Mindfulness Therapy on Disrupted Sleep in Bipolar Disorder

Not Applicable

Completed

• Conditions: Sleep Problems; Bipolar Disorder; Insomnia; Hypersomnia
• Interventions: Behavioral: Body Scan (BS) Meditation Intervention; Behavioral: Brief Supportive Psychotherapy (SP)

• Registration Number: NCT01764035
• Lead Sponsor: Massachusetts General Hospital

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.

Study Timeline

• Study First Submitted: 2013-01-07
• Study First Submitted QC: 2013-01-08
• Study First Posted: 2013-01-09
• Study Start: 2013-02
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-22
• Last Update Posted: 2016-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Body Scan (BS) Meditation Intervention	Body Scan (BS) Meditation Intervention	30 people will be randomized receive the Body Scan Meditation Intervention.
Brief Supportive Psychotherapy (SP)	Brief Supportive Psychotherapy (SP)	30 people will be randomized to receive Brief Supportive Psychotherapy.

Primary Outcome Measures

Name	Time	Method
Total Sleep Time (TST)	8 weeks

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States