Mindfulness Therapy on Disrupted Sleep in Bipolar Disorder
|ClinicalTrials.gov Identifier: NCT01764035|
Recruitment Status : Completed
First Posted : January 9, 2013
Last Update Posted : June 24, 2016
|Condition or disease||Intervention/treatment||Phase|
|Bipolar Disorder Insomnia Hypersomnia Sleep Problems||Behavioral: Body Scan (BS) Meditation Intervention Behavioral: Brief Supportive Psychotherapy (SP)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||48 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||The Effects of Mindfulness on Disrupted Sleep in Bipolar Disorder|
|Study Start Date :||February 2013|
|Actual Primary Completion Date :||February 2016|
|Actual Study Completion Date :||February 2016|
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.
- Total Sleep Time (TST) [ Time Frame: 8 weeks ]
- Young Mania Rating Scale (YMRS) [ Time Frame: 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.
- Hamilton Depression Rating Inventory (HAM-D 17). [ Time Frame: 20 weeks ]The HAM-D 17 is an established clinician-rated outcome measure in treatment trials for depression.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01764035
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Thilo Deckersbach, Ph.D.||Massachusetts General Hospital|