Mindfulness Therapy on Disrupted Sleep in Bipolar Disorder

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effects of Mindfulness on Disrupted Sleep in Bipolar Disorder

Conditions
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Bipolar Disorder, Insomnia, Hypersomnia, Sleep Problems

Intervention / Treatment
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* Behavioral: Body Scan (BS) Meditation Intervention
* Behavioral: Brief Supportive Psychotherapy (SP)


Participation Criteria
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Eligibility Criteria
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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: 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. 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Brief Supportive Psychotherapy (SP)<br>30 people will be randomized to receive Brief Supportive Psychotherapy. | Behavioral: Brief Supportive Psychotherapy (SP)<br>* 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).<br>|
| Experimental: Body Scan (BS) Meditation Intervention<br>30 people will be randomized receive the Body Scan Meditation Intervention. | Behavioral: Body Scan (BS) Meditation Intervention<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Sleep Time (TST) |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Young Mania Rating Scale (YMRS) | Young Mania Rating Scale is an 11-item, clinician-rated measure that assesses the presence and severity of patient's current symptoms of mania. | 20 weeks | 
| Hamilton Depression Rating Inventory (HAM-D 17). | The HAM-D 17 is an established clinician-rated outcome measure in treatment trials for depression. | 20 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Psychotherapy, Bipolar Disorder, Sleep Problems, Insomnia, Hypersomnia, Mindfulness, Meditation, Sleep Disturbance