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Chronic Fatigue Self-Management in Primary Care: A Randomized Trial

Bob

Senior Member
Messages
16,455
Location
England (south coast)

Bob

Senior Member
Messages
16,455
Location
England (south coast)
I haven't read the full paper, but judging only by the results in the abstract, the study seems to suggest that "fatigue self-management" (FSM) is at least as effective as CBT/GET were found to be in the PACE trial. And more effective by some measures. And it seems "fatigue self-management" would be significantly cheaper to implement than CBT/GET as it only involves a 'brief' intervention.

But that's only judging by the abstract, so take it with a pinch of salt, until the methodology and analysis is scrutinised.

I'm trying to find out what exactly "fatigue self-management" involves.

Dr. Friedberg, lead author, is President of the International Association for Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (IACFS/ME.)


(Edited)
 
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15,786
Notice that is says "Chronic Fatigue", not "Chronic Fatigue Syndrome".
The first sentence of the abstract says this:
Objective To assess the efficacy of brief fatigue self-management (FSM) for medically unexplained chronic fatigue (UCF) and chronic fatigue syndrome (CFS) in primary care.
So basically they're equating CF with CFS.
 

Bob

Senior Member
Messages
16,455
Location
England (south coast)
Actually, I think they've used the term 'chronic fatigue' to refer to both unexplained chronic fatigue (UCF) and CFS. They just seem to have used an unhelpful sloppy short-hand for a 'catchy' title.

Conclusion:
"A brief self-management intervention for patients with UCF or CFS seemed to be clinically effective for reducing the impact of fatigue on functioning."

But, I agree, 'Chronic Fatigue' isn't a helpful term, and neither is the name of the intervention: "fatigue self-management', which is suggestive that CFS patients simply suffer from ordinary fatigue.
 

Bob

Senior Member
Messages
16,455
Location
England (south coast)
I'm trying to find out what exactly "fatigue self-management" involves.

I haven't got access to the full paper, and I'm trying to understand the exact nature of "fatigue self-management" (FSM).
I don't know much about Dr Friedberg (lead author of the study & president of the IACFS/ME), but I had always thought that he and the IACFS/ME were not supportive of the cognitive-behavioural model of CFS/ME.

However, I think that "fatigue self-management" is actually based on CBT. I can't find exact details, but I've found some details about 'brief self-management', which I think might be the same or similar (my emphasis added):
The hypothesis was tested that a brief self-management- focused cognitive-behavioral intervention will yield improvements in fatigue, physical and role functioning, and psychological distress in comparison to the two control conditions: standard medical care alone or standard medical care plus an attention control symptom monitoring condition.

http://www.iacfsme.org/LinkClick.aspx?fileticket=+G6GTkbP33I=&tabid=499


Looking at Dr Friedberg's "7 steps" plan for CFS & FM, which the following website describes as a 'treatment' for CFS & FM, I'm really not impressed with the way he associates emotional problems with CFS/ME symptoms:
http://www.cfidsselfhelp.org/library/fred-friedberg%25E2%2580%2599s-seven-step-protocol-treating-cfs-fm

Dr Friedberg is a psychologist, which is news to me:
http://phoenixrising.me/interviews-...with-dr-fred-friedberg-by-cort-johnson-part-i
 

Dolphin

Senior Member
Messages
17,567
Chronic Fatigue Self-Management in Primary Care: A Randomized Trial

Fred Friedberg, PhD, Anthony Napoli, PhD, Janna Coronel, MA, Jenna Adamowicz, MA, Viktoria Seva, MA, Indre Caikauskaite, BA, Man Chi Ngan, MA, Jeremy Chang, MA and Hongdao Meng, PhD

Psychosomatic Medicine

August 6, 2013 (Published online before print.)

doi: 10.1097/PSY.0b013e31829dbed4

http://www.psychosomaticmedicine.org/content/early/2013/08/01/PSY.0b013e31829dbed4.abstract
For anyone interested, the full text can now be accessed for free at: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3785003/
 

Dolphin

Senior Member
Messages
17,567
The abstract doesn't point out that the intervention was not efficacious for the three secondary outcome measures either in the intention-to-treat or per-protocol analyses.

The main results are in this Table: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3785003/table/T2/.

Friedberg Table 2 part 1.png


Friedberg Table 2 part 2.png


FSS is scored 1-7 (7 is worst). SF-36 PF 0-100 (100 is best and quite a lot of people in the general population score 100).
 
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Dolphin

Senior Member
Messages
17,567
Active Treatment: Fatigue Self-Management (FSM)—This two-session nurseconducted individual self-management protocol was based on a modified version of an efficacious 12-session cognitive-behavioral treatment program for CFS (14) and a self-help book for CFS and fibromyalgia (15). A 61-page self-management booklet provided to these participants contained material discussed and assigned in therapy sessions for the three month self-management period

14. Jason LA, Torres-Harding S, Friedberg F, Corradi K, Njoku MG, Donalek J, Reynolds N, Brown
M, Weitner BB, Rademaker A, Papernik M. Non-pharmacologic Interventions for CFS: A
randomized trial. J Clin Psycholo Med S. 2007; 14:275–296.
15. Friedberg, F. Fibromyalgia and chronic fatigue syndrome: Seven proven steps to less pain and
more energy. New Harbinger; Oakland, CA: 2006.

14. is an interesting trial that doesn't get referred to much. An intervention that is based on pacing (COG) did a bit better than King's College London-type CBT (i.e. Chalder-/Wessely-type CBT).

It's free at: http://www.cfids-cab.org/cfs-inform/CFStreatment/jason.etal07.pdf

Here's a description of COG which Friedberg et al. said was a basis for this trial:

Cognitive Therapy Treatment (COG)

This condition, formulated and supervised by Fred Friedberg, a clinical psychologist, incorporated a broad-based cognitive approach that focused on developing cognitive strategies to better tolerate and reduce stress and symptoms, and to lessen self-criticism. Cognitive changes were linked, in principle, to achieving a healthy balance between activity, rest, and leisure.

COG training was focused on treating maladaptive beliefs associated with illness-related depression, anxiety, and anger. It is a credible condition because it involves actively listening to participant’s complaints, as well as teaching coping and stress reduction skills. In comparison to CBT and ACT, the COG condition does not include structured schedules of increasing activity or exercise (Deale et al., 1997; Fulcher & White, 1997; Sharpe et al., 1996). Rather, this approach emphasizes pacing activities, which involves trying to remain as active as possible while avoiding over-exertion. Low effort activities that are not associated with symptom flare-ups are selectively increased while symptom-producing activities are decreased or managed more effectively. For instance, activity pacing was applied to completing job or household tasks in energy-conserving small steps that were less likely to produce symptom flare-ups. In a more narrowly focused early version of this protocol (Friedberg & Krupp,1994), a trend toward reduced depression scores and significant reductions in maladaptive illness beliefs were found. However, there were no changes in functional status. The 13-session COG protocol is summarized below.

Sessions 1–3. During the initial session, the therapist explained the purpose and goals of the intervention. Because of numerous encounters with physicians and others who have treated patients with CFS with condescension and even ridicule (McKenzie, Dechene, Friedberg, & Fontanetta,1995), rapport building was a critical aspect of the treatment regimen (Deale et al., 1997). As an initial intervention, the participant’s personal account of his/her illness, including CFS symptoms and their effects on vocational functioning, marital satisfaction, social relationships, and physical exercise was placed in the context of the four stage progressive model of chronic illness (Fennell, 1995). The model serves as a coping tool that allows the participant to view his/her reactions to the illness as understandable adjustments to an unpredictable, disabling condition. It also allowed the therapist to better target and individualize the coping techniques presented below.

Sessions 4–8. These sessions focused on stress reduction techniques for intrusive illness symptoms and limitations, as well as emotional distress. Initially, relaxation exercises were demonstrated and rehearsed in session. They were later prescribed for home use with audiocassette tapes. Cue-controlled relaxation was then introduced to create an association between the self-instructed relaxation and the feeling state of being relaxed. Specific relaxation benefits were addressed to the participant so that active use of relaxation as a coping skill (Ost, 1987) was clearly explained. In addition, cognitive coping statements were formulated and prescribed to counteract (1) catastrophic thinking about illness limitations and its vocational and social consequences; (2) symptom-exacerbating selfdemands for high achievement; and (3) intolerance of illness symptoms. To encourage practice of these coping skills, daily stress and fatigue records were reviewed to identify stress/symptom associations and then to prescribe relaxation and cognitive coping techniques to ameliorate these symptoms.

Sessions 9–13. As participants incorporated stress management and cognitive coping strategies into their daily routine, the imagery technique of pleasant mood induction was introduced as a method of alleviating depressed mood and uplifting mood in general. Pleasant mood induction involved visualizing enjoyable activities and events that could be performed by the participant, given the limitations of his or her illness. If the imagery exercises succeeded in elevating mood, they were incorporated into daily relaxation practice. The quality of social support was discussed in order to identify maladaptive beliefs that were detrimental to marital, family, and other significant relationships. Once identified, these maladaptive beliefs were used to generate cognitive coping statements that were intended to ameliorate relationship-damaging beliefs. These individually constructed coping statements were assigned as daily homework and were designed to counteract maladaptive thinking about relationships. Such sessions were devoted to the identification of specific cognitive difficulties and exposure to memory compensation and cognitive retraining techniques. For instance, to reduce debilitating feelings of cognitive overload, the participant was encouraged to (1) allow extra time to complete activities, (2) minimize distractions, and (3) watch for signs of increased mental fatigue and take necessary rest breaks. During the final session, the therapist and participant reviewed the course of therapy, including specific coping techniques that were learned and utilized. Improvements were also assessed in light of the four stage progressive model of CFS. Finally, a plan was developed to maintain the effective coping skills gained.

Jason et al 2007 Table 1 part 1 larger.png


Jason et al 2007 Table 1 part 2 larger.png
 
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Dolphin

Senior Member
Messages
17,567
Other information from Friedberg et al (2013) on the intervention:


Our treatment model (8) was based on ameliorating the detrimental influences of
affective distress, absence of pleasant affect and experiences, and maladaptive activity
patterns. No assumptions were made about physical deconditioning and fear-based
avoidance (9), the principles that guided the above intervention studies.

Active Treatment: Fatigue Self-Management (FSM)—This two-session nurseconducted individual self-management protocol was based on a modified version of an efficacious 12-session cognitive-behavioral treatment program for CFS (14) and a self-help book for CFS and fibromyalgia (15). A 61-page self-management booklet provided to these participants contained material discussed and assigned in therapy sessions for the three month self-management period.

Session 1: This session educated the participant about (1) diagnosis and possible causal factors in UCF and 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 selfmanagement was intended to achieve a healthy balance between mental and physical exertion and periods of rest (8). Assignments included the self-management booklet and a daily web diary to identify baseline activities, symptoms, and stress levels.

Session 2: Scheduled two weeks after session 1, this session identified unhelpful behaviors and beliefs about the illness followed by development of more useful cognitive and behavioral coping strategies. With information gathered from the week 1 web diary, the scheduling of home-based activities, rest/sleep assignments, and cognitive coping skills was individualized for each participant. Walking, if included, was intended as a voluntary leisure activity, rather than a fitness regimen. For instance, a relatively low functioning individual might be assigned a regular sleep /wake schedule and gradual low effort walking to increase tolerance of physical activity. A higher functioning participant might respond more favorably to pacing of activity and low effort pleasant activities. The final topic was postintervention planning for maintenance of new self-management skills which included recognizing and managing early symptoms of setbacks before they affected functioning.

The theory of illness used in the current study was based on a clinical model of CFS (8) which posits maladaptive activity levels (too high or too low or an alternating combination) in association with emotional stress and/or a lack of pleasant experiences. Although substantial improvements are considered possible in this model, interventions are not assumed to lead to recovery or cure. The physical deconditioning and avoidance model cited in previous intervention trials (9) is based on different underlying assumptions; however, the intervention techniques used are similar.
 

Dolphin

Senior Member
Messages
17,567
Looks like they intended to use two more objective measures but weren't able to collect sufficient data - disappointing:
Also, only self-report measures were used, given that data collection for our more objective assessments (six minute walk test and actigraphy) was not adequate for analysis.

A study on the economic costs/benefits will be published separately.
 

Dolphin

Senior Member
Messages
17,567
39% had CFS (Fukuda et al.)

Thirty-nine percent of the sample met symptom criteria for CFS and the remaining 61% who
did not meet full CFS criteria were classified as UCF. At baseline, the primary outcome
measure of fatigue impact (FSS) was significantly higher in those with a CFS diagnosis as
compared to those with a UCF diagnosis (t(109) = −2.55, p= .012). However, large
majorities of both groups (UCF: 77%; CFS: 84%) exhibited FSS scores that exceeded 5.0,
considered to be “high fatigue” impact, i.e., 2 SDs above healthy controls (36, 37)

---

Changes in FSS scores from baseline to 12-month were unrelated to diagnostic group (CFS vs. UCF; p= .38) or to the interaction of diagnostic group by treatment condition (p= .45).

---

I believe the following means that the UCF (non-CFS) group had lower fatigue scores across the study but there wasn't a difference in response between the UCF and CFS group (however in the per protocol analyses, the sample sizes are reduced reducing the power to find differences).

Per Protocol Analysis for the Primary Outcome Measure

In comparison to the ITT analysis, differences found between treatments were similar but of
greater magnitude in the per-protocol analysis. The main effect for Diagnostic Group was
significant (F(1, 53) = 11.4, p< .001, η2p = .18), indicating that the mean FSS score for the
UCF group was reliably lower (less fatigue impact) than the mean FSS score for the CFS
group. The interactions effects for Diagnostic Group × Time (p = .67), Diagnostic Group ×
Treatment (p= .54), and Diagnostic Group × Treatment × Time (p= .66) were all nonsignificant
 
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Dolphin

Senior Member
Messages
17,567
Clinically significant change:
To assess clinically significant change (34, 35) for fatigue impact, a patient was considered clinically improved if his/her 12 month post-treatment score was more than two standard deviations below the pre-treatment sample mean on the FSS (M= 5.57; SD= .94).

Threshold doesn't seem to match: 5.57 - (2 * .94) = 3.65:

Clinical Significance
Using our criterion for clinical significance of the primary outcome measure (FSS mean <=
3.9) in the per protocol data, the number of clinically improved participants at the 12-month
follow-up was as follows: 10/19 (53%) in the FSM condition, 3/22 (14%) in the AC
condition, and 3/18 (17%) in the UC condition. In healthy adults, the FSS mean is 2.3 (SD
= .70) (23). FSS baseline scores were significantly associated (r= −.49; p<.001) with
clinically significant changes at 12 month follow-up indicating that lower fatigue impact
scores at baseline were less likely to show clinically significant change