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

[Dolphin]

This is across the 3 trial arms:

Ten participants dropped out after randomization for an overall dropout rate of 7.3%. The majority (70%) dropped out within the first month of assignment. Reasons for dropping out were: unexpected medical problems, unable to follow study protocol (e.g. unable to access web diary, inability to begin treatment in a timely manner), fear of energy drain from doing study activities, or unknown reasons. No significant differences were found between study dropouts and completers on any baseline demographic variable.

7 of these dropped out before starting the therapies (none in the control group).

 

[Dolphin]

Sixty-nine percent of the full sample reported PEM of at least 24 hours duration, 18% reported PEM lasting under 24 hours, and 13% of the sample reported no PEM (Table 3).

Note that the percentages given in table 3 are incorrect, though the figures themselves look correct (I haven't calculated them)

 

[Dolphin]

Diaries, actigraphy, step counters, and six-minute walk test

Web and paper diary compliance for the FSM:ACT, FSM:CTR, and UC groups was 69.23%, 98.07%, and 83.44%, respectively. Diary compliance was not significantly associated with change in FSS scores (p > .21) at 3- or 12- month follow-up. Actigraphy counts were log transformed to normalize their distributions. No significant change was found in actigraphy counts from baseline to 12-month follow-up in the FSM:ACT condition (p = .75). In addition, no significant change in actigraphy was found for participants classified as clinically improved in the FSM:ACT condition (n = 8; p = .23). Furthermore, steps recorded on the step counters in the FSM:CTR condition were not associated with change on the FSS at the 3-month follow-up.

The mean six-minute walk distance of the full sample at baseline was 336.2 m (n = 124). There were no significant changes in walk distance by time (p = .91), group (p = .65) or time by group interaction (p = .70).

FSS=Fatigue Severity Scale

Given that this therapy was a mixture of scheduling increasing exercise and pacing, these results are less damning than if the intervention was simply about graded activity/exercise.

 

[Dolphin]

Useful reference if you want to say the more severely affected respond less to therapy:

Consistent with our low rate of clinical significance, the Knoop et al. [4] self-management trial in CFS noted that the treatment effect was halved for the most disabled.

[4] Knoop H, van der Meer JWM, Bleijenberg G. Guided self-instructions for people with chronic fatigue syndrome: randomized controlled trial. Br J Psychiatr. 2008;193:340–341.

Of the interaction terms, only the condition6 SIP8 total score interaction effect was significant (B=3.533, t=2.250, P=0.026), indicating that the treatment effect is more than halved for patients with an SIP8 score of 1 standard deviation above the mean.

 

[Dolphin]

Thus these alternate interpretations of our findings seem less plausible than the likelihood that this severely ill group of CFS patients was simply more refractory to behaviorally oriented treatment.

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.

Finally mean illness duration (14.5 years overall; 17.3 years in the control group, p < .05) in the current study was considerably longer than prior self-management trials which ranged from 4 to 10 years.[9,10,20,45] The probability of remission is higher for individuals ill less than five years [46,47] and thus the lower effect sizes in this study may be in part attributable to long illness duration.

 

[Dolphin]

The absence of significant actigraphy change is consistent with previous behavioral intervention studies that incorporated activity monitors.[11] A plausible explanation is that while certain therapeutic activities (e.g. leisurely regular walking and uplifting activities) may be increased, other more stressful and fatigue-producing endeavors may be reduced,[6] yielding no net change in activity levels.

 

[Dolphin]

Conclusions

This randomized trial of home-based self-management in severe CFS found modest, but statistically significant improvements in fatigue severity in the short-term and depression in the longer term with about one in four participants showing clinically significant improvement in fatigue. In comparison to other self-management trials in CFS, the rate of clinical improvement was lower, perhaps attributable to high illness severity in combination with longer illness duration. Attrition was notably low, less than 8%, plausibly due to the absence of a travel requirement. The value of this intervention may be based on its minimal labor and cost that could serve patients who are less likely to travel to a facility for treatment. A subsequent report will address the cost effectiveness of the intervention delivered in this study. Future research that incorporates interventional feedback to participants based on diary data could potentially yield more clinically significant outcomes.