Mindfulness Therapy on Disrupted Sleep in Bipolar Disorder

Completed · Not applicable

Conditions studied: Bipolar Disorder, Insomnia, Hypersomnia, Sleep Problems

In brief

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.

Key facts

Study ID

NCT01764035

Run by

Massachusetts General Hospital

People needed

48

Starts

2013-02-01

Expected to finish

2016-02-01

Last updated by the study team

2016-06-24

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• Insomnia Severity Index score of > 15 (moderate clinical insomnia)
• 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.

You may not qualify if…

• 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.

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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