Clinical trial NCT01764035: Mindfulness Therapy on Disrupted Sleep in Bipolar Disorder
Official title: The Effects of Mindfulness on Disrupted Sleep in Bipolar Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bipolar Disorder
Insomnia
Hypersomnia
Sleep Problems
Keywords: Psychotherapy
Bipolar Disorder
Sleep Problems
Insomnia
Hypersomnia
Mindfulness
Meditation
Sleep Disturbance
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: The Depressive and Bipolar Disorder Alternative Treatment Foundation
First posted: 2013-01-09
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Total Sleep Time (TST)
timeFrame: 8 weeks
Secondary outcomes:
measure: Young Mania Rating Scale (YMRS)
timeFrame: 20 weeks
measure: Hamilton Depression Rating Inventory (HAM-D 17).
timeFrame: 20 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Thilo Deckersbach, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: