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5 Review of Treatments for Comorbid and Related Conditions Chronic multisymptom illness (CMI) is a serious condition that imposes an enormous burden of suffering on our nation’s veterans. It can affect every facet of a veteran’s health: physical, psychologic, social, economic, and spiritual; it can impair a person’s capacities whether the person is a soldier, worker, or family member. Despite its impact, CMI remains poorly understood and in need of additional study. The medical community does not yet know exactly which signs and symptoms should be part of the diagnostic criteria, and, as science and discovery change, the definition and diagnostic criteria of CMI may also change. It is known, however, that a number of events or preconditions are fre- quently seen in association with CMI. In some cases, a common exposure can lead to more than one condition; for example, an explosion can cause a concussion, deafness, body injury, and pain. Different but similar condi- tions share symptoms; for example, cognitive impairment can be a feature of CMI and traumatic brain injury (TBI). Some medical conditions can lead to other clinical problems; for example, chronic pain can lead to depression, and chronic lung disease can lead to anxiety. And some common conditions may cluster without obvious explanation. CMI may include symptoms that are not severe enough for diagnosis as a clinically recognized syndrome or that are associated with defined disorders. It is clear that the possibilities are many and that not all are fully defined. The purpose of this report is to describe the current optimal approach to care for patients who have CMI. In the quest to help patients, the entire spectrum of their complaints must be considered and addressed. A compre- hensive, individualized, patient-centered plan of care must acknowledge and 93

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94 GULF WAR AND HEALTH address all conditions and comorbidities that are present and their possible interrelationships. This chapter briefly describes 12 common conditions that are comorbid with or related to CMI and presents treatments that are known to be effective. The committee believes that symptoms shared between CMI and those treatments may respond to similar approaches in symptom management. Treatments that are recommended in evidence-based clinical practice guidelines or that have been found effective in systematic reviews are highlighted. The chapter concludes with a general therapeutic approach to patients who have the most common diagnostic clusters. FIBROMYALGIA Primary fibromyalgia is a relatively common chronic condition that is thought to be caused by abnormal processing of pain by the central nervous system (Abeles et al., 2007). Using US population estimates from 2005, the estimated prevalence of fibromyalgia in the United States was about 5 mil- lion people (Lawrence et al., 2008). It is characterized by chronic wide- spread pain, fatigue, cognitive symptoms, and sleep disturbance. Anxiety ­ and depression can accompany the syndrome (Wolfe et al., 1990). The diagnostic criteria of the American College of Rheumatology are as follows (Wolfe et al., 2010): 1. Pain over the preceding week identified from a list of 19 areas of the body. 2. Fatigue, waking unrefreshed, and cognitive symptoms (memory disturbance). 3. Symptoms lasting longer than 3 months. 4. Symptoms not explained by any other medical condition. Other conditions may resemble fibromyalgia closely, including hypo­ thyroidism, polymyalgia rheumatica, rheumatoid arthritis, and systemic lupus erythematosus. Fibromyalgia and Chronic Multisymptom Illness Fibromyalgia and CMI share symptoms. The hallmark of fibromyalgia is chronic widespread pain. In CMI, muscle pain and tenderness are very common but are not required for the diagnosis. Treatments for Fibromyalgia Many pharmacologic and nonpharmacologic treatments have been demonstrated to be effective for fibromyalgia. Many categories of phar-

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REVIEW OF TREATMENTS FOR COMORBID AND RELATED CONDITIONS 95 macologic medications are somewhat to very effective in treatment for this syndrome. Systematic reviews identified several pharmacologic treatments for fibromyalgia. Amitryptyline, a tricyclic medication, was found to have a short-term benefit—6–8 weeks—when given at 25 mg/day (Nishishinya et al., 2008). The serotonin–norepinephrine reuptake inhibitors duloxetine and milnacipran also demonstrated beneficial effects on pain reduction, fatigue, sleep, depression, and quality of life in systematic reviews (Sultan et al., 2008; Uceyler et al., 2008). The neuropathic agent pregabalin has proved to be effective (Choy et al., 2011; Nuesch et al., 2012; Siler et al., 2011; Tzellos et al., 2010). Gabapentin, another neuropathic medication, has also been shown to have modest benefits in patients who have fibro- myalgia (Moore et al., 2011). Duloxetine, milnacipran, and pregabalin are approved by the US Food and Drug Administration (FDA) for the manage- ment of fibromyalgia. Other medications have shown less consistent ben- eficial study results, including cyclobenzaprine and the atypical analgesic tramadol (Hauser et al., 2011; Russell et al., 2000). Nonpharmacologic interventions that have proved beneficial for patients who have fibromyalgia include cognitive behavioral therapy (CBT) (Bernardy et al., 2010) and aerobic exercise (Maquet et al., 2007). Many studies of fibromyalgia have shown benefits of multimodal therapies: a combination of treatments that include exercise, CBT, education, and self- help tools (Hauser et al., 2009). It is well established that most patients benefit from an interdisciplinary and integrative approach to the long-term management of fibromyalgia and that medications alone are rarely benefi- cial for maintaining effective reduction in chronic pain. CHRONIC PAIN Chronic pain is defined as pain that is associated with a chronic medical condition or that persists beyond the expected time for tissue healing and adversely affects the function or well-being of the person (American Society of Anesthesiologists Task Force on Chronic Pain Management and Ameri- can Society of Regional Anesthesia and Pain Medicine, 2010). Chronic pain affects about 100 million adults in the United States (IOM, 2011b). Chronic Pain and Chronic Multisymptom Illness Chronic pain is one of the symptoms that might be associated with CMI. Veterans of the 1991 Gulf War who have CMI may not have had a specific injury but can have common and persistent diffuse chronic pain (for example, joint pain). Pain is the most frequent presenting complaint of troops returning from the Iraq and Afghanistan wars who are treated at a VA polytrauma clinic

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96 GULF WAR AND HEALTH (Lew et al., 2009). Many Iraq and Afghanistan war veterans have chronic pain due to specific injuries. As discussed in Chapter 2, the most common health outcome reported in that population is the triad of posttraumatic stress disorder (PTSD), mild TBI, and pain (Walker et al., 2010). The preva- lence of CMI in veterans of the Iraq and Afghanistan wars has not been well studied, so it is not known whether the pain reported by these veterans is associated with CMI. Treatments for Chronic Pain Treatment for chronic pain requires a long-term approach, coordinated care, and periodic reevaluation. The scientific literature and clinical experi- ence support a multidisciplinary approach to treatment for chronic pain as recommended by guidelines of the American Society of ­ nesthesiologists A Task Force on Chronic Pain Management and American Society of Regional Anesthesia and Pain Medicine (2010). Pharmacologic management of chronic pain includes nonsteroidal anti- inflammatory drugs (NSAIDs), antidepressants, anticonvulsants, opioid therapy, and other agents. Evidence supporting pharmacologic manage- ment of chronic pain of varied etiology is strong. Tricyclic medications and s ­ erotonin–norepinephrine reuptake inhibitors (SNRIs) are recommended for chronic pain in conjunction with other therapies; there have been multiple randomized controlled trials (RCTs), and the aggregated findings are sup- ported by meta-analyses (American Society of Anesthesiologists Task Force on Chronic Pain Management and American Society of Regional ­ nesthesia A and Pain Medicine, 2010). Pregabalin has been shown to be effective for central neuropathic pain (Moore et al., 2009). The use of NSAIDs or t ­ ramadol for chronic back pain is supported by the results of multiple RCTs (American Society of Anesthesiologists Task Force on Chronic Pain Man- agement and American Society of Regional Anesthesia and Pain Medicine, 2010). Although there are data that show that opioids provide effective relief of low back pain and some forms of neuropathic pain for periods ranging from 1 to 9 weeks, the data are limited with respect to the safety and efficacy of long-term opioid therapy for chronic pain. In addition, the risks and potential harm associated with opioid therapy are serious, and guidelines should be followed (VA and DOD, 2010b). The use of radiofrequency ablation of branch nerves to facet joints for low back pain is supported by results of multiple RCTs and meta-analyses (American Society of Anesthesiologists Task Force on Chronic Pain Man- agement and American Society of Regional Anesthesia and Pain Medicine, 2010). Ablative techniques also are recommended for neck pain, but the evidence comes from a single RCT. The use of transcutaneous electric nerve stimulation for chronic back pain and other types of pain as part of

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REVIEW OF TREATMENTS FOR COMORBID AND RELATED CONDITIONS 97 a multimodal treatment is supported by results of multiple RCTs, and the aggregated findings are supported by meta-analyses. There is no strong evidence supporting epidural injections for back pain, but there has been a single RCT on relief of leg pain. Neither is there strong evidence to sup- port intrathecal drug therapies for neuropathic pain or minimally invasive spinal procedures for vertebral compression fractures (American Society of Anesthesiologists Task Force on Chronic Pain Management and American Society of Regional Anesthesia and Pain Medicine, 2010). A growing body of evidence demonstrates that acupuncture can be useful for chronic pain (Lee et al., 2012; Manheimer et al., 2005; Vickers, 2012). The strongest evidence supports its use in treatment for headache, but it may be effective for other forms of chronic pain, such as low back pain and osteoarthritis. Therefore, acupuncture should be considered for use in customizing pain treatment of patients who have CMI. CHRONIC FATIGUE SYNDROME Chronic fatigue syndrome (CFS), also known as myalgic encephalo­ myelitis, affects an estimated 4 million people in the United States, according to the Centers for Disease Control and Prevention (CDC), with prevalence estimates ranging from 0.2% to 2.54% (Maquet et al., 2006; Reeves et al., 2007). CFS is more common and more severe in women and people who have Latino and African-American backgrounds, and its prognosis w ­ orsens with age (Jason et al., 2011). People who have CFS often have other ­ omorbid conditions, such as obesity and metabolic disorders, depres- c sion, irritable bowel syndrome (IBS), fibromyalgia, and multiple chemical sensitivity. Multiple symptoms of each of those conditions can overlap substantially with CMI, including fatigue, nonrestorative sleep, tenderness on palpation, and some mild cognitive dysfunction (CDC, 1994). Defini- tions of CFS vary, but the diagnosis is the result of careful review of patient history, physical health and mental health examinations, clinical laboratory testing, and indicated imaging studies to rule out other medical and psy- chologic diagnoses that may explain the symptoms of CFS. Definitions of CFS used by CDC and UK National Health Service are included in Box 5-1. Chronic Fatigue Syndrome and Chronic Multisymptom Illness Much research on CFS has targeted infectious triggers associated with low-grade fever, adenopathy, and influenza symptoms. Regardless, no con- sistent viral agents (such as human herpesvirus 6 and Epstein-Barr virus) have been definitively identified (Glaser and Kiecolt-Glaser, 1998). Fever, adenopathy, and infection-like symptoms tend to decrease over time, and fatigue and other somatic symptoms common in CMI become more promi-

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98 GULF WAR AND HEALTH BOX 5-1 Definitions of Chronic Fatigue Syndrome International CFS Case NICE Guidelines for CFS, Definition, 1994a 2007b Duration 6 months or longer 4 months or longer in adults Fatigue Severe chronic fatigue not Fatigue with explained by any medical or •  ew or specific date N psychiatric diagnosis of onset, persistent or recurrent, unexplained by other conditions •  ubstantially reduced S activity level •  ostexertional malaise or P fatigue Symptoms At least four of the following: At least one of the following: •  ostexertion malaise lasting P •  ifficulty in sleeping or D more than 24 hours insomnia •  nrefreshing or U •  uscle or joint pain without M nonrestorative sleep inflammation (swelling) •  ubstantial impairment S manifested as tenderness of short-term memory or on palpation in characteristic concentration soft-tissue areas •  uscle pain M •  eadaches H •  ain in joints without P •  ainful lymph nodes that are P swelling or redness not enlarged •  eadaches of a new type, H •  ore throat S pattern, or severity •  oor mental function, such P •  ender lymph nodes in the T as difficulty in thinking neck or armpit •  orsening of symptoms W •  ore throat that is frequent S after physical or mental or recurring exertion •  eeling of being unwell F or having influenza-like symptoms •  izziness or nausea D •  eart palpitations without H heart disease And All other medical conditions have been ruled out. NOTE: CFS = chronic fatigue syndrome; NICE = National Institute for Health and Clinical Excellence. aCDC, 1994. bNHS, 2007.

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REVIEW OF TREATMENTS FOR COMORBID AND RELATED CONDITIONS 99 nent (Krilov et al., 1998). Many of the symptoms of CFS and CFS-like ill- ness (meeting some but not all of the criteria for CFS) are similar to those experienced by people who have CMI. Both CMI and CFS include a variety of symptoms—fatigue, cognitive symptoms, and pain. Treatments for Chronic Fatigue Syndrome Both US and UK treatment guidelines emphasize the lack of a particular medication or therapy to cure CFS. However, an individualized treatment program and a patient-centered care model to tailor symptom management to a patient’s needs are recommended. Symptoms of CFS may be man- aged in primary care (CDC, undated; Mayo Clinic staff, 2011; National C ­ ollaborating Centre for Primary Care, 2007). Two specific therapies are recommended for people who have CFS: CBT and graded exercise therapy (GET) (CDC, 1994; Mayo Clinic staff, 2011; National Collaborating Centre for Primary Care, 2007). CBT provides a framework for patients to change how they think and feel about their illness and teaches behaviors that provide patients with a greater sense of control over symptoms (CDC, undated; National Collaborating Centre for Primary Care, 2007). Exercise has been associated with the body’s natural release of endorphins, natural pain relievers. Both exercise and endorphins have been shown to improve a number of the symptoms of CFS and related syndromes (Cleare, 2003; Harber and Sutton, 1984). Additional CFS management strategies can be recommended to improve quality of life. Pacing to balance activities and rest throughout the day may be helpful to avoid “crashing” after too much activity; however, evidence is insufficient to determine efficacy (CDC, 1994; National Collaborat- ing Centre for Primary Care, 2007). Disturbance of restorative or deep sleep may play a role in triggering symptoms of CFS (Moldofsky, 1993). Sleep patterns should be changed gradually to introduce a regular sleep- ing schedule, bedtime routine, noise and light control, and avoidance of c ­ affeine, alcohol, and tobacco (CDC, 1994; National Collaborating Centre for Primary Care, 2007). Clinicians should also encourage patients to learn coping skills through counseling and support groups and to maintain their independence as much as possible (CDC, 1994; Mayo Clinic staff, 2011). Management may focus on treating specific symptoms. Drug therapy is recommended to manage some symptoms, but clinicians are encour- aged to use as few drugs as possible and to use minimal doses because people who have CFS are often more sensitive to medications. Pain may be managed with acetaminophen, aspirin, or NSAIDs, but narcotics are not recommended. Sleep medications or treatments, such as melatonin and continuous positive airway pressure, may be useful if indicated by the patient’s history and improvements are not seen with good sleep hygiene

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100 GULF WAR AND HEALTH (CDC, 1994; Mayo Clinic staff, 2011; National Collaborating Centre for Primary Care, 2007). It is clear that CFS is not depression, but it may be associated with depression. Multivitamins can be useful for patients who do not have a balanced diet. Clinicians may offer recommendations to reduce stress and improve sleep, such as relaxation techniques and limitation of caffeine intake. Such relaxation techniques as visualization can be used to manage pain, sleep problems, and comorbid anxiety. Alternative therapies (for example, yoga, Tai Chi, acupuncture, and massage) may help to lessen pain and increase energy (CDC, 1994; Mayo Clinic staff, 2011; National Collaborating C ­ entre for Primary Care, 2007). SOMATIC SYMPTOM DISORDERS There appears to be a tendency to experience and communicate psycho- logic distress in the form of physical symptoms and to seek medical atten- tion for these symptoms (Katon and Walker, 1998; Shorter, 1993). Often, the physical symptoms remain medically unexplained and are associated with increased medical visits and unnecessary medical tests, which may result in iatrogenic complications. Among the many terms used in the litera- ture to label these somatic presentations, somatization symptoms was the most common for decades. That designation has been gradually replaced with more descriptive terms, such as medically unexplained symptoms, unexplained symptoms, and functional somatic symptoms. In the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edi- tion (DSM-5), the new criteria being developed by the American Psychiatric Association, those syndromes are classified under the heading “Somatic Symptom Disorders” (SSDs). Their key characteristic is the presence of or preoccupation with physical symptoms that suggest a medical condition but cannot be satisfactorily explained with traditional physical and laboratory assessments (APA, 2012). DSM-5’s SSDs include illness anxiety disorder, functional neurologic disorder (conversion disorder), psychologic problems that affect a medical condition, and disorders not elsewhere classified. A distinctive characteristic of patients who have SSDs is not a somatic symp- tom itself but how a patient experiences it, interprets it, and presents it to a clinician. Despite the relevance of these somatic presentations in medicine, their definition and classification remain difficult and controversial, and this has led to frequent revisions of nomenclatures that move the target used to designate “cases” and complicate the clinical recognition and management of the syndromes.

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REVIEW OF TREATMENTS FOR COMORBID AND RELATED CONDITIONS 101 Somatic Symptom Disorders and Chronic Multisymptom Illness Because SSDs typically present with multiple physical symptoms of unclear etiology that tend to persist, the syndromes often overlap with CMI, and differential diagnosis is difficult. Treatments for Somatic Symptom Disorders Effective treatments for SSDs include nonpharmacologic approaches, such as CBT and communication with the primary care physician by the psychiatrist or psychologist via consultation letters (Escobar, 2009). Other forms of psychotherapy and biofeedback are also effective (Katsamanis et al., 2011). In some instances, particularly when SSD symptoms are accom- panied by anxiety and depression symptoms (a common co-occurrence, particularly in primary care settings), such antidepressants as venlafaxine may be helpful (Kroenke et al., 2006). However, treatments have to be adapted to give proper attention to the somatic component because tradi- tional treatments alone (for example, antidepressants) may not be sufficient. SLEEP DISORDERS Sleep disorders are a group of about 70 syndromes characterized by persistent disturbance in sleep that interferes with activities of daily living. The most common syndromes are chronic insomnia, nightmare dis­ rder, o rapid eye movement (REM) sleep behavior disorder, circadian-rhythm sleep disorders, and obstructive sleep apnea. Like CMI, sleep disorders are asso- ciated with fatigue, mood disturbances, cognitive difficulties, and other somatic symptoms; comorbidity with depression, anxiety, and substance abuse is common. Sleep Disorders and Chronic Multisymptom Illness Several types of sleep disorders are among the common symptoms associated with CMI. Nightmare disorders, subjective perceptions of dif- ficulty with sleep initiation or duration, and early awakening (insomnia) have been described in persons who have PTSD, chronic pain disorders, and other comorbid conditions, including general medical and neurologic dis­ rders (Chokroverty, 2000). Other types of sleep disorders are less o common in people who have CMI. REM sleep behavior disorder may be idiopathic or secondary to neurologic disorders, such as Parkinson’s disease, stroke, multiple sclerosis, and spinocerebellar ataxia. Obstructive sleep apnea is most common among those who are obese or have congestive heart failure, stroke, or pulmonary hypertension. Circadian-rhythm sleep dis­

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102 GULF WAR AND HEALTH TABLE 5-1  Best-Practice Guidelines and Recommendations for Treatment for Nightmare Disorders and Chronic Insomnia Type of Intervention Nightmare Disordera Chronic Insomniab Pharmacologic Prazosin (for PTSD- Pharmaceutical agent selected on associated nightmares) basis of symptom pattern, treatment goals, past treatment response, patient preference, cost, availability of other treatments, comorbid conditions, concurrent medication interactions, and side effects Nonpharmacologic CBT, including image At least one behavioral intervention rehearsal therapy of these: stimulus-control therapy, relaxation therapy, or combination CBT aAmerican Academy of Sleep Medicine (Aurora et al., 2010). bAmerican Academy of Sleep Medicine (Schutte-Rodin et al., 2008). NOTE: CBT = cognitive behavioral therapy; PTSD = posttraumatic stress disorder. orders may be exogenous (for example, jet lag or difficulties in shift work) or ­ndogenous (for example, advanced sleep-phase disorder or irregular e sleep–wake rhythm). Nightmare disorders and insomnia are the two sleep disorders more commonly associated with CMI. Treatments for Sleep Disorders Because of the large number of sleep disorders and evidence that effective treatment varies among them, it is vital to evaluate the patient adequately and accurately to characterize the specific symptoms, identify potential comorbid conditions or risk factors, and diagnose the specific type of disorder. Table 5-1 summarizes best-practice guidelines and recom- mendations for treatment for nightmare disorder and chronic insomnia. The clinician should consider a number of other approaches that may be useful when individualizing the treatment and management of CMI, such as good sleep hygiene, exercise, acupuncture, and mind–body approaches. Some of those approaches, such as acupuncture, have been documented with systematic reviews (Lee et al., 2012), but they have not yet risen to the level of guidelines. FUNCTIONAL GASTROINTESTINAL DISORDERS: IRRITABLE BOWEL SYNDROME AND FUNCTIONAL DYSPEPSIA The functional gastrointestinal disorders (FGIDs) are best understood as disorders that affect gastrointestinal functioning; the ones most recog-

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REVIEW OF TREATMENTS FOR COMORBID AND RELATED CONDITIONS 103 nized and most relevant to this discussion are IBS and functional dyspepsia (FD) (Drossman, 2006). IBS and FD present as recurrent or prolonged clusters of gastrointestinal symptoms that remain consistent in their fea- tures over time and among populations. IBS and FD are common in young adults and are associated with wartime deployment of Gulf War veterans (IOM, 2010). The diagnosis of an FGID is made by fulfilling standardized symptom- based criteria (“Rome criteria”) for a minimal period, usually 6 months. The criteria for IBS and FD are shown in Boxes 5-2 and 5-3. Functional Gastrointestinal Disorders and Chronic Multisymptom Illness The most common symptoms of IBS are abdominal pain or discomfort, diarrhea, constipation, and abdominal bloating, and common symptoms of FD are early satiety with upper abdominal fullness, burning, or pain—all in the absence of other structural abnormalities that explain the symptoms. The symptoms are common in veterans deployed to the 1991 Gulf War (IOM, 2010). There is overlap between symptoms associated with IBS and FD and the gastrointestinal symptoms associated with CMI. A veteran may fulfill criteria for IBS and also have other extraintestinal symptoms and receive a diagnosis of IBS, at another time have gastrointestinal symptoms that are not sufficient for a diagnosis of IBS, and, by virtue of having several other unexplained symptoms, be classified as having CMI. Therefore, from a therapeutic standpoint, these conditions that share symptoms are likely BOX 5-2 Rome III Diagnostic Criteriaa for Irritable Bowel Syndrome Recurrent abdominal pain or discomfort at least 3 days per month in last 3 months associated with two or more of 1. Improvement with defecation. 2. Onset associated with a change in frequency of stool. 3. Onset associated with a change in form (appearance) of stool. aCriteriafulfilled for the last 3 months with symptom onset at least 6 months before diagnosis. SOURCE: Reprinted from Gastroenterology 130(5), Longstreth et al., Functional bowel disor- ders, pages 1480–1491, Copyright 2006, with permission from Elsevier.

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122 GULF WAR AND HEALTH TABLE 5-3 Continued Condition Pharmacologic Nonpharmacologic Substance-use For alcohol-use disorders: For alcohol-use disorders: and addictive • Naltrexone • Behavioral couples therapy disorders • Acamprosate • CBT • Disulfiram • Social network and • Topiramate (possibly) environment-based therapies For tobacco-use disorders: • Other behavioral therapies • Nicotine-replacement therapy (for example, cue exposure, • Bupropion behavioral self-control • Varenicline training, aversion therapy, and For opioid-use disorders: contingency management) • Methadone For tobacco-use disorders: • Buprenorphine • Individual and group behavioral • Naltrexone interventions focused on smoking cessation For opioid-use disorders: • Referral to a pain specialist or center that specializes in withdrawal treatment Self-harm • SSRIs • CBT, including dialectic behavior therapy • Interpersonal therapy NOTES: CBT = cognitive behavioral therapy; CPAP = continuous positive airway pressure; NSAIDs = nonsteroidal anti-inflammatory drugs; SNRIs = serotonin–norepinephrine reuptake inhibitors; SSRIs = selective serotonin reuptake inhibitors. There also is substantial evidence in guidelines and from systematic reviews that CBT is effective in managing more than one of the related conditions. CBT has been shown to be effective in nearly all the conditions examined in this chapter. It is important to note that there are multiple types of CBT and that the choice of the appropriate type to use for a par- ticular patient will depend on the person’s symptoms. As summarized in this chapter, many other treatments, both phar- macologic and nonpharmacologic, have been shown to be effective in managing conditions related to and comorbid with CMI. Because symp- toms of CMI have a pattern of presentation similar to those of the other conditions, treatments found to be effective for the conditions should be considered as parts of an integrated and multimodal treatment plan for patients who have CMI.

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