Mindfulness-Based Approaches to Insomnia

Insomnia Clinical Trial

Official title:

Augmenting Behavior Therapy for Insomnia With Mindfulness Meditation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00768781
• Other study ID #: K23AT003678
• Secondary ID: K23AT003678
• Status: Completed
• Phase: Phase 2
• First received: October 7, 2008
• Last updated: May 28, 2013
• Start date: November 2008
• Est. completion date: April 2013

Study information

• Verified date: May 2013
• Source: Rush University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: April 2013
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Insomnia

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Sleep Disorders Center, Rush University Medical Center	Chicago	Illinois

Sponsors (3)

Lead Sponsor	Collaborator
Rush University Medical Center	Stanford University, University of Toronto

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pre-Sleep Arousal Scale (PSAS) total score		Baseline, during txt, post-txt, 3 month follow-up, 6 month follow-up	No
Primary	Sleep Diaries (Total Wake Time)		Baseline, post-txt, 6 month follow-up	No
Secondary	Actigraphy measures of sleep/wake time		Baseline, during txt, post-txt, 3 month follow-up, 6 month follow-up	No
Secondary	Polysomnographic measures of sleep parameters		Baseline, post-txt, 6 month follow-up	No
Secondary	Insomnia Severity Index (ISI) total score		Baseline, post-txt, 3 month follow-up, 6 month follow-up	No
Secondary	Five Factor Questionnaire (Mindfulness Skills) Total score		Baseline, post-txt, 3 month follow-up, 6 month follow-up	No
Secondary	Dysfunctional Beliefs and Attitudes about Sleep (DBAS) score		Baseline, post-txt, 3 month follow-up, 6 month follow-up	No
Secondary	Hyperarousal Scale (HAS) score		Baseline, post-txt, 3 month follow-up, 6 month follow-up	No
Secondary	Heart Rate variability (HR)		Baseline, post-treatment, 6-month follow-up	No

External Links

•   More information about study