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Mindfulness-Based Approaches to Insomnia

Primary Purpose

Insomnia

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Mindfulness-Based Stress Reduction
Mindfulness-Based Therapy for Insomnia
Wait-List + Behavioral Therapy for Insomnia
Sponsored by
Rush University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insomnia focused on measuring insomnia, hyperarousal, mindfulness meditation, complementary and alternative medicine, cognitive-behavioral therapy

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sleep Disorders Center, Rush University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Other

Arm Label

Mindfulness-Based Stress Reduction

Mindfulness-Based Therapy for Insomnia

Behavioral Therapy for Insomnia (Delayed treatment condition)

Arm Description

Outcomes

Primary Outcome Measures

Pre-Sleep Arousal Scale (PSAS) total score
Sleep Diaries (Total Wake Time)

Secondary Outcome Measures

Actigraphy measures of sleep/wake time
Polysomnographic measures of sleep parameters
Insomnia Severity Index (ISI) total score
Five Factor Questionnaire (Mindfulness Skills) Total score
Dysfunctional Beliefs and Attitudes about Sleep (DBAS) score
Hyperarousal Scale (HAS) score
Heart Rate variability (HR)

Full Information

First Posted
October 7, 2008
Last Updated
May 28, 2013
Sponsor
Rush University Medical Center
Collaborators
Stanford University, University of Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT00768781
Brief Title
Mindfulness-Based Approaches to Insomnia
Official Title
Augmenting Behavior Therapy for Insomnia With Mindfulness Meditation
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rush University Medical Center
Collaborators
Stanford University, University of Toronto

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia
Keywords
insomnia, hyperarousal, mindfulness meditation, complementary and alternative medicine, cognitive-behavioral therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mindfulness-Based Stress Reduction
Arm Type
Active Comparator
Arm Title
Mindfulness-Based Therapy for Insomnia
Arm Type
Active Comparator
Arm Title
Behavioral Therapy for Insomnia (Delayed treatment condition)
Arm Type
Other
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness-Based Stress Reduction
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness-Based Therapy for Insomnia
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Wait-List + Behavioral Therapy for Insomnia
Intervention Description
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 Outcome Measure Information:
Title
Pre-Sleep Arousal Scale (PSAS) total score
Time Frame
Baseline, during txt, post-txt, 3 month follow-up, 6 month follow-up
Title
Sleep Diaries (Total Wake Time)
Time Frame
Baseline, post-txt, 6 month follow-up
Secondary Outcome Measure Information:
Title
Actigraphy measures of sleep/wake time
Time Frame
Baseline, during txt, post-txt, 3 month follow-up, 6 month follow-up
Title
Polysomnographic measures of sleep parameters
Time Frame
Baseline, post-txt, 6 month follow-up
Title
Insomnia Severity Index (ISI) total score
Time Frame
Baseline, post-txt, 3 month follow-up, 6 month follow-up
Title
Five Factor Questionnaire (Mindfulness Skills) Total score
Time Frame
Baseline, post-txt, 3 month follow-up, 6 month follow-up
Title
Dysfunctional Beliefs and Attitudes about Sleep (DBAS) score
Time Frame
Baseline, post-txt, 3 month follow-up, 6 month follow-up
Title
Hyperarousal Scale (HAS) score
Time Frame
Baseline, post-txt, 3 month follow-up, 6 month follow-up
Title
Heart Rate variability (HR)
Time Frame
Baseline, post-treatment, 6-month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason C Ong, PhD
Organizational Affiliation
Rush University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sleep Disorders Center, Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
30929703
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.
Results Reference
derived
PubMed Identifier
25142566
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.
Results Reference
derived

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Mindfulness-Based Approaches to Insomnia

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