collaborator

Source ClinicalTrials.gov
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