InsomniaNCT00935376
Sleep Management in Cancer Survivors
A study testing Sleep Education Program, Mind-Body Bridging Program and Mindfulness Meditation Program in people with Insomnia, run by University of Utah at 1 site in United States.
Trial summary
The pilot project will investigate three short-term intervention programs for sleep management in cancer survivors in a randomized controlled clinical study. Three programs to be examined in the study are: 1. the mind-body bridging program (MBBP), 2. mindfulness meditation program (MMP), and 3. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Insomnia
- What is being tested?
- Sleep Education Program, Mind-Body Bridging Program and Mindfulness Meditation Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- May 2009to Jul 2010
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Selection of subjects will be based on their exhibiting sleep disturbance as assessed by a validated sleep questionnaire (MOS Sleep Scale, Hayes et al, 2005).
- Participant is willing to be randomized to any one of the three interventions, will be willing to attend all three classes, complete self-report questionnaires and collect saliva samples, at pre- and post- treatment, weekly intervals and 2-3 months follow-up.
- Participant must be English speaking and comprehend information presented during the course of study, including the consent form.
Who cannot join
- Underlying psychiatric illness, such as severe or untreated psychopathology (e.g. schizophrenia), or cognitive impairments, neurologic disorders, or dementia.
- Use of psychotropic medication for any of the above, and for any other unspecified condition.
- Has had previous exposure to MBBP or MBSR/MMP.
- Incidence of metastatic cancer
- Currently taking immuno-suppressants and/or corticosteroids.
- Compromised physical health, in which individual has impaired mobility: unable to carry out movement exercises, cannot lie down on the floor, kneel, get up from the floor to a standing position.
- Individuals who are considered at the 'end-of-life' stage of their cancer.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study of Three Short-term Intervention Programs for Sleep Management in Cancer Survivors
The pilot project will investigate three short-term intervention programs for sleep management in cancer survivors in a randomized controlled clinical study. Three programs to be examined in the study are:
- the mind-body bridging program (MBBP),
- mindfulness meditation program (MMP), and
- sleep education program (SEP).
Read the detailed description
This pilot randomized study investigates whether the two awareness training programs (ATP), MBBP and MMP are effective in improving sleep disturbance and in reducing stress in post-treatment cancer patients. The two experimental conditions and the SEP control will each comprise 3 sessions of 2 hr. duration and conducted over 3 consecutive weeks (Week 1-3).
- Conditions
- Insomnia
- Being tested
- Sleep Education Program, Mind-Body Bridging Program, Mindfulness Meditation Program
- Keywords
- Sleep Management, Awareness Training Programs, Mindfulness Meditation, Mind Body Bridging
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep Education ProgramBehavioural
Also called SEP
Treatment as usual.
Mind-Body Bridging ProgramBehavioural
Also called MBBP
Bridging aims to reduce the impact of negative thought patterns that contribute to stress in the body.
Mindfulness Meditation ProgramBehavioural
Also called MMP
Mindfulness Meditation Program is based on Mindfulness-Based Stress Reduction, which teaches participants awareness and mindfulness skills using techniques that include a basic meditation practice and yoga.
| Study group | Role | What they receive |
|---|---|---|
| Mind-Body Bridging Program | Experimental | The Mind-Body Bridging Program (MBBP) is an awareness training program (ATP)to help individuals improve their health condition and attain a state of well-being. Bridging is the primary technique that facilitates the healing process, by bringing one back to the present moment to experience thoughts, emotions and physical sensations. Bridging aims to reduce the impact of negative thought patterns that contribute to stress in the body. Receives: Behavioral: Mind-Body Bridging Program |
| Mindfulness Meditation Program | Experimental | Mindfulness Meditation Program (MMP) is based on Mindfulness-Based Stress Reduction (MBSR), which teaches participants mindfulness skills such as meditation and yoga. Mindfulness may be defined as paying attention in a particular way, on purpose, in the present moment, and nonjudgmentally. The goal of MBSR is to provide participants with experiential tools and mindfulness practices to assist them to become more mindful of themselves, others and their external environment. The techniques are easy to learn and teach individuals to be aware of the present moment, with an open mind in which they can perceive their thoughts, physical sensations, and emotions nonjudgmentally. Receives: Behavioral: Mindfulness Meditation Program |
| Sleep Education Program | Active comparator | The Sleep Education Program (SEP) will serve as the control intervention in which participants will receive classes informing them how to change their habits to improve their sleep, and what to do if they have concerns about their sleep quality. Receives: Behavioral: Sleep Education Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medical Outcomes Study-Sleep Scale
Measured: Pre-treatment, Week 1, Week 2, Week 3, Post treatment, Follow up
Functional Assessment of Cancer Therapy - General
Measured: Pre-treatment, Post treatment, Follow up
Perceived Stress Scale
Measured: Pre-treatment, Week 1, Week 2, Week 3, Post treatment, Follow up
Secondary outcomes (6)
Impact of Event Scale
Measured: Pre-treatment, Post treatment, Follow up
Center for Epidemiologic Studies Depression Scale
Measured: Pre-treatment, Post treatment, Follow up
Positive Affect-Negative Affect
Measured: Pre-treatment, Week 1, Week 2, Week 3, Post treatment, Follow up
Five-factor Mindfulness Questionnaire
Measured: Pre-treatment, Post treatment, Follow up
Self-Compassion Scale
Measured: Pre-treatment, Post treatment, Follow up
Well-Being Index
Measured: Pre-treatment, Week 1, Week 2, Week 3, Post treatment, Follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2009 (estimated)
- Study startMay 2009
- Primary completionMay 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by University of UtahThe 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
- Participant
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Yoshio Nakamura, University of Utah
- Investigators
- Yoshio Nakamura, Ph.D., Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00935376
- Sponsor's protocol ID
- 33669
- Other IDs
- 5R21AT002209
- Status last verified
- Apr 2017
- First submitted
- 18 Jun 2009
- Last updated
- 18 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Lipschitz DL, Kuhn R, Kinney AY, Donaldson GW, Nakamura Y. Reduction in salivary alpha-amylase levels following a mind-body intervention in cancer survivors--an exploratory study. Psychoneuroendocrinology. 2013 Sep;38(9):1521-31. doi: 10.1016/j.psyneuen.2012.12.021. Epub 2013 Feb 1.
PubMed 23375640Nakamura Y, Lipschitz DL, Kuhn R, Kinney AY, Donaldson GW. Investigating efficacy of two brief mind-body intervention programs for managing sleep disturbance in cancer survivors: a pilot randomized controlled trial. J Cancer Surviv. 2013 Jun;7(2):165-82. doi: 10.1007/s11764-012-0252-8. Epub 2013 Jan 22.
PubMed 23338490
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Three Short-term Intervention Programs for Sleep Management in Cancer Survivors
- ClinicalTrials.gov ID
- NCT00935376
- Acronym / sponsor ID
- 33669
- Conditions
- Insomnia
- Keywords
- Sleep Management, Awareness Training Programs, Mindfulness Meditation, Mind Body Bridging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- May 2009
- Primary completion
- May 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 9 Jul 2009 (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 pilot project will investigate three short-term intervention programs for sleep management in cancer survivors in a randomized controlled clinical study. Three programs to be examined in the study are:
- the mind-body bridging program (MBBP),
- mindfulness meditation program (MMP), and
- sleep education program (SEP).
Detailed description
This pilot randomized study investigates whether the two awareness training programs (ATP), MBBP and MMP are effective in improving sleep disturbance and in reducing stress in post-treatment cancer patients. The two experimental conditions and the SEP control will each comprise 3 sessions of 2 hr. duration and conducted over 3 consecutive weeks (Week 1-3).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mind-Body Bridging Program | Experimental | Behavioral: Mind-Body Bridging ProgramThe Mind-Body Bridging Program (MBBP) is an awareness training program (ATP)to help individuals improve their health condition and attain a state of well-being. Bridging is the primary technique that facilitates the healing process, by bringing one back to the present moment to experience thoughts, emotions and physical sensations. Bridging aims to reduce the impact of negative thought patterns that contribute to stress in the body. |
| Mindfulness Meditation Program | Experimental | Behavioral: Mindfulness Meditation ProgramMindfulness Meditation Program (MMP) is based on Mindfulness-Based Stress Reduction (MBSR), which teaches participants mindfulness skills such as meditation and yoga. Mindfulness may be defined as paying attention in a particular way, on purpose, in the present moment, and nonjudgmentally. The goal of MBSR is to provide participants with experiential tools and mindfulness practices to assist them to become more mindful of themselves, others and their external environment. The techniques are easy to learn and teach individuals to be aware of the present moment, with an open mind in which they can perceive their thoughts, physical sensations, and emotions nonjudgmentally. |
| Sleep Education Program | Active comparator | Behavioral: Sleep Education ProgramThe Sleep Education Program (SEP) will serve as the control intervention in which participants will receive classes informing them how to change their habits to improve their sleep, and what to do if they have concerns about their sleep quality. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Selection of subjects will be based on their exhibiting sleep disturbance as assessed by a validated sleep questionnaire (MOS Sleep Scale, Hayes et al, 2005).
- Participant is willing to be randomized to any one of the three interventions, will be willing to attend all three classes, complete self-report questionnaires and collect saliva samples, at pre- and post- treatment, weekly intervals and 2-3 months follow-up.
- Participant must be English speaking and comprehend information presented during the course of study, including the consent form.
Key exclusion criteria (7 listed)
- Underlying psychiatric illness, such as severe or untreated psychopathology (e.g. schizophrenia), or cognitive impairments, neurologic disorders, or dementia.
- Use of psychotropic medication for any of the above, and for any other unspecified condition.
- Has had previous exposure to MBBP or MBSR/MMP.
- Incidence of metastatic cancer
- Currently taking immuno-suppressants and/or corticosteroids.
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 |
|---|---|---|
| Sleep Education ProgramAlso: SEPTreatment as usual. | Behavioural | Sleep Education Program |
| Mind-Body Bridging ProgramAlso: MBBPBridging aims to reduce the impact of negative thought patterns that contribute to stress in the body. | Behavioural | Mind-Body Bridging Program |
| Mindfulness Meditation ProgramAlso: MMPMindfulness Meditation Program is based on Mindfulness-Based Stress Reduction, which teaches participants awareness and mindfulness skills using techniques that include a basic meditation practice and yoga. | Behavioural | Mindfulness Meditation Program |
Primary outcome
Medical Outcomes Study-Sleep Scale
Time frame: Pre-treatment, Week 1, Week 2, Week 3, Post treatment, Follow up
Functional Assessment of Cancer Therapy - General
Time frame: Pre-treatment, Post treatment, Follow up
Perceived Stress Scale
Time frame: Pre-treatment, Week 1, Week 2, Week 3, Post treatment, Follow up
6 secondary outcomes
Impact of Event Scale
Time frame: Pre-treatment, Post treatment, Follow up
Center for Epidemiologic Studies Depression Scale
Time frame: Pre-treatment, Post treatment, Follow up
Positive Affect-Negative Affect
Time frame: Pre-treatment, Week 1, Week 2, Week 3, Post treatment, Follow up
Five-factor Mindfulness Questionnaire
Time frame: Pre-treatment, Post treatment, Follow up
Self-Compassion Scale
Time frame: Pre-treatment, Post treatment, Follow up
Well-Being Index
Time frame: Pre-treatment, Week 1, Week 2, Week 3, Post treatment, Follow up
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 18 Apr 2017.
- Derived from this study: PubMed 23375640Lipschitz DL, Kuhn R, Kinney AY, Donaldson GW, Nakamura Y. Reduction in salivary alpha-amylase levels following a mind-body intervention in cancer survivors--an exploratory study. Psychoneuroendocrinology. 2013 Sep;38(9):1521-31. doi: 10.1016/j.psyneuen.2012.12.021. Epub 2013 Feb 1.
- Derived from this study: PubMed 23338490Nakamura Y, Lipschitz DL, Kuhn R, Kinney AY, Donaldson GW. Investigating efficacy of two brief mind-body intervention programs for managing sleep disturbance in cancer survivors: a pilot randomized controlled trial. J Cancer Surviv. 2013 Jun;7(2):165-82. doi: 10.1007/s11764-012-0252-8. Epub 2013 Jan 22.
- Individual participant dataSharing planned: No
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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.
Yoshio Nakamura, Ph.D. principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep Education Program, Mind-Body Bridging Program and Mindfulness Meditation Program in people with Insomnia, run by University of Utah 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 3 inclusion and 7 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 18 Apr 2017. 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?
Medical Outcomes Study-Sleep Scale (time frame: Pre-treatment, Week 1, Week 2, Week 3, Post treatment, Follow up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00935376, which also lists 2 linked publications.
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 18 Apr 2017.