Sleep DeprivationNCT01648062
Sleep Self-Regulation Using Mental Imagery
A study testing Sleep Self-Regulation Using Mental Imagery in people with Sleep Deprivation and Insomnia, run by University of Auckland, New Zealand at 1 site in New Zealand.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sleep Deprivation, Insomnia
- What is being tested?
- Sleep Self-Regulation Using Mental Imagery
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 1 siteNew Zealand
- Study dates
- Oct 2008to Apr 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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);
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Using Mental Imagery to Deliver Self-Regulation Techniques That Target Sleep Initiation Behaviors and Pre-Sleep Arousal
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.
Read the 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
- Conditions
- Sleep Deprivation, Insomnia
- Being tested
- Sleep Self-Regulation Using Mental Imagery
- Keywords
- Sleep, self-regulation, Implementation intentions, intervention, mental simulation
- Medical subject headings
- Sleep Deprivation, Sleep Initiation and Maintenance Disorders, Self-Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep Self-Regulation Using Mental ImageryBehavioural
Also called mental imagery, guided imagery, Implementation intentions, sleep
Comparison of two forms of mental imagery to instigate behaviors that assist in the sleeping process
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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 Receives: 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 Receives: Behavioral: Sleep Self-Regulation Using Mental Imagery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
The Sleep Hygiene Index (Mastin et al, 2006). Respondents rate on a scale from 1 (never) to 5 (all the time) how frequently they engaged in 13 behaviors (e.g. "I take naps lasting two or more hours"). Ratings were summed to provide a total negative sleep habit frequency score.
Measured: Baseline and Final follow-up (at 21-days)
Sleep Efficacy
Participants rated their sleep self-efficacy with the item, "how confident are you that you can take the actions necessary to get a good sleep tonight?" Sleep response efficacy was rated with the item "how confident are you that you will actually get a good sleep tonight?" ratings ranged from 1 (not at all confident) to 10 (very confident), and they were summed; r=.69, p<.01 at baseline and r=.20, p<.05 at final follow-up.
Measured: Baseline and final follow-up (at 21 days)
Pre-Sleep Arousal
The Pre-sleep Arousal Scale (Nicasso et al, 1985) includes an 8-item somatic subscale (e.g. "how often in the last week before bed have you had a tight, tense feeling in your muscles?") and an 8-item cognitive subscale (e.g. "how often in the last week before bed do you review or ponder events of the day?"). Ratings range from 1 (not at all) to 5 (extremely) and are summed to generate scores.
Measured: Baseline and final follow-up (Day 21)
Imagery Adherence
Measure adapted from the Vividness of Imagery Questionnaire (White et al, 1978). Participants rated the vividness of the following images: (1) putting things into a bag, (2) releasing a bag, (3) getting home from work, (4) relaxing at home, (5) their night-time routine, (6) the time that they visualised going to bed, (7) the environment of their bedroom, (8) the details of the bed they are sleeping in, (9) the image of themselves falling asleep. Response options were: 1 (no image at all) 2 (vague and dim), 3 (somewhat vivid), 4 (reasonably clear), and 5 (perfectly clear and vivid).
Measured: Post-session, Daily, Final follow-up (21 days)
Action Planning
An adaptation of the action planning measure developed by Luszczynska and Schwarzer (2003) was used. The items included: "I have made a detailed plan for (1) how I am going to wind down before going to sleep (2) how I am going to prepare for bed (3) how I am going to prepare the place where I will sleep, and (4) the time when I go to sleep". Responses ranged from 1 (not at all) to 7 (very much); ratings were summed to generate scores.
Measured: Baseline, Final follow-up (Day 21)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2012 (estimated)
- Study startOct 2008
- Primary completionApr 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DeprivationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Auckland, New Zealand
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Marisa Loft, University of Auckland, New Zealand
- Investigators
- Marisa H Loft, PhD, Principal investigator, Monash University (Sunway Campus, Malaysia)Linda D Cameron, PhD, Study director, University of California, Merced
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01648062
- Sponsor's protocol ID
- IISleepTrial12
- Status last verified
- Jul 2012
- First submitted
- 18 Jul 2012
- Last updated
- 24 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Mental Imagery to Deliver Self-Regulation Techniques That Target Sleep Initiation Behaviors and Pre-Sleep Arousal
- ClinicalTrials.gov ID
- NCT01648062
- Acronym / sponsor ID
- IISleepTrial12
- Conditions
- Sleep Deprivation, Insomnia
- Keywords
- Sleep, self-regulation, Implementation intentions, intervention, mental simulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- University of Auckland, New ZealandUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 24 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arousal reduction using guided imagery | Active comparator | Behavioral: Sleep Self-Regulation Using Mental ImagerySleep 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. |
| Mental simulation of sleep behavior | Active comparator | Behavioral: Sleep Self-Regulation Using Mental ImagerySleep 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. |
| Combination | Active comparator | Behavioral: Sleep Self-Regulation Using Mental ImagerySleep 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 |
| Control | Sham comparator | Behavioral: Sleep Self-Regulation Using Mental ImagerySleep Self-Regulation Using Mental Imagery: Participants in this condition were asked to imagine a typical post work activity |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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);
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sleep Self-Regulation Using Mental ImageryAlso: mental imagery, guided imagery, Implementation intentions, sleepComparison of two forms of mental imagery to instigate behaviors that assist in the sleeping process | Behavioural | Arousal reduction using guided imagery, Combination, Control, Mental simulation of sleep behavior |
Primary outcome
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.
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.
5 secondary outcomes
Negative Sleep Habits
Time frame: Baseline and Final follow-up (at 21-days)
Sleep Efficacy
Time frame: Baseline and final follow-up (at 21 days)
Pre-Sleep Arousal
Time frame: Baseline and final follow-up (Day 21)
Imagery Adherence
Time frame: Post-session, Daily, Final follow-up (21 days)
Action Planning
Time frame: Baseline, Final follow-up (Day 21)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marisa H Loft, PhD principal investigator
Monash University (Sunway Campus, Malaysia)
Linda D Cameron, PhD study director
University of California, Merced
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep Self-Regulation Using Mental Imagery in people with Sleep Deprivation and Insomnia, run by University of Auckland, New Zealand at 1 site in New Zealand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2012.