Mindfulness Therapy on Disrupted Sleep in Bipolar Disorder

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Massachusetts General Hospital
Sponsor:
Collaborator:
The Depressive and Bipolar Disorder Alternative Treatment Foundation
Information provided by (Responsible Party):
Thilo Deckersbach, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01764035
First received: January 7, 2013
Last updated: June 26, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Bipolar Disorder
Insomnia
Hypersomnia
Sleep Problems
Behavioral: Body Scan (BS) Meditation Intervention
Behavioral: Brief Supportive Psychotherapy (SP)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effects of Mindfulness on Disrupted Sleep in Bipolar Disorder

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Total Sleep Time (TST) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Young Mania Rating Scale (YMRS) [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
    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). [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
    The HAM-D 17 is an established clinician-rated outcome measure in treatment trials for depression.


Estimated Enrollment: 60
Study Start Date: February 2013
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Brief Supportive Psychotherapy (SP)
30 people will be randomized to receive Brief Supportive Psychotherapy.
Behavioral: Brief Supportive Psychotherapy (SP)
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).
Experimental: Body Scan (BS) Meditation Intervention
30 people will be randomized receive the Body Scan Meditation Intervention.
Behavioral: Body Scan (BS) Meditation Intervention
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.

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and women age 18-65
  • DSM-IV diagnosis of bipolar I disorder
  • HAM-D-17 score < 12 (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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01764035

Contacts
Contact: Alexandra Gold, B.A. 617-643-6194 akgold@mgh.harvard.edu

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Principal Investigator: Thilo Deckersbach, PhD         
Sponsors and Collaborators
Massachusetts General Hospital
The Depressive and Bipolar Disorder Alternative Treatment Foundation
Investigators
Principal Investigator: Thilo Deckersbach, Ph.D. Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Thilo Deckersbach, Assistant Professor of Psychology, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01764035     History of Changes
Other Study ID Numbers: 2012P002550
Study First Received: January 7, 2013
Last Updated: June 26, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
Psychotherapy
Bipolar Disorder
Sleep Problems
Insomnia
Hypersomnia
Mindfulness
Meditation
Sleep Disturbance

Additional relevant MeSH terms:
Bipolar Disorder
Disease
Dyssomnias
Sleep Disorders
Parasomnias
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Pathologic Processes
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on September 22, 2014