Mindfulness-Based Approaches to Insomnia

NCT ID: NCT00768781

Last Updated: 2013-05-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-11-30
• Study Completion Date: 2013-04-30

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.

Conditions

Insomnia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Mindfulness-Based Stress Reduction

Group Type: ACTIVE_COMPARATOR

Mindfulness-Based Stress Reduction

Intervention Type: 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

Group Type: ACTIVE_COMPARATOR

Mindfulness-Based Therapy for Insomnia

Intervention Type: 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.

Behavioral Therapy for Insomnia (Delayed treatment condition)

Group Type: OTHER

Wait-List + Behavioral Therapy for Insomnia

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: collaborator

University of Toronto

OTHER

Sponsor Role: collaborator

Rush University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Jason C. Ong, PhD

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jason C Ong, PhD

Role: PRINCIPAL_INVESTIGATOR

Rush University Medical Center

Locations

Sleep Disorders Center, Rush University Medical Center

Chicago, Illinois, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 30929703 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 25142566 (View on PubMed)

Other Identifiers

K23AT003678

Identifier Type: NIH

Identifier Source: secondary_id

View Link

K23AT003678

Identifier Type: NIH

Identifier Source: org_study_id

View Link