Masked Taper, Targeted CBT May Help Older Patients With Insomnia Discontinue Benzodiazepines

Implementing a masked taper along with targeted cognitive behavioral therapy (CBT) designed to address the placebo effect may help older patients discontinue benzodiazepine use for insomnia better than CBT and standard tapering alone, according to a study published today in JAMA Internal Medicine.

Constance H. Fung, M.D., M.S.H.S., of the VA Greater Los Angeles Healthcare System, and colleagues enrolled 188 adults ages 55 years or older who had used benzodiazepines and/or zolpidem for insomnia at doses of less than 8 mg diazepam equivalent two or more nights per week for at least three months. One group, the supervised taper group, received a paper schedule for tapering their medication over nine weeks along with a pill cutter. They also received eight sessions of standard CBT for insomnia during the nine-week taper and had periodic withdrawal check-ins.

The other group, the masked taper group, also received eight sessions of CBT for insomnia along with withdrawal check-ins. However, their CBT included additional exercises aimed at disrupting pathways thought to result in placebo effects. In essence, the exercises challenged any preconceived notions the participants may have had about whether benzodiazepines—which some studies have shown to have at least a moderate placebo effect for treating insomnia—actually helped them sleep and whether they would experience renewed insomnia or other discomfort upon discontinuing their medication.

Further, this group received their medication capsules in seven-day blister packs that, unbeknownst to the participants, contained progressively larger amounts of inert filler over nine weeks. The participants in this group were instructed to take one pill per night, with no pill cutting.

There were 179 participants at one-week posttreatment follow-up. Of those, 88.4% in the masked taper group had stopped taking their benzodiazepine, compared with 67.4% in the supervised taper group. There were 176 patients at six-month follow-up, and 73.4% in the masked taper group had stopped taking their benzodiazepine, compared with 58.6% in the supervised taper group.

“Although the 14.8% difference between groups [at six months] fell short of the 20% threshold used for power calculations, the sustained and high percentage of discontinuation, which is statistically significant and not without merit, may be attributed to our novel approach,” Fung and colleagues wrote. “The results are most applicable to individuals who use (not misuse) benzodiazepine receptor agonists for chronic insomnia disorder, can attend weekly therapy sessions and engage in prescribed homework, and are not at high risk for complicated withdrawal.”

For related information, see the Psychiatric News article “To Improve Safety in Older Patients, Consider Deprescribing.”

(Image: Getty Images/iStock/Filmstax)

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Placebo Response Strongest in Depression Trials, but Robust Across Multiple Psychiatric Disorders

In a meta-analysis published yesterday in JAMA Psychiatry, researchers found that people with major depression showed the strongest placebo response in clinical trials among nine psychiatric disorders assessed, followed by individuals with generalized anxiety disorder. However, the placebo response was significant across all nine disorders.

“A genuine placebo effect, by definition, encompasses improvements induced by suggestion, hope for effective treatment, and conditioning effects through the administration of medications,” wrote Tom Bschor, M.D., of the Technical University of Dresden, Germany, and colleagues. In the case of psychiatric illness, factors such as the episodic course of many disorders and the attentive and compassionate care that clinical trial participants often receive also influences the placebo response, they added.

“A better understanding of placebo responses may improve treatments, especially in psychiatric disorders where confidence, conditioning, and belief play a significant role,” the researchers wrote.

Bschor and colleagues assessed placebo response for nine psychiatric disorders commonly treated with medications: attention-deficit/hyperactivity disorder, generalized anxiety disorder, major depressive disorder, mania, obsessive-compulsive disorder, panic disorder, posttraumatic stress disorder, schizophrenia, and social anxiety disorder.

For each disorder, they combined patient data from 10 high-quality placebo-controlled trials; their final sample included nearly 10,000 clinical trial participants who received placebo.

Overall, placebo group participants showed strong symptom improvements for all nine disorders assessed. The greatest placebo response was seen for major depression and generalized anxiety, which had effect sizes of 1.40 and 1.23, respectively. An effect size is a standardized value to quantify changes like symptom improvements; an effect size above 1.2 is considered a very large change. At the other end were patients with schizophrenia and obsessive-compulsive disorder, who had placebo response effect sizes of 0.59 and 0.65, respectively (medium-to-large changes).

“[P]atients with schizophrenia had the least benefit associated with placebo treatment, possibly due to episodic relapses and an unfavorable prognosis,” Bschor and colleagues wrote. “Impaired interpersonal functioning might reduce the impact of personal attention and nonspecific effects in placebo groups. Distorted reality perception and limited insight into illness may hinder the development of hope and belief in effective treatment.”

The researchers also found that females appeared to show a stronger placebo response than males on average, though this sex difference alone did not explain why the strongest effect sizes were found in the depression and anxiety clinical trials (whose participants were ~65% female). For example, 21% of the participants in the posttraumatic stress disorder trials were female, yet the effect size was still large (0.84).

For related information, thee the American Journal of Psychiatry article, “Patient Expectancy as a Mediator of Placebo Effects in Antidepressant Clinical Trials.”

(Image: Getty Images/iStock/Kudryavtsev Pavel)

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Antidepressant Drugs and the Placebo Effect Make Headlines

The effects of antidepressant medications are all in people's heads. That’s what a Harvard psychologist told Lesley Stahl on “60 Minutes” last Sunday. Irving Kirsch, Ph.D., said that antidepressant drugs are no better than placebo pills for people with mild to moderate depression. He agreed that people with severe cases show a much stronger response.

Kirsch’s studies of the placebo effect lead him to argue that taking the drugs may work, but that "the reason [people] get better is not because of the chemicals in the drug.” Simply the act of taking a pill or the added attention from clinicians may make patients feel better, he said.

Psychiatrists and Food and Drug Administration scientists interviewed on the program disagreed with Kirsch’s views. “It is unfortunate that ‘60 Minutes’ has provided its viewers with highly misleading information, and I encourage everyone taking antidepressants to talk with your doctor before making any changes,” said APA President John Oldham, M.D., in a statement.

APA’s treatment guidelines on depression recommend psychotherapy first for mild to moderate depression, and only if this intervention falls short should the physician decide whether antidepressants are needed.

For a discussion in Psychiatric News about the complexities of the placebo effect, click here. And for an in-depth review of medications in depression treatment, see The Evidence-Based Guide to Antidepressant Medications from American Psychiatric Publishing.

(Image: Julie Ten Eyck [JTeffects]/Shutterstock.com)