Mindfulness Therapy on Disrupted Sleep in Bipolar Disorder

Description

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.

Study Start Date

February 2013

Estimated Completion Date

February 2016

Interventions

  • Behavioral: Brief Supportive Psychotherapy (SP)
  • Behavioral: Body Scan (BS) Meditation Intervention

Specialties

  • Internal Medicine: Neurology,Psychiatry
  • Psychiatry: Mood Disorders
  • Neurology: Neuropsych Sciences,Sleep

MeSH Terms

  • Bipolar Disorder
  • Bipolar Disorder
  • Disorders of Excessive Somnolence
  • Parasomnias
  • Sleep Disorders

Study ID

Massachusetts General Hospital -- 2012P002550

Status

Unknown

Trial ID

NCT01764035

Study Type

Interventional

Trial Phase

N/A

Enrollment Quota

60

Sponsor

Massachusetts General Hospital

Inclusion Criteria

  • Men and women age 18-65
  • DSM-IV diagnosis of bipolar I disorder
  • HAM-D-17 score < 12 (i.e. low or no depressive symptoms)
  • YMRS score < 8 (i.e. no or low manic symptoms)
  • Optimized, stable maintenance pharmacotherapy at maximum tolerated dosages in accordance with the revised Texas Implementation of Medication Algorithm
  • DSM-IV insomnia A and B criteria are met (i.e. difficulty initiating or maintaining sleep, for at least 1 month) as operationally defined by: 1. Insomnia Severity Index score of > 15 (moderate clinical insomnia) 2. M1 derived average actigraphic total sleep time < 6 hours, and < 40% average total sleep time in high frequency coupling, as measured with the M1 device over 5 days pre-randomization, corresponding to < 1SD below the mean of the M1 normative comparison sample of healthy control participants.

Exclusion Criteria

  • DSM-IV bipolar I disorder subtype rapid cycling
  • DSM-IV manic or mixed episode in the past 2 months
  • DSM-IV major depressive episode in the past 2 months
  • Psychotropic medication not in accordance with the revised Texas Implementation of Medication Algorithm
  • Pregnancy
  • Medical illness or non-psychiatric medical treatment that is the likely cause of the sleep disturbance or interferes with study participation
  • Neurologic disorder, previous ECT, or history of head trauma (i.e. known structural brain lesion)
  • Current or past history of selected DSM-IV Axis I disorders other than bipolar disorder including: organic mental disorder, substance abuse within the past 12 months and/or history of substance abuse for > 1 year
  • past or current substance dependence (including alcohol), schizophrenia, delusional disorder, psychotic disorders not otherwise specified
  • Axis I disorder that needs to be the primary focus of treatment (e.g. current DSM-IV anxiety disorder that disrupts sleep)
  • Sleep apnea, restless leg syndrome, or narcolepsy
  • Concurrent psychotherapy to BS or SP.

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

No

Study Locations and Contact Information (1)

Study Location Distance Name Phone Email
Massachusetts General Hospital - Boston, Massachusetts 2.8 miles None None None

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