Influence of rituals on open-label placebo effect in healthy volunteers

Not Applicable

Completed

• Conditions: egative emotional states; Poor sleep quality; Low perceived well-being; Perceived fatigue; Negative emotional states; Alternative and Complementary Medicine - Other alternative and complementary medicine; Mental Health - Studies of normal psychology, cognitive function and behaviour

• Registration Number: ACTRN12620000305921
• Lead Sponsor: Dr Kate Faasse

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-03-05
• Study Completion: 2021-06-02
• Last Update Posted: 27 December 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 101

Inclusion Criteria

Participants will be healthy undergraduate students seeking to improve well-being.

Exclusion Criteria

Lactose intolerance

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
egative emotional state: depression, anxiety, and stress symptoms (DASS-21; Lovibond & Lovibond, 1995)[Follow-up 6 days post-randomisation (at completion of the 6-day course of placebo pills)];Sleep quality (ISI, Morin, Belleville, Belanger, & Ivers, 2011)<br>[6 days post-randomisation (at completion of the 6-day course of placebo pills)];Positive mental Well-Being (WEMWBS, Tennant et al., 2006)[6 days post-randomisation (at completion of the 6-day course of placebo pills)]

Secondary Outcome Measures

Name	Time	Method
Vigour and Fatigue (POMS, McNair, Droppleman, & Lorr, 1992) - This is a fourth primary outcome[6 days post-randomisation (at completion of the 6-day course of placebo pills)];For the two intervention groups: adherence to placebo treatment - assessed using brief self-report measures (number of days when pills were taken, from 0 (no pills were taken) to 6 (all pills taken)). Participants will be asked to indicate how well they have adhered to the instructions to take one placebo pill per day, with response recorded on a VAS from 0 (not at all) to 10<br>(perfect adherence).[6 days post-randomisation (at completion of the 6-day course of placebo pills)]