Feasibility trial of a self-help digital intervention for functional cognitive disorder, 2025, Cabreira, Stone, Carson et al

[Andy]

Abstract

Functional cognitive disorder is the cognitive subtype of functional neurological disorders. Symptoms are associated with a high level of distress and typically arise due to various risk factors including abnormal focused attention, high memory expectations and poor metacognition. Easily accessible specialized treatments for functional cognitive disorder are needed. Digital interventions are less costly and scalable and allow individuals to engage in self-care in a flexible manner.

In this study, we aimed to (i) evaluate the feasibility and safety of a novel self-help digital intervention based on principles of cognitive behavioural therapy and related approaches, (ii) explore preliminary effects of this intervention and (iii) learn about participants’ experience with the intervention. Patients were recruited via a neuropsychiatry clinic. They autonomously completed a 6-week intervention, with phone and email technical support, and were assessed at baseline and at the end of the intervention, using self-reported questionnaires. Besides feasibility outcomes, main measures were the metamemory in adulthood questionnaire, subjective memory complaints, clinical global impression of change, Brief Illness Perception Questionnaire, Behavioural Responses to Illness Questionnaire, Compensatory Cognitive Strategies Questionnaire, depressive and anxiety symptoms, work and social functioning and quality of life. A within-group design was employed. Means, standard deviations and effect sizes were estimated. Post-treatment semi-structured interviews were conducted to further explore the acceptability and usability of the programme.

Of the 38 patients eligible, 37 completed the baseline questionnaires (97% recruitment rate). Thirty started the intervention (54% female, mean age 50.4). Four dropped out (4/30, 13%), with 23/30 (77%) completing three or more modules, and the attrition rate was 37%. Twenty-seven treatment-related negative effects were reported (5% of total). Overall satisfaction with the programme was high with 62% (16/26) reporting feeling ‘satisfied’ or ‘very satisfied’. Sixteen (62%) reported improvement in their cognitive symptoms (‘minimally improved’, ‘much improved’ and ‘very much improved’). Paired t-tests showed significant improvements on illness perceptions (mean change −6.65, P = 0.001), depressive symptoms (mean change −2.96, P = 0.008) and quality of life (mean change 10.06, P = 0.03) at post-treatment. Five patients were dissatisfied with the lack of personalization and found the content unhelpful, with some experiencing increased anxiety.

While the intervention met most of its feasibility benchmarks, efficacy needs to be explored in a future randomized controlled trial. Self-help digital therapy may be a flexible and cost-effective option to increase availability and accessibility of specialized treatment for functional cognitive disorder, within a stepped care model, as a complement to other multidisciplinary face-to-face interventions.

Open access

 

[Andy]

Selected quotes.

"While FCD may present in isolation, it is often part of a broader syndrome such as fibromyalgia or chronic fatigue syndrome.5,6"

"Intervention

Mementum was designed as a self-help app supporting the delivery of education about predisposing, precipitating and maintaining factors contributing to functional cognitive symptoms. Its development is described separately.28 It includes (i) CBT-based strategies aimed at shifting how participants think and feel about their memory and encouraging behavioural activation to reduce reliance on excessive safety strategies and promote tolerance to cognitive failures, (ii) mindfulness-based strategies to decrease hyperarousal and cognitive symptom-related distress (iii) cognitive rehabilitation strategies to manage external and internal distractions and increase ‘memory successes’ (e.g. spaced retrieval, active noticing) and (iv) optional content on symptoms that contribute to a depletion of attentional resources reinforcing inattentive cognitive lapses (e.g. pain, fatigue, poor sleep). The programme was delivered over 6 weeks. This duration was selected based on similar self-help interventions and evidence suggesting that longer treatment duration does not necessarily translate to higher treatment effects.26,28"

Table 1 Baseline participant characteristics

Functional symptoms and disorders 18 (48.6)
Tremor (n = 2)
Motor and sensory FND (n = 3)
Fatigue (n = 12)
Dissociation/seizures (n = 2)
Dizziness/PPPD (n = 4)
Chronic pain (n = 5)
IBS (n = 1)
Functional jerks (n = 1)


"While no other self-help digital interventions specific for FCD are available for direct comparison, similar self-guided interventions have shown small-to-moderate improvements in quality of life and symptom reduction in conditions like chronic pain, chronic fatigue, anxiety and depression.53,64-67 Similar trials of low-intensity structured CBT-based strategies often face similar challenges in balancing standardization with personalization, leading to unwanted heightened anxiety and isolation feelings in some patients.68"

 

[Hutan]

That paper is really begging to be satirised.
"Self-help digital intervention" - I can think of one that is suitable.
And "functional jerks"

Do they seriously think they are curing anyone of their cognitive issues with 6 weeks using an app? Perhaps they only need to convince the governments they sell it to.

and were assessed at baseline and at the end of the intervention, using self-reported questionnaires

Self-reported assessments, no follow-up. Straight out of the BPS recipe book for producing a positive result.

Of the 38 patients eligible, 37 completed the baseline questionnaires (97% recruitment rate). Thirty started the intervention (54% female, mean age 50.4). Four dropped out (4/30, 13%), with 23/30 (77%) completing three or more modules, and the attrition rate was 37%.

49 patients were screened for eligibility according to the text; the waterfall diagram says that 48 people were screened.

38 patients were invited to participate.​

37 patients completed baseline questionnaires.​

30 patients logged in to the program​

26 patients completed the final assessment at 6 weeks​

24 patients completed 1 or more modules​

23 patients completed 3 or more of the 7 modules (23/38 is 60.5%) - this was the predefined adherence criteria​

17 patients completed all 7 modules​

​

22 patients answered the question 'would you recommend this program to others?' - 18 patients said yes.​

The 6 week point is called 'followup', but actually it is the end of the intervention.
It's clear from the reasons given for dropping out that lots of the patients were not impressed. One patient who, along with the rest of the participants, came to the study suffering from troublesome cognitive issues, started having seizures, which these investigators called 'frequent functional seizures'.

It's easy to forget that the participants are dealing with something really concerning - the loss of their ability to think like they used to. And the investigators are making light of that by suggesting that if they just didn't expect to be able to think so well, they wouldn't have a problem. The investigators suggest that the changing of expectations will make reality fine.

Symptoms typically arise due to a variety of risk factors including abnormal focused attention, high expectations and concern about memory, which tends to drive ensuing monitoring and concern that further reduce memory efficiency.

 

[Hutan]

There's a bit of text telling us about changes at the individual level.

While 13 (50%) patients had lower impairment scores in work and social functioning at follow-up, including 4 patients who moved from significant and moderately severe functional impairment to subclinical and 4 patients who were able to return to work, three patients moved to the severe impairment category mainly due to external circumstances (unemployment, son committed suicide, cardiovascular intercurrence) (Supplementary Fig. 5).

So, 50% of the 26 patients reported lower impairment scores in work and social functioning. That means that 50% reported higher or the same impairment scores. And then there were the 11 more patients who started the program and withdrew.

Table 3 is interesting. Very few measures (3 out of 9) showed statistically significant change for the 26 people who filled out baseline and treatment end surveys. Of the measures that did have significant p values, improvements were barely clinically significant, and definitely within the likely range of a placebo response. There was no significant change on the Work and Social adjustment scale or a measure of memory. The measure that did improve a bit are the most vague measures, the ones most susceptible to a placebo effect for an intervention that trains you to be less concerned about your cognitive impairment - Brief Illness Perception Questionnaire (p=0.001); Patient Health Questionnaire (p=0.008) and Self-rated health (p=0.03).

It's really looking pretty much a bust, in terms of useful effect on cognition.

 

[Hutan]

There's a qualitative evaluation, only done with 6 people. And, from their comments, I can see that some of the content was helpful to people.

There is value in making the best of things, and worrying less about what other people think when you can't find the word you are searching for. I just think it's such a shame to present these ideas with the functional overlay. People who have suffered a cognitive loss of function due to any cause might benefit from hearing some of this content.

‘I felt confident enough to try and for the first time in 2–3 years was able to meet with friends and clients in the evening after  work.’​

‘I feel what’s been hugely helpful is accepting that there are things under my control and others I do not control.’​

​

‘I used to get stuck more in my conversations, and as soon as I would forget a word, I would be panicking. But now I take a deep  breath and I say, hey, it's not big deal.’​

‘I cried when I was listening to the stories of people who have the same experience in dealing with this difficult problem. For the  first time I'm actually feeling validated.’​

‘I am putting a big effort to rest physically and mentally, avoiding ‘pushing through’.’​

‘It allows me to work on my perspective and mindset at a time that suits me. I can reinforce the messages as often as I need to.’​

A lot of people seemed to be immensely comforted by the reassurance that they do not have dementia - as you would be. However, I'm not sure the app really has the insight to say that. MRI's were only available to the researchers for something like half of the participants.

So, it looks like a bit of a mixed bag. Some of the content helped people realise that there were things they could do to feel better, but, there are also risks from minimising symptoms and suggesting to people that reframing things will change the underlying cognitive issue. I'm not sure that the app is any better at the things it does well than the sort of self-help booklet that organisations like stroke foundations give out. And, there were some people who were harmed by the functional dogma.

 

[rvallee]

Functional cognitive disorder is the cognitive subtype of functional neurological disorders. Symptoms are associated with a high level of distress and typically arise due to various risk factors including abnormal focused attention, high memory expectations and poor metacognition.

This is total nonsense. These people are completely clueless and offensive. Also it's completely implausible and simply ignores everything patients are telling them.

Actually, I just noticed that this is the only real difference between unofficial alternative medicine and this official kind: alternative medicine is polite and kind, almost tries a bit too hard at it. This is just finding ways to call us stupid without us being aware of it, but we mostly are so they call us stupid twice for it. Good talk.

In this study, we aimed to (i) evaluate the feasibility and safety of a novel self-help digital intervention based on principles of cognitive behavioural therapy and related approaches

OK, so just another CBT trial. Like hundreds of others. Waste of everything.

Overall satisfaction with the programme was high with 62% (16/26) reporting feeling ‘satisfied’ or ‘very satisfied’.

"So, Jimmy, how are your grades this semester?"
"They are high, daddy! 62% Isn't that high? I think that's very high!"
"It, uh, sure, us, is..." sighs in despair

 

[rvallee]

Do they seriously think they are curing anyone of their cognitive issues with 6 weeks using an app? Perhaps they only need to convince the governments they sell it to.

In an ironic twist, the push to apps may reveal how much of a scam this is. There is no market for this. If people are to go with woowoo programs, they're going to go with ones that don't shy away from the woowoo, instead of couching it all in fake science nonsense. Especially the ones that are realistic, and make no false promises like "this will cure your chronic condition".

If the apps are available for consumers to use, they just wouldn't. So of course there is always an element of having therapists available, or some other function that prevent them from being truly self-help. You can't use it like some of the mindfulness and meditation apps, which do make a lot of money. It always has to be prescribed or controlled through some health care institution.

So, the only people they have to convince is their peers, who then recommend those to governments. But it's a strictly supply-side thing, there is no demand for their junk. They're really like, well, junk pics. Lots of supply, very little demand for them.

 

[Hutan]

"So, Jimmy, how are your grades this semester?"
"They are high, daddy! 62% Isn't that high? I think that's very high!"
"It, uh, sure, us, is..." sighs in despair

And that's 62% of the people who actually bothered to start the intervention and then bothered to turn up for the final assessment. 16 out of 49 is not so great. Even 16 out of the 38 people who were invited to participate is only 42%.

But, these type of researchers seem to get an infinite number of chances to try again. Maybe next time it will work.

 

[Joan Crawford]

Abstract

Functional cognitive disorder is the cognitive subtype of functional neurological disorders. Symptoms are associated with a high level of distress and typically arise due to various risk factors including abnormal focused attention, high memory expectations and poor metacognition. Easily accessible specialized treatments for functional cognitive disorder are needed. Digital interventions are less costly and scalable and allow individuals to engage in self-care in a flexible manner.

In this study, we aimed to (i) evaluate the feasibility and safety of a novel self-help digital intervention based on principles of cognitive behavioural therapy and related approaches, (ii) explore preliminary effects of this intervention and (iii) learn about participants’ experience with the intervention. Patients were recruited via a neuropsychiatry clinic. They autonomously completed a 6-week intervention, with phone and email technical support, and were assessed at baseline and at the end of the intervention, using self-reported questionnaires. Besides feasibility outcomes, main measures were the metamemory in adulthood questionnaire, subjective memory complaints, clinical global impression of change, Brief Illness Perception Questionnaire, Behavioural Responses to Illness Questionnaire, Compensatory Cognitive Strategies Questionnaire, depressive and anxiety symptoms, work and social functioning and quality of life. A within-group design was employed. Means, standard deviations and effect sizes were estimated. Post-treatment semi-structured interviews were conducted to further explore the acceptability and usability of the programme.

Of the 38 patients eligible, 37 completed the baseline questionnaires (97% recruitment rate). Thirty started the intervention (54% female, mean age 50.4). Four dropped out (4/30, 13%), with 23/30 (77%) completing three or more modules, and the attrition rate was 37%. Twenty-seven treatment-related negative effects were reported (5% of total). Overall satisfaction with the programme was high with 62% (16/26) reporting feeling ‘satisfied’ or ‘very satisfied’. Sixteen (62%) reported improvement in their cognitive symptoms (‘minimally improved’, ‘much improved’ and ‘very much improved’). Paired t-tests showed significant improvements on illness perceptions (mean change −6.65, P = 0.001), depressive symptoms (mean change −2.96, P = 0.008) and quality of life (mean change 10.06, P = 0.03) at post-treatment. Five patients were dissatisfied with the lack of personalization and found the content unhelpful, with some experiencing increased anxiety.

While the intervention met most of its feasibility benchmarks, efficacy needs to be explored in a future randomized controlled trial. Self-help digital therapy may be a flexible and cost-effective option to increase availability and accessibility of specialized treatment for functional cognitive disorder, within a stepped care model, as a complement to other multidisciplinary face-to-face interventions.

Open access

Straightforward to assess many aspects of cognitive functioning using objective neuropsychological testing.

Seems lazy to not assess pre and post as a primary outcome

All Q outcome measures. Same old, same old.

 

[Peter T]

Straightforward to assess many aspects of cognitive functioning using objective neuropsychological testing.

Seems lazy to not assess pre and post as a primary outcome

All Q outcome measures. Same old, same old.

Ah but you don’t want the subject to focus any on objective measures as when that is unchanged you will reinforce their belief that there is an underlying neurological condition, which in turn will undermine your (the researcher’s) belief there is not.