Investigating the effects of a micronutrient formula on insomnia in teachers

Not Applicable

Completed

• Conditions: Insomnia; Mental Health - Other mental health disorders

• Registration Number: ACTRN12616001026415
• Lead Sponsor: niversity of Canterbury

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-08-03
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Participants must be teachers 18 years or over working in earthquake affected schools, and must be registered and have at least 2 years experience working full time. They must meet the criteria of 'insomnia' according to the Pittsburgh Insomnia Symptom Questionnaire which they complete during the screening process, and have scores in the 'moderate' or 'severe' range for insomnia symptoms on the Pittsburgh Insomnia Rating Scale -20.

Exclusion Criteria

Participants must not be taking psychotropic medications (e.g., antidepressants, anxiolytics) or prescribed sleep medications. They must not be pregnant or breastfeeding, or intend to attempt to conceive in the near future, and must not have a child 2 years or under. They must not have sleep apnoea. They will be asked to not take any other products for assisting with sleep during the course of the trial.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The Pittsburgh Insomnia Rating Scale-20 (PIRS-20) - a 20 item self-report instrument designed to assess severity of insomnia.[Primary outcome 1 completed at weeks 4 and 10 of the micronutrient phase and at follow-up 3 months post end of the micronutrient phase. ];The Expanded Consensus Sleep Diary for Morning (CSD-M) - collects data about sleep each morning for the previous night, including sleep onset latency, number of awakenings, and sleep efficiency. [To be completed daily from the start of study until end of intervention phase. ]

Secondary Outcome Measures

Name	Time	Method
The Depression, Anxiety, and Stress Scale - 21 (DASS-21) will also be completed during the study. [Participants will complete the DASS-21 at the start and end of baseline, as well as during the placebo phases (time points 5, 9, and 14 days), and biweekly once the micronutrient phase has begun until the end of the intervention, and then at 3 month follow up. ];Maslach Burnout Inventory Educators Survey (MBI-ES) - The MBI-ES will also be completed during the study to assess the two core burnout dimensions of emotional exhaustion and cynicism.[Participants will complete the MBI-ES once at the beginning of baseline and once at the end of intervention. ]