Cognitive behavioral therapy for insomnia in euthymic bipolar disorder: study protocol for a randomized controlled trial

Abstract

BackgroundPatients with bipolar disorder experience sleep disturbance, even in euthymic phases. Changes in sleep pattern are frequent signs of a new episode of (hypo)mania or depression. Cognitive behavioral therapy for insomnia (CBT-I) is an effective treatment for primary insomnia, but there are no published results on the effects of CBT-I in patients with bipolar disorder. In this randomized controlled trial, we wish to compare CBT-I and treatment as usual with treatment as usual alone to determine its effect in improving quality of sleep, stabilizing minor mood variations and preventing new mood episodes in euthymic patients with bipolar disorder and comorbid insomnia.MethodsPatients with euthymic bipolar I or II disorder and insomnia, as verified by the Structured Clinical Interview for DSM Disorders (SCID-1) assessment, will be included. The patients enter a three-week run-in phase in which they complete a sleep diary and a mood diary, are monitored for seven consecutive days with an actigraph and on two of these nights with polysomnography in addition before randomization to an eight-week treatment trial. Treatment as usual consists of pharmacological and supportive psychosocial treatment. In this trial, CBT-I will consist of sleep restriction, psychoeducation about sleep, stabilization of the circadian rhythm, and challenging and correcting sleep state misperception, in three to eight sessions.DiscussionThis trial could document a new treatment for insomnia in bipolar disorder with possible effects on sleep and on stability of mood. In addition, more precise information can be obtained about the character of sleep disturbance in bipolar disorder.Trial registrationClinicalTrials.gov: NCT01704352.

Sleep problems in bipolar disorders: more than just insomnia

“…The cut‐off scores used to operationalize current mental states and the rationale for their selection were based on those employed in a clinical intervention trial for sleep problems in BD . To briefly summarize, the goal was to maximize the specificity of episode identification (i.e.…”

“…Several clinical studies have explored the sleep profiles of BD cases and identified a range of individual characteristics associated with the presence or absence of sleep problems. Also, a number of research studies have employed actigraphy or other objective measures to record sleep patterns and their associations with circadian or other systemic disturbances . In addition, exploring how sleep symptoms respond to the treatments prescribed for acute BD episodes, there is increasing interest in the adjunctive use of chronobiotics such as melatonin agonists and/or chronotherapeutics such as cognitive and behavioural therapies to specifically target sleep problems in BD cases .…”

“…Also, a number of research studies have employed actigraphy or other objective measures to record sleep patterns and their associations with circadian or other systemic disturbances . In addition, exploring how sleep symptoms respond to the treatments prescribed for acute BD episodes, there is increasing interest in the adjunctive use of chronobiotics such as melatonin agonists and/or chronotherapeutics such as cognitive and behavioural therapies to specifically target sleep problems in BD cases . However, these approaches have exposed the lack of a full understanding of the range of sleep profiles that may be observed in BD and as yet it is not known whether the reported sleep patterns are mainly associated with different phases or subtypes of BD and/or how much of the variance in sleep might be explained by other known influences such as age, gender, body mass index (BMI) or indeed be a result of the confounding effects of BD treatments .…”

Feasibility and Acceptability of the ‘HABIT’ Group Programme for Comorbid Bipolar and Alcohol and Substance use Disorders

“…So, the first module comprised of modified IGT sessions that incorporated psycho‐education, CBT and RP elements and helped familiarize clients with group processes and master basic self‐regulations and self‐management techniques. We hypothesized that these initial sessions could enable individuals to develop a more stable mental state and also act as a ‘lead‐in’ period that could enhance motivation to attend the second module based on MBRP (Simon et al , ; Steinan et al , ).…”

Serum levels of carcinoembryonic antigen (CEA) in patients with bipolar disorder

“…BP has a chronic and remitting nature characterised by periods of depression and periods of hypomania or mania in many patients (11).…”