There is no evidence to support the use of neurofeedback over cognitive-behavioral therapy (CBT), which is commonly used to treat adults with attention-deficit/hyperactivity disorder (ADHD), new research suggests.
A triple-blind study of 118 patients in Germany showed that patients who underwent electroencephalographic (EEG) neurofeedback training experienced similar reductions in symptoms as those who underwent sham neurofeedback or group CBT.
“This first randomized, sham-controlled trial did not show any specific effects of neurofeedback on ADHD symptoms in adults,” Michael Schöneberg, PhD, Department of Clinical Psychology and Psychotherapy at the University of Tübingen, Germany, and colleagues write.
Before any treatments for this indication can be recommended, they “must first demonstrate they are superior to standard, CBT methods,” Dr Schöneberg added in a press release.
He pointed out that CBT required fewer sessions and allowed for group vs individual work. In addition, there were no additional costs associated with creating and maintaining technical equipment, unlike neurofeedback.
Asked for comment, Julian Keith, PhD, professor and chair of the Department of Psychology at the University of North Carolina, Wilmington, told Medscape Medical News that the take-away message isn’t so much that neurofeedback didn’t beat CBT ― it’s that all three conditions worked equally well.
Dr Julian Keith
“The good news was that people benefited pretty substantially from cognitive and neurofeedback therapy, but the bad news was it didn’t matter whether it was real or sham neurofeedback,” said Dr Keith.
“The inclusion of the sham controls shows that the thing we thought was producing benefit, the therapy itself, may not be the active ingredient. Instead, it may be something it shares in common with the sham condition,” he added.
The findings are published in the September issue of Lancet Psychiatry.
Brain Activity Patterns
With neurofeedback, patients learn to selectively control brain activity patterns in order to alleviate their symptoms.
“Clinicians typically use a training protocol that aims to increase EEG fast-wave activity (primarily in the ß range), while suppressing slow-wave activity (primarily in the ϴ range),” write the investigators.
Although previous research has suggested that this type of training is effective for those with ADHD, the question has been raised as to whether improvements were from active training elements or from a nonspecific placebo effect.
In the current study, 118 patients between the ages of 18 and 60 years who had symptoms of ADHD were randomly assigned to one of three treatment groups: 30 sessions over 15 weeks of verum neurofeedback (n = 38; 51% men; mean age, 40.0 years), 15 sessions over 15 weeks of sham neurofeedback followed by 15 sessions over an additional 15 weeks of verum neurofeedback (n = 39; 61% men; mean age, 35.7 years), or 12 sessions over 12 weeks of group CBT-oriented psychotherapy (n = 41; 58% men; mean age, 38.2 years).
“We decided not to provide a pure sham condition over 30 sessions on the basis of ethical considerations assuming that participants would benefit only from real but not from sham neurofeedback therapy,” report the researchers.
The primary outcome measure was change from baseline on the self-reported Conners’ adult ADHD rating scale (CAARS). The baseline scores were 134.97, 132.29, and 137.76 for the neurofeedback, sham neurofeedback, and CBT groups, respectively.
Efficacy for All
No treatment- or trial-related serious adverse events were reported.
Efficacy was shown for all three groups at the 6-month assessment ( P < .0001 for all). In addition, neurofeedback was not statistically superior to sham neurofeedback (CAARS sum score, 103.51 vs 94.25, respectively; P = .168) or to CBT (CAARS, 103.68; P = .639).
The findings were similar at the midtreatment/8-week assessment and posttreatment/16 week assessment.
Table. CAARS Sum Scores for Treatment Groups at 8 and 16 Weeks
| CAARS Sum Score | Neurofeedback | Sham Neurofeedback | CBT |
|---|---|---|---|
| Midtreatment | 108.73 | 113.42 | 113.89 |
| Posttreatment | 111.34 | 104.39 | 108.11 |
Also, there were no significant between-group differences at any timepoint for CAARS impulsivity, hyperactivity, and inattention scores.
Moreover, there were no changes in the EEG Ɵ-to-ß ratio for the neurofeedback group. This finding contrasts “with the widely held hypothesis that the positive effects of neurofeedback are due to a feedback-driven training of specific frequency bands,” write the investigators.
“Hence, other mechanisms must have driven the clinical improvements shown in our study as well as previous studies,” they add. This may include “positive expectation, confidence in technology, and fascination with brain science,” as well as factors associated with the method itself.
On the basis of the results, “meta-cognitive therapy should be viewed as a viable and efficient treatment option for adults with ADHD.”
More Rigor Needed
In an accompanying editorial, Winfried Rief, Department of Psychology, Philipps University Marburg, Germany, writes that although this study fulfills “most quality criteria of modern clinical trials, future trials should address some aspects more rigorously.”
Dr Rief suggests that observer ratings in addition to self-ratings should be used to assess treatment outcomes and that negative effects from psychotherapy, although uncommon, should be examined.
He also notes that because patients’ expectations can affect outcomes, this factor needs to be closely monitored. “Beyond these shortcomings,” he went on to praise the investigators.
“At first sight, their study results fall into the category of more insignificant findings that compared different and real psychotherapies. However, it would be incorrect to close this file without further discussion,” writes Dr Rief.
“Schöneberg and colleagues’ study is one of the most sophisticated trials with a high-quality design in the field of ADHD in adults, and it provides us with relevant findings.”
He adds that the finding of positive results for the CBT group “should encourage physicians and therapists to be careful about embracing new intervention approaches too quickly; some traditional interventions…are not easily bettered.”
“Heroic” Research Effort
Dr Keith agreed with Dr Rief that this was a well-designed study, calling it a “heroic effort” in research.
“These kinds of studies are difficult to do. And this is really the first in adults with ADHD with a convincing sham control,” he commented to Medscape Medical News.
However, he speculated that perhaps the sham neurofeedback protocol wasn’t a true placebo condition and that the process of coming in for an office visit and sitting quietly may have conferred benefit.
He also questioned whether the sham group received sensor feedback when they moved around a lot, which a normal neurofeedback system will give.
“If so, then the sham condition is acting as an actual biofeedback training condition, where you’re teaching people to sit still and not be fidgety.” On the other hand, if the protocol isn’t realistic enough, the participant will easily figure out if they’re receiving an active or sham condition.
Dr Keith and colleagues recently completed their own study on neurofeedback. They noted that a balanced sham protocol can be difficult.
“It’s very much like a mindfulness meditation training session. Even if you’re in the sham condition, you’re concentrating on something and being very quiet. So there’s a meditative benefit,” he said.
In the current study, “maybe quiet training is the key ingredient, or maybe it’s giving movement feedback. We don’t know yet, but the hopeful thing is that we saw pretty convincing improvement in symptoms across the board,” said Dr Keith.
“Clinicians have been using these techniques for a while, and patient reports have been that they work. So they may say, ‘That’s good enough for us, and we don’t know need to know why.’ But of course, we do need to understand why – and if it’s the placebo effect or not.”
If it is the placebo effect, “that’s interesting in itself, but it’s then difficult to justify all the expensive technology” and the hours of training needed with neurofeedback, “especially because you can get placebo at a deeply discounted rate,” he said.
“We need to better understand how it works and how to perhaps harness the power of placebo. In fact, mindfulness meditation may be about gaining control over some of the effects of placebo,” said Dr Keith. “If you can gain control over placebo, as a clinician or a patient, you may gain substantial cognitive and psychological benefits. So there’s a whole interesting realm to explore there.”
The study was funded by a grant from the German Research Foundation. The study authors and Dr Keith have reported no relevant financial relationships. Dr Rief has received honoraria for talks on placebo mechanisms from Berlin Chemie, Heel, and Bayer.
Lancet Psychiatry. 2017:4;650-651, 673-684. Abstract, Editorial
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