By Jessica A. Orner, MD

Family Medicine Physician, Lebanon, PA

Dr. Orner reports no financial relationships relevant to this field of study.

SYNOPSIS: Cognitive behavioral therapy for insomnia (CBT-I) is an effective intervention for moderate to severe insomnia disorder and should be considered as an initial treatment.

SOURCE: Brasure M, Fuchs E, MacDonald R, et al. Psychological and behavioral interventions for managing insomnia disorder: An evidence report for a clinical practice guideline by the American College of Physicians. Ann Intern Med 2016;165:113-24. doi:10.7326/M15-1782.

Many Americans suffer from sleep disturbance and insomnia. Approximately 10% of people meet diagnostic criteria for insomnia disorder, and it is estimated that $30 billion is spent on insomnia treatment each year in the United States.1,2 According to the American Psychiatric Association’s Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, insomnia disorder, previously known as chronic insomnia, is defined by a predominant complaint of poor sleep quantity or quality and difficulty with sleep initiation, maintaining sleep, or early morning waking with inability to return to sleep. The symptoms must cause clinically significant distress or impairment in areas of functioning. Symptoms must be present at least three nights per week for at least three months. Also, individuals must have adequate opportunity for sleep, and symptoms cannot be better explained by other conditions.3 Options for treating insomnia disorder include pharmacologic therapies, behavioral and psychological therapies, and integrative medicine, including herbal preparations and supplements. There are several types of psychological and behavioral interventions for insomnia disorder in adults: cognitive behavioral therapy, cognitive therapy, sleep hygiene education, stimulus control, and relaxation training.4

Cognitive therapy aims to change how those with insomnia think about sleep and to replace dysfunctional attitudes surrounding sleep with useful beliefs.4 Sleep hygiene education aims to educate patients about factors they can change to improve their sleep, such as limiting caffeine and maintaining a cool bedroom.4 Relaxation training includes techniques such as progressive muscle relaxation, guided imagery, and breathing techniques.4 CBT-I combines cognitive therapy, education, and behavioral interventions,4 which allows for several different elements of insomnia to be addressed. In this evidence report on psychological and behavioral interventions, randomized, controlled trials published between 2004 and September 2015 were identified using bibliographic databases, including MEDLINE and the Cochrane Library. Two investigators independently reviewed the texts for the following inclusion criteria: randomized, controlled trials of psychological and behavioral interventions; adult enrollees; treatment duration of four weeks or more; published in English; and report of global or sleep outcomes. Of the 3,572 citations identified, 60 trials were analyzed. Trials were grouped by intervention type (i.e., single, multi-component) and comparison (e.g., CBT-I compared with inactive control). Insomnia Severity Index (ISI) or Pittsburgh Sleep Quality Index (PSQI) scores are two questionnaires that were used in the evaluated clinical trials to assess sleep quality and associated distress and dysfunction (i.e., global outcomes).

The American College of Physicians uses a grading system for quality of evidence and strength of recommendation based on the Grading of Recommendations Assessment, Development and Evaluation approach.5 Strength of recommendation was either strong or weak. A strong recommendation indicated that the benefits clearly outweighed the risks or vice versa. A weak recommendation was given if the benefits finely balanced with the risks. Quality was graded as high, moderate, or low depending on study limitations (e.g., methodological flaws).5 Single component interventions included one type of behavioral therapy. Examples of behavioral therapies are sleep restriction, stimulus control, and relaxation. The goal of stimulus control is to create routine sleep patterns and bedroom behaviors that promote sleep. There was insufficient evidence for most global and sleep outcomes. However, there was low-strength evidence that showed longer total sleep time with stimulus control than with inactive controls. For multicomponent behavior therapy, which contained no cognitive component but did feature several behavioral components, there was insufficient evidence for all outcomes for the general adult population. When focusing on older adults, there appeared to be low- to moderate-strength evidence for better sleep quality based on the PSQI. Also, sleep onset was reduced by 10 minutes in this population with multicomponent behavior therapy than inactive control.

Interventions with CBT-I, which featured cognitive and behavioral components, showed improvement in most sleep outcomes across several delivery models, such as in-person, group sessions, book, handouts, or electronic resources. In the 22 trials comparing this intervention to inactive controls, 11 reported post-treatment ISI or PSQI scores. Overall, response to treatment and remission of insomnia were higher with CBT-I than inactive controls. Of the 168 people in the CBT groups, there were 89 reports of remission. Whereas, of the 159 participants in the control groups, there were 26 reports of remission (P < 0.00001). CBT-I sessions typically occurred once a week for one hour or less. They lasted from four to six weeks.

The authors noted several concerns and potential pitfalls. Even though these interventions are low-harm, there were no articles with high-strength evidence for psychological and behavioral interventions for insomnia disorder, and trials did not report adverse events or withdrawals from the trials routinely. The types of adverse events were not mentioned in the evidence report. Also, the authors were unable to compare different models of CBT-I delivery, such as face-to-face, internet, group therapy, or book-based. Additionally, patients in the trials presented with at least moderate to severe insomnia disorder, and trials analyzed featured well-designed CBT-I interventions with documented procedures and trained providers. Many facilities do not employ providers nor have created procedures to implement CBT-I. Both these factors lead to concern over the applicability and generalizability of the findings.

COMMENTARY

The latest clinical practice guideline on this subject from the American College of Physicians recommends that all adult patients receive CBT-I as the initial treatment for chronic insomnia disorder (strong recommendation, moderate-quality evidence). It also recommends shared decision-making when deciding whether to add pharmacological therapy in those for whom CBT-I was unsuccessful.5 These recommendations are based on the evidence report reviewed above. Furthermore, the guideline states that, ideally, medications for chronic insomnia should be used no longer than four to five weeks. There is insufficient evidence to accurately weigh the benefits and harms from long-term use of medications, and it is unknown whether medications decrease the harmful effects of sleep deprivation.5 Although medications can be useful in some populations, we know there are potential side effects, such as sleep walking, sleep eating, and engaging in intercourse while sleeping. There is also the risk of becoming physically dependent on the medications, increased risk of falls, and increased risk of mobility problems in the geriatric population. CBT-I offers a low-harm treatment option for insomnia. However, there are barriers to implementing CBT-I and other behavioral therapies on a wide scale. One barrier is identifying patients who may benefit from the intervention. Patient-completed instruments, such as the ISI, can be used in medical practices to identify candidates for CBT-I. It can help clinicians distinguish clinical from nonclinical insomnia and determine the severity, with a score of ≥ 15 meeting criteria for CBT-I intervention. Another concern with recommending CBT-I is patient access. This may be the biggest barrier to physicians recommending it. The evidence report noted that there were several models for delivery of CBT-I, but there is not enough evidence to determine which are the most effective.4 If shown to be effective, internet-based or book-based models may provide wider access to patients. Also, few practitioners are trained in this therapy.6 For those who are trained, insurance reimbursement is not always available. Unfortunately, there are few immediate options to overcome this barrier. Highly motivated patients may pursue out-of-pocket treatment or veterans can pursue therapy through Veteran Affairs. Regardless of the therapy used, patients likely will turn to their clinician for advice on treatment and with questions during the process. It is important that clinicians be comfortable with the evidence and current recommendations for diagnosis and treatment of chronic insomnia.

REFERENCES

  1. Buysse DJ. Insomnia. JAMA 2013;309:706. doi:10.1001/jama.2013.193.
  2. Kraus SS, Rabin LA. Sleep America: Managing the crisis of adult chronic insomnia and associated conditions. J Affect Disord 2012;138:192-212. doi:10.1016/j.jad.2011.05.014.
  3. American Psychiatric Association. American Psychiatric Association, 2013. Diagnostic and Statistical Manual of Mental Disorders (5th Ed.).; 2013. doi:10.1176/appi.books.9780890425596.744053.
  4. Brasure M, Fuchs E, MacDonald R, et al. Psychological and behavioral interventions for managing insomnia disorder: An evidence report for a clinical practice guideline by the American College of Physicians. Ann Intern Med 2016;165:113-124. doi:10.7326/M15-1782.
  5. Qaseem A, Kansagara D, Forciea MA, et al. Management of chronic insomnia disorder in adults: A clinical practice guideline from the American College of Physicians. Ann Intern Med 2016;165:125-133. doi:10.7326/M15-2175.
  6. Kathol RG, Arnedt JT. Cognitive behavioral therapy for chronic insomnia: Confronting the challenges to implementation. Ann Intern Med 2016;165:149. doi:10.7326/M16-0359.