How do different message framing manipulations influence the effects of active placebos?

Not Applicable

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

• Registration Number: ACTRN12620000232932
• Lead Sponsor: The University of Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-02-25
• Study Completion: 2021-06-02
• Last Update Posted: 15 November 2021

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 104

Inclusion Criteria

(1) at least 18 years of age; (2) threshold score of =10 on the ISI

Exclusion Criteria

(1) taking prescription medication (other than the contraceptive pills); (2) pregnancy, trying to conceive, or breastfeeding; (3) received treatment for sleep difficulty in the last three months; (4) antihistamine, beetroot, or lactose allergy, or any other intolerances; (5) abnormal/deficient kidney functioning or any other medical condition; (6) gastric problems or sensitive stomach (e.g. acid reflux)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Insomnia severity assessed using the Insomnia Severity Index (ISI)[Baseline (assessed at a single timepoint on the day starting treatment, for the 7 nights period prior to receiving treatment)<br>Treatment (assessed at a single timepoint on the day after finishing 7 nights of treatment, for the 7 nights period receiving treatment)];Reports of daily bothersome of red urine colouration assessed as part of an amended 10-item version of the General Assessment of Side Effects (GASE). We shortened the GASE to only include the most relevant items and added a question regarding urine colouration – the target side effect. We assessed how bothersome the complaints are on a visual analogue scale (VAS) ranging from 0 (= not bothersome at all”) to 100 (= absolutely bothersome”), with 33 (= mildly bothersome”) and 66 (= moderately bothersome”)[Baseline (assessed daily during the 7 nights prior to randomisation)<br>Treatment (assessed daily during the 7 nights receiving treatment after randomisation)]