Friedberg et al: Efficacy of two delivery modes of behavioral self-management in severe CFS

[mango]

Efficacy of two delivery modes of behavioral self-management in severe chronic fatigue syndrome

Fred Friedberg a*, Jenna Adamowicz a, Indre Caikauskaite a, Viktoria Seva a & Anthony Napoli b

Author affiliations
a Department of Psychiatry, Stony Brook University Health Sciences Center, Stony Brook, NY, USA
b Department of Social Science, Orient Building/Eastern Campus, Riverhead, NY, USA

Fatigue: Biomedicine, Health & Behavior Volume 4, Issue 3, 2016 pages 158-174
Received: 11 Apr 2016. Accepted: 21 Jun 2016. Published online: 29 Jul 2016.
DOI:10.1080/21641846.2016.1205876

ABSTRACT
Purpose: To assess the efficacy of fatigue self-management for severe chronic fatigue syndrome (CFS).

Methods: This randomized trial enrolled 137 patients with severe CFS. Participants were randomized to one of three conditions: fatigue self-management with web diaries and actigraphs (FSM:ACT); fatigue self-management with less expensive paper diaries and pedometers (FSM:CTR); or an usual care control condition (UC). The primary outcome assessed fatigue severity at 3-month follow-up. Analysis was by intention-to-treat.

Results: At 3-month follow-up, the FSM:CTR condition showed significantly greater reduction in fatigue severity compared to UC (p = .03; d = .58). No significant improvement was found at 12-month follow-up for the FSM:ACT or the FSM:CTR condition as compared to UC (p > .10). The combined active treatment conditions revealed significantly reduced fatigue at 3-month follow-up (p = .03), but not at 12-month follow-up (p = .24) compared to UC. Clinically significant improvements were found for 24–28% of the intervention groups as compared to 9% of the UC group. Attrition at 12-month follow-up was low (< 8%).

Conclusion: Home-based self-management for severe CFS appeared to be less effective in comparison to findings reported for higher functioning groups. Home-based management may be enhanced by remotely delivered interventional feedback.

Keywords: Fatigue self-management, chronic fatigue syndrome, unexplained chronic fatigue, cognitive-behavior therapy, home-based self-management

http://www.tandfonline.com/doi/abs/10.1080/21641846.2016.1205876?journalCode=rftg20

 

[SilverbladeTE]

So, are they talking about the aural or anal routes of injection Bos Taurus faeces?


Earth to Muppets! Earth to Muppets! Come in, bioscocial Muppets!
Wasting time on this garbage with *SEVERELY ILL*, horribly distressed patients, instead of treatments to actual improve their primary medical condition is like forcing a cancer patient to listen to an IPod to "make them feel better" and deliberately denying them surgery, radiological or chemotherapy to stop them dying.

it's not merely "Nero fiddling while Rome burns"
It's like some terrorist loons are setting of atomic bombs and the biosocial, self obsessed assholes are going around pissing on the gigantic firestorms as cities burn and saying "Hey, look, we can put it out!"
Uh, no.

 

[worldbackwards]

Home-based management may be enhanced by remotely delivered interventional feedback.

I'm imagining someone popping up on your TV screen every couple of days, screaming "JUST GET UP! THERE'S NOTHING WRONG WITH YOU! STOP THAT NOW!"

 

[mango]

Our treatment model [6] is based on the clinical principles of ameliorating the detrimental influences of affective distress, absence of pleasant affect and experiences, and maladaptive activity patterns.

A behavioral approach targeted to these factors is proposed to effectuate reductions in fatigue symptoms and improvements in functioning.

The overarching goal is to help the patient achieve a healthy balance between activity, rest, and leisure.

(my bold)

Ref 6 is "Friedberg F. Chronic fatigue syndrome, fibromyalgia, and related illnesses: a clinical model of
assessment and intervention. J Clin Psychol. 2010;6:641–665."

...and it's available here:
http://thirdworld.nl/chronic-fatigu...clinical-model-of-assessment-and-intervention

Also, I looked up the definition of "affect" in a medical textbook. It says:

affect
/af·fect/ (af´ekt) the external expression of emotion attached to ideas or mental representations of objects.

 

[mango]

Candidates were eligible for the study if they met these criteria:

(a) age between 18 and 65, not pregnant, and considered physically capable of doing the self-management program (e.g. walking assignments);

(b) at least 6-months of persistent, unremitting fatigue; and

(c) symptom and impairment criteria for CFS,[1] including at least 6 months of persistent fatigue and four out of eight secondary symptoms (sore throats, muscle pain, joint pain, headaches, sleep difficulties, PEM, tender or sore lymph glands, and concentration difficulties).

Ref 1 = Fukuda

Forty-seven percent sent in a physician note confirming a CFS diagnosis.

mean illness duration (14.5 years overall; 17.3 years in the control group, p < .05)

 

[mango]

Exclusionary psychiatric disorders included any self-reported psychosis, substance or alcohol abuse in the two years prior to illness onset or at any time afterward, or current or past depression with melancholic or psychotic features within the five years prior to illness onset or any time afterward.

Intervention
The intervention [6] involved no face-to-face visits or clinical contacts (phone, email, etc.) with an interventionist.

The program (delivered by booklet and audio CDs) educated the participant about (1) diagnosis and possible causal factors in CFS and (2) stress factors and behaviors that play a role in disturbed sleep patterns, post-exertional symptoms, and push-crash activity cycles.

Persistent fatigue was explained as a symptom associated with doing too much or too little.

Optimal self-management was intended to achieve a healthy balance between mental and physical exertion and periods of rest.

Initial assignments included a daily diary to identify baseline activities, symptoms, and stress levels.

Next the self-management text showed participants how to identify unhelpful behaviors and beliefs about the illness followed by development of more useful cognitive and behavioral coping strategies.

(my bold)

 

[Gijs]

They really don't understand ME at all. Poor science and a waste of money. I really doubt their intelligence.

 

[mango]

I believe this might be their definition of "severe" CFS?

Illness-related fatigue and functional limitations in the study sample appeared to be severe based on the fact that the vast majority of participants presented baseline FSS scores equal to or higher than 5.0 (98.5%), considered to be ‘high fatigue’ severity, that is, two SDs above healthy controls.[41,42]

In addition, the mean FSS score at baseline, 6.52 (SD = .49), was about two SDs higher than that found in a primary care sample of combined unexplained chronic fatigue and CFS patients that underwent a similar cognitivebehavioral self-management intervention.[20]

Also, on the baseline web diary, the mean seven-day numerical fatigue rating (0–10) was 6.92 (SD = 1.28) which was about 1 SD higher than that reported in a previous CFS study sample recruited from the local community.[43]

Finally, the mean SF-36 PF score of 37 was 2.0 SDs below the US population mean, [44] and 1.0 SD below SF-36 PF scores averaged over five published CFS self-management studies (Discussion). Based on population data, only 16% of individuals with SF-36 PF scores in the 30–39 range can walk one block or more.[23] These statistics suggest that our sample was severely ill.

Consistent with their severely ill status, the mean SF-36 PF score at baseline for our sample was 37 (>2SD below the population mean; [44]). This was the lowest score on the SF-36 PF among published CFS behavioral self-management studies which ranged from 50 to 72

The lower functioning in our CFS participants is also suggested by the short walk distances recorded on the 6MWT at baseline (mdn: 336 m)

 

[mango]

Ok, one last one:

Perhaps profound functional limitation in CFS is less amenable to behavioral intervention, although a significant lessening of both fatigue severity and depressive symptoms suggested that improved quality of life is still a realistic goal.

 

[mango]

I have to admit that I'm feeling even more sceptical about Friedbergs big new study now...

The thread for that study is here:
http://forums.phoenixrising.me/inde...daily-activity-patterns-and-heart-rate.45343/

 

[Bob]

I'm not impressed either. Did they seriously expect to see meaningful short-term improvements in severely affected patients simply from writing a diary and recording activity levels?

The overarching goal is to help the patient achieve a healthy balance between activity, rest, and leisure.

It's not at all clear to me how a bed-bound patient could possibly "achieve a healthy balance between activity, rest, and leisure"?!? Are they supposed to go for walks in their beds, and attend leisure activities in their beds?


Edited to add: To be fair, if this study investigated an activity management program similar to pacing (and I'm not sure if it did?), I think pacing is very helpful, but it's not a treatment and I wouldn't expect to see any meaningful improvements in severely affected patients after just three months of activity management.

 

[mango]

It's not at all clear to me how a bed-bound patient could possibly "achieve a healthy balance between activity, rest, and leisure"?!? Are they supposed to go for walks in their beds, and attend leisure activities in their beds?

The inclusion criteria say that you have to be "physically capable of doing the self-management program (e.g. walking assignments)", so it sounds to me like no bedbound patients took part in this study?

 

[Comet]

Methods: This randomized trial enrolled 137 patients with severe CFS. Participants were randomized to one of three conditions: fatigue self-management with web diaries and actigraphs (FSM:ACT); fatigue self-management with less expensive paper diaries and pedometers (FSM:CTR); or an usual care control condition (UC). The primary outcome assessed fatigue severity at 3-month follow-up. Analysis was by intention-to-treat.

Usual care? For PwME...?

Results: At 3-month follow-up, the FSM:CTR condition showed significantly greater reduction in fatigue severity compared to UC (p = .03; d = .58). No significant improvement was found at 12-month follow-up for the FSM:ACT or the FSM:CTR condition as compared to UC (p > .10). The combined active treatment conditions revealed significantly reduced fatigue at 3-month follow-up (p = .03), but not at 12-month follow-up (p = .24) compared to UC. Clinically significant improvements were found for 24–28% of the intervention groups as compared to 9% of the UC group. Attrition at 12-month follow-up was low (< 8%).

No lasting results? Shocking.

Conclusion: Home-based self-management for severe CFS appeared to be less effective in comparison to findings reported for higher functioning groups.

C'mon Fred, did you really have to do a study to discover this? I thought you have ME/CFS.

Home-based management may be enhanced by remotely delivered interventional feedback.

This wouldn't be lightly veiled CBT by chance, would it?
(My bolds)

 

[Comet]

Ref 1 = Fukuda

So this study likely includes people suffering from illnesses other than ME/CFS.

Forty-seven percent sent in a physician note confirming a CFS diagnosis.

Oh wait... they have a note, so we can just assume a correct diagnosis of ME/CFS.

mean illness duration (14.5 years overall; 17.3 years in the control group, p < .05)

But still, is any illness causing severe fatigue for 14+ years really likely to be cured/managed/successfully treated by writing diaries and listening to instructional CDs?

What are these people thinking and why is it allowed to continue (rhetorical question)?!

 

[Kati]

Basically Fred wants to remain a NIH funded investigator so his conclusions will keep the door open for further behavioral interventions.

It's pretty sad that he is using the term 'severe' when his subjects are able to walk.

Patients need to be aware of these studies researching behavioral interventions. I am not sure if this particular one paid participants, but the financial incentive is not worth another publication on behavioral interventions for ME and CFS.

 

[Snowdrop]

<sigh> More waste. And nothing at all for patients.

 

[Comet]

Fred Friedberg, if you are reading this, why not do a study that is helpful to PwME? Maybe a study of supportive care and the difference in quality of life it might make for us?

For example, do people with moderate ME/CFS (ICC or CCC criteria, please) have better QoL when given support workers to help with chores, cleaning, driving to doctor appts, etc?

Perhaps a study highlighting what PwME must give up in order to have the physical strength and energy just to get through the day if we have to see a doctor or do other 'extra' tasks on a particular day.

How about this one? What is the impact made on the self esteem of PwME, as we are routinely disbelieved and mocked by modern medicine? This must take an incredible amount of fortitude to battle every single day, for years on end, with no end in sight, in addition to battling ME/CFS in the first place.

Pardon my tone, it's just that it seems to me that this sort of study would be far more helpful to us than attempted behavior modification, which, as the study highlighted in this thread seems to have proved does not work.

We really could use your help. Please stand up for patients. The NIH seems more open than ever to helping PwME. Are you?

 

[Sean]

maladaptive activity patterns.

Did he demonstrate these alleged maladaptive activity patterns exist in the first place, and are significant causal factors?

Or did he just assume them to be so?

 

[alex3619]

For example, do people with moderate ME/CFS (ICC or CCC criteria, please) have better QoL when given support workers to help with chores, cleaning, driving to doctor appts, etc?

I will save someone a lot of money. The answer is yes. Please spend the money on more useful research.

However in order to justify public funds being spent on such things the research may have to be done.

So far as I am concerned if there are no objective markers you cannot speak of improvement, recovery etc. All you can speak about, with even limited reliability, is quality of life. That does have some value, though limited. Its time research aiming at effective treatment, based entirely on subjective outcomes, is put to rest.

 

[Comet]

So far as I am concerned if there are no objective markers you cannot speak of improvement, recovery etc. All you can speak about, with even limited reliability, is quality of life. That does have some value, though limited. Its time research aiming at effective treatment, based entirely on subjective outcomes, is put to rest.

Agreed. I just wanted to throw out a thought that psych research might be more helpful to the patient if approached differently, because I don't think Fred Friedberg is going to be analyzing gut microbes or the like any time soon.

As we all know, there is a mountain of biomedical research in urgent need of funding. I certainly hope this is given the highest priority and psych studies are put on the back burner... Way back.