Investigation into the effect of micronutrients on stress and anxiety following the Christchurch Mosque shootings

Phase 4

Withdrawn

• Conditions: stress; anxiety; Mental Health - Anxiety; Alternative and Complementary Medicine - Other alternative and complementary medicine

• Registration Number: ACTRN12619000759190
• Lead Sponsor: Julia Rucklidge

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-05-22
• Last Update Posted: 1 June 2020

Recruitment & Eligibility

• Status: Withdrawn
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Participants must be a victim of the mosque shooting – either present in one of the mosques or know someone who was in the mosque. Further, they must be over 18 years of age, possess a level of understanding sufficient to complete the questionnaires and examinations required by the protocol and be considered reliable and compliant with the protocol (including the ingestion of as many as 6 capsules/day), and must be able to eat at least a snack twice per day. They must self identify as struggling with psychological symptoms as a consequence of the Christchurch events.

Exclusion Criteria

1) Neurological disorder involving brain or other central function (e.g., epilepsy, MS, narcolepsy), 2) Any serious medical condition, 3) Any participant known to be allergic to the ingredients of the intervention, 4) Evidence of untreated or unstable thyroid disease, 5) Any known abnormality of mineral metabolism (e.g., Wilson’s disease, haemochromatosis), 6) evidence of substance dependence within the previous month, 7) Any participant judged clinically to be at serious risk for suicide or violence in the opinion of the researchers.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical Global Impression - I (CGI-I) - modified for completion by participants - documenting the number of responders to the treatment[2 weeks, 4 weeks, 6 weeks (primary endpoint), 6 months (post enrollment), 12 months (post enrollment). The data will also be summarized as number of responders at 6 weeks based on a 1 or 2 on the CGI-I.];Depression, Anxiety and Stress Scale (Lovibond and Lovibond, 1995) - DASS-21 [baseline, 2 weeks, 4 weeks, 6 weeks (primary endpoint), 6 months (post enrollment), 12 months (post enrollment). We will also report on number who fall into the nonclinical range at 6 weeks.]

Secondary Outcome Measures

Name	Time	Method
Impact of Events Scale: (Weiss & Marmar, 1997). The Impact of Events Scale Revised (IES-R, Weiss & Marmar, 1997) is a 22-item measure of commonly experienced symptoms following a distressing event.[baseline, 2 weeks, 4 weeks, 6 weeks, 6 months (post enrollment), 12 months (post enrollment). ];side effects - checklist of symptoms commonly experienced when taking capsules. We have modified the Antidepressant Side-Effects Checklist for use with micronutrients (Uher et al., 2016). <br>Side effects observed as a result of taking this micronutrient formula are:<br>Frequent: change in urine colour (a fluorescent yellow colour due to riboflavin).<br>Infrequent: headache, loose stools, nausea.<br>Rare: flatulence, diarrhoea, stomach ache, vomiting.<br>[baseline, 2 weeks, 4 weeks, 6 weeks ]