Bipolar DisorderNCT01764035
Mindfulness Therapy on Disrupted Sleep in Bipolar Disorder
A study testing Body Scan (BS) Meditation Intervention and Brief Supportive Psychotherapy (SP) in people with Bipolar Disorder and Insomnia, run by Massachusetts General Hospital at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bipolar Disorder, Insomnia, Hypersomnia
- What is being tested?
- Body Scan (BS) Meditation Intervention and Brief Supportive Psychotherapy (SP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2013to Feb 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: The Effects of Mindfulness on Disrupted Sleep in Bipolar Disorder
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.
Read the 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.
- Conditions
- Bipolar Disorder, Insomnia, Hypersomnia, Sleep Problems
- Being tested
- Body Scan (BS) Meditation Intervention, Brief Supportive Psychotherapy (SP)
- Keywords
- Psychotherapy, Bipolar Disorder, Sleep Problems, Insomnia, Hypersomnia, Mindfulness, Meditation, Sleep Disturbance
- Medical subject headings
- Bipolar Disorder, Sleep Initiation and Maintenance Disorders, Disorders of Excessive Somnolence, Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Body Scan (BS) Meditation InterventionBehavioural
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)Behavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Brief Supportive Psychotherapy (SP) | Active comparator | 30 people will be randomized to receive Brief Supportive Psychotherapy. Receives: Behavioral: Brief Supportive Psychotherapy (SP) |
| Body Scan (BS) Meditation Intervention | Experimental | 30 people will be randomized receive the Body Scan Meditation Intervention. Receives: Behavioral: Body Scan (BS) Meditation Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Sleep Time (TST)
Measured: 8 weeks
Secondary outcomes (2)
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.
Measured: 20 weeks
Hamilton Depression Rating Inventory (HAM-D 17).
The HAM-D 17 is an established clinician-rated outcome measure in treatment trials for depression.
Measured: 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2013 (estimated)
- Study startFeb 2013
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Depressive and Bipolar Disorder Alternative Treatment Foundation
- Responsible party
- Principal investigator, Thilo Deckersbach, Massachusetts General Hospital
- Investigators
- Thilo Deckersbach, Ph.D., Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01764035
- Sponsor's protocol ID
- 2012P002550
- Status last verified
- Jun 2016
- First submitted
- 7 Jan 2013
- Last updated
- 24 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Mindfulness on Disrupted Sleep in Bipolar Disorder
- ClinicalTrials.gov ID
- NCT01764035
- Acronym / sponsor ID
- 2012P002550
- Conditions
- Bipolar Disorder, Insomnia, Hypersomnia, Sleep Problems
- Keywords
- Psychotherapy, Bipolar Disorder, Sleep Problems, Insomnia, Hypersomnia, Mindfulness, Meditation, Sleep Disturbance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- The Depressive and Bipolar Disorder Alternative Treatment Foundation
- Study start
- Feb 2013
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 9 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brief Supportive Psychotherapy (SP) | Active comparator | Behavioral: Brief Supportive Psychotherapy (SP)30 people will be randomized to receive Brief Supportive Psychotherapy. |
| Body Scan (BS) Meditation Intervention | Experimental | Behavioral: Body Scan (BS) Meditation Intervention30 people will be randomized receive the Body Scan Meditation Intervention. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Body Scan (BS) Meditation InterventionThis 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. | Behavioural | Body Scan (BS) Meditation Intervention |
| 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). | Behavioural | Brief Supportive Psychotherapy (SP) |
Primary outcome
Total Sleep Time (TST)
Time frame: 8 weeks
2 secondary outcomes
Young Mania Rating Scale (YMRS)
Time frame: 20 weeks
Hamilton Depression Rating Inventory (HAM-D 17).
Time frame: 20 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thilo Deckersbach, Ph.D. principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Body Scan (BS) Meditation Intervention and Brief Supportive Psychotherapy (SP) in people with Bipolar Disorder and Insomnia, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Sleep Time (TST) (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2016.