NCT01648062

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

July 18, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 24, 2012

Completed
Last Updated

July 24, 2012

Status Verified

July 1, 2012

Enrollment Period

1.5 years

First QC Date

July 18, 2012

Last Update Submit

July 19, 2012

Conditions

Keywords

Sleepself-regulationImplementation intentionsinterventionmental simulation

Outcome Measures

Primary Outcomes (1)

  • Sleep Quality

    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.

    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.

Secondary Outcomes (5)

  • Negative Sleep Habits

    Baseline and Final follow-up (at 21-days)

  • Sleep Efficacy

    Baseline and final follow-up (at 21 days)

  • Pre-Sleep Arousal

    Baseline and final follow-up (Day 21)

  • Imagery Adherence

    Post-session, Daily, Final follow-up (21 days)

  • Action Planning

    Baseline, Final follow-up (Day 21)

Study Arms (4)

Arousal reduction using guided imagery

ACTIVE COMPARATOR

Sleep Self-Regulation Using Mental Imagery: Participants in the arousal reduction condition were instructed to imagine wearing a backpack loaded with their worries, then putting the heavy backpack down, and then experiencing the relief and freedom from tension.

Behavioral: Sleep Self-Regulation Using Mental Imagery

Mental simulation of sleep behavior

ACTIVE COMPARATOR

Sleep Self-Regulation Using Mental Imagery: Participants in this condition received instructions to visualize a specific behavioral plan designed to meet the goal of obtaining quality sleep each night through the practice of certain behaviors. To form the behavioral plan, participants visualised changing into comfortable clothes and taking time to relax prior to going to bed, the time they planned to go to sleep, where they planned to sleep, and the bedtime routine they follow to help them to get to sleep. At bedtime, they were instructed to mentally run through a checklist of these behaviors and then do any behaviors that they had not yet completed.

Behavioral: Sleep Self-Regulation Using Mental Imagery

Combination

ACTIVE COMPARATOR

Sleep Self-Regulation Using Mental Imagery: Participants in this condition were asked to practice a combination of the guided imagery (for relaxation) and mental simulation imagery for sleep-related behaviour

Behavioral: Sleep Self-Regulation Using Mental Imagery

Control

SHAM COMPARATOR

Sleep Self-Regulation Using Mental Imagery: Participants in this condition were asked to imagine a typical post work activity

Behavioral: Sleep Self-Regulation Using Mental Imagery

Interventions

Comparison of two forms of mental imagery to instigate behaviors that assist in the sleeping process

Also known as: mental imagery, guided imagery, Implementation intentions, sleep, self-regulation, behavior change
Arousal reduction using guided imageryCombinationControlMental simulation of sleep behavior

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ability to read and write in English;
  • full-time employment;
  • work shifts during daytime hours (i.e., participants were excluded if they worked night shifts either through the organization or through a secondary job) in a position that provided daily access to email;
  • a score of five or greater on the Pittsburgh Sleep Quality Inventory (PSQI) which indicates at least moderate difficulties in two or more areas (e.g., sleep quality and daytime dysfunction);

You may not qualify if:

  • An identifiable biological cause of current sleep deprivation (e.g., sleep apnoea, narcolepsy, restless leg syndrome, periodic limb movement disorder, or pregnancy)
  • An identified psychological disorder
  • Caring for a child under the age of 5 or have a reason outside of work that caused them to regularly lack sleep.
  • Incomplete data (over 50% of daily data missing or missing final follow-up assessment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

10 Private Businesses in the Region

Auckland, New Zealand

Location

MeSH Terms

Conditions

Sleep DeprivationSleep Initiation and Maintenance DisordersSelf-Control

Interventions

Imagery, PsychotherapySleepProfessional Autonomy

Condition Hierarchy (Ancestors)

DyssomniasSleep Wake DisordersNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental DisordersSleep Disorders, IntrinsicSocial BehaviorBehavior

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsPsychotherapyBehavioral Disciplines and ActivitiesNervous System Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaProfessional PracticeOrganization and AdministrationHealth Services Administration

Study Officials

  • Marisa H Loft, PhD

    Monash University (Sunway Campus, Malaysia)

    PRINCIPAL INVESTIGATOR
  • Linda D Cameron, PhD

    University of California, Merced

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

July 18, 2012

First Posted

July 24, 2012

Study Start

October 1, 2008

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

July 24, 2012

Record last verified: 2012-07

Locations