Investigation into the effect of a micronutrient formula on symptoms of insomnia
Not Applicable
Completed
- Conditions
- InsomniaMental Health - Other mental health disorders
- Registration Number
- ACTRN12613000364774
- Lead Sponsor
- niversity of Canterbury
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 15
Inclusion Criteria
Participants must be 18 years or over, be classified as having a diagnosis of 'insomnia' according to the Pittsburgh Insomnia Symptom Questionnaire which they complete during the screening process, and scores in the 'moderate' or 'severe' range for insomnia symptoms on the Piitsburgh Insomnia Rating Scale.
Exclusion Criteria
Participants must not be taking psychotropic medciations (eg antidepressants, anxiolytics) or prescribed sleep medications. They must not be pregnant or breastfeeding, and must not have a child two 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 (PIRS) -a 65 item self report instrument designed to assess severity of insomnia. [To be completed at the start of the study, and then weekly throughout baseline and intervention phases.];Consensus Daily Sleep Diary- collects data about sleep each morning for the previous night, including sleep onset latency, number of awakenings, sleep efficiency.[To be completed daily from start of study until end of treatment phase.];Clinical Global Impression - Improvement (CGI-I), patient rated - after the randomized baseline phase and end of study[On completion of the 8 week treatment phase - the CGI will be used to determine what percentage of participants see themselves as much to very much improved in their sleep since starting the micronutrients.]
- Secondary Outcome Measures
Name Time Method The Depression, Anxiety and Stress scale (DASS) will also be completed during the study.[Participants will complete the DASS at the start of the study and then weekly throughout baseline and intervention phases.]