Clinical trial NCT00768781: Mindfulness-Based Approaches to Insomnia
Official title: Augmenting Behavior Therapy for Insomnia With Mindfulness Meditation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Insomnia
Keywords: insomnia
hyperarousal
mindfulness meditation
complementary and alternative medicine
cognitive-behavioral therapy
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
Collaborators: name: Stanford University
name: University of Toronto
First posted: 2008-10-08
Enrollment: 54
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* Meets criteria for psychophysiological insomnia
* Males and females of age 21 or older

Exclusion Criteria:

* 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
* 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

Primary outcomes:
measure: Pre-Sleep Arousal Scale (PSAS) total score
timeFrame: Baseline, during txt, post-txt, 3 month follow-up, 6 month follow-up
measure: Sleep Diaries (Total Wake Time)
timeFrame: Baseline, post-txt, 6 month follow-up
Secondary outcomes:
measure: Actigraphy measures of sleep/wake time
timeFrame: Baseline, during txt, post-txt, 3 month follow-up, 6 month follow-up
measure: Polysomnographic measures of sleep parameters
timeFrame: Baseline, post-txt, 6 month follow-up
measure: Insomnia Severity Index (ISI) total score
timeFrame: Baseline, post-txt, 3 month follow-up, 6 month follow-up
measure: Five Factor Questionnaire (Mindfulness Skills) Total score
timeFrame: Baseline, post-txt, 3 month follow-up, 6 month follow-up
measure: Dysfunctional Beliefs and Attitudes about Sleep (DBAS) score
timeFrame: Baseline, post-txt, 3 month follow-up, 6 month follow-up
measure: Hyperarousal Scale (HAS) score
timeFrame: Baseline, post-txt, 3 month follow-up, 6 month follow-up
measure: Heart Rate variability (HR)
timeFrame: Baseline, post-treatment, 6-month follow-up
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Sleep Disorders Center, Rush University Medical Center
state: Illinois
Study officials:
affiliation: Rush University Medical Center
name: Jason C Ong, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Ong 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.