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Effect of a mindfulness-based intervention on sleep quality

Beneficial effects of an online minDfulness-based inteRvention on sleEp quAlity in a sample of Italian poor-sleepers during the COVID-19 pandeMic (DREAM)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN39530091
Enrollment
100
Registered
2022-09-23
Start date
2020-09-01
Completion date
Unknown
Last updated
2025-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Impaired sleep quality Mental and Behavioural Disorders

Interventions

Eligible participants are randomly assigned to the intervention or control group. Method of randomization: simple randomization procedure with a 1:1 allocation ratio, by using the R package "randomize
ii) stabilizing the mind to stop ruminations and perennial inner chatter
iii) refining the ability to hear and recognize the dynamics between emotions and thought
iv) enhancing the balance between openness to others and attention to oneself that in turn promotes psycho-physical well-being in general. IM simultaneously uses breathing, focusing attention, the rel

Sponsors

University of Pavia
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Pittsburgh Sleep Quality Index (PSQI) score >5 indicating impaired sleep quality 2. Not suffering at the time of recruitment from severe anxiety or depression, severe mental illness (e.g., hypomania or psychotic episode), or any other diagnosed mental or physical health condition

Exclusion criteria

Exclusion criteria: 1. PSQI score <5 2. Suffering at the time of recruitment from severe anxiety or depression, severe mental illness (e.g., hypomania or psychotic episode), or any other diagnosed mental or physical health condition

Design outcomes

Primary

MeasureTime frame
Different aspects of sleep quality and quantity measured by six self-reported questionnaires: 1. Seven different components of sleep quality (i.e., sleep duration, disturbance, latency, daytime dysfunction due to sleepiness, sleep efficiency, overall sleep quality, and sleep medication used) measured using the Pittsburgh Sleep Quality Index (PSQI) at baseline and after the intervention 2. Insomnia disorder measured using the Sleep Condition Indicator (SCI) questionnaire at baseline and after the intervention 3. The nature, severity, and impact of insomnia measured using the Insomnia Severity Index (ISI) questionnaire at baseline and after the intervention 4. Presence of sleep hygiene behaviors assessed using the Sleep Hygiene Index (SHI) questionnaire at baseline and after the intervention 5. An individual's likelihood of experiencing sleep difficulties in response to common stressful situations assessed using the Ford Insomnia Response to Stress Test (FIRST) questionnaire at baseline and after the intervention 6. Arousability measured using the APS questionnaire at baseline and after the intervention

Secondary

MeasureTime frame
Emotion regulation and level of mindfulness measured by two self-reported questionnaires: 1. Two different emotion regulation strategies, cognitive reappraisal and expressive suppression, measured using the Emotion Regulation Questionnaire (ERQ) at baseline and after the intervention 2. Level of mindfulness measured using the Five Facet Mindfulness Questionnaire (FFMQ) before and after the intervention

Countries

Italy

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026