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(PACE Trial) Training, supervision and therapists' adherence to manual-based therapy

Dolphin

Senior Member
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17,567
http://www.ijtr.co.uk/cgi-bin/go.pl/library/abstract.html?uid=97926
Training, supervision and therapists' adherence to manual-based therapy

Diane Cox, Mary Burgess, Trudie Chalder, Michael Sharpe, Peter White, Lucy Clark

International Journal of Therapy and Rehabilitation, Vol. 20, Iss. 4, 08 Apr 2013, pp 180 - 186

Objectives:

To describe the development, delivery and quality control of three manual-based therapies as given in an inter-professional multi-centre randomized controlled trial of therapies for chronic fatigue syndrome (CFS).

Methods:

Experienced therapy leaders were recruited. These therapy leaders then developed the treatments and therapy manuals, piloted them, and planned training and supervision.

Appropriately-qualified therapists were recruited to deliver each therapy and trained in the specific therapy philosophy, model and delivery.

Training and supervision was face-to-face and by telephone, and included reviewing audio recordings of therapy sessions.

Results:

At the end of the trial, the therapists delivering all three trial therapies were similarly highly rated as adhering well to their manuals and scored similarly and highly on therapeutic alliance with patients and therapy differentiation.

Conclusions:

High-quality delivery of therapy can be achieved if there is an experienced therapy lead, if therapy manuals have been piloted, and if therapists are well trained and supervised, including the review of recorded treatment sessions.


Routine clinical practice could benefit from the implementation of these procedures.
 

Dolphin

Senior Member
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17,567
For what it's worth:


Key points

- Therapy manuals and therapist training in these manuals can decrease deviations from therapy adherence and fidelity.

- Supervision helps to ensure therapy integrity is maintained and therapy drift is avoided.

- Therapists and participants in this study had their own therapy manuals, which were amended by therapy leads after a 3-month pilot and in line with their experience.

- Therapists received eight therapy-specific group training days.

- Therapy leaders observed therapists, facilitated reflections in therapists’ supervision sessions, and monitored their performance.

- Therapy was similarly-highly rated by participants as adhering well to manuals, was not significantly different across therapies, and nearly all sessions delivered were the session the manuals had allocated.
 

Dolphin

Senior Member
Messages
17,567
Not sure this paper is worth spending time reading for most people interested in ME/CFS (and perhaps a lot of other people also!).

As far as I can see, it doesn't contain any new quantitative data.

The results section is really short for a 7-page paper:


Results

Evidence of adherence to manuals and therapy All three trial therapies were similarly highly rated by participants as adhering well to their manuals (6–6.5 out of 7 where 1=not at all and 7=very much so). The median scores for therapeutic therapeutic alliance were high (6.5 out of 7 where 1=poor and 7=excellent) and not significantly different across therapies (White et al, 2011). Therapy differentiation was also high; the two independent therapy assessors rated 94% (58/62) and 92% (57/62) of therapy sessions as being the one allocated, with only one session rated by both assessors as different from that allocated (White et al, 2011). See Table 1.

Table 1. Adherence to therapy and therapy manuals is just data from Table 2 in White et al, 2011 on five items:

i.e.


Column #1: Adaptive pacing therapy (n=159)
Column #2: Cognitive behaviour therapy (n=161)
Column #3: Graded exercise therapy (n=160)


Therapy sessions attended†
13 (12-15) 14 (12-15) 13 (12-14)

Adequate treatment§ 143 (90%) 140 (87%) 136 (85%)

Drop-outs from treatment
11 (7%) 17 (11%) 10 (6%)

Therapeutic alliance* 6.5 (6.0-6.5) 6.5 (5.5-6.8) 6.5 (5.5-7.0)

Adherence to manual** 6.0 (6.0-6.5) 6.0 (5.0-6.5) 6.5 (6.0-6.5)

Data are median (IQR) or n (%)

†86% sessions of therapy were received face-to-face, 14% by telephone
§Adequate treatment was 10 or more sessions of therapy

*Scored 1-7 (1=poor, 7=excellent)

** Scored 1-7 (1=not at all, 7=very much so)

Data from White et al, 2011
 

Dolphin

Senior Member
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17,567
Therapists’ qualifications and recruitment

Therapists who had trained in the most suitable clinical discipline and had at least 1 year of patient assessment experience were recruited. They had to show evidence of knowledge and an insight into the issues around CFS or chronic pain management. In contrast to the therapy leaders, therapists were not required to have had experience of treating CFS, or to have any research experience.
This reminds me of something in the main PACE Trial paper in the Lancet I thought I'd highlight again:

The finding that APT when added to SMC was no more eff ective than SMC alone was contrary to our initial hypothesis. This finding might in part be caused by greater improvement after SMC than was expected. Suboptimum delivery of APT is an unlikely explanation because APT therapists were the most experienced; the therapeutic alliance and the adherence to manuals were rated highly in this group and participant satisfaction did not diff er from that for other therapies.

From Appendix:
Years of post-qualification experience APT/CBT/GET: median (range) 7 (5-22) 3 (0-10) 5 (1-23)

This is clearly not CFS experience as most didn't have any (see next set of figures). So I find the underline quote potentially misleading.

Also,
Previous experience in a CFS or chronic pain service APT/CBT/GET: N (%) 3 (33) 7 (54) 4 (36)

So 54% for CBT.

Also, I think they should have given the figure for CFS on its own, rather than also including "chronic pain". I'm suspicious the reason they didn't is because the figures for APT would have been lower again.
 

Dolphin

Senior Member
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17,567
Therapist training Training consisted of an introduction to CFS, its commonly-used definitions (Sharpe et al, 1991; Fukuda et al, 1994) and previous evidence for its successful management (Bagnall et al, 2001; Whiting et al, 2001; Edmonds et al, 2004).
So all therapists, APT, GET & CBT, told there was evidence for GET & CBT but not for APT.
 

Dolphin

Senior Member
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17,567
Implications for research and practice

It is acknowledged that the amount of training and supervision provided within the PACE trial was expensive and time consuming, and would be unlikely to be available in routine clinical practice. However, research indicates that making available and reading a manual alone is not sufficient to ensure competent therapy delivery (Sholomskas et al, 2005). Research indicates that adequate training in manual-based therapies is required for effective delivery in both clinical trials and in clinical practice (Morgenstern et al, 2001; Bazelmans et al, 2004).
So they're acknowledging the PACE Trial is an artificial environment.

Here is what they had said earlier about the efficacy inside and outside trials/what they said about Bazelmans et al., 2004:
The most recent treatment trials of patients with CFS suggest that inexperienced therapists and therapists with little experience of treating CFS can effectively deliver the therapies (Bazelmans et al, 2004), although the size of efficacy can be less (Prins et al, 2001). Further recent research supports the trainability of qualified therapists with no prior experience of treating CFS (Scheeres et al, 2008). However, when general practitioners (GPs) were trained to deliver CBT, it was found to be no more effective than a usual GP care control intervention (Whitehead and Campion, 2002). This suggests that therapy requires therapists to be suitably qualified.
 

Dolphin

Senior Member
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17,567
A number of components of training and supervision of a trial-based therapy are not necessarily required in routine clinical practice. These include the trial-specific aspects, such as understanding and following the trial protocol in relation to booking appointments, dealing with adverse events, trial assessments, and completing trial-related documentation.
It may well be an accurate description of what currently does happen; but it's not necessarily good that routine clinical practice would be like this and it shouldn't be encouraged (i.e. the view that adverse events are not relevant for clinical practice) particularly with graded activity/exercise-oriented therapies.
 

WillowJ

คภภเє ɠรค๓թєl
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Here is what they had said earlier about the efficacy inside and outside trials/what they said about Bazelmans et al., 2004:
...
However, when general practitioners (GPs) were trained to deliver CBT, it was found to be no more effective than a usual GP care control intervention (Whitehead and Campion, 2002). This suggests that therapy requires therapists to be suitably qualified.

Could this be because GP's have no allegiance to CBT?
http://blogs.scientificamerican.com...-effect-why-psychotherapies-never-get-better/
 

WillowJ

คภภเє ɠรค๓թєl
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It looks to me like the longer amount of experience they say counted, was in any field other than CFS or chronic pain. So could have been eating disorders, GAD, OCD, substance abuse, insomnia, and whatever else they normally use cognition/behaviour-modification CBT for.

Or, you know, coping skills for living with a disease you can't change CBT (not that none of the others are permanent diseases, just that psychiatry doesn't see them as not having a significant cognitive behavioural component... then again, they think cancer fatigue does, too!) but I sort of doubt PACE would hire someone with that experience.
 

Roy S

former DC ME/CFS lobbyist
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Location
Illinois, USA
Hear Ye! Hear Ye! Hear Ye!


Fantastic news! As we have made clear (well,... of course only to those superior beings who are able to see -- and you know who you are) The Emperor's New Clothes were elegantly designed and mass produced with proven precision. Even the House of Cards they were made in is precise. And even though we are aware (of course) that meta-analyses of other clothes prove that they are no better than those in other wardrobes ... that clearly doesn't apply to ours and we have proven it because we have said that before.
You know, someone who is really good at parody could do a series with things like alternate names with objectives, methods, results, and conclusions.

Resurrect Monty Python!
 

Bob

Senior Member
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16,455
Location
England (south coast)

There's some interesting stuff in that article (my emphasis):
Over the last few decades, the psychologist Lester Luborsky of the University of Pennsylvania tested the dodo effect by comparing different psychotherapies, including psychoanalysis, cognitive-behavioral therapy and interpersonal therapy. His research confirmed that all methods are equally helpful to patients. Claims that one therapy is more effective than others, Luborsky showed, can usually be explained by the "allegiance effect," the tendency of researchers to find evidence for the therapy that they practice or favor.
Other prominent researchers—notably Jerome Frank, a psychiatrist at Johns Hopkins—realized that the dodo effect undermined the validity of all psychotherapies. Frank’s own research corroborated the dodo effect. In one study, he and colleagues provided depressed patients with three treatments: weekly individual therapy, weekly group therapy and minimal individual therapy, which consisted of just one half-hour session every two weeks. "To our astonishment and chagrin, patients in all three conditions showed the same average relief of symptoms," Frank wrote in Persuasion and Healing: A Comparative Study of Psychotherapy, first published in 1961 by Johns Hopkins Press and reissued in 1993.
Frank asserted that "relief of anxiety and depression in psychiatric outpatients by psychotherapy closely resembles the placebo response, suggesting that the same factors may be involved." The specific theoretical framework within which therapists work has little or nothing to do with their ability to "heal" patients, Frank contended. The most important factor is the therapist’s ability to persuade patients that they will improve.
Frank’s view should disturb anyone who thinks psychotherapy has a scientific basis. It doesn’t matter whether your therapist is a Jungian, cognitive behaviorist, witch doctor—or a cybertherapist that exists only in a computer. What matters is whether you believe you will get better.

The text that I've bolded applies to CBT vs APT in the PACE trial, where CBT patients were told that they had the potential to improve and recover, whereas APT patients were told that they could expect to manage their illness. (I'm paraphrasing, as I can't remember the exact wording of the methodology.)
 

biophile

Places I'd rather be.
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8,977
WillowJ. Interesting article you found!

http://blogs.scientificamerican.com...o-effect-why-psychotherapies-never-get-better

On the right column of the article there was the "Image of the week":

CostaConcordia.jpg


It reminded me of the following send up which someone made me aware of recently:

BUkvdfmCYAA0Hba.jpg:large


https://twitter.com/maxwhd/status/380887827224879105/photo/1
 

Graham

Senior Moment
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Location
Sussex, UK
I think we should have had Engineer Chalder blaming the hull for thinking that it was suffering from metal fatigue, and collapsing when there was no real need.

According a survey carried out of elderly hulls in various ship breaking yards, it is quite normal for them to be showing signs of some fatigue.
 

Dolphin

Senior Member
Messages
17,567
I think we should have had Engineer Chalder blaming the hull for thinking that it was suffering from metal fatigue, and collapsing when there was no real need.

According a survey carried out of elderly hulls in various ship breaking yards, it is quite normal for them to be showing signs of some fatigue.
:)

Yes, after that intervention from Engineer Chalder, the (metal) fatigue was measured and found to be in the normal range for ships that exist.

Initially it was announced that this rate of metal fatigue was in the normal range for ships of working age but after a good-for-nothing pointed out this was not the case, Engineer Chalder agreed that it was the normal range for ships of all ages.
 

WillowJ

คภภเє ɠรค๓թєl
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Location
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There's a link from the SciAm provider allegiance article to a PDF of a paper on meta-analysis, but it's highly technical. Some of the maths/stats people would probably like it.

It's the Dodo paper under "allegiance effect" in one of Bob's quotes. The Dodo Bird from Alice in Wonderland (or possibly Through the Looking Glass) organizes a haphazard "race" and at the end he decides, "Everybody has won and all must have prizes" (which Alice must supply).

Hence the SciAm blogger's conclusion "All are losers, and none must have prizes."
 

Dolphin

Senior Member
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17,567
Regarding allegiance, I thought I'd point out some promised data which followed some comments on the protocol:

PD White, MC Sharpe, T Chalder, JC DeCesare, R Walwyn, for the PACE trial management group:

Beliefs and expectations of treatment and who is running the trial

The trial has been designed and is being managed by many different healthcare and research professionals, including doctors, therapists, health economists, statisticians and a representative of a patient charity. The Trial Management Group includes five physicians and four psychiatrists. To measure any bias consequent upon individual expectations, all staff involved in the PACE trial recorded their expectations as to which intervention would be most efficacious before their participation, and we will publish these data after the end of the trial.

site: http://www.biomedcentral.com/1471-2377/7/6/comments
 

biophile

Places I'd rather be.
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8,977
A variation of Dolphin's theme: The definition for normal range in the ship's function after revival overlapped with the definition of unseaworthiness during the original inspection of the ship.