Investigation into the effect of micronutrients for the maintenance of good health after the Southern Alberta flood:Comparison of three micronutrient formulas

Phase 3

Completed

• Conditions: Symptoms of depression; Symptoms of anxiety; Mental Health - Depression; Mental Health - Anxiety; Alternative and Complementary Medicine - Other alternative and complementary medicine

• Registration Number: ACTRN12613001051730
• Lead Sponsor: niversity of Calgary

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-09-20
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 210

Inclusion Criteria

1. Over 18 years of age whose homes were damaged by the Southern Alberta flood. 2. Have at least one score above the cutoffs of the Depression, Anxiety and Stress Scale, as follows: 10 (for depression), 7 (for anxiety) or 14 (for stress). 3. Free of psychiatric medications (defined as having taken none for at least four weeks)

Exclusion Criteria

1. Neurological disorder involving brain or other central function (e.g., epilepsy, MS, narcolepsy),
2. Any serious medical condition,
3. Known to be allergic to the ingredients of the intervention,
4. Pregnant or breastfeeding,
5. Evidence of untreated or unstable thyroid disease,
6. Known abnormality of mineral metabolism (e.g., Wilson’s disease, haemochromatosis),
7. Reporting substance dependence within the previous month.
8. Currently participating in the Pure North health program (a local nutritional program).
9. Judged clinically to be at serious risk for suicide or violence in the opinion of the researchers (based on screening information and the intake interview).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Modified Clinical Global Impressions (CGI-I; Spearing et al., 1997) The questions ask participants to rate how much they think their mood, anxiety, stress, energy, and sleep have changed since they started the trial, using a 7 point scale from 1 (very much improved) to 7 (very much worse). [Following 6 weeks of treatment, again after 12 weeks for those who participate in the extension];The Depression Anxiety and Stress Scale (DASS; Lovibond and Lovibond, 1995b) is a 42-item questionnaire which assesses an individual’s current severity of symptoms relating to depression, anxiety and stress. [Baseline and after 6 weeks of treatment, again after 12 weeks for those who participate in the extension]

Secondary Outcome Measures

Name	Time	Method
Impact of event Scale - Revised (IES-R; Weiss & Marmar, 1997)[Baseline, and after 6 weeks of treatment, and again after 12 weeks for those who participate in the extension.]