Mindfulness Therapy on Disrupted Sleep in Bipolar Disorder

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.

Inclusion Criteria:

- Men and women age 18-65

- DSM-IV diagnosis of bipolar I or II disorder

- HAM-D-17 score < 17 (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.