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Completed

NCT Number: NCT00768781

Mindfulness-Based Approaches to Insomnia

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.

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Key information

Conditions

Insomnia Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Sleep Disorders Center, Rush University Medical Center

Chicago, Illinois, 60612, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mindfulness-Based Stress Reduction

Behavioral

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 Insomnia

Behavioral

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 Insomnia

Behavioral

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.

Primary outcomes

  1. Pre-Sleep Arousal Scale (PSAS) total score

    Time frame: Baseline, during txt, post-txt, 3 month follow-up, 6 month follow-up

  2. Sleep Diaries (Total Wake Time)

    Time frame: Baseline, post-txt, 6 month follow-up

Secondary outcomes

  1. Actigraphy measures of sleep/wake time

    Time frame: Baseline, during txt, post-txt, 3 month follow-up, 6 month follow-up

  2. Polysomnographic measures of sleep parameters

    Time frame: Baseline, post-txt, 6 month follow-up

  3. Insomnia Severity Index (ISI) total score

    Time frame: Baseline, post-txt, 3 month follow-up, 6 month follow-up

  4. Five Factor Questionnaire (Mindfulness Skills) Total score

    Time frame: Baseline, post-txt, 3 month follow-up, 6 month follow-up

  5. Dysfunctional Beliefs and Attitudes about Sleep (DBAS) score

    Time frame: Baseline, post-txt, 3 month follow-up, 6 month follow-up

  6. Hyperarousal Scale (HAS) score

    Time frame: Baseline, post-txt, 3 month follow-up, 6 month follow-up

  7. Heart Rate variability (HR)

    Time frame: Baseline, post-treatment, 6-month follow-up

Sponsors and collaborators

Lead sponsor

Rush University Medical Center

Other

Collaborators

  • Stanford University
  • University of Toronto

Registry information

Official study title

Augmenting Behavior Therapy for Insomnia With Mindfulness Meditation

Important dates

Study start
2008
Primary completion
2012
Study completion
2013
First posted
Oct 8, 2008
Registry last updated
May 30, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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