Mindfulness Therapy on Disrupted Sleep in Bipolar Disorder
Condition: Bipolar Disorder; Insomnia; Hypersomnia; Sleep Problems
MeSH terms: Sleep Initiation and Maintenance Disorders; Dyssomnias; Parasomnias; Disorders of Excessive Somnolence; Bipolar Disorder
Study type: Interventional

Summary: 
      The investigators propose to investigate the efficacy of a brief (4-session) Body Scan (BS)
      meditation intervention for individuals with bipolar I disorder with insomnia (i.e.
      difficulties falling or staying asleep). The investigators will compare the Body Scan
      intervention with a 4-session brief supportive psychotherapy (SP) intervention. The
      investigators hypothesize that the Body Scan will improve objective sleep quantity and
      quality.
    

Detailed description: 
      This is the first evaluation of the efficacy of a mindfulness-based intervention for insomnia
      in bipolar disorder. It distills the findings from previous mindfulness-based interventions
      for other disorders that documented beneficial effects for sleep, by concentrating on the
      most active mindfulness ingredient for treating sleep (the Body Scan). To date, mindfulness
      based studies have focused on either subjective sleep reports or laboratory-based measures of
      sleep, both of which have long been called into question because of their lack of ecological
      validity. This study takes advantage of recent developments in ambulatory sleep monitoring by
      using the new, FDA approved M1 device, which assesses sleep objectively in a patient's home
      environment. The M1 device is also the only ambulatory sleep-monitoring device to date that
      simultaneously assesses both sleep quantity and quality. Finally, this study broadens the
      view above and beyond sleep and mood and investigates the impact on cognitive and
      sleep-related psychosocial functioning, both at the end of treatment as well as at a 3-month
      follow-up. Overall, this work could result in a brief, easy to administer, and easy to
      disseminate intervention for patients with bipolar disorder with insomnia.
    

Intervention name(s): Body Scan (BS) Meditation Intervention; Brief Supportive Psychotherapy (SP)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): This intervention consists of 4 individual 60-minute sessions (week 1, 2, 4, and 6) in which participants learn the body scan meditation exercise and practice it at home, daily, lying in bed at their usual bedtime after going to bed (and when waking up at night, unable to go back to sleep). The Body-Scan meditation consists of a 30-minute exercise during which participants are guided to focus their attention on certain parts of their body (e.g. toes, feet). The core skill involves gradually adopting an observant, non-judgmental, and accepting stance towards bodily sensations, including feelings and thoughts.; SP is a common form of non-specific psychotherapy available to patients with bipolar disorder in the community. It focuses on addressing a patient's current concerns, supporting a patient's adaptive coping skills, improving self-esteem, and expressing feelings and the therapeutic alliance. Using a conversational style, SP involves conveying empathy, validation, comforting and supporting patients in coping with distress about current life issues as well as providing encouragement and praise, clarification and opportunity to vent. SP will match BS in length, number of sessions and delivery schedule (four, 60-minute sessions, week 1, 2, 4, 6).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Psychotherapy; Bipolar Disorder; Sleep Problems; Insomnia; Hypersomnia; Mindfulness; Meditation; Sleep Disturbance