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Mindfulness Therapy on Disrupted Sleep in Bipolar Disorder

Primary Purpose

Bipolar Disorder, Insomnia, Hypersomnia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Body Scan (BS) Meditation Intervention
Brief Supportive Psychotherapy (SP)
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bipolar Disorder focused on measuring Psychotherapy, Bipolar Disorder, Sleep Problems, Insomnia, Hypersomnia, Mindfulness, Meditation, Sleep Disturbance

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Brief Supportive Psychotherapy (SP)

Body Scan (BS) Meditation Intervention

Arm Description

30 people will be randomized to receive Brief Supportive Psychotherapy.

30 people will be randomized receive the Body Scan Meditation Intervention.

Outcomes

Primary Outcome Measures

Total Sleep Time (TST)

Secondary Outcome Measures

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.
Hamilton Depression Rating Inventory (HAM-D 17).
The HAM-D 17 is an established clinician-rated outcome measure in treatment trials for depression.

Full Information

First Posted
January 7, 2013
Last Updated
June 22, 2016
Sponsor
Massachusetts General Hospital
Collaborators
The Depressive and Bipolar Disorder Alternative Treatment Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT01764035
Brief Title
Mindfulness Therapy on Disrupted Sleep in Bipolar Disorder
Official Title
The Effects of Mindfulness on Disrupted Sleep in Bipolar Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
The Depressive and Bipolar Disorder Alternative Treatment Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder, Insomnia, Hypersomnia, Sleep Problems
Keywords
Psychotherapy, Bipolar Disorder, Sleep Problems, Insomnia, Hypersomnia, Mindfulness, Meditation, Sleep Disturbance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Brief Supportive Psychotherapy (SP)
Arm Type
Active Comparator
Arm Description
30 people will be randomized to receive Brief Supportive Psychotherapy.
Arm Title
Body Scan (BS) Meditation Intervention
Arm Type
Experimental
Arm Description
30 people will be randomized receive the Body Scan Meditation Intervention.
Intervention Type
Behavioral
Intervention Name(s)
Body Scan (BS) Meditation Intervention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Brief Supportive Psychotherapy (SP)
Intervention Description
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).
Primary Outcome Measure Information:
Title
Total Sleep Time (TST)
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Young Mania Rating Scale (YMRS)
Description
Young Mania Rating Scale is an 11-item, clinician-rated measure that assesses the presence and severity of patient's current symptoms of mania.
Time Frame
20 weeks
Title
Hamilton Depression Rating Inventory (HAM-D 17).
Description
The HAM-D 17 is an established clinician-rated outcome measure in treatment trials for depression.
Time Frame
20 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thilo Deckersbach, Ph.D.
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

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Mindfulness Therapy on Disrupted Sleep in Bipolar Disorder

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