Trial Details

Recruiting
Basic Information
Clinical ID c2111
Identifier ISRCTN61071324
Trial Title Supporting psychosocial and emotional well-being and resilience in family members of people with IBD: RCT feasibility and acceptability study
Trial URL Visit Original Page
Study Information
Study Results

Yes

Conditions Supporting psychosocial and emotional well-being and resilience in family members of people with inflammatory bowel disease (IBD) Digestive System
Interventions The web-based online intervention delivers psychoeducation, a peer forum, and incorporates various interactive components. Following the completion of baseline questionnaires, participants allocated to the intervention group will be granted continuous 24/7 access to the online intervention for a duration of 8 weeks. From the outset, participants will be encouraged to engage with the intervention for a minimum of one hour per week, with flexibility to select the content to their specific needs. Participants will receive support in utilising the intervention, including instructional information integrated within the programme, as well as access to assistance via the online coordinator's email. After the 16-week trial period, the waitlist control group will be granted access to the website. Participants in the control group will have access for 8 weeks after their registration on the website. Randomisation will be performed after participants have provided informed consent and completed and returned the baseline questionnaire. Participants will be randomly allocated to either the online resource (website) or waitlist control arm, using a 2:1 ratio generated in the Statistical Package for Social Sciences (SPSS). The randomisation sequence was generated electronically by an independent statistician with no prior patient contact. The trial coordinator, who will maintain blinding until this stage, will then access the randomisation database to allocate participants into two groups. However, it's important to note that, given the nature of the intervention, neither the participants, the statistician, the research team, nor the website moderator will be able to remain blinded to the treatment allocation after randomisation.
Participant Information
Sponsor King's College London
City -
Country/Region United Kingdom
Enrollment Criteria
Sex Requirement ALL
Age Requirement -
Study Design
Study Type Interventional
Phase Not Available
Time Information
Start Date 2025-04-24
Primary Completion Date -
Completion Date 2024-11-30