Can we use an online intervention supporting psychosocial and emotional well-being in family members of individuals with inflammatory bowel disease (IBD)?

Supporting psychosocial and emotional well-being and resilience in family members of people with IBD: RCT feasibility and acceptability study

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN61071324

Enrollment

Registered

2024-01-19

Start date

2024-03-15

Completion date

Unknown

Last updated

2024-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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 t

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Living with or have lived with an individual with IBD including parents, partner or spouse, child and siblings 2. Aged 16 years old or above 3. No IBD themselves 4. Able to write and speak in English so that you can understand the study information and the website. 5. Only one participant per family unit

Exclusion criteria

Exclusion criteria: 1. Friend or colleague of the patient diagnosed with IBD 2. Aged below 16 years old 3. Never co-habited 4. Insufficient ability with written and spoken English to understand the study information and procedures

Design outcomes

Primary

Measure	Time frame
In this feasibility study, we will gauge the outcome by measures as outlined below: 1. Recruitment: Recruitment will be quantitatively evaluated by tracking the following participant counts: 1.1. Those expressing interest in taking part and sent Participant Information Sheet (PIS) 1.2. Participants asking further questions 1.3. Participants who have provided their consent 1.4. Participants who have been randomised into the study 1.5. Additionally, we will provide a description, including sex, age, the relationship with the person with IBD, and the types of IBD, of the individuals who were excluded to assist in identifying possible future eligibility criteria. We will also actively seek reasons for non-participation to gain insights into this aspect of the study. However, participants do not have to provide a reason for withdrawing if they do not wish to. 2. Retention: We will assess retention by analysing the withdrawal rates during the intervention and by evaluating the rates of participants who furnish both baseline and follow-up data. Additionally, we will inquire about the reasons behind participants declining to continue with the intervention or with the research. However, participants do not have to provide a reason for withdrawing if they do not wish to. 3. The feasibility of using potential clinical outcomes: We will quantitatively evaluate this outcome by: 3.1. Examining the completion rates for data collection forms involves assessing both the return of outcomes and identifying missing individual items. 3.2. Assessing the appropriateness and diversity of the data to serve as outcome measures for clinical effectiveness. 4. Acceptance, adherence to and fidelity of the intervention will be assessed by: 4.1. Analysing feedback, reflections, and insights shared by participants through exit interviews. 4.2. Evaluate the competence in organising and moderating the website. 4.3. Analysing usage patterns (number and length of log-ins) 5. To inform the p	—

Measure

Time frame

In this feasibility study, we will gauge the outcome by measures as outlined below: 1. Recruitment: Recruitment will be quantitatively evaluated by tracking the following participant counts: 1.1. Those expressing interest in taking part and sent Participant Information Sheet (PIS) 1.2. Participants asking further questions 1.3. Participants who have provided their consent 1.4. Participants who have been randomised into the study 1.5. Additionally, we will provide a description, including sex, age, the relationship with the person with IBD, and the types of IBD, of the individuals who were excluded to assist in identifying possible future eligibility criteria. We will also actively seek reasons for non-participation to gain insights into this aspect of the study. However, participants do not have to provide a reason for withdrawing if they do not wish to. 2. Retention: We will assess retention by analysing the withdrawal rates during the intervention and by evaluating the rates of participants who furnish both baseline and follow-up data. Additionally, we will inquire about the reasons behind participants declining to continue with the intervention or with the research. However, participants do not have to provide a reason for withdrawing if they do not wish to. 3. The feasibility of using potential clinical outcomes: We will quantitatively evaluate this outcome by: 3.1. Examining the completion rates for data collection forms involves assessing both the return of outcomes and identifying missing individual items. 3.2. Assessing the appropriateness and diversity of the data to serve as outcome measures for clinical effectiveness. 4. Acceptance, adherence to and fidelity of the intervention will be assessed by: 4.1. Analysing feedback, reflections, and insights shared by participants through exit interviews. 4.2. Evaluate the competence in organising and moderating the website. 4.3. Analysing usage patterns (number and length of log-ins) 5. To inform the p

—

Secondary

Measure	Time frame
There are no secondary outcome measures	—

Countries

England, Northern Ireland, Scotland, United Kingdom, Wales

Contacts

Public ContactParichat Thapwong

K1815045@kcl.ac.uk+44 7710023181

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026