Mindfulness-Based Approaches to Insomnia

Rush

Status and phase: Completed; Phase 2

Conditions: Insomnia

Treatments: Behavioral: Wait-List + Behavioral Therapy for Insomnia; Behavioral: Mindfulness-Based Stress Reduction; Behavioral: Mindfulness-Based Therapy for Insomnia

Study type: Interventional

Funder types: Other

Identifiers

NCT00768781

K23AT003678 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 54 patients

Sex: All

Ages: 21+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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54 participants in 3 patient groups

Mindfulness-Based Stress Reduction

Active Comparator group

Treatment:

Behavioral: Mindfulness-Based Stress Reduction

Mindfulness-Based Therapy for Insomnia

Active Comparator group

Treatment:

Behavioral: Mindfulness-Based Therapy for Insomnia

Behavioral Therapy for Insomnia (Delayed treatment condition)

Other group

Treatment:

Behavioral: Wait-List + Behavioral Therapy for Insomnia