InsomniaPhase 1/2NCT00933959
Pilot Study on Sleep Management for US Veterans
A Phase 1/2 study testing Mind-Body Bridging Program and Sleep Hygiene in people with Insomnia, run by University of Utah at 1 site in United States.
Trial summary
The aim of the proposed pilot study is to scientifically evaluate the use of Mind-Body Bridging Program (MBBP) as an effective intervention for improving health outcomes in veterans exhibiting sleep disturbance in the Primary Care Clinic at the Veterans Administration Salt Lake City Health Care System (VASLCHCS). Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Insomnia
- What is being tested?
- Mind-Body Bridging Program and Sleep Hygiene
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2008to Mar 2009
- Phase
- Phase 1/2
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Selection of subjects will be based on the patients exhibiting sleep disturbance as assessed by a standardized sleep questionnaire. Because we are also interested in the effects of MBBP on co-morbid illnesses besides insomnia, we will include subjects that are being treated for depression, pain, and general medical conditions, except as defined as exclusion criteria. Subjects using anti-depressants, sleep and pain medications, and other medications for any condition that is not under exclusion criteria will be admitted to the study. Thus our inclusion criteria will be broader than those based on DSM-IV for primary insomnia.
- On the day of the study session, patients must arrive before the session for intervention assignment and to turn in their packets, and thereafter on the same day they must be able to attend a mind-body bridging program or sleep hygiene class (see Study Procedure). In addition, they must also be able to attend the second session the following week.
Who cannot join
- The patient presents with significant mental health issues, such as severe psychosis or major depression (as verified by the primary care provider) or the patient is under intensive mental health case management.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study of Two Contrasting Intervention Programs for Sleep Management
The aim of the proposed pilot study is to scientifically evaluate the use of Mind-Body Bridging Program (MBBP) as an effective intervention for improving health outcomes in veterans exhibiting sleep disturbance in the Primary Care Clinic at the Veterans Administration Salt Lake City Health Care System (VASLCHCS).
Read the detailed description
Participants will be randomly assigned to either MBBP or a treatment as usual sleep hygiene (SH) group. The interventions will last two weeks in which participants will attend 2 classes 1-1.5 hr each over two consecutive weeks. Assessment of the effects of the treatments will be based on self-report outcome measures; participants will complete five questionnaires approximately one week prior to the start of the interventions (pre-treatment) and one week after the second session (post-treatment). The sleep quality assessment questionnaire will be additionally completed after the first session (Week 1).
- Conditions
- Insomnia
- Being tested
- Mind-Body Bridging Program, Sleep Hygiene
- Keywords
- Sleep problems, Awareness training program, Mind body bridging
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mind-Body Bridging ProgramBehavioural
Also called MBBP
Bridging aims to reduce the impact of negative thought patterns that contribute to stress in the body.
Sleep HygieneBehavioural
Also called SH
Treatment as usual
| Study group | Role | What they receive |
|---|---|---|
| Mind-Body Bridging Program | Experimental | Subjects will undergo two approximately 1.5 hr training sessions using MBBP spaced one week apart at the VASLCHCS. Each training session will comprise a number of objectives:
Session 1:
1. The patient will discover the underlying cause of the insomnia.
2. The patient will learn how to use easy to apply tools to quieten the mind to sleep soundly.
Session 2:
1. The patient will learn how to reduce daytime stress.
2. The patient will experience a greater sense of self.
To be maximally effective, the participant should master these objectives and practice MBBP on a daily basis. Bridging and all the other MBBP techniques can be implemented at any time throughout the day and right up to the onset of sleep. Receives: Behavioral: Mind-Body Bridging Program |
| Sleep Hygiene | Active comparator | Participants in the sleep hygiene arm will receive a 1 hr class directing them to the importance of following a list of up to 15 points (tips) for getting to sleep. These points include: limiting alcohol and caffeine intake before bed, using the bed only for sleeping, and having regular bedtimes. Once the instructor has gone over this list and has described in detail each of the 15 points, the class will have an opportunity to ask questions. The participant will be encouraged to learn and practice the objectives of the sleep hygiene class on a daily basis. Receives: Behavioral: Sleep Hygiene |
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, Post treatment
Medical Outcomes Study Short Form-36 for Veterans
Measured: Pre-treatment, Post treatment
Secondary outcomes (3)
Center for Epidemiologic Studies Depression Scale
Measured: Pre-treatment, Post treatment
Five-factor Mindfulness Questionnaire
Measured: Pre-treatment, Post treatment
PTSD Check List-Military
Measured: Pre-treatment, Post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2009 (estimated)
- Study startMar 2008
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Investigators
- Gavin West, M.D., Principal investigator, Salt Lake City VA/University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00933959
- Sponsor's protocol ID
- 27522
- Status last verified
- Jul 2009
- First submitted
- 18 Jun 2009
- Last updated
- 8 Jul 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Two Contrasting Intervention Programs for Sleep Management
- ClinicalTrials.gov ID
- NCT00933959
- Acronym / sponsor ID
- 27522
- Conditions
- Insomnia
- Keywords
- Sleep problems, Awareness training program, Mind body bridging
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 8 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 aim of the proposed pilot study is to scientifically evaluate the use of Mind-Body Bridging Program (MBBP) as an effective intervention for improving health outcomes in veterans exhibiting sleep disturbance in the Primary Care Clinic at the Veterans Administration Salt Lake City Health Care System (VASLCHCS).
Detailed description
Participants will be randomly assigned to either MBBP or a treatment as usual sleep hygiene (SH) group. The interventions will last two weeks in which participants will attend 2 classes 1-1.5 hr each over two consecutive weeks. Assessment of the effects of the treatments will be based on self-report outcome measures; participants will complete five questionnaires approximately one week prior to the start of the interventions (pre-treatment) and one week after the second session (post-treatment). The sleep quality assessment questionnaire will be additionally completed after the first session (Week 1).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mind-Body Bridging Program | Experimental | Behavioral: Mind-Body Bridging ProgramSubjects will undergo two approximately 1.5 hr training sessions using MBBP spaced one week apart at the VASLCHCS. Each training session will comprise a number of objectives: Session 1: 1. The patient will discover the underlying cause of the insomnia. 2. The patient will learn how to use easy to apply tools to quieten the mind to sleep soundly. Session 2: 1. The patient will learn how to reduce daytime stress. 2. The patient will experience a greater sense of self. To be maximally effective, the participant should master these objectives and practice MBBP on a daily basis. Bridging and all the other MBBP techniques can be implemented at any time throughout the day and right up to the onset of sleep. |
| Sleep Hygiene | Active comparator | Behavioral: Sleep HygieneParticipants in the sleep hygiene arm will receive a 1 hr class directing them to the importance of following a list of up to 15 points (tips) for getting to sleep. These points include: limiting alcohol and caffeine intake before bed, using the bed only for sleeping, and having regular bedtimes. Once the instructor has gone over this list and has described in detail each of the 15 points, the class will have an opportunity to ask questions. The participant will be encouraged to learn and practice the objectives of the sleep hygiene class on a daily basis. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Selection of subjects will be based on the patients exhibiting sleep disturbance as assessed by a standardized sleep questionnaire. Because we are also interested in the effects of MBBP on co-morbid illnesses besides insomnia, we will include subjects that are being treated for depression, pain, and general medical conditions, except as defined as exclusion criteria. Subjects using anti-depressants, sleep and pain medications, and other medications for any condition that is not under exclusion criteria will be admitted to the study. Thus our inclusion criteria will be broader than those based on DSM-IV for primary insomnia.
- On the day of the study session, patients must arrive before the session for intervention assignment and to turn in their packets, and thereafter on the same day they must be able to attend a mind-body bridging program or sleep hygiene class (see Study Procedure). In addition, they must also be able to attend the second session the following week.
Key exclusion criteria (1 listed)
- The patient presents with significant mental health issues, such as severe psychosis or major depression (as verified by the primary care provider) or the patient is under intensive mental health case management.
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 |
|---|---|---|
| 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 |
| Sleep HygieneAlso: SHTreatment as usual | Behavioural | Sleep Hygiene |
Primary outcome
Medical Outcomes Study-Sleep Scale
Time frame: Pre-treatment, Week 1, Post treatment
Medical Outcomes Study Short Form-36 for Veterans
Time frame: Pre-treatment, Post treatment
3 secondary outcomes
Center for Epidemiologic Studies Depression Scale
Time frame: Pre-treatment, Post treatment
Five-factor Mindfulness Questionnaire
Time frame: Pre-treatment, Post treatment
PTSD Check List-Military
Time frame: Pre-treatment, Post treatment
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 8 Jul 2009.
Related trials for Insomnia
Not yet recruiting
Mandala Coloring in Late Pregnancy
Pregnancy, Anxiety
Not yet recruiting
HALO Clarity™ Cranial Alternating Current Stimulation Therapy for Adults With Moderate-to-Severe Insomnia
Moderate to Severe Insomnia
Enrolling by invitation
Recreational Badminton, Sleep and Melatonin
Sedentary Behavior
Not yet recruiting
CannaRiver CBD Calm for Anxiety, Sleep, and Well-Being in Adults With Generalized Anxiety Disorder
Generalized Anxiety Disorder
Enrolling by invitation
Physical Activity Interventions for Sleep Improvement and Sedative-Hypnotic Reduction in Middle-Aged and Older Adults: Investigating the Role of Sarcopenia
Insomnia Chronic, Hypnotics and Sedatives
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.
Gavin West, M.D. principal investigator
Salt Lake City VA/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 Phase 1/2 study testing Mind-Body Bridging Program and Sleep Hygiene 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 2 inclusion and 1 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 8 Jul 2009. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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, Post treatment). The study lists 2 primary outcomes in all. 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 8 Jul 2009.