InsomniaPhase 2NCT00768781
Mindfulness-Based Approaches to Insomnia
A Phase 2 study testing Mindfulness-Based Stress Reduction, Mindfulness-Based Therapy for Insomnia and Wait-List + Behavioral Therapy for Insomnia in people with Insomnia, run by Rush University Medical Center at 1 site in United States.
Trial summary
The overall goal of this project is to evaluate the evidence for the efficacy of two mindfulness-based interventions, mindfulness-based therapy for insomnia (MBT-I) and mindfulness-based stress reduction (MBSR), for reducing arousal and improving sleep among individuals with psychophysiological insomnia. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Insomnia
- What is being tested?
- Mindfulness-Based Stress Reduction, Mindfulness-Based Therapy for Insomnia and Wait-List + Behavioral Therapy for Insomnia
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2008to Apr 2013
- Phase
- Phase 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meets criteria for psychophysiological insomnia
- Males and females of age 21 or older
Who cannot join
- Unstable medical condition that is known to impact sleep
- Psychiatric conditions likely to impact the practice of meditation
- Current active suicidal ideation
- Presence of a primary sleep disorder other than primary insomnia
- Evidence of paradoxical insomnia
- Evidence of idiopathic insomnia
Show all 12Show fewer
- Frequent use of alcohol at bedtime
- Excessive daily caffeine consumption
- Current use of sleep medications on a regular basis
- Inadequate proficiency in English
- Inability to commit to attending therapy sessions due to schedule conflicts
- Women who are pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
Sleep Disorders Center, Rush University Medical Center
Chicago, Illinois, 60612
About this study
Official title: Augmenting Behavior Therapy for Insomnia With Mindfulness Meditation
The overall goal of this project is to evaluate the evidence for the efficacy of two mindfulness-based interventions, mindfulness-based therapy for insomnia (MBT-I) and mindfulness-based stress reduction (MBSR), for reducing arousal and improving sleep among individuals with psychophysiological insomnia.
Specific Aim 1: To obtain evidence for the relative effects of MBT-I and MBSR compared to a delayed-treatment control condition followed by behavior therapy for insomnia (BT-I) on arousal levels. It is hypothesized that MBSR and MBT-I will be superior to the control condition at reducing arousal levels.
Read more
Specific Aim 2: To obtain evidence for the relative effects of MBT-I, MBSR, and the delayed-treatment control on sleep. It is hypothesized that MBT-I will be superior to the MBSR and control conditions at improving sleep parameters.
Specific Aim 3: To investigate the relationship between measures of arousal (self-report and objective measures) and sleep (self-report and objective measures) to enhance the understanding of the role of arousal in psychophysiological insomnia.
Read the detailed description
The conceptual model for this study identifies two possible targets of treatment: arousal and sleep. In this model, BT for insomnia directly targets nighttime symptoms of insomnia (BT pathway), which improves sleep by increasing the homeostatic drive for sleep. Although BT is hypothesized to indirectly reduce arousal, no study has specifically investigated this effect. In contrast, MBSR is an intervention that is hypothesized to target arousal and, as preliminary findings suggest, also improves some symptoms of insomnia (MBSR pathway). It is therefore hypothesized that a combination of BT and mindfulness is superior to each treatment alone as it targets both nighttime symptoms and hyperarousal (Mindfulness + BT pathway). Our preliminary data suggests that this combination treatment has effects on both self-reported arousal and sleep. Conceptually, this novel approach would provide a set of self-regulating skills that could potentially target a broader range of daytime and nighttime symptoms that is characteristic of an insomnia disorder.
To test the conceptual model, this study employs a randomized clinical trial design with three conditions: 1) Mindfulness-Based Therapy for insomnia (MBT-I), 2) mindfulness-based stress reduction (MBSR), and 3) delayed-treatment condition followed by behavior therapy for insomnia (BT-I). Each of the three treatments will be delivered in a group format with 8 weekly sessions spanning an 8-week period.
- Conditions
- Insomnia
- Being tested
- Mindfulness-Based Stress Reduction, Mindfulness-Based Therapy for Insomnia, Wait-List + Behavioral Therapy for Insomnia
- Keywords
- insomnia, hyperarousal, mindfulness meditation, complementary and alternative medicine, cognitive-behavioral therapy
- 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.
Mindfulness-Based Stress ReductionBehavioural
The rationale for treatment is that MBSR targets arousal, which is a prominent perpetuating factor of insomnia. Each session meets weekly for 120 minutes and consists of a therapist-led mindfulness meditation, followed by a discussion of the meditation and its application into the participant's everyday life. For homework, each participant is required to practice formal meditation at least 45 minutes a day, 6 days per week. Participants will be provided a tape, an mp3 file, or CD to aid in the participant's personal practice at home. Formal meditations that will be led and discussed include eating meditation, body scan, sitting meditation, Hatha Yoga, and walking meditation. In addition, informal mindfulness practices will be discussed.
Mindfulness-Based Therapy for InsomniaBehavioural
MBTI treatment includes the hypothesized active elements of both mindfulness meditation and behavior therapy for insomnia. The intervention includes 8 weekly sessions. Each session meets weekly for approximately 120 minutes. The general format of each session includes formal mindfulness meditation (quiet and movement meditations) and instructions for the behavioral intervention, with a focus on integrating the principles of mindfulness with these instructions. Each participant is required to practice formal meditation for at least 45 minutes a day, 6 days per week as homework. Participants are provided a tape, mp3 file, or CD to aid in the participant's personal practice at home.
Wait-List + Behavioral Therapy for InsomniaBehavioural
This delayed treatment condition consists of an 8-week monitoring period (sleep diaries, PSAS) and then BT. The BT treatment consists of 8 sessions of behavioral interventions for insomnia, with instructions targeting the nighttime symptoms of insomnia. The primary components of this treatment package are stimulus control, sleep restriction, and sleep hygiene education. In the BT condition, each weekly session lasts 120 minutes and consists of formal instructions for the behavioral interventions along with a time for discussion of the application of these instructions into each participant's unique circumstances.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness-Based Stress Reduction | Active comparator | Not described Receives: Behavioral: Mindfulness-Based Stress Reduction |
| Mindfulness-Based Therapy for Insomnia | Active comparator | Not described Receives: Behavioral: Mindfulness-Based Therapy for Insomnia |
| Behavioral Therapy for Insomnia (Delayed treatment condition) | Other | Not described Receives: Behavioral: Wait-List + Behavioral Therapy for Insomnia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pre-Sleep Arousal Scale (PSAS) total score
Measured: Baseline, during txt, post-txt, 3 month follow-up, 6 month follow-up
Sleep Diaries (Total Wake Time)
Measured: Baseline, post-txt, 6 month follow-up
Secondary outcomes (7)
Actigraphy measures of sleep/wake time
Measured: Baseline, during txt, post-txt, 3 month follow-up, 6 month follow-up
Polysomnographic measures of sleep parameters
Measured: Baseline, post-txt, 6 month follow-up
Insomnia Severity Index (ISI) total score
Measured: Baseline, post-txt, 3 month follow-up, 6 month follow-up
Five Factor Questionnaire (Mindfulness Skills) Total score
Measured: Baseline, post-txt, 3 month follow-up, 6 month follow-up
Dysfunctional Beliefs and Attitudes about Sleep (DBAS) score
Measured: Baseline, post-txt, 3 month follow-up, 6 month follow-up
Hyperarousal Scale (HAS) score
Measured: Baseline, post-txt, 3 month follow-up, 6 month follow-up
Heart Rate variability (HR)
Measured: Baseline, post-treatment, 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2008 (estimated)
- Study startNov 2008
- Primary completionNov 2012
- Study completionApr 2013
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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Stanford University, University of Toronto
- Responsible party
- Principal investigator, Jason C. Ong, PhD, Rush University Medical Center
- Investigators
- Jason C Ong, PhD, Principal investigator, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00768781
- Sponsor's protocol ID
- K23AT003678
- Other IDs
- K23AT003678
- Status last verified
- May 2013
- First submitted
- 7 Oct 2008
- Last updated
- 30 May 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Goldstein MR, Turner AD, Dawson SC, Segal ZV, Shapiro SL, Wyatt JK, Manber R, Sholtes D, Ong JC. Increased high-frequency NREM EEG power associated with mindfulness-based interventions for chronic insomnia: Preliminary findings from spectral analysis. J Psychosom Res. 2019 May;120:12-19. doi: 10.1016/j.jpsychores.2019.02.012. Epub 2019 Feb 28.
PubMed 30929703Ong JC, Manber R, Segal Z, Xia Y, Shapiro S, Wyatt JK. A randomized controlled trial of mindfulness meditation for chronic insomnia. Sleep. 2014 Sep 1;37(9):1553-63. doi: 10.5665/sleep.4010.
PubMed 25142566
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Augmenting Behavior Therapy for Insomnia With Mindfulness Meditation
- ClinicalTrials.gov ID
- NCT00768781
- Acronym / sponsor ID
- K23AT003678
- Conditions
- Insomnia
- Keywords
- insomnia, hyperarousal, mindfulness meditation, complementary and alternative medicine, cognitive-behavioral therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Collaborators
- Stanford University, University of Toronto
- Study start
- Nov 2008
- Primary completion
- Nov 2012 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 8 Oct 2008 (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 overall goal of this project is to evaluate the evidence for the efficacy of two mindfulness-based interventions, mindfulness-based therapy for insomnia (MBT-I) and mindfulness-based stress reduction (MBSR), for reducing arousal and improving sleep among individuals with psychophysiological insomnia.
Specific Aim 1: To obtain evidence for the relative effects of MBT-I and MBSR compared to a delayed-treatment control condition followed by behavior therapy for insomnia (BT-I) on arousal levels. It is hypothesized that MBSR and MBT-I will be superior to the control condition at reducing arousal levels.
Specific Aim 2: To obtain evidence for the relative effects of MBT-I, MBSR, and the delayed-treatment control on sleep. It is hypothesized that MBT-I will be superior to the MBSR and control conditions at improving sleep parameters.
Specific Aim 3: To investigate the relationship between measures of arousal (self-report and objective measures) and sleep (self-report and objective measures) to enhance the understanding of the role of arousal in psychophysiological insomnia.
Detailed description
The conceptual model for this study identifies two possible targets of treatment: arousal and sleep. In this model, BT for insomnia directly targets nighttime symptoms of insomnia (BT pathway), which improves sleep by increasing the homeostatic drive for sleep. Although BT is hypothesized to indirectly reduce arousal, no study has specifically investigated this effect. In contrast, MBSR is an intervention that is hypothesized to target arousal and, as preliminary findings suggest, also improves some symptoms of insomnia (MBSR pathway). It is therefore hypothesized that a combination of BT and mindfulness is superior to each treatment alone as it targets both nighttime symptoms and hyperarousal (Mindfulness + BT pathway). Our preliminary data suggests that this combination treatment has effects on both self-reported arousal and sleep. Conceptually, this novel approach would provide a set of self-regulating skills that could potentially target a broader range of daytime and nighttime symptoms that is characteristic of an insomnia disorder.
To test the conceptual model, this study employs a randomized clinical trial design with three conditions: 1) Mindfulness-Based Therapy for insomnia (MBT-I), 2) mindfulness-based stress reduction (MBSR), and 3) delayed-treatment condition followed by behavior therapy for insomnia (BT-I). Each of the three treatments will be delivered in a group format with 8 weekly sessions spanning an 8-week period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-Based Stress Reduction | Active comparator | Behavioral: Mindfulness-Based Stress Reduction |
| Mindfulness-Based Therapy for Insomnia | Active comparator | Behavioral: Mindfulness-Based Therapy for Insomnia |
| Behavioral Therapy for Insomnia (Delayed treatment condition) | Other | Behavioral: Wait-List + Behavioral Therapy for Insomnia |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Meets criteria for psychophysiological insomnia
- Males and females of age 21 or older
Key exclusion criteria (12 listed)
- Unstable medical condition that is known to impact sleep
- Psychiatric conditions likely to impact the practice of meditation
- Current active suicidal ideation
- Presence of a primary sleep disorder other than primary insomnia
- Evidence of paradoxical insomnia
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 |
|---|---|---|
| Mindfulness-Based Stress ReductionThe rationale for treatment is that MBSR targets arousal, which is a prominent perpetuating factor of insomnia. Each session meets weekly for 120 minutes and consists of a therapist-led mindfulness meditation, followed by a discussion of the meditation and its application into the participant's everyday life. For homework, each participant is required to practice formal meditation at least 45 minutes a day, 6 days per week. Participants will be provided a tape, an mp3 file, or CD to aid in the participant's personal practice at home. Formal meditations that will be led and discussed include eating meditation, body scan, sitting meditation, Hatha Yoga, and walking meditation. In addition, informal mindfulness practices will be discussed. | Behavioural | Mindfulness-Based Stress Reduction |
| Mindfulness-Based Therapy for InsomniaMBTI treatment includes the hypothesized active elements of both mindfulness meditation and behavior therapy for insomnia. The intervention includes 8 weekly sessions. Each session meets weekly for approximately 120 minutes. The general format of each session includes formal mindfulness meditation (quiet and movement meditations) and instructions for the behavioral intervention, with a focus on integrating the principles of mindfulness with these instructions. Each participant is required to practice formal meditation for at least 45 minutes a day, 6 days per week as homework. Participants are provided a tape, mp3 file, or CD to aid in the participant's personal practice at home. | Behavioural | Mindfulness-Based Therapy for Insomnia |
| Wait-List + Behavioral Therapy for InsomniaThis delayed treatment condition consists of an 8-week monitoring period (sleep diaries, PSAS) and then BT. The BT treatment consists of 8 sessions of behavioral interventions for insomnia, with instructions targeting the nighttime symptoms of insomnia. The primary components of this treatment package are stimulus control, sleep restriction, and sleep hygiene education. In the BT condition, each weekly session lasts 120 minutes and consists of formal instructions for the behavioral interventions along with a time for discussion of the application of these instructions into each participant's unique circumstances. | Behavioural | Behavioral Therapy for Insomnia (Delayed treatment condition) |
Primary outcome
Pre-Sleep Arousal Scale (PSAS) total score
Time frame: Baseline, during txt, post-txt, 3 month follow-up, 6 month follow-up
Sleep Diaries (Total Wake Time)
Time frame: Baseline, post-txt, 6 month follow-up
7 secondary outcomes
Actigraphy measures of sleep/wake time
Time frame: Baseline, during txt, post-txt, 3 month follow-up, 6 month follow-up
Polysomnographic measures of sleep parameters
Time frame: Baseline, post-txt, 6 month follow-up
Insomnia Severity Index (ISI) total score
Time frame: Baseline, post-txt, 3 month follow-up, 6 month follow-up
Five Factor Questionnaire (Mindfulness Skills) Total score
Time frame: Baseline, post-txt, 3 month follow-up, 6 month follow-up
Dysfunctional Beliefs and Attitudes about Sleep (DBAS) score
Time frame: Baseline, post-txt, 3 month follow-up, 6 month follow-up
Hyperarousal Scale (HAS) score
Time frame: Baseline, post-txt, 3 month follow-up, 6 month follow-up
Heart Rate variability (HR)
Time frame: Baseline, post-treatment, 6-month 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 30 May 2013.
- Derived from this study: PubMed 30929703Goldstein MR, Turner AD, Dawson SC, Segal ZV, Shapiro SL, Wyatt JK, Manber R, Sholtes D, Ong JC. Increased high-frequency NREM EEG power associated with mindfulness-based interventions for chronic insomnia: Preliminary findings from spectral analysis. J Psychosom Res. 2019 May;120:12-19. doi: 10.1016/j.jpsychores.2019.02.012. Epub 2019 Feb 28.
- Derived from this study: PubMed 25142566Ong JC, Manber R, Segal Z, Xia Y, Shapiro S, Wyatt JK. A randomized controlled trial of mindfulness meditation for chronic insomnia. Sleep. 2014 Sep 1;37(9):1553-63. doi: 10.5665/sleep.4010.
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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.
Jason C Ong, PhD principal investigator
Rush University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Mindfulness-Based Stress Reduction, Mindfulness-Based Therapy for Insomnia and Wait-List + Behavioral Therapy for Insomnia in people with Insomnia, run by Rush University Medical Center 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 12 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 30 May 2013. 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 phase mean?
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?
Pre-Sleep Arousal Scale (PSAS) total score (time frame: Baseline, during txt, post-txt, 3 month follow-up, 6 month follow-up). 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?
On the ClinicalTrials.gov record for NCT00768781, 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 30 May 2013.