Mindfulness Therapy on Disrupted Sleep in Bipolar Disorder

NCT01764035 | Completed

• 1 other identifier: 2012P002550
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Bipolar Disorder; Insomnia; Hypersomnia; Sleep Problems

Keywords

Psychotherapy; Bipolar Disorder; Sleep Problems; Insomnia; Hypersomnia; Mindfulness; Meditation; Sleep Disturbance

Outcome Measures

Primary Outcomes (1)

• Total Sleep Time (TST)

  8 weeks

Secondary Outcomes (2)

• Young Mania Rating Scale (YMRS)

  20 weeks

• Hamilton Depression Rating Inventory (HAM-D 17).

  20 weeks

Study Arms (2)

Brief Supportive Psychotherapy (SP)

ACTIVE COMPARATOR

30 people will be randomized to receive Brief Supportive Psychotherapy.

Behavioral: Brief Supportive Psychotherapy (SP)

Body Scan (BS) Meditation Intervention

EXPERIMENTAL

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

Behavioral: Body Scan (BS) Meditation Intervention

Interventions

Body Scan (BS) Meditation Intervention BEHAVIORAL

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.

Body Scan (BS) Meditation Intervention

Brief Supportive Psychotherapy (SP) BEHAVIORAL

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).

Brief Supportive Psychotherapy (SP)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• The Depressive and Bipolar Disorder Alternative Treatment Foundation: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Bipolar Disorder; Sleep Initiation and Maintenance Disorders; Disorders of Excessive Somnolence; Parasomnias

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Thilo Deckersbach, Ph.D.

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Psychology

Study Record Dates

• First Submitted: January 7, 2013
• First Posted: January 9, 2013
• Study Start: February 1, 2013
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: June 24, 2016

Record last verified: 2016-06

Locations

US (1)