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Mindfulness-Based Approaches to Insomnia

28. maj 2013 opdateret af: Jason C. Ong, PhD, Rush University Medical Center

Augmenting Behavior Therapy for Insomnia With Mindfulness Meditation

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

54

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60612
        • Sleep Disorders Center, Rush University Medical Center

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

21 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Mindfulness-baseret stressreduktion
Adfærdsmæssigt: 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.
Aktiv komparator: Mindfulness-Based Therapy for Insomnia
Adfærdsmæssigt: 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.
Andet: Behavioral Therapy for Insomnia (Delayed treatment condition)
Adfærdsmæssigt: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Pre-Sleep Arousal Scale (PSAS) total score
Tidsramme: Baseline, during txt, post-txt, 3 month follow-up, 6 month follow-up
Baseline, during txt, post-txt, 3 month follow-up, 6 month follow-up
Sleep Diaries (Total Wake Time)
Tidsramme: Baseline, post-txt, 6 month follow-up
Baseline, post-txt, 6 month follow-up

Sekundære resultatmål

Resultatmål
Tidsramme
Actigraphy measures of sleep/wake time
Tidsramme: Baseline, during txt, post-txt, 3 month follow-up, 6 month follow-up
Baseline, during txt, post-txt, 3 month follow-up, 6 month follow-up
Polysomnographic measures of sleep parameters
Tidsramme: Baseline, post-txt, 6 month follow-up
Baseline, post-txt, 6 month follow-up
Insomnia Severity Index (ISI) total score
Tidsramme: Baseline, post-txt, 3 month follow-up, 6 month follow-up
Baseline, post-txt, 3 month follow-up, 6 month follow-up
Five Factor Questionnaire (Mindfulness Skills) Total score
Tidsramme: Baseline, post-txt, 3 month follow-up, 6 month follow-up
Baseline, post-txt, 3 month follow-up, 6 month follow-up
Dysfunctional Beliefs and Attitudes about Sleep (DBAS) score
Tidsramme: Baseline, post-txt, 3 month follow-up, 6 month follow-up
Baseline, post-txt, 3 month follow-up, 6 month follow-up
Hyperarousal Scale (HAS) score
Tidsramme: Baseline, post-txt, 3 month follow-up, 6 month follow-up
Baseline, post-txt, 3 month follow-up, 6 month follow-up
Heart Rate variability (HR)
Tidsramme: Baseline, post-treatment, 6-month follow-up
Baseline, post-treatment, 6-month follow-up

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Rush University Medical Center

Samarbejdspartnere

Stanford University
University of Toronto

Efterforskere

  • Ledende efterforsker: Jason C Ong, PhD, Rush University Medical Center

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. november 2008

Primær færdiggørelse (Faktiske)

1. november 2012

Studieafslutning (Faktiske)

1. april 2013

Datoer for studieregistrering

Først indsendt

7. oktober 2008

Først indsendt, der opfyldte QC-kriterier

7. oktober 2008

Først opslået (Skøn)

8. oktober 2008

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

30. maj 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

28. maj 2013

Sidst verificeret

1. maj 2013

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • K23AT003678 (U.S. NIH-bevilling/kontrakt)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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