Exploring Multiple Self-Help Interventions to Promote Self-Efficacy and Overcome Disability (EMPOWER-IBD)
Status
Completed
Conditions
Ulcerative Colitis (UC)
Crohn Disease (CD)
Treatments
Behavioral: CBT
Behavioral: APP
Behavioral: PEER
Behavioral: HELP
Details and patient eligibility
About
EMPOWER-IBD aims to identify behavioral interventions to strengthen patients' self-efficacy for self-management as a mechanism to reduce IBD-related disability. This multisite, randomized controlled trial with 16 arms will randomize adults with moderate-to-severe IBD-related disability to a combination of four multimodal behavioral interventions to test their clinical effectiveness in reducing IBD-related disability and improving self-efficacy. The interventions are four existing, publicly available disease-specific self-help resources offered at no cost to the participants: a book, smart app, help center, and peer mentor. Participants will complete online surveys and may engage in virtual focus groups. Participants may receive an honorarium (e-gift card) and/or be entered into a lottery for a giftcards post-survey completion and focus group participation.
Enrollment
803 patients
Sex
All
Ages
18+ years old
Volunteers
No Healthy Volunteers
Inclusion criteria
- Adults (age ≥ 18 years) with IBD and moderate-to-severe IBD-related (IBD) Disability Index score > 35 26,27)
- Able to consent, complete surveys, and participate in focus groups in English.
Exclusion criteria
- No/low disability (IBD-DI < 35) on the baseline survey
- Inability or unwillingness to participate in the interventions
- Inability to download apps from the Apple AppStore or Google Play store (necessary to engage with the smartapp intervention)
- Limited English proficiency (necessary because some interventions are currently only offered in English)
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Factorial Assignment
Masking
None (Open label)
803 participants in 16 patient groups
Arm 1
No Intervention group
Description:
No resource provision
Arm 2
Experimental group
Description:
Power of Two (PEER) is a one-on-one peer mentoring program operated by the Crohn's \& Colitis Foundation
Treatment:
Behavioral: PEER
Arm 3
Experimental group
Description:
IBD Help Center (HELP) is a resource operated by the Crohn's and Colitis Foundation (CCF) for individuals to connect with an information specialist via email, call, or online live chat at no cost
Treatment:
Behavioral: HELP
Arm 4
Experimental group
Description:
IBD Help Center (HELP) is a resource operated by the Crohn's and Colitis Foundation (CCF) for individuals to connect with an information specialist via email, call, or online live chat at no cost Power of Two (PEER) is a one-on-one peer mentoring program operated by the Crohn's \& Colitis Foundation
Treatment:
Behavioral: PEER
Behavioral: HELP
Arm 5
Experimental group
Description:
"Coping with Crohn's and Colitis: A Patient and Clinician's Guide to CBT for IBD" (CBT) is an IBD-specific cognitive behavioral therapy (CBT) workbook (e-book or hardcopy)
Treatment:
Behavioral: CBT
Arm 6
Experimental group
Description:
"Coping with Crohn's and Colitis: A Patient and Clinician's Guide to CBT for IBD" (CBT) is an IBD-specific cognitive behavioral therapy (CBT) workbook (e-book or hardcopy)
Power of Two (PEER) is a one-on-one peer mentoring program operated by the Crohn's \& Colitis Foundation
Treatment:
Behavioral: PEER
Behavioral: CBT
Arm 7
Experimental group
Description:
"Coping with Crohn's and Colitis: A Patient and Clinician's Guide to CBT for IBD" (CBT) is an IBD-specific cognitive behavioral therapy (CBT) workbook (e-book or hardcopy) IBD Help Center (HELP) is a resource operated by the Crohn's and Colitis Foundation (CCF) for individuals to connect with an information specialist via email, call, or online live chat at no cost
Treatment:
Behavioral: HELP
Behavioral: CBT
Arm 8
Experimental group
Description:
"Coping with Crohn's and Colitis: A Patient and Clinician's Guide to CBT for IBD" (CBT) is an IBD-specific cognitive behavioral therapy (CBT) workbook (e-book or hardcopy) IBD Help Center (HELP) is a resource operated by the Crohn's and Colitis Foundation (CCF) for individuals to connect with an information specialist via email, call, or online live chat at no cost Power of Two (PEER) is a one-on-one peer mentoring program operated by the Crohn's \& Colitis Foundation
Treatment:
Behavioral: PEER
Behavioral: HELP
Behavioral: CBT
Arm 9
Experimental group
Description:
1\) My IBD Care (APP) is a free smartapp that supports patients' tracking of symptoms, medical appointments, and medications; self-paced behavioral change programs
Treatment:
Behavioral: APP
Arm 10
Experimental group
Description:
My IBD Care (APP) is a free smartapp that supports patients' tracking of symptoms, medical appointments, and medications; self-paced behavioral change programs
Power of Two (PEER) is a one-on-one peer mentoring program operated by the Crohn's \& Colitis Foundation
Treatment:
Behavioral: PEER
Behavioral: APP
Arm 11
Experimental group
Description:
My IBD Care (APP) is a free smartapp that supports patients' tracking of symptoms, medical appointments, and medications; self-paced behavioral change programs
IBD Help Center (HELP) is a resource operated by the Crohn's and Colitis Foundation (CCF) for individuals to connect with an information specialist via email, call, or online live chat at no cost
Treatment:
Behavioral: HELP
Behavioral: APP
Arm 12
Experimental group
Description:
My IBD Care (APP) is a free smartapp that supports patients' tracking of symptoms, medical appointments, and medications; self-paced behavioral change programs
IBD Help Center (HELP) is a resource operated by the Crohn's and Colitis Foundation (CCF) for individuals to connect with an information specialist via email, call, or online live chat at no cost
Power of Two (PEER) is a one-on-one peer mentoring program operated by the Crohn's \& Colitis Foundation
Treatment:
Behavioral: PEER
Behavioral: HELP
Behavioral: APP
Arm 13
Experimental group
Description:
My IBD Care (APP) is a free smartapp that supports patients' tracking of symptoms, medical appointments, and medications; self-paced behavioral change programs
"Coping with Crohn's and Colitis: A Patient and Clinician's Guide to CBT for IBD" (CBT) is an IBD-specific cognitive behavioral therapy (CBT) workbook (e-book or hardcopy)
Treatment:
Behavioral: APP
Behavioral: CBT
Arm 14
Experimental group
Description:
My IBD Care (APP) is a free smartapp that supports patients' tracking of symptoms, medical appointments, and medications; self-paced behavioral change programs
"Coping with Crohn's and Colitis: A Patient and Clinician's Guide to CBT for IBD" (CBT) is an IBD-specific cognitive behavioral therapy (CBT) workbook (e-book or hardcopy)
Power of Two (PEER) is a one-on-one peer mentoring program operated by the Crohn's \& Colitis Foundation
Treatment:
Behavioral: PEER
Behavioral: APP
Behavioral: CBT
Arm 15
Experimental group
Description:
My IBD Care (APP) is a free smartapp that supports patients' tracking of symptoms, medical appointments, and medications; self-paced behavioral change programs
"Coping with Crohn's and Colitis: A Patient and Clinician's Guide to CBT for IBD" (CBT) is an IBD-specific cognitive behavioral therapy (CBT) workbook (e-book or hardcopy)
IBD Help Center (HELP) is a resource operated by the Crohn's and Colitis Foundation (CCF) for individuals to connect with an information specialist via email, call, or online live chat at no cost
Treatment:
Behavioral: HELP
Behavioral: APP
Behavioral: CBT
Arm 16
Experimental group
Description:
1. My IBD Care (APP) is a free smartapp that supports patients' tracking of symptoms, medical appointments, and medications; self-paced behavioral change programs
2. "Coping with Crohn's and Colitis: A Patient and Clinician's Guide to CBT for IBD" (CBT) is an IBD-specific cognitive behavioral therapy (CBT) workbook (e-book or hardcopy)
3. IBD Help Center (HELP) is a resource operated by the Crohn's and Colitis Foundation (CCF) for individuals to connect with an information specialist via email, call, or online live chat at no cost
4. Power of Two (PEER) is a one-on-one peer mentoring program operated by the Crohn's \& Colitis Foundation
Treatment:
Behavioral: PEER
Behavioral: HELP
Behavioral: APP
Behavioral: CBT
Trial contacts and locations
1
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