Mindfulness-Based Approaches to Insomnia

This study has been completed.
Sponsor:
Collaborators:
Stanford University
University of Toronto
Information provided by (Responsible Party):
Jason C. Ong, PhD, Rush University Medical Center
ClinicalTrials.gov Identifier:
NCT00768781
First received: October 7, 2008
Last updated: May 28, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention Phase
Insomnia
Behavioral: Mindfulness-Based Stress Reduction
Behavioral: Mindfulness-Based Therapy for Insomnia
Behavioral: Wait-List + Behavioral Therapy for Insomnia
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Augmenting Behavior Therapy for Insomnia With Mindfulness Meditation

Further study details as provided by Rush University Medical Center:

Primary Outcome Measures:
  • Pre-Sleep Arousal Scale (PSAS) total score [ Time Frame: Baseline, during txt, post-txt, 3 month follow-up, 6 month follow-up ] [ Designated as safety issue: No ]
  • Sleep Diaries (Total Wake Time) [ Time Frame: Baseline, post-txt, 6 month follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Actigraphy measures of sleep/wake time [ Time Frame: Baseline, during txt, post-txt, 3 month follow-up, 6 month follow-up ] [ Designated as safety issue: No ]
  • Polysomnographic measures of sleep parameters [ Time Frame: Baseline, post-txt, 6 month follow-up ] [ Designated as safety issue: No ]
  • Insomnia Severity Index (ISI) total score [ Time Frame: Baseline, post-txt, 3 month follow-up, 6 month follow-up ] [ Designated as safety issue: No ]
  • Five Factor Questionnaire (Mindfulness Skills) Total score [ Time Frame: Baseline, post-txt, 3 month follow-up, 6 month follow-up ] [ Designated as safety issue: No ]
  • Dysfunctional Beliefs and Attitudes about Sleep (DBAS) score [ Time Frame: Baseline, post-txt, 3 month follow-up, 6 month follow-up ] [ Designated as safety issue: No ]
  • Hyperarousal Scale (HAS) score [ Time Frame: Baseline, post-txt, 3 month follow-up, 6 month follow-up ] [ Designated as safety issue: No ]
  • Heart Rate variability (HR) [ Time Frame: Baseline, post-treatment, 6-month follow-up ] [ Designated as safety issue: No ]

Enrollment: 54
Study Start Date: November 2008
Study Completion Date: April 2013
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Mindfulness-Based Stress Reduction Behavioral: Mindfulness-Based Stress Reduction
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.
Active Comparator: Mindfulness-Based Therapy for Insomnia Behavioral: Mindfulness-Based Therapy for Insomnia
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.
Behavioral Therapy for Insomnia (Delayed treatment condition) Behavioral: Wait-List + Behavioral Therapy for Insomnia
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.

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

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00768781

Locations
United States, Illinois
Sleep Disorders Center, Rush University Medical Center
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
Rush University Medical Center
Stanford University
University of Toronto
Investigators
Principal Investigator: Jason C Ong, PhD Rush University Medical Center
  More Information

Additional Information:
No publications provided

Responsible Party: Jason C. Ong, PhD, Assistant Professor, Rush University Medical Center
ClinicalTrials.gov Identifier: NCT00768781     History of Changes
Other Study ID Numbers: K23 AT003678, K23 AT003678
Study First Received: October 7, 2008
Last Updated: May 28, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Rush University Medical Center:
insomnia
hyperarousal
mindfulness meditation
complementary and alternative medicine
cognitive-behavioral therapy

ClinicalTrials.gov processed this record on September 18, 2014