Recent RCTs of psychological interventions in healthcare: a review of their quantity, scope, and cha

[Dolphin]

When this came out, Keith Laws (a psychological researcher) tweeted:

So much for blinding! RCTs for published Psych Interventions (all disorders in 2010) majority (n = 210, 71%) use patient-reported outcomes

This is now available for free: http://www.diva-portal.org/smash/get/diva2:643327/FULLTEXT01.pdf

J Psychosom Res. 2013 Nov;75(5):401-8. doi: 10.1016/j.jpsychores.2013.08.019. Epub 2013 Aug 31.
Recent randomized controlled trials of psychological interventions in healthcare: a review of their quantity, scope, and characteristics.
Arnberg FK1, Alaie I, Parling T, Jonsson U.

Abstract
OBJECTIVE:
This study aimed to describe the quantity, scope, and fundamental characteristics of recently published randomized controlled trials (RCTs) of psychological interventions.

METHODS:
We queried two major databases (PsycINFO and PubMeD) for primary reports published in 2010 of RCTs of psychological interventions for participants with a medical condition. We collected data on the characteristics of the trials, participants, interventions, outcomes, and reports.

RESULTS:
Of 3696 retrieved reports 295 primary publications were included. About half (53%) of trials included participants with a mental disorder and more than half evaluated interventions based on a cognitive behavioral therapy (CBT) framework. A majority of trials recruited participants in North America and Europe (79%). A minority of the trials focused on children and adolescents (17%) or the elderly (8%). The median sample size of the intervention arm was n=41. Thirty-nine percent of trials reported solely patient-reported outcomes. Only 5% of reports indicated funding from for-profit organizations. The median 2010 impact factor of the journals in which reports were published was 2.96.

CONCLUSION:
This snapshot of the research on psychological interventions suggests that the evidence base for psychological interventions is expanding mainly for CBT interventions for adults in high-income countries. Although the restrictive inclusion criteria limit the generalizability of these results, researchers and funding agencies might be advised to strive for greater diversity regarding interventions, geographical/cultural settings and age groups. Regularly updated reviews of this research field, with gradually refined methodology and increased scope, may further inform funders and researchers.

© 2013 Elsevier Inc. All rights reserved.

KEYWORDS:
Behavioral interventions; Evidence base; Healthcare policy; Psychotherapy; Randomized controlled trials; Systematic review

PMID: 24182626

[PubMed - indexed for MEDLINE]

 

[alex3619]

The blinding issue is a big one in psychopsychiatry. Its impossible for the patients to be blinded. They know what therapy they are getting You could however have evaluators deciding on response who are blinded to what treatment is received.

 

[chipmunk1]

The blinding issue is a big one in psychopsychiatry. Its impossible for the patients to be blinded. They know what therapy they are getting You could however have evaluators deciding on response who are blinded to what treatment is received.

this has been done at least once.. with horrible results.. CBT did not help at all for most conditions it was believed to be effective. i don't think we will see more of these studies.

 

[alex3619]

this has been done at least once.. with horrible results.. CBT did not help at all for most conditions it was believed to be effective. i don't think we will see more of these studies.

Which might mean most CBT is just fancy placebo.

 

[Woolie]

this has been done at least once.. with horrible results.. CBT did not help at all for most conditions it was believed to be effective. i don't think we will see more of these studies.

@chipmunk, I'd love to know more about this article (sorry if you've already posted and I missed it!).

 

[chipmunk1]

@chipmunk, I'd love to know more about this article (sorry if you've already posted and I missed it!).

i have not posted it (i believe - it's been a while)

i think it is this one:

http://www.academia.edu/307214/Cogn...a-analytical_review_of_well-controlled_trials

 

[Woolie]

i have not posted it (i believe - it's been a while)

i think it is this one:

http://www.academia.edu/307214/Cogn...a-analytical_review_of_well-controlled_trials

Thanks for this, @chipmunk1! really interesting!

Anyone interested in CBT and GET studies should have a look at chipmunk1's paper! This is a metanalysis of studies of the the effectiveness of CBT on major psychiatric disorders (schizophrenia, major depression, bipolar). But uniquely:

* They selected only studies with objective measures (for example, ratings of symptoms made by someone other than the patient, noting whether or not the rater was blind to the intervention).

* They selected only studies with some sort of control condition, that at least had the appearance of a treatment, but wouldn't be expected to be as effective as the CBT (befriending, relaxation sessions, etc.)
​

Guess what, virtually no effects of CBT! A small effect for major depression, but only when the control condition was a placebo pill (not when it was something involving regular human contact).

The point isn't whether or not CBT is effective for this that or the other, The point is that it illustrates the dangers of not applying the usual medical study quality standards to assessments of psychological interventions.

Btw, I know Keith Laws' work well (we had the same PhD supervisor) and have a high opinion of it.

 

[Woolie]

also on the topic of placebos, I'm amazed how many doctors believe that the placebo effect is "real" - that is, that the effect reflects a genuine underlying improvement in a person's health due to their positive thinking.

Other studies that have compared self-rated vs objectively rated improvement also show that the placebo effect is rarely observed on objective measures:

http://summaries.cochrane.org/CD003974/placebo-interventions-for-all-clinical-conditions

A common hypothesis, especially when an actual therapist was involved, is that people are biased to "please" the therapist - to "reward" their efforts. So they overestiamte the benefits.

I think a more important mechanism might be confirmation bias effects on recall - our tendency towards better recall of recent experiences that are consistent with our broader hopes/expectations, and poorer recall of those disconfirming them.

 

[IreneF]

I think the placebo effect is real if subjective. Problem is it doesn't last very long, and it doesn't work for everyone. I think all of us have seen people say they got better with x, then complain that x "isn't working anymore". It works best, it seems, for things like pain, especially if the "painkiller" is injected by a nurse.

 

[Woolie]

I think the placebo effect is real if subjective. Problem is it doesn't last very long, and it doesn't work for everyone. I think all of us have seen people say they got better with x, then complain that x "isn't working anymore". It works best, it seems, for things like pain, especially if the "painkiller" is injected by a nurse.

That's a fair point, @IreneF. There are situations where "mind over matter" might very probably work - like perception of pain, which does seem to vary with the experiencer's stress levels, etc. - but as you say, perhaps only for certain complaints and only over the very short term.

 

[A.B.]

The placebo effect was a scientific error. The person who came up with the idea failed to account for various sources of bias that could influence the results, instead ascribing any improvement to a putative mind-body effect.

The powerful placebo effect: fact or fiction?

 

[chipmunk1]

A common hypothesis, especially when an actual therapist was involved, is that people are biased to "please" the therapist - to "reward" their efforts. So they overestiamte the benefits.

the placebo effect can be social. if you have a therapist(maybe the only person in the world that seemed to care about you) you will want to see only the good things about that person, this includes the treatment.

if you have a (possibly intimidating) authority figure like a doctor many will just comply and tell what the doctor wants to hear.

then if you're are being part of a scientific study it is something special you will put effort into finding changes in your condition(and possible ignore things that changed for the worse or remained unchanged)

you are putting effort into something you expect to see some changes and will look for them.

then if you are measuring subjective symptoms, people have a poor long-term memory about subjective feelings. How did you feel a few weeks ago? How do you feel today? It's hard to tell if there is a difference or not if your condition hasn't changed dramatically. it's easy to make you believe things were a bit better than a few weeks ago if you believe you are receiving a highly effective treatment.

i think psych studies sometimes include psychology students that believe (or have been indoctrinated to believe) what they are doing definitely works/will cause changes.Behaviour and subjective experience will reflect that belief.

Then studies include people who are motivated to change something, they have already decided they want to get rid of symptom X next month. They will badly want to see change and they will look for changes and might work as hard as possible to get them.

 

[Bob]

The blinding issue is a big one in psychopsychiatry. Its impossible for the patients to be blinded. They know what therapy they are getting You could however have evaluators deciding on response who are blinded to what treatment is received.

this has been done at least once.. with horrible results.. CBT did not help at all for most conditions it was believed to be effective. i don't think we will see more of these studies.

@chipmunk, I'd love to know more about this article (sorry if you've already posted and I missed it!).

i have not posted it (i believe - it's been a while)

i think it is this one:

http://www.academia.edu/307214/Cogn...a-analytical_review_of_well-controlled_trials

Thanks for this, @chipmunk1! really interesting!

Anyone interested in CBT and GET studies should have a look at chipmunk1's paper! This is a metanalysis of studies of the the effectiveness of CBT on major psychiatric disorders (schizophrenia, major depression, bipolar). But uniquely:

* They selected only studies with objective measures (for example, ratings of symptoms made by someone other than the patient, noting whether or not the rater was blind to the intervention).

* They selected only studies with some sort of control condition, that at least had the appearance of a treatment, but wouldn't be expected to be as effective as the CBT (befriending, relaxation sessions, etc.)
​

Guess what, virtually no effects of CBT! A small effect for major depression, but only when the control condition was a placebo pill (not when it was something involving regular human contact).

The point isn't whether or not CBT is effective for this that or the other, The point is that it illustrates the dangers of not applying the usual medical study quality standards to assessments of psychological interventions.

Btw, I know Keith Laws' work well (we had the same PhD supervisor) and have a high opinion of it.

Thanks for highlighting that paper.

Here's a more recent paper (2014) co-authored by Keith Laws, which looks at CBT for schizophrenia...
It's a meta-analysis that looks closely at the quality of the studies, and finds that CBT has very little benefit when studies are properly controlled (for biases etc)...

It concludes: "Cognitive-behavioural therapy has a therapeutic effect on schizophrenic symptoms in the 'small' range. This reduces further when sources of bias, particularly masking, are controlled for."

It's worth reading the 'discussion' section.


Cognitive-behavioural therapy for the symptoms of schizophrenia: systematic review and meta-analysis with examination of potential bias.
Jauhar S1, McKenna PJ, Radua J, Fung E, Salvador R, Laws KR.
2014
Br J Psychiatry. 204:20-9.
doi: 10.1192/bjp.bp.112.116285.
http://bjp.rcpsych.org/content/204/1/20.full


There was actually a BBC news article about this paper:
http://www.bbc.co.uk/news/health-25574773

 

[IreneF]

Schizophrenics are often so detached from reality that it's hard to imagine that CBT would penetrate whatever's going on inside their heads. I used to try to talk to a local " crazy lady" and it was more like trying to converse with a random word generator. The stuff inside was way more important than anything I said. Although she was the only person to ever point out that my lips are blue.

 

[chipmunk1]

Schizophrenics are often so detached from reality that it's hard to imagine that CBT would penetrate whatever's going on inside their heads. I used to try to talk to a local " crazy lady" and it was more like trying to converse with a random word generator. The stuff inside was way more important than anything I said. Although she was the only person to ever point out that my lips are blue.

wouldn't it be nice if we could cure all kinds of serious illnesses with a little bit of talk?