Do placebos that elicit side effects enhance the placebo effect for sleep compared with conventional placebos that only contain lactose fibres?

Not Applicable

Completed

• Conditions: Sleep difficulty; Neurological - Other neurological disorders

• Registration Number: ACTRN12618001493235
• Lead Sponsor: The University of Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-09-05
• Study Completion: 2018-10-31
• Last Update Posted: 4 December 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 71

Inclusion Criteria

(1) at least 18 years of age

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

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)];Self-reports of urine colouration, using the same 4-point scale as the GASE (0=not present, 1=mild, 2=moderate, 3=severe)[Baseline (assessed daily during the 7 nights prior to randomisation)<br>Treatment (assessed daily during the 7 nights receiving treatment after randomisation)]