• Another insomnia RCT

    Yesterday I summarized two randomized controlled trials (RCTs) that compared cognitive behavioral therapy (CBT) to pharmacological therapy (PCT) and placebo for insomnia. I also mentioned that there was a third, by Siversten and colleagues. I’ve now read it, and it corroborates the results of the other two. It considers yet another drug, zopiclone. So across the three studies, three different drugs have been compared to CBT, and in none of them does PCT offer an advantage over CBT.

    Design, Setting, and Participants: A randomized, double-blinded, placebocontrolled trial of 46 adults (mean age, 60.8 y; 22 women) with chronic primary insomnia conducted between January 2004 and December 2005 in a single Norwegian university-based outpatient clinic for adults and elderly patients.

    Intervention: CBT (sleep hygiene, sleep restriction, stimulus control, cognitive therapy, and relaxation; n=18), sleep medication (7.5-mg zopiclone each night; n=16), or placebo medication (n=12). All treatment duration was 6 weeks, and the 2 active treatments were followed up at 6 months.

    Main Outcome Measures: Ambulant clinical polysomnographic data and sleep diaries were used to determine total wake time, total sleep time, sleep efficiency, and slow-wave sleep (only assessed using polysomnography) on all 3 assessment points.

    Results: CBT resulted in improved short- and long-term outcomes compared with zopiclone on 3 out of 4 outcome measures. For most outcomes, zopiclone did not differ from placebo. Participants receiving CBT improved their sleep efficiency from 81.4% at pretreatment to 90.1% at 6-month follow-up compared with a decrease from 82.3% to 81.9% in the zopiclone group. Participants in the CBT group spent much more time in slow-wave sleep (stages 3 and 4) compared with those in other groups, and spent less time awake during the night. Total sleep time was similar in all 3 groups; at 6 months, patients receiving CBT had better sleep efficiency using polysomnography than those taking zopiclone.

    Conclusion: These results suggest that interventions based on CBT are superior to zopiclone treatment both in short- and long-term management of insomnia in older adults.

    The authors cite a paper that estimates the direct medical costs associated with insomnia to be about $14 billion per year in 1995. I’d love to see an updated figure. Medical inflation (6.5% per year, typically) would suggest it is closer to $40 billion today. If proportionally more people are suffering from insomnia (which is plausible) then the cost could be higher. We’re starting to talk about a lot of money. Most people with insomnia (85% of them, say the authors) go untreated. Since sleep difficulties are more common in older adults (that the population is aging is one reason why there could be more insomniacs today than in 1995), a lot of the health spending that results from under-treatment is taxpayer financed (Medicare). Of course, employer-based insurance is tax financed too (the tax subsidy), and your premium dollars help fund your colleagues’ health spending. It may be worth kicking a few more dollars toward CBT. It’s actually pretty cheap. The course I’m following cost me about $40.

    The authors also note that PCT is “the treatment of choice for insomnia” among primary care physicians. I am willing to believe a lot of patients demand it, whether informed by direct-to-consumer advertising or just on the typical presumption that there must be a solution in a pill. What I’d like to know from the physicians who offer PCT is whether they also suggest CBT. Do they routinely tell patients that CBT has been shown to be more effective? If not, why not?

    @afrakt

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    • I’m a family physician with a bit more than 30 years of on the job training. I’ll make a couple comments about insomnia as a primary or incidental issue.

      Most of the time, the issue of insomnia surfaces either as an ‘oh, by the way’ when I ask if the patient has other concerns, or when I am asking a series of questions (the ‘review of systems’ or ROS) to tie up loose ends and fill in the gaps from the history given by the patient about their primary concern. For example, we have been evaluating abdominal pain and I ask if the patient has any other concerns, or the patient has fatigue or concerns about memory and I ask about specifically about sleep. In this setting, it is appropriate at that visit to make some general comments about insomnia and suggest a return visit to actually address it. This irritates many patients in this world of one-stop shopping, insta-cash, and drive through shopping. It also means additional time taken off work and an additional co-pay, not insignificant issues.

      If the patient comes in specifically to address insomnia, it is likely to be in a 15 or 20 minutes visit, hardly enough time to do a full psychosocial and lifestyle assessment, let alone teach about insomnia and discuss the options in any depth. The fact that our system (US) pays for doing things and not for talking or thinking or deciding (coupled with the current emphasis on patient satisfaction) is a powerful force for doing the fastest thing that will make the patient happy!

      If, by chance, I am seeing the patient about their sleep issue on the day of a major snowstorm, when cancellations give me time to do my job well, I would certainly like to suggest CBT. Except that there are no available resources to do this in many smaller communities, including mine. (It is a 3 month wait to see a psychiatrist for disabling depression if one has insurance. With Medicaid or without insurance…)

      I’m enjoying this series of posts – and learning – but don’t underestimate the role that our broken system plays in making it unreasonable to expect good care.

      • Just to add my own experience and not at all to suggest yours is not valid (of course it is!): My sleep issues have been an ongoing conversation with my primary care physician for years. He gave me the name of a sleep specialist and told me to call him whenever I was ready. I finally did, but I emphasize that it took me over a year to do so. It was the sleep specialist who recommended CBT, though we also discussed PCT. In an informal, shared decision making type conversation, we both thought CBT was well worth trying. The doctor referred me to the work of Dr. Jacobs, to which I’ve linked in both posts.

        Notice how this began, through a regular, ongoing relationship with my PCP. Isn’t that how it should be?

    • I agree with Pheski.

      ‘ve been fascinated by CBT for years. The data behind it is regularly stunning and it’s very well-designed for the modern world:

      1. It’s short-term so it’s relatively cheap to patients
      2. It’s regimented so it can be fairly easily taught to practitioners in a modular fashion – eg, it’s very common to meet psychiatric social workers who know CBT for depression and anxiety, but are learning it for sleep.
      3. It’s very evidence-based. It’s been well-validated for depression and anxiety, dialectical BT (a spin-off) is the only treatment for borderline personality disorder, low back pain (Lamb et al, Lancet), and many more (Clin Psych Reviews Butler 2006)

      I’ve seen a few problems, though.

      1. This article is concerning: A quality-based review of randomized controlled trials of cognitive-behavioral therapy for depression: an assessment and metaregression. Am J Psych 2012. It shows that most RCTs of CBT for depression (the core, primary indication) were local and low-quality, and there was a strong association between higher quality and lower effect sizes.

      2. A lot of patients don’t want it – to a lot of people it really feels like homework and they can resent it, esp once they’ve already overcome the stigma to ask for mental health aid, they’ve usually already planned ‘talk’ vs. ‘drug.’

      3. Referral for it is awkward. In university settings we often refer to Mental Health and they decide which modality to use, many communities don’t have options. In the community, simply keeping track of the therapists + insurance coverage makes it all pretty hard to focus on modality, also.