Trial Report Effectiveness of a group-based self-management program for people with chronic fatigue syndrome: a randomized controlled trial, 2016, Pinxsterhuis et

[Utsikt]

Effectiveness of a group-based self-management program for people with chronic fatigue syndrome: a randomized controlled trial

Spoiler: Authors

Pinxsterhuis, Irma; Sandvik, Leiv; Strand, Elin Bolle; Bautz-Holter, Erik; Sveen, Unni

Abstract
Objective:
To evaluate the effectiveness of a group-based self-management program for people with chronic fatigue syndrome.

Design:
A randomized controlled trial.

Setting:
Four mid-sized towns in southern Norway and two suburbs of Oslo.

Subjects:
A total of 137 adults with chronic fatigue syndrome.

Intervention:
A self-management program including eight biweekly meetings of 2.5 hours duration. The control group received usual care.

Main measures:
Primary outcome measure:
Medical Outcomes Study-Short Form-36 physical functioning subscale.

Secondary outcome measures:
Fatigue severity scale, self-efficacy scale, physical and mental component summary of the Short Form-36, and the illness cognition questionnaire (acceptance subscale).

Assessments were performed at baseline, and at six-month and one-year follow-ups.

Results:
At the six-month follow-up, a significant difference between the two groups was found concerning fatigue severity ( p = 0.039) in favor of the control group, and concerning self-efficacy in favor of the intervention group ( p = 0.039). These significant differences were not sustained at the one-year follow-up.

No significant differences were found between the groups concerning physical functioning, acceptance, and health status at any of the measure points.

The drop-out rate was 13.9% and the median number of sessions attended was seven (out of eight).

Conclusions:
The evaluated self-management program did not have any sustained effect, as compared with receiving usual care.

Web | DOI | PDF | Clinical Rehabilitation

PDF from ResearchGate

 

[Utsikt]

Crossposted from BACME dysregulation thread:

They compared self management groups with usual care. 8 meetings over 16 weeks and follow-up for a year. Subjective outcomes.

They were encouraged to pace and essentially optimise their life, and then increase activity when they felt they were ready. It looks very much like the BACME pacing up.

No differences at all. The authors speculate that it was due to non-compliance with the method, i.e. that they didn’t do more as they should.

I’ve seen this mentioned as evidence that pacing is not effective. I think that is the wrong interpretation, that would be like comparing no chemo to no chemo+acupuncture for cancer, finding no differences, and concluding that everyone with cancer should do acupuncture.

This shows that pacing up does not produce better outcomes. Therefore, the patients should be encouraged to pace based on their own experiences and priorities. After all, agency should be valued, and resources should not be wasted on something that doesn’t help.

 

[Lou B Lou]

'Intervention:
A self-management program including eight biweekly meetings of 2.5 hours duration. The control group received usual care.'




2 and a half hour meetings twice a week!! On top of traveling to the meetings. How mild/moderate would a patient have to be to keep up with those study participation requirements?

I'm amazed that only 13% dropped out.

 

[Trish]

2.5 hour meetings excludes all but the mildest. What on earth can they find to do in all those hours of meetings if they are just teaching self management?

 

[Utsikt]

Description of the programme:

Therefore, a pilot study was conducted to develop a self-management program based on the self-efficacy theory8 and Energy Envelope Theory10 that could be organized in a primary healthcare setting in Norway.11 The Energy Envelope Theory is based on the hypothesis that avoiding over-exertion by maintaining expended energy levels within the envelope of perceived energy levels, might prevent relapses and increase energy levels and the tolerance of activity.10 Several studies have shown results supporting the Energy Envelope Theory.12,13

This is essentially boom/bust, where they think pacing up will produce improvements.

At the six municipalities, the self-management program was conducted by a peer counsellor (i.e. experienced individual with chronic fatigue syn- drome) and occupational therapist after participa- tion in a three-day training program.

They followed a detailed manual to teach the self-management program. The program was conducted with 6–14 participants in each group and included eight meetings of 2.5 hours duration every other week.

As others have pointed out, this excludes everyone but the mild.

The participants were taught how to take greater initiative for coping with their illness and for deal- ings with healthcare professionals and significant others. These capabilities were developed through educational presentations, the exchange of expe- riences among participants, modeling of self- management skills, guided mastery practice, and informative feedback.8

Is this normal for chronic diseases? Learning how to deal with healthcare workers?

The program covered a number of topics rele- vant to coping with chronic fatigue syndrome and the content is presented in Table 1.

At the beginning of the program, the participants set personal goals for coping and constructed action plans to achieve these goals. During each meeting, action plans were evaluated, and the participants were offered feed- back from the other participants in overcoming obstacles they faced. At the end of each meeting, the current action plans were adjusted if necessary, or were replaced with new action plans.

I can’t think of anything in my life where I would need an action plan. This sounds a lot like thinking that the patients are unable to manage their lives, so they need someone to help them.

In addition, one meeting was organized for rela- tives of the participants with an educational presen- tation about chronic fatigue syndrome; this meeting covered the content of the self-management pro- gram and allowed for the exchange of experiences among relatives.

If the carers are told the same, this is just going to reinforce the stigma and abuse.


From the discussion:

Our program encouraged increasing activity levels when the participants were able to manage their daily activities, and symptom fluctuations were reduced to a manageable level.

In case it was unclear if this is pacing up or not.

The lack of improvement in physical functioning in the intervention group might indicate that the participants continued to operate at lower levels than advocated. An objective measure of activity might have confirmed compliance.

Of course it can’t be that the intervention doesn’t work.

The use of specific strategies to facilitate increased physical activity, as included in the PACE-trial,29 might have been more helpful for the participants in our study.

Embracing PACE, even in 2015, tells you all you have to know.

It is also possible that the participants in our study had severe limitations and used adaptive coping strategies to deal with their illness and to prevent relapses rather than to increase activity levels.30

…

Based on the results of other studies using adaptive coping strategies, it was also expected that the program would lead to improvements in fatigue severity.12,13,31 The lack of improvement in fatigue severity in the intervention group might indicate that the participants had severe limitations30 or were doing less than they were able to, providing them with more time to focus on symptoms.32

They are saying the quiet part out loud again: it’s not about improving their symptoms but to get them to ignore them or just report less symptoms.

 

[Kitty]

Think I'll stick to S4ME as my group-based self-management programme for ME/CFS.

 

[Mij]

Authors from the Department of Occupational Therapy, Prosthetics and Orthotics, Oslo, Norway and one from the Center Biostatistics and Epidemiology that came up with a conception or mental image of something to be done. Do they think we need to learn how to walk again?