Mindfulness-Based Approaches to Insomnia
- Conditions
- Insomnia
- Interventions
- Behavioral: Mindfulness-Based Stress ReductionBehavioral: Mindfulness-Based Therapy for InsomniaBehavioral: Wait-List + Behavioral Therapy for Insomnia
- Registration Number
- NCT00768781
- Lead Sponsor
- Rush University Medical Center
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 54
- Meets criteria for psychophysiological insomnia
- Males and females of age 21 or older
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Mindfulness-Based Stress Reduction Mindfulness-Based Stress Reduction - Mindfulness-Based Therapy for Insomnia Mindfulness-Based Therapy for Insomnia - Behavioral Therapy for Insomnia (Delayed treatment condition) Wait-List + Behavioral Therapy for Insomnia -
- Primary Outcome Measures
Name Time Method Pre-Sleep Arousal Scale (PSAS) total score Baseline, during txt, post-txt, 3 month follow-up, 6 month follow-up Sleep Diaries (Total Wake Time) Baseline, post-txt, 6 month follow-up
- Secondary Outcome Measures
Name Time Method Actigraphy measures of sleep/wake time Baseline, during txt, post-txt, 3 month follow-up, 6 month follow-up Polysomnographic measures of sleep parameters Baseline, post-txt, 6 month follow-up Insomnia Severity Index (ISI) total score Baseline, post-txt, 3 month follow-up, 6 month follow-up Five Factor Questionnaire (Mindfulness Skills) Total score Baseline, post-txt, 3 month follow-up, 6 month follow-up Dysfunctional Beliefs and Attitudes about Sleep (DBAS) score Baseline, post-txt, 3 month follow-up, 6 month follow-up Hyperarousal Scale (HAS) score Baseline, post-txt, 3 month follow-up, 6 month follow-up Heart Rate variability (HR) Baseline, post-treatment, 6-month follow-up
Trial Locations
- Locations (1)
Sleep Disorders Center, Rush University Medical Center
🇺🇸Chicago, Illinois, United States