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.
Highlights
Patients with bipolar disorder experience sleep disturbance, even in euthymic phases
Study design The study is a randomized controlled trial aimed to study the efficacy of Cognitive behavioral therapy for insomnia (CBT-I) in euthymic bipolar disorder patients with comorbid insomnia compared with treatment as usual (TAU)
Patients will not be accepted if they meet any of the following exclusion criteria: they are in an affective episode; they work night shifts; they have an ongoing alcohol or substance abuse problem, or sleep apnea or other confounding sleep disorders, or medical conditions that may account for a sleep disturbance; or they have conditions or cognitive impairments incompatible with participation
Summary
Study design The study is a randomized controlled trial aimed to study the efficacy of CBT-I in euthymic bipolar disorder patients with comorbid insomnia compared with TAU. The patients will receive US $85 in compensation for each polysomnography session, and another US $85 in compensation for transport costs and other expenses related to participation Those patients who are able to complete the three-week run-in phase and meet diagnostic criteria for insomnia will be randomized to the treatment trial. N = 40 3 weeks run-in Diagnostic interview Self-report Sleep and mood diary Actigraphy (AG) 1 week Polysomnography (PSG) 2 nights. Beck Depression Inventory (BDI) This is a self-report questionnaire used to assess the level of depression [19] It will be used before and after treatment, and at follow-up. Beck Anxiety Inventory (BAI) This is a self-report questionnaire used to assess the level of anxiety [20] This will be done on two nonconsecutive nights during the last week
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