Sleep Self-Regulation Using Mental Imagery

Insomnia Clinical Trial

Official title:

Using Mental Imagery to Deliver Self-Regulation Techniques That Target Sleep Initiation Behaviors and Pre-Sleep Arousal

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01648062
• Other study ID #: IISleepTrial12
• Status: Completed
• Phase: N/A
• First received: July 18, 2012
• Last updated: July 19, 2012
• Start date: October 2008
• Est. completion date: April 2010

Study information

• Verified date: July 2012
• Source: University of Auckland, New Zealand
• Contact: n/a
• Is FDA regulated: No
• Health authority: New Zealand: Ethics Committee
• Study type: Interventional

Clinical 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 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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);

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Insomnia
• Sleep Deprivation

Intervention

Behavioral:
• Sleep Self-Regulation Using Mental Imagery
Comparison of two forms of mental imagery to instigate behaviors that assist in the sleeping process

Locations

Country	Name	City	State
New Zealand	10 Private Businesses in the Region	Auckland

Sponsors (1)

Lead Sponsor	Collaborator
University of Auckland, New Zealand

Country where clinical trial is conducted

New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	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.	Baseline and Final follow-up (at 21-days)	No
Secondary	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.	Baseline and final follow-up (at 21 days)	No
Secondary	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.	Baseline and final follow-up (Day 21)	No
Secondary	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).	Post-session, Daily, Final follow-up (21 days)	No
Secondary	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.	Baseline, Final follow-up (Day 21)	No