A Novel Digital Self-management Intervention for Symptoms of Fatigue, Pain, and Urgency in Inflammatory Bowel Disease, 2022, Moss-Morris et al

[Sly Saint]

A Novel Digital Self-management Intervention for Symptoms of Fatigue, Pain, and Urgency in Inflammatory Bowel Disease: Describing the Process of Development

Abstract
Background: Empirical studies and systematic reviews have demonstrated the role of biological, cognitive, behavioral, and emotional factors in fatigue, pain, and urgency in inflammatory bowel disease (IBD). Behavioral management that addresses the cognitive, behavioral, and emotional factors offered alongside medical treatment is seldom available to people with IBD. Digital interventions provide a potentially scalable and cost-effective way of providing behavioral support to patients.

Objective: This paper aimed to describe the process of developing a supported digital self-management intervention for fatigue, pain, and urgency in IBD using theory and evidence-based approaches and stakeholder input.

Methods: The Medical Research Council framework for complex health interventions and a person-based approach were used to guide intervention development, consulting with 87 patients with IBD and 60 nurses. These frameworks informed the selection and use of a theoretical model that subsequently guided cognitive behaviorally based intervention content. They also guided the design of tailored digital intervention pathways for individuals with IBD that matched the predominant symptoms.

Results: A transsymptomatic cognitive behavioral framework of symptom perpetuation was developed for the symptoms of fatigue, pain, and urgency in IBD. A logic model was used to define the intervention techniques. Patient feedback and qualitative interviews refined the website content and functionalities, including the use of visual aids, email reminders, and graphical tracking of symptoms. Nurse focus groups informed the volume and delivery model of the therapist facilitator support. Ratings of acceptability out of 10 following feasibility testing (31/87, 36%) demonstrated accessibility (scoring 9.43, SD 1.040), ease (scoring 8.07, SD 3.205), clarity, and the relevant tone of the intervention. The final intervention comprised 12 web-based sessions (8 core and 4 symptom-specific), with one 30-minute facilitator phone call following session 1 and subsequent on-site messaging.

Conclusions: The use of theory and integration of stakeholders’ views throughout informed the development of an evidence-based digital intervention for fatigue, pain, and urgency in IBD. This is the first web-based self-management intervention designed to address these multiple symptoms with the aim of improving the quality of life and reducing the symptom burden of IBD. The intervention is being tested in a large multicenter randomized controlled trial.

Trial Registration: ISRCTN Registry ISRCTN71618461; https://www.isrctn.com/ISRCTN71618461

https://formative.jmir.org/2022/5/e33001

 

[Milo]

Novel? what did I miss?

A transsymptomatic cognitive behavioral framework of symptom perpetuation was developed for the symptoms of fatigue, pain, and urgency in IBD.

Ah, right. If you got urgency, run to the washroom.

A logic model was used to define the intervention techniques.

If your pants are brown, wash them. If your pants are clean, return to your normal activities.

(I hope no one is offended by my potty humor. It is meant to explain how logic researchers are. We do not need a decision tree on how to behave with IBD)
Head-desk head-desk.

 

[Snowdrop]

One could call their logic assinine.

 

[rvallee]

"Novel". "Theory".

The "theory", somehow "novel", is the exact same as usual:

A cognitive behavioral model of symptom perpetuation was identified as a framework from which to understand and create changes across fatigue, pain, and urgency. The cognitive behavioral model postulates that the way individuals think about and perceive their experiences (symptoms) affects how they feel and consequently respond to them [47]. Interventions that target unhelpful thoughts about symptoms and unhelpful behavioral responses have the potential to improve distress arising from symptoms and improve the symptoms themselves [48]. Although physiological triggers may differ, similar affective, cognitive, and behavioral responses to symptoms appear to exacerbate and maintain symptoms across long-term conditions [49]. A number of systematic reviews have identified specific cognitive, behavioral, and emotional factors associated with fatigue, pain, and urgency, along with other psychological factors [7,15,16,50,51]. Anxiety and depression were found to be associated with each symptom independent of disease activity.

Common cognitive factors associated with fatigue, pain, and urgency include negative perceptions of symptoms and catastrophizing [52-54]. Behavioral factors shared across the 3 symptoms included avoidance of activity, generally because of anxiety about outcomes specific to the symptoms [53,55-57]. Boom-bust patterns of behavior, which are common in other long-term conditions, including IBS [58,59], were also identified in studies exploring IBD pain and fatigue [52,53,55,56,60]. In IBD, pain, acceptance, pain self-efficacy, and mental well-being are associated with lower pain severity and pain-related disability [53,56]. A range of safety-seeking and avoidance behaviors designed to avert the possibility of incontinence was identified as often having a significant cognitive and affective burden [8,16,61,62].

Their "theory", the same as usual, has the "potential" to do something. How compelling. Einstein had nothing on those geniuses.

The joke is that this is an actual field of medicine that has immense power over a captive audience deprived of rights and protections against quackery. It's outrageous that this mediocrity is actually funded with public resources.

And by their own description of their "theory", they are basing it on the usual biased pragmatic trials. So not even a theory, it's the same nonsense they pushed in pragmatic trials, then pretend it's a theory because oh who even gives a crap?

But basically this is ACTIB, as far as I can tell, as a model. So it's about sales. They are selling this crap and making money because charlatanism is now normal and good in medicine.

 

[Sly Saint]

Trial Registration: ISRCTN Registry ISRCTN71618461; https://www.isrctn.com/ISRCTN71618461

A supported online self-management for symptoms of fatigue, pain and urgency/incontinence in people with inflammatory bowel disease: the IBD-BOOST trial

Condition category
Digestive System
Date applied
02/09/2019
Date assigned
09/09/2019
Last edited
04/05/2022
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting
Plain English Summary
Background and study aims
Inflammatory Bowel Disease (IBD) affects 300,000 people in the UK , causing unpredictable bouts of gut inflammation, with acute illness, diarrhoea, and pain. In remission, many people with IBD live with fatigue, chronic abdominal pain, and bowel urgency/incontinence. There is no current cure for IBD, which usually starts in childhood or as a young adult. Most previous IBD research has focused on controlling inflammation. However, many people report continuing IBD-related fatigue (41%), abdominal pain (62%) and difficulty with continence (up to 75%) even when IBD is in remission. These symptoms limit peoples’ quality of life and ability to work and socialise. Patients feel that these symptoms are not taken seriously by health professionals and report that little help is given. However, the James Lind Alliance IBD research priority-setting consensus put fatigue, pain, and continence in the top 10 issues that IBD patients and clinicians want to be addressed by research.

The current application is stage four of IBD-BOOST, a National Institute of Health Research (NIHR) Programme Grant for Applied Research (PGfAR) funded programme. The overall aim of the Programme Grant is to improve the quality of life of people with IBD by reducing the burden of IBD-related fatigue, abdominal pain, and urgency/incontinence. The current application is for the final part of the project, a 2-arm randomised controlled trial (RCT) of a facilitator supported online intervention for people who have expressed a desire for intervention for fatigue, pain and/or urgency/incontinence, compared to care as usual.

Who can participate?
Patients 18 years old or over with a diagnosis of IBD, living in England, Scotland or Wales, and have participated in Stage 2 of the programme (IBD-BOOST) survey

What does the study involve?
This trial is testing whether an online self-management programme can improve symptoms and quality of life. Participants who consent to take part will complete an online questionnaire. An automated computer system will then put you into participants into one of two groups by chance (randomly):
- One group will receive a password to access an online self-management programme. It has 11 sessions, depending on the participant’s symptoms and can be completed over a few weeks or up to 6 months. The sessions can be done at any time, with some exercises in between, and should take a total of 1-2 hours per week. Participants will also have a professional facilitator who can give the participant online or telephone support.
- The other group will not have access to the online programme until 12 months later.
We will ask both groups to complete the questionnaires again 6 and 12 months later and you will receive £5 each time. 12 months after taking part, BOTH groups will have open access to the website but without facilitator support.

see Mahana Therapeutics.

@dave30th