Mindfulness-Based Approaches to Insomnia

NCT00768781 | Completed Phase 2

• 1 other identifier: K23AT003678
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Insomnia

Keywords

insomnia; hyperarousal; mindfulness meditation; complementary and alternative medicine; cognitive-behavioral therapy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• 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

Study Arms (3)

Mindfulness-Based Stress Reduction

ACTIVE COMPARATOR

Behavioral: Mindfulness-Based Stress Reduction

Mindfulness-Based Therapy for Insomnia

ACTIVE COMPARATOR

Behavioral: Mindfulness-Based Therapy for Insomnia

Behavioral Therapy for Insomnia (Delayed treatment condition)

OTHER

Behavioral: Wait-List + Behavioral Therapy for Insomnia

Interventions

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 Stress Reduction

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.

Mindfulness-Based Therapy for Insomnia

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.

Behavioral Therapy for Insomnia (Delayed treatment condition)

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rush University Medical Center: lead
• Stanford University: collaborator
• University of Toronto: collaborator

Study Sites (1)

Sleep Disorders Center, Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Related Publications (2)

• 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.

  PMID: 30929703 DERIVED

• 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.

  PMID: 25142566 DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Mindfulness-Based Stress Reduction; Waiting Lists; Behavior Therapy

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Psychotherapy; Behavioral Disciplines and Activities; Appointments and Schedules; Organization and Administration; Health Services Administration

Study Officials

• Jason C Ong, PhD

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 7, 2008
• First Posted: October 8, 2008
• Study Start: November 1, 2008
• Primary Completion: November 1, 2012
• Study Completion: April 1, 2013
• Last Updated: May 30, 2013

Record last verified: 2013-05

Locations

US (1)