Sleep Self-Regulation Using Mental Imagery
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| First Received Date ICMJE | July 18, 2012 | ||||||||
| Last Updated Date | July 19, 2012 | ||||||||
| Start Date ICMJE | October 2008 | ||||||||
| Primary Completion Date | April 2010 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Sleep Quality [ Time Frame: Baseline and at 3 weeks. Data will also be presented for every day for the duration of the 3 week period so change can be reported. ] [ Designated as safety issue: No ] Assessed using the Pittsburgh Sleep Quality Index (PSQI; Buysse et al, 1989).The PSQI includes 19 items that assess sleep quality, hours of sleep, sleep onset length, sleep efficiency, sleep disturbances, use of medication and daytime. Item ratings are recoded and combined to form seven component scores. These scores are then summed into a global score ranging from 0(no difficulty) to 21(severe difficulties in all areas). Daily sleep quality was assessed with five PSQI items. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01648062 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Sleep Self-Regulation Using Mental Imagery | ||||||||
| Official Title ICMJE | Using Mental Imagery to Deliver Self-Regulation Techniques That Target Sleep Initiation Behaviors and Pre-Sleep Arousal | ||||||||
| Brief Summary | This randomised controlled trial assessed the efficacy of four mental imagery techniques for improving sleep and its related behaviour: (1) imagery focused on reducing arousal levels; (2) imagery incorporating implementation intentions (a strategy designed to link specified behaviour with the anticipated context) for sleep-related behaviour; (3) a combination of imagery using arousal reduction and implementation intention strategies; or (4) a condition where participants were asked to imagine their typical post work activities. |
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| Detailed Description | Sleep deprivation is a significant health issue in the modern workplace. We conducted a randomized controlled trial to test the efficacy of techniques involving mental imagery promoting relaxation (arousal reduction; AR) and simulation of the appropriate sleep behavior in the likely environments (implementation intentions; II) in a population of daytime employees |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE | Behavioral: Sleep Self-Regulation Using Mental Imagery
Comparison of two forms of mental imagery to instigate behaviors that assist in the sleeping process
Other Names:
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | 104 | ||||||||
| Completion Date | April 2010 | ||||||||
| Primary Completion Date | April 2010 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | New Zealand | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01648062 | ||||||||
| Other Study ID Numbers ICMJE | IISleepTrial12 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Dr Marisa Loft, University of Auckland, New Zealand | ||||||||
| Study Sponsor ICMJE | University of Auckland, New Zealand | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | University of Auckland, New Zealand | ||||||||
| Verification Date | July 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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