The efficacy of guided self-instruction for patients with idiopathic chronic fatigue: A RCT

[Tom Kindlon]

https://www.ncbi.nlm.nih.gov/pubmed/26950098

J Consult Clin Psychol. 2016 May;84(5):377-88. doi: 10.1037/ccp0000085. Epub 2016 Mar 7.
The efficacy of guided self-instruction for patients with idiopathic chronic fatigue: A randomized controlled trial.
Janse A1, Wiborg JF1, Bleijenberg G1, Tummers M1, Knoop H1.

Abstract
OBJECTIVE:
To determine the efficacy of a cognitive-behavioral intervention for patients meeting U.S. Centers for Disease Control and Prevention (CDC) criteria for idiopathic chronic fatigue (ICF). ICF is thought to be a less severe disorder than chronic fatigue syndrome (CFS). The intervention consisted of a booklet with self-instructions combined with e-mail contact with a therapist.

METHOD:
Randomized controlled trial conducted at an outpatient facility. All patients suffered from severe and persistent fatigue with moderate impairment levels or fewer than 4 additional symptoms. Patients were randomly allocated to either guided self-instruction or a wait-list control group. Primary outcome measures were fatigue severity assessed with the Checklist Individual Strength and level of overall impairment assessed with the Sickness Impact Profile. Outcome measures were assessed prior to randomization and following treatment or wait-list control group.

RESULTS:
One hundred patients were randomly allocated to the intervention or a wait-list control group and 95 completed second assessment. An intention-to-treat analysis showed significant treatment effects for fatigue severity (-8.98, 95% confidence interval [CI] [-13.99, -3.97], Cohen's d = 0.68, p < .001) and for overall impairment (-317.19, 95% CI [-481.70, -152.68], Cohen's d = 0.53, p < .01) in favor of the intervention. The number of additional symptoms and overall impairment at baseline did not moderate posttreatment fatigue severity. Baseline overall impairment moderated posttreatment impairment.

CONCLUSIONS:
Patients with ICF can be treated effectively with a minimal intervention. This is relevant as ICF is more prevalent than CFS and treatment capacity is limited.

(c) 2016 APA, all rights reserved).

PMID:
26950098
DOI:
10.1037/ccp0000085
[PubMed - indexed for MEDLINE]

 

[Tom Kindlon]

I just posted a comment on this on PubMed Commons:

https://www.ncbi.nlm.nih.gov/pubmed/26950098#cm26950098_62209

Tom Kindlon 2017 Feb 28 3:44 p.m. (just added)

A major limitation was not mentioned: no objective outcome measures were used

I was amazed to read the long (906-word) limitations section and find no mention of the limitation that the results rely solely on subjective outcome measures[1].

The most obvious outcome measure to use would have been actometers which measure activity levels objectively. The equipment was available to the researchers as it was used at baseline ["Physical activity was assessed with an actometer, a motion-sensing device worn at the ankle for 14 days"].

The importance of the use of such a measure can be seen in the results of an earlier study using the the same or very similar intervention on people with chronic fatigue syndrome[2]. That study involved two of the current research team with one of them being its corresponding author. That paper reported improvements in the intervention group on the CIS fatigue severity, SIP8 total score and SF–36 physical functional questionnaires (which were also used in the current study). Subsequently to that, data from the actometers were reported in a paper co-authored by three of the current team[3]. Both the intervention group and the control group had the same change in activity, 4.3 units, during the trial. The intervention group finished at 67.8 units, significantly less than the actometer scores for healthy controls of 91.

Numerous response biases could be at play in this nonblinded study with such interventions causing participants to report improvements without their objectively-measured levels of functioning having improved.

If actometers were used during or after the current study, it is important that the researchers should now release such data, rather than delay for years as they have done with some trials before[3].

References:

1 Janse A, Wiborg JF, Bleijenberg G, Tummers M, Knoop H. The efficacy of guided self-instruction for patients with idiopathic chronic fatigue: A randomized controlled trial. J Consult Clin Psychol. 2016 May;84(5):377-88.

2 Knoop H, van der Meer JW, Bleijenberg G. Guided self-instructions for people with chronic fatigue syndrome: randomised controlled trial. Br J Psychiatry. 2008 Oct;193(4):340-1.

3 Wiborg JF, Knoop H, Stulemeijer M, Prins JB, Bleijenberg G. How does cognitive behaviour therapy reduce fatigue in patients with chronic fatigue syndrome? The role of physical activity. Psychol Med. 2010 Aug;40(8):1281-7.

 

[Grigor]

Bravo. Take 'm down. Ugh. Can't believe Knoop is being promoted to professor.

https://www.amsterdamresearch.org/w...l-psychology-amc-appointed-as-professor.-.htm

 

[A.B.]

So one group got something, the other got nothing and was probably disappointed since they did visit a hospital with the intention to find some help.

It's the same old problem all these CBT/GET studies have: everything is set up to introduce bias in favor of the intervention preferred by the authors.

 

[Tom Kindlon]

The treatment is based on the protocol of face-to-face CBT for CFS (Knoop & Bleijenberg, 2010). The cognitive– behavioral model for CFS for this intervention is based on the assumptions that fatigue-related cognitions and behavior perpetuate fatigue (Wiborg, Knoop, Frank, & Bleijenberg, 2012). Patients learn to change these cognitions and behaviors.

In order to reduce the focus on fatigue patients learned to shift their attention away from the fatigue. Patients were instructed to no longer discuss their fatigue with others and learned to cope with negative or overprotective responses of significant others. Patients then started with gradually increasing their physical activity.

 

[Dolphin]

There was a positive and significant correlation between the mean number of words written by the patient (Spearman’s rho = .288, p = .049) and the change in fatigue severity but not with change in impairment. The number of e-mails sent by therapist of patient, and the number of words used by the therapist did not correlate with change in fatigue or impairment at second assessment. We repeated the correlation analysis with those patients who did start treatment (N = 44), and the change in fatigue severity correlated positively with the mean number of words used by the therapist (Spearman’s rho = .414, p = .005) but not with the number of words used by the patient. The change in impairment did not correlate with any of the e-mail variables.

 

[Dolphin]

Patients with a higher level of overall impairment profited less from the intervention.

This indicates that baseline overall impairment predicts whether patients profit from the minimal intervention, which is a replication of previous findings (Knoop et al., 2008) in CFS patients. Knoop et al. also found that patients with high overall impairment profited less from guided self-instructions.

 

[Dolphin]

Recovery. For fatigue severity, a healthy level of fatigue for ICF patients was defined as a CIS fatigue score of 27 or lower at second assessment. This score is the mean plus 1 SD of a norm group of healthy adults (Vercoulen et al., 1999). By choosing the mean plus the range of 1 SD of a healthy norm group, ICF patients who score within this range cannot be differentiated from healthy adults. Norm scores of healthy people were also used to set a criterion for healthy functioning on the other outcome measures (see Knoop, Bleijenberg, Gielissen, van der Meer, & White, 2007). Full recovery was defined as a combination of a CIS fatigue score of 27 or lower, a SIP8 score of 203 or lower, a SF-36 physical functioning score of 80 or higher and a SF-36 social functioning score of 75 or higher at second assessment (Knoop et al., 2007).

So they didn't use the threshold of 60+ on the SF 36 physical functioning subscale used in the PACE trial.

 

[Dolphin]

No significant difference—F(1, 97) = 2.57 p = .110; SF-36 physical functioning—was found on physical functioning between the guided self-instruction group (M = 81.86, SD = 18.00) and the wait-list participants (M = 79.76, SD = 14.23).

There was no positive effect of the intervention on physical functioning. We think that this can be explained by the fact that the ICF patient already scored high (M = 71.8, SD = 18.4) on this scale at baseline, compared with the norm score for healthy adults without a chronic condition (M = 93.1, SD = 11.7; Aaronson et al., 1998). This indicates that a substantial number of patients do not experience many problems in their physical functioning and room for improvement is limited. In previous studies testing the effect of guided self-instruction in CFS patients, a significant increase in physical functioning was found (Knoop et al., 2008; Tummers et al., 2012). In the latter study a significant increase in physical functioning was only found in a subgroup, with lower scores on the physical functioning subscale at baseline.

 

[Hutan]

There was a positive and significant correlation between the mean number of words written by the patient (Spearman’s rho = .288, p = .049) and the change in fatigue severity but not with change in impairment. The number of e-mails sent by therapist of patient, and the number of words used by the therapist did not correlate with change in fatigue or impairment at second assessment.

We repeated the correlation analysis with those patients who did start treatment (N = 44), and the change in fatigue severity correlated positively with the mean number of words used by the therapist (Spearman’s rho = .414, p = .005) but not with the number of words used by the patient. The change in impairment did not correlate with any of the e-mail variables.

and Huh?

I find it hilarious that it was thought worth trying to find (and then reporting) a relationship between the mean number of words written in the emails, particularly the number of words written by the therapist, and changes in fatigue severity. So, we just need to read or write longer emails to get better?

(Perhaps they should have checked to see if there was a correlation between the number of words in the emails starting with 's' and change in fatigue - I find the sound of such words rather soothing...
Or perhaps they could have analysed the number of 'I's (as in 'I am') used by the patients in their emails - as high levels might indicate an unhealthy pre-occupation with oneself....)

But what is this paragraph actually saying @Dolphin? I can't see the whole report.

In the second part of the paragraph they found that the number of words written by the therapist was correlated with change in fatigue but the mean number of words written by the patient was irrelevant. This group was described as 'patients who started treatment' n=44.

In the first part of the paragraph they found the opposite - that the mean number of words written by the patient was correlated with change in fatigue but the mean number of words written by the therapist was irrelevant. But what group was that in? Perhaps those who both started and finished the treatment?

If the results can change 180 degrees with just a tweak of the group studied, it is all even more laughably random.

Of course this whole paper is irrelevant to scientific progress and my question about the group composition is just idle curiosity.

 

[Dolphin]

and Huh?

I find it hilarious that it was thought worth trying to find (and then reporting) a relationship between the mean number of words written in the emails, particularly the number of words written by the therapist, and changes in fatigue severity. So, we just need to read or write longer emails to get better?

(Perhaps they should have checked to see if there was a correlation between the number of words in the emails starting with 's' and change in fatigue - I find the sound of such words rather soothing...
Or perhaps they could have analysed the number of 'I's (as in 'I am') used by the patients in their emails - as high levels might indicate an unhealthy pre-occupation with oneself....)

But what is this paragraph actually saying @Dolphin? I can't see the whole report.

In the second part of the paragraph they found that the number of words written by the therapist was correlated with change in fatigue but the mean number of words written by the patient was irrelevant. This group was described as 'patients who started treatment' n=44.

In the first part of the paragraph they found the opposite - that the mean number of words written by the patient was correlated with change in fatigue but the mean number of words written by the therapist was irrelevant. But what group was that in? Perhaps those who both started and finished the treatment?

If the results can change 180 degrees with just a tweak of the group studied, it is all even more laughably random.

Of course this whole paper is irrelevant to scientific progress and my question about the group composition is just idle curiosity.

All analyses were based on intention-to-treat for all randomized patients.

We analyzed e-mail data to determine if treatment outcome was related to the communication between patient and therapist. Correlations coefficients were calculated between the number of e-mails sent by therapists or patients, the mean number of words per e-mail and the change score in fatigue severity and overall impairment. First, data of all patients allocated to the guided self-instruction with complete outcome measures were analyzed. Second, the correlation analysis was repeated with the subset of patients who had started treatment, that is, had sent more than one e-mail to their therapist.

Of the five patients who did not complete the second assessment, three were in the treatment group and two were from the wait-list control group. The three patients from the treatment group did not e-mail with their therapist. One patient found the information in the treatment booklet not applicable to his situation and one patient did not start treatment because he was diagnosed with colon cancer (shortly after randomization) and refused to fill in the questionnaires because it would reflect the consequences of the illness. Of the third patient the reasons for not starting treatment were unknown.

50 were allocated to the intervention group so does were the people who were analysed initially.

As the quote says above, 3 of those never did the therapy bringing the number down to 47.

I'm not sure why it went down to 44.

The results aren't necessarily a full 180° turn. They could be going from borderline significant to just over the P equals 0.05 threshold and vice versa. But it is a little odd all right.

 

[Skippa]

Is it not refreshing for once to see "chronic fatigue" being differentiated from "CFS"?

 

[A.B.]

Is it not refreshing for once to see "chronic fatigue" being differentiated from "CFS"?

It's going to be hilarious watching them once a diagnostic test is available. In the blink of an eye, they will abandon the idea that all CFS is the same, and start babbling about subgroups for which CBT is still supposedly relevant. And those subgroups will coincidentally begin where relevance of the diagnostic test ends.

 

[Sean]

And those subgroups will coincidentally begin where relevance of the diagnostic test ends.

And always will.

 

[Snow Leopard]

Doesn't this study really prove how useless these questionnaires are in unblinded studies?

 

[slysaint]

I'd never heard of ICF until I read this, but after a few searches see it appears to have been around a while. But I can't find it on the NHS sites. Is it recognised by WHO?
Does anyone know of people who have been diagnosed with ICF?