Internet-delivered treatment for patients suffering from severe functional somatic disorders: Protocol for a randomized controlled trial, 2023, Fink

[Andy]

Highlights

• This is the first e-based treatment for severe functional somatic disorders.
• Two active conditions, a guided and an unguided treatment program, are compared.
• We expect both programs will prove effective in enhancing physical health.
• We hypothesize that the guided program will be superior to the unguided in effect.
• If effective, e-based treatment can make specialized treatment more accessible.

Abstract

Background
Functional somatic disorders (FSDs) with symptoms from multiple organs, i.e., multi-system type, are common in the general population and may lead to disability and reduced quality of life. Evidence for efficient treatment programs has been established, however, there is a need for making treatments accessible to a larger group of patients. Internet-delivered therapy has become prevalent and has proven as effective as face-to-face therapy, while providing a flexible and easily accessible treatment alternative. The aim of the current study is to compare the efficacy of the therapist-assisted internet-delivered treatment program One step at a time (OneStep) with the internet-delivered self-help program Get started (GetStarted).

Methods
A total of 166 participants aged 18–60 years diagnosed with multi-system FSD will be assessed and randomized to either 1) OneStep: a 14-week program consisting of 11 treatment modules based on principles from cognitive behavioural therapy or 2) GetStarted consisting of 1 module on psychoeducation. The primary outcome is physical health, assessed by a Short Form Health Survey (SF-36) aggregate score of the subscales vitality, physical functioning, and bodily pain 3 months after end-of-treatment and self-reported improvement assessed by the Clinical Global Improvement Scale. Secondary outcomes include symptom load, depression, anxiety, and illness worry. Process measures include emotional distress, illness perception, illness behaviour, and symptom interference.

Conclusions
This study is the first study to test an internet-delivered treatment program for FSD, multi-system type and has the potential to show the importance of making evidence-based internet-delivered treatment for FSD more accessible.

Open access, https://www.sciencedirect.com/science/article/pii/S2451865423000157


ETA: Related thread, In Progress: "One Step at a Time" - an Internet-delivered Treatment for Patients Moderately Impaired by Bodily Distress Syndrome..., 2021 -

 

[Trish]

A few quotes:

In the healthcare system, patients frequently receive medical specialty-specific syndrome diagnoses (FSS) such as fibromyalgia, chronic widespread pain, chronic fatigue syndrome, and irritable bowel syndrome [6,7]. Nevertheless, a substantial overlap of symptoms has been shown between the various types of FSS, indicating that the syndromes are not entirely independent conditions but different representations of a family of related disorders [8]. In order to meet this issue, the unifying research diagnostic construct bodily distress syndrome (BDS) has been proposed [3,9,10]. Thus, patients who report symptoms from 3 or more organ systems are classified as having multi-organ BDS.

So trying to kill off any suggestion that these conditions are actually different physical comditions.

The introduction to graded exercise as a means of moderating maladaptive illness behaviour and increasing physical function is also considered an important element in the treatment and has been found effective for chronic fatigue syndrome [21].

Reference is the PACE trial.

Further, we hypothesize illness perceptions, illness behaviour and, emotional distress to mediate change in health status as measured by the primary outcome, the aggregate score.

Patients aged 18–60 years fulfilling the criteria for FSD multi-organ type, operationalized as multi-organ BDS [10] and with a symptom duration >6 months, are eligible for inclusion. Furthermore, participants should have had an affiliation to the labour market or educational system for at least 12 months during the last 2 years (at least part time (18.5 h/week).

So for ME/CFS only the mildest cases will be eligible.

 

[Shadrach Loom]

So for ME/CFS only the mildest cases will be eligible.

Not sure about that. 18.5hrs a week is a pretty low bar for working from home in managerial functions. I’d agree it’s not sustainable for anything involving physical or emotional labour, or professional interactions with service users. But Fink would only rule someone out after two years abstinence from even short-term part-time gigs. Surely that lets quite a few moderates in?

This may result in findings which are less helpful to Fink, but it also increases the risk to participants if and when their apps tell them to push through.

 

[Sean]

We expect both programs will prove effective in enhancing physical health.​

Yes, that is how science is done. Start with the conclusion and work backwards to make sure the evidence fits it.

self-help program Get started (GetStarted).​

Get Stuffed.

The primary outcome is physical health, assessed by a Short Form Health Survey (SF-36) aggregate score of the subscales vitality, physical functioning, and bodily pain 3 months after end-of-treatment and self-reported improvement assessed by the Clinical Global Improvement Scale. Secondary outcomes include symptom load, depression, anxiety, and illness worry. Process measures include emotional distress, illness perception, illness behaviour, and symptom interference.

All subjective self-report.

They are just taking the piss now.

 

[rvallee]

All the past trials like this have been rated as either low quality, very low quality, or excluded on grounds of being so methodologically weak they can't be used reasonably. There is no excuse to continue doing this, there isn't a single other profession that would just mindlessly keep doing stuff like this.

And they just keep doing the same thing anyway. How is it that funders and approval boards don't care that this research is junk? They haven't changed anything, just keep doing the same things, have likely breached the thousand mark, always with low quality and high bias.

Hundreds and being the current coercive paradigm, and somehow they actually whine about being stifled. Even though their whole thing has been debunked again and again. Completely dysfunctional system enabling fanaticism. There is a "debate" currently with some German neurologist doing the old "provoke people who are suffering and gloat that their anger justifies doing horrible things to them", but really the issue here is of fanaticism, of being unable to let go of a belief system no matter how much harm is done.

 

[Kitty]

My mother told me I should always try to find something positive to say.

So, at least the participants will be able to watch something interesting on TV whilst the online self-help program's running on mute.

 

[Mithriel]

Did Fink not do the original trial of internet based treatments that Crawley copied? It is only original for this new name for the disease!

 

[Peter T]

Did Fink not do the original trial of internet based treatments that Crawley copied? It is only original for this new name for the disease!

I guess one of the reasons advocates of GET/CBT as a curative treatment for functional disorders want to characterise it as a novel approach is that they don’t want people looking at their decades of failure with other conditions, most particularly ME/CFS.

 

[rvallee]

I guess one of the reasons advocates of GET/CBT as a curative treatment for functional disorders want to characterise it as a novel approach is that they don’t want people looking at their decades of failure with other conditions, most particularly ME/CFS.

And mostly that they know it will work because the whole system is corrupt to the ideology. It's blatantly fraudulent but too many people are complicit in it so they don't want to admit either that the emperor was naked all along because they've all been gushing for years over how uh-may-zing the colors and fabric are and stuff.

First do no harm: or else what? Turns out if you only have one half of a thought, you may as well have none at all. A marketing slogan at best. In fact I don't think I've ever seen it used more than a handful of times other than to use it as an excuse to continue doing nothing, it's an empty platitude.