Lopez et al: A pilot study of CB stress management effects in CFS

Dolphin

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A pilot study of cognitive behavioral stress management effects on stress, quality of life, and symptoms in persons with chronic fatigue syndrome
Corrected Proof, 18 January 2011
Corina Lopez, Michael Antoni, Frank Penedo, Donna Weiss, Stacy Cruess, Mary-Catherine Segotas, Lynn Helder, Scott Siegel, Nancy Klimas, Mary Ann Fletcher
Journal of Psychosomatic Research
DOI: 10.1016/j.jpsychores.2010.11.010
http://www.jpsychores.com/article/S0022-3999(10)00447-2/abstract

A pilot study of cognitive behavioral stress management effects on stress, quality of life, and symptoms in persons with chronic fatigue syndrome☆

Corina Lopez, Michael Antoni, Frank Penedo, Donna Weiss, Stacy Cruess, Mary-Catherine Segotas, Lynn Helder, Scott Siegel, Nancy Klimas, Mary Ann Fletcher


Received 21 September 2010; received in revised form 26 November 2010; accepted 29 November 2010. published online 18 January 2011.
Corrected Proof

Abstract
Objective
The present pilot study was designed to test the effects of a 12-week group-based cognitive behavioral stress management (CBSM) intervention on stress, quality of life, and symptoms in chronic fatigue syndrome (CFS). We hypothesized that participants randomized to CBSM would report improvements in perceived stress, mood, quality of life, and CFS symptomatology from pre- to postintervention compared to those receiving a psychoeducational (PE) seminar control.

Method
We recruited 69 persons with a bona fide diagnosis of CFS and randomized 44 to CBSM and 25 to PE. Participants completed the Perceived Stress Scale (PSS), Profile of Mood States (POMS), Quality of Life Inventory (QOLI), and a Centers for Disease Control (CDC)-based CFS symptom checklist pre- and postintervention.

Results
Repeated measures analysis of variance revealed a significant GroupTime interaction for PSS, POMStotal mood disturbance (TMD), and QOLI scores, such that participants in CBSM evidenced greater improvements than those in PE. Participants in CBSM also reported decreases in severity of CFS symptoms vs. those in PE.

Conclusions
Results suggest that CBSM is beneficial for managing distress, improving quality of life, and alleviating CFS symptom severity.

Keywords: CDC symptoms, Chronic fatigue syndrome, Quality of life, Stress, Stress management
University of Miami, Miami, FL, USA

Corresponding author. Department of Psychology, 5665 Ponce DeLeon Blvd., Coral Gables, FL 33124, USA.

☆ This study was funded by the National Institutes of Health (NIH) (1 U01 AI45940 and 1R01 NS055672-01).

PII: S0022-3999(10)00447-2

doi:10.1016/j.jpsychores.2010.11.010
 

Dolphin

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Only got significant results because control group got worse!!?

It looks to me that they only got statistically significant improvements (none large) because the control group (who got another intervention) got worse on all the measures.

Also, it looks to me like they should have shown the sort of results I'm copying below but didn't do it (i.e. where is the within group analysis?).

The final sample consisted of 69 participants: 44 were
randomized to the CBSM condition and 25 to the
psychoeducation control group using a 2:1 ratio method.
This technique was used to ensure that there was a
sufficient sample size for conducting within-group analyses
in the experimental condition.
A paired t-test would have been better but we don't have that data. However, lots of times one can't do a paired t-test as data is missing for one reason or another.

Maybe I'm missing something?

People can feel free to use this if they want to write a letter. I've way too much in my "to be done" basket

------------
Analysing all the data in Table 2. We are also told in the text that there was no difference for "CFS symptom frequency" but I think it is slightly misleading not to put it in Table 2 as it looks like everything improved compared to the controls.

http://www.graphpad.com/quickcalcs/ttest1.cfm?Format=SD

----------

Perceived stress

Unpaired t test results

P value and statistical significance:
The two-tailed P value equals 0.3327 By conventional criteria, this difference is considered to be not statistically significant.

Confidence interval:
The mean of Before minus After equals 2.1100
95% confidence interval of this difference: From -2.2014 to 6.4214

Intermediate values used in calculations:
t = 0.9751
df = 74
standard error of difference = 2.164

Review your data:


Group Before After
Mean 29.2200 27.1100
SD 8.7700 10.0500
SEM 1.4227 1.6303
N 38 38
-------
POMS-Fatigue

Unpaired t test results
P value and statistical significance:
The two-tailed P value equals 0.7318 By conventional criteria, this difference is considered to be not statistically significant.

Confidence interval:
The mean of Before minus After equals 0.5000
95% confidence interval of this difference: From -2.3964 to 3.3964

Intermediate values used in calculations:
t = 0.3440
df = 74
standard error of difference = 1.454

Review your data:


Group Before After
Mean 18.3500 17.8500
SD 5.1400 7.3400
SEM 0.8338 1.1907
N 38 38
-------------
POMS-Total mood disturbance

Unpaired t test results
P value and statistical significance:
The two-tailed P value equals 0.2001 By conventional criteria, this difference is considered to be not statistically significant.

Confidence interval:
The mean of Before minus After equals 9.9800
95% confidence interval of this difference: From -5.4018 to 25.3618

Intermediate values used in calculations:
t = 1.2928
df = 74
standard error of difference = 7.720


Review your data:


Group Before After
Mean 44.0100 34.0300
SD 32.8500 34.4300
SEM 5.3290 5.5853
N 38 38
------

QOLI Category

Unpaired t test results
P value and statistical significance:
The two-tailed P value equals 0.1957 By conventional criteria, this difference is considered to be not statistically significant.

Confidence interval:
The mean of Before minus After equals 0.3200
95% confidence interval of this difference: From -0.1684 to 0.8084

Intermediate values used in calculations:
t = 1.3056
df = 74
standard error of difference = 0.245


Review your data:


Group Before After
Mean 3.1300 2.8100
SD 0.9800 1.1500
SEM 0.1590 0.1866
N 38 38
----------
QOLI Raw score

Unpaired t test results
P value and statistical significance:
The two-tailed P value equals 0.4545 By conventional criteria, this difference is considered to be not statistically significant.

Confidence interval:
The mean of Before minus After equals -0.3200
95% confidence interval of this difference: From -1.1680 to 0.5280

Intermediate values used in calculations:
t = 0.7519
df = 74
standard error of difference = 0.426

Review your data:


Group Before After
Mean 0.8500 1.1700
SD 1.8800 1.8300
SEM 0.3050 0.2969
N 38 38
----------
QOLI T score

Unpaired t test results
P value and statistical significance:
The two-tailed P value equals 0.4458 By conventional criteria, this difference is considered to be not statistically significant.

Confidence interval:
The mean of Before minus After equals -2.5300
95% confidence interval of this difference: From -9.1064 to 4.0464

Intermediate values used in calculations:
t = 0.7665
df = 74
standard error of difference = 3.301


Review your data:


Group Before After
Mean 36.7500 39.2800
SD 14.6000 14.1700
SEM 2.3684 2.2987
N 38 38
----------
Total CDC symptom severity

Unpaired t test results
P value and statistical significance:
The two-tailed P value equals 0.4647 By conventional criteria, this difference is considered to be not statistically significant.

Confidence interval:
The mean of Before minus After equals 0.0600
95% confidence interval of this difference: From -0.1027 to 0.2227

Intermediate values used in calculations:
t = 0.7349
df = 74
standard error of difference = 0.082


Review your data:


Group Before After
Mean 2.0700 2.0100
SD 0.3800 0.3300
SEM 0.0616 0.0535
N 38 38
 

Dolphin

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Descriptions of the two interventions

Descriptions of the two interventions

The CBSM intervention [14] consisted of 12 weekly
group meetings held in 2-h sessions. Each 2-h session
consisted of two parts: a relaxation component lasting from
20 to 30 min and a didactic and discussion component that
lasted 90 min. During the relaxation component, participants
were instructed in specific relaxation techniques, including
progressive muscle relaxation and visualization techniques.
During this 20- to 30-min period, participants discussed their
views on the helpfulness of the techniques, as well as any
barriers to practice, and the progress of their at-home
practice. During the 90-min didactic component, participants
were taught to better recognize how stress impacts
them emotionally and physically, and the relationship
between thoughts, feelings, and behaviors. The primary
therapeutic technique used was cognitive restructuring
targeting cognitive appraisals of ongoing stressors. In
contrast to previously studied CBT techniques that target
CFS-specific cognitions and physical deconditioning behaviors,
a specific focus of CBSM is on teaching participants
general stress management skills that they can apply to
ongoing life events as well as CFS-specific stressors. In
addition to cognitive restructuring, they also learned specific
coping skills and interpersonal communication skills such as
assertiveness and anger management, which are designed to
better attract, utilize, and maintain social support, an
important stress moderator. Homework pertaining to session
topics was assigned each week and was collected and
discussed in the subsequent week. Home practice of
relaxation techniques was also encouraged. The CBSM
groups were led by a postdoctoral clinical fellow and by
advanced psychology graduate students.
The half-day PE condition summarized many of the strategies from the
12-week CBSM group but in a condensed format. The
seminar was scheduled during the sixth week of the CBSM
group and was run by a clinical postdoctoral fellow.
Participants in both conditions were given a workbook and
three relaxation tapes to practice at home.
 
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It looks to me that they only got statistically significant improvements (none large) because the control group (who got another intervention) got worse on all the measures.

Also, it looks to me like they should have shown the sort of results I'm copying below but didn't do it (i.e. where is the within group analysis?).

A paired t-test would have been better but we don't have that data. However, lots of times one can't do a paired t-test as data is missing for one reason or another.

Maybe I'm missing something?
What sort of statistical analysis did they use - was it some sort of ANOVA? And did they try to calculate an effect size as well as stating significance? I'm somwthing of a Stats novice so my questions may be off target.
 

Dolphin

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What sort of statistical analysis did they use - was it some sort of ANOVA?
F-test. Here's an example:
A significant interaction of TimeGroup emerged for PSS
[F(1, 53)=5.07, P=.028], such that participants in the CBSM
condition experienced greater decreases in perceived stress
from T1 to T2 than participants in the PE group.
And did they try to calculate an effect size as well as stating significance? I'm somwthing of a Stats novice so my questions may be off target.
Yes, they calculated a cohen's D effect size. All the ones that were statistically significant had an absolute value of 0.20 to 0.43.

However, these looks like effect sizes of the differences. Given that the control group got worse on all the measures, what is more interesting I think is the changes within the experimental group. Can one calculate effects sizes with the data we have?
I'm not sure based on this comment:
Within-subjects Studies
For within-subjects studies, one must correct for dependence among means in order to make direct comparisons to effect sizes from between-subjects studies. To do this, you also need to enter the correlation between the two means, so that Morris and DeShon's (2002) equation 8 can be applied.
http://www.cognitiveflexibility.org/effectsize/

This is what I get when I stick the data we have in for "Perceived stress":
Input data provided:
Mean 1: 29.22
SD 1: 8.77
Mean 2: 27.11
SD 2: 10.05

I have assumed your data are between-subjects.

Output:
Cohen's d: 0.224

This is based on the average SD from two means.
All the figures are given in my second post so if people are used to calculating effect sizes, feel free to do them.

If one uses (mean2-mean1)/SD1=-0.24
 

Cort

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It doesn't sound like they had much success. Did they even try to measure functionality? It seems like yet another CBT study; some improvements in symptoms and stress but nothing very dramatic....When are they going to stop throwing money at this? This was a big NIH ROI grant....Don't they know what they know by now?
 
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It doesn't sound like they had much success. Did they even try to measure functionality? It seems like yet another CBT study; some improvements in symptoms and stress but nothing very dramatic....When are they going to stop throwing money at this? This was a big NIH ROI grant....Don't they know what they know by now?
How very true. do you know how much the study cost?
 

Cort

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The answer to that is its really hard to tell. It appears to be part of a 5 year study - which is focused on telephone CBSM (although no tele CBSM was used in this study. It looks like they got some good preliminary data indicating the program was reducing cytokine and inflammatory marker levels and cortisols abnormalities and repackaged it and got more money in 2010 to include looking at those and added patients having partners to the study. I imagine there are other studies coming out.

http://projectreporter.nih.gov/reporter_searchresults.cfm?&new=1&icde=6818037&loc=2&CFID=34433770&CFTOKEN=49016940

  • 2006 - $343,000
  • 2007 - $334,000
  • 2008 - $327,000
  • 2009- $343,000
  • 2010 - $536,000
  • Grand Total - @ $1,800,000

There appears to the latest iteration of the study...It has a different RO1 number.

DESCRIPTION (provided by applicant): This is a 5-year study to evaluate the effect of a 10-week patient-partner telephone- based cognitive behavioral stress management (CBSM) intervention on chronic fatigue syndrome (CFS) symptoms in 150 patients diagnosed with CFS. Because many patients with CFS are unable to attend intervention sessions in clinical settings due to unpredictable periods of debilitating fatigue and limited mobility, we created a form of CBSM intervention that is delivered at the participant's home through a telecommunications system (i.e., Telephone-based CBSM, T-CBSM). A unique aspect of T-CBSM is that it uses the telephone to convene groups of individuals in their homs-thus it retains some of the supportive elements of a group-based intervention.

We have observed that over a 5-month period this patient-focused T-CBSM intervention is associated with decreases in CDC-based CFS symptoms and decreases in the pro- inflammatory cytokines, interleukin-1b (IL-1b) and tumor necrosis factor-a (TNF-a) and increases in the anti-inflammatory cytokine, IL-13. Greater decreases in pro- inflammatory cytokines were associated with greater increases in the negative pitch of the AM-PM slope of salivary cortisol and greater decreases in CFS symptoms. This supported our neuroimmune model as an explanation for the effects of T-CBSM on CFS symptoms.

We also conducted subgroup analyses comparing partnered and unpartnered CFS patients and found that the effects of the intervention were much larger in the partnered group.

We have designed a study to follow up on these findings by testing a newly designed partner-patient dual focus videotelephone-delivered CBSM intervention (PP-T-CBSM) that allows the partner to learn stress management techniques with the patient in a group setting and to then practice together a set of stress management techniques such as relaxation and cognitive, behavioral and interpersonal skills training.

We will compare changes in CFS symptoms, neuroimmune indicators, and psychosocial (patient and partner) functioning in participants assigned to PP-T-CBSM vs an attention time-matched telephone-based health information (T-HI) control condition in a 2 X 3 randomized experimental design with group (PP-T-CBSM, n=75 vs. T-HI, n=75) as the between-group factor, and time (Pre-intervention, 5- and 9- month follow-up) as the within-group factor.

PUBLIC HEALTH RELEVANCE: Because chronic fatigue syndrome (CFS) is a debilitating condition, that has no cure, and which represents an economic burden for society due to high rates of unemployment due to disability and repeated utilization of healthcare resources it is critical that interventions target long-term management by addressing the multi-level factors that maintain the symptoms of this disorder. The results of this study have major significance since they might offer an intervention that is efficacious in managing CFS symptoms through a theory-based comprehensive stress management approach, and one that will reach a broader population of CFS patients who would not otherwise be able to benefit from these empirically supported techniques. The proposed study is innovative in being the first randomized trial to test the effects of a patient-partner Video- Telephone-delivered psychosocial intervention (PP-T-CBSM) for CFS patients while examining a neuroimmune mechanism (hypothalamic-pituitary-adrenal [HPA] axis-cytokine regulation) to explain the effects of this intervention on CFS symptoms.
 
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It looks to me that they only got statistically significant improvements (none large) because the control group (who got another intervention) got worse on all the measures. Also, it looks to me like they should have shown the sort of results I'm copying below but didn't do it (i.e. where is the within group analysis?).
I agree on both counts.

Selective reporting of results. Basically they've failed to report the main effect measures (ie the effect of the CBT vs control, and the before/after effect) presumably because they were not significant, as shown by Dolphin's calculation. Doesn't say much for the peer review process or the standards of the journal that they let the authors get away with this. Instead, the authors report the GroupxTime interaction, which is probably only significant because the control group got slightly worse - and even then the results are only just significant.

Study design flaws. As the authors acknowledge in the discussion, the control group is flawed as it invloved far less contact time, and they didn't measure whether or not results were sustained by follow-up. Doing either of these is likely to reduce any measured effect so the fig leaf of significance they've conjured up is likely to disappear.

Surely a sensible response to these results would be to publish what they've got then slip quietly into the night, not to suggest spending more funds and effort pursuing a lost cause? Thanks to Cort for the funding figures.

Finally, it's worth noting that this study was based on using CBT with a stress model for CFS, rather than the more usual deconditioning model, so the results are not directly relevant to the debate about 'usual' CBT for CFS.
 

Dolphin

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The CBSM intervention [14] consisted of 12 weekly group meetings held in 2-h sessions.
[14] Weiss D, Helder L, Antoni MH. Development of the SMART ENERGY
program. In: Jason L, Fenell P, Taylor R, editors. Handbook
of Chronic Fatigue Syndrome and Fatiguing Illnesses. New York: John
Wiley & Sons, 2003. p. 54660.
Ellen Goudsmit reviews that handbook at:
http://freespace.virgin.net/david.axford/bookrev8.htm

There are 4 paragraphs on the Weiss et al section although maybe only one on the SMART ENERGY program.

Ellen was annoyed about that handbook and given the Bleijenberg chapter (which I have read) I couldn't blame her. Generally I have no problem with stuff Lenny Jason writes and he was just the editor which isn't the same thing at all as writing "bad" stuff like the Bleijenberg chapter.
 

Cort

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Dr. Klimas comments on the study

"I pressed Dr. Antoni to get this study published in large part to rebut Dr. Whites claim to cure 25% of ME/CFS patients with CBT. Dr Antonis study shows that while CBT helps people with the illness as it does in every chronic disease model ever tested, it does not cure the illness. Dr. White challenged me in a meeting a year ago saying nothing else had been published to deny this finding. SO now you have a publication, written by a psychologist and well regarded CBT expert to use when you want to argue that CBT helps people with this illness (as it does in every chronic disease model ever tested) but does not cure the illness.

It is easy to pick apart any study after the fact, but put this in the context of the time (2001 when the grant request was written) and place (the US where we were absolutely obliged to use the CDC case definition if we hoped for funding at the time.)

I am very proud to work with a multidisciplinary team that includes experts in autonomic function, immunology, cell biology, psychoneuroimmunology, genomics, systems biology, nutrition, measurement illness state the list goes on. Its a very exciting time and the team is very much jazzed and wants to see the work we do in all of these areas lead to both a clear understanding of the illness at the cellular level and then to effective treatments. You are going to see many papers this year from the different members of the team and taken separately you may fail to see the big picture. Dont get sucked into too narrow a view. Wait and see some amazing science is underway."

Nancy G. Klimas, M.D.
 

Dolphin

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Given the intervention in the Lopez et al. study is quite different from Dutch/UK CBT, I'm not sure it tells us anything about the cure rate from the latter.
Not that I believe that study* really showed "full recovery" in 23%. I have a half finished paper on the topic I might submit sometime.

*Knoop H, Bleijenberg G, Gielissen MF, van der Meer JW, White PD. Is a full recovery possible after cognitive behavioural therapy for chronic fatigue syndrome?Psychother Psychosom. 2007;76(3):171-6. PMID: 17426416
 

Enid

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Dr Nancy Klimas comments sound good to me Cort, especially if she going to unravel the claims of Psychos. Personally happy to wait.
 

biophile

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Really?

"nklimas" said:

I had pressed Dr Antoni to get this study published in large part to rebut Dr Whites claim to cure 25% of ME/CFS patients with CBT. Dr Antonis study shows that while CBT helps people with the illness as it does in every chronic disease model ever tested, it does not cure the illness. - C-308

Dr White challenged me in a meeting a year ago saying nothing else had been published to deny this finding. So now you have a publication, written by a psychologist and well regarded CBT expert to use when you want to argue that CBT helps people with this illness (as it does in every chronic disease model ever tested) but does not cure the illness. - C-307.
Hmmm, something doesn't add up here, am I missing something? Unless either Klimas misinterpreted something he said, or White himself is shockingly ignorant of the research published in his own field of interest and/or engaging in purposeful cherry picking and/or making shit up to be frank.

First of all, Lloyd et al 1993 demonstrated no overall effect in a trial which used CBT, nearly two decades ago, no apparent cures from CBT. Since then, there have been a few other studies which have demonstrated basically no effect worth considering, AFAIK no "25% cure rate". There are one or two highly optimistic studies which do report such rates of "full recovery", which apparently White sees as representative of the entire literature?

All that is before you consider what others have already said, such as the burden is on White to prove he is studying ME/CFS and that there is a reliable 25% "cure" rate in ME/CFS using appropriate measurements rather than dubious fatigue scales etc. Otherwise his claim is just another "CFS assfact" and he may be engaging in outright quackery if pushing those claims onto his patients.

On the study Klimas was involved in (Lopez et al 2011), White could attempt to argue that CBSM is not the same style of CBT he uses. In the full text they claim that "a recent review showed that out of 15 studies, CBT was more successful in alleviating fatigue, depression, physical functioning, and more when compared to usual care.", citing the 2008 Cochrane systematic review on CBT. However, they failed to mention that review deemed those effects for physical functioning and depression (and more?) as non-significant.
 

WillowJ

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White is probably misrepresenting the literature. It's typical for the psychobabble crowd to ignore everything which cannot be contorted to support their pet ideas.

Perhaps there aren't any psychologist/psychiatirst CBT studies? Lloyd is, I think not a psych.
 

biophile

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White is probably misrepresenting the literature. It's typical for the psychobabble crowd to ignore everything which cannot be contorted to support their pet ideas.

Perhaps there aren't any psychologist/psychiatirst CBT studies? Lloyd is, I think not a psych.
Ian Hickie was also involved, I think he's a psychiatrist.