Mindfulness-Based Approaches to Insomnia
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.
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 2
Contatti e Sedi
Luoghi di studio
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Illinois
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Chicago, Illinois, Stati Uniti, 60612
- Sleep Disorders Center, Rush University Medical Center
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Comparatore attivo: Riduzione dello stress basata sulla consapevolezza
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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.
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Comparatore attivo: Mindfulness-Based Therapy for Insomnia
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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.
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Altro: Behavioral Therapy for Insomnia (Delayed treatment condition)
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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.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
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Pre-Sleep Arousal Scale (PSAS) total score
Lasso di tempo: Baseline, during txt, post-txt, 3 month follow-up, 6 month follow-up
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Baseline, during txt, post-txt, 3 month follow-up, 6 month follow-up
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Sleep Diaries (Total Wake Time)
Lasso di tempo: Baseline, post-txt, 6 month follow-up
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Baseline, post-txt, 6 month follow-up
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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
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Actigraphy measures of sleep/wake time
Lasso di tempo: Baseline, during txt, post-txt, 3 month follow-up, 6 month follow-up
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Baseline, during txt, post-txt, 3 month follow-up, 6 month follow-up
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Polysomnographic measures of sleep parameters
Lasso di tempo: Baseline, post-txt, 6 month follow-up
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Baseline, post-txt, 6 month follow-up
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Insomnia Severity Index (ISI) total score
Lasso di tempo: Baseline, post-txt, 3 month follow-up, 6 month follow-up
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Baseline, post-txt, 3 month follow-up, 6 month follow-up
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Five Factor Questionnaire (Mindfulness Skills) Total score
Lasso di tempo: Baseline, post-txt, 3 month follow-up, 6 month follow-up
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Baseline, post-txt, 3 month follow-up, 6 month follow-up
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Dysfunctional Beliefs and Attitudes about Sleep (DBAS) score
Lasso di tempo: Baseline, post-txt, 3 month follow-up, 6 month follow-up
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Baseline, post-txt, 3 month follow-up, 6 month follow-up
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Hyperarousal Scale (HAS) score
Lasso di tempo: Baseline, post-txt, 3 month follow-up, 6 month follow-up
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Baseline, post-txt, 3 month follow-up, 6 month follow-up
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Heart Rate variability (HR)
Lasso di tempo: Baseline, post-treatment, 6-month follow-up
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Baseline, post-treatment, 6-month follow-up
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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Jason C Ong, PhD, Rush University Medical Center
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
- 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.
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Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- K23AT003678 (Sovvenzione/contratto NIH degli Stati Uniti)
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