Mindfulness Therapy on Disrupted Sleep in Bipolar Disorder

Bipolar Disorder Clinical Trial

Official title:

The Effects of Mindfulness on Disrupted Sleep in Bipolar Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01764035
• Other study ID #: 2012P002550
• Status: Completed
• Phase: N/A
• First received: January 7, 2013
• Last updated: June 22, 2016
• Start date: February 2013
• Est. completion date: February 2016

Study information

• Verified date: June 2016
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar Disorder
• Dyssomnias
• Hypersomnia
• Insomnia
• Parasomnias
• Sleep Problems
• Sleep Wake Disorders

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.
• 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).

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	The Depressive and Bipolar Disorder Alternative Treatment Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Sleep Time (TST)		8 weeks	No
Secondary	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	No
Secondary	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	No