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Trial registered on ANZCTR


Registration number
ACTRN12620000305921
Ethics application status
Approved
Date submitted
24/02/2020
Date registered
5/03/2020
Date last updated
17/12/2021
Date data sharing statement initially provided
5/03/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Influence of rituals on open-label placebo effect in healthy volunteers
Scientific title
Open-label placebo administration, performing a ritual, and wellbeing in healthy participants
Secondary ID [1] 300606 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Negative emotional states 316358 0
Poor sleep quality 316505 0
Low perceived well-being 316506 0
Perceived fatigue 316507 0
Condition category
Condition code
Alternative and Complementary Medicine 314619 314619 0 0
Other alternative and complementary medicine
Mental Health 314620 314620 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Open-label placebo administration (2 placebo pills per day to take every morning, with or without a ritual procedure to perform when taking the pills) for 6 days compared to a no treatment control
condition. Adherence will be assessed via self-report at follow-up after completion of the course of placebo pills (day 6). Participants in the 'placebo plus ritual' group will be given a ritual procedure to follow every time they take the pills (A sequence of actions to perform, including shaking the capsules, blowing on them, gently tapping three times with one's hand on their forehead, chest and abdomen- see below for the complete procedure). Participants in the 'placebo only' group will be told to take two pills every day at the same time, without further instructions.
All participants will be provided with information about the placebo effect following the talking points outlined by Kaptchuk and colleagues (2010) - namely that placebos are powerful, can produce an automatic healing response, that positive expectations are not necessary but keeping an open mind is important, and that taking pills faithfully (i.e. adherence) is critical.
Information and instructions will be provided to both groups during an initial half hour face-to-face research session. Information provision will take approximately 10 minutes. At the end of this session, after completing a baseline assessment, participants will be given lactose-filled vegetarian gelatin placebo capsules to take every morning for the next 6 days and instructions on how to take them.


Ritual procedure (approx. 90 seconds to complete):
- Wash your hands up to your wrists;
- Get the container and some water to drink;
- Find a quiet and comfortable place;
- Open the container and pick an orange capsule and a pink capsule;
- Hold them in the palm of your non-dominant hand, keeping the hand open;
- Close both hands together, holding the capsules;
- Shake your hands lightly three times;
- Close your eyes and gently blow into your hands, on the capsules;
- Open your eyes and release your hands;
- Pick the orange capsule and take it with some water;
- Take a deep inhale and slowly exhale;
- Pick the pink capsule and take it with some water;
- Close your eyes and with the index and middle fingers of your dominant hand:
• Tap your forehead three times;
• Tap your heart three times;
• Tap your abdomen three times;
- Merge your hands in front of your chest and bow your head;
- Lift up.
Intervention code [1] 316916 0
Other interventions
Comparator / control treatment
No treatment control condition - control participants will not take placebo pills and will be observed only through completion of study questionnaires
Control group
Active

Outcomes
Primary outcome [1] 322949 0
Negative emotional state: depression, anxiety, and stress symptoms (DASS-21; Lovibond & Lovibond, 1995)
Timepoint [1] 322949 0
Follow-up 6 days post-randomisation (at completion of the 6-day course of placebo pills)
Primary outcome [2] 322950 0
Sleep quality (ISI, Morin, Belleville, Belanger, & Ivers, 2011)
Timepoint [2] 322950 0
6 days post-randomisation (at completion of the 6-day course of placebo pills)
Primary outcome [3] 322951 0
Positive mental Well-Being (WEMWBS, Tennant et al., 2006)
Timepoint [3] 322951 0
6 days post-randomisation (at completion of the 6-day course of placebo pills)
Secondary outcome [1] 380343 0
Vigour and Fatigue (POMS, McNair, Droppleman, & Lorr, 1992) - This is a fourth primary outcome
Timepoint [1] 380343 0
6 days post-randomisation (at completion of the 6-day course of placebo pills)
Secondary outcome [2] 380344 0
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
(perfect adherence).
Timepoint [2] 380344 0
6 days post-randomisation (at completion of the 6-day course of placebo pills)

Eligibility
Key inclusion criteria
Participants will be healthy undergraduate students seeking to improve well-being.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Lactose intolerance

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment via sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation table created by computer software (Excel)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
3-way ANCOVA assessing primary outcomes across groups, controlling for baseline on primary outcomes,
Regression analyses assessing the influence of expectations about and adherence to placebo treatment, psychological flexibility, mindfulness, awe, expectations.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
13/03/2020
Actual
13/03/2020
Date of last participant enrolment
Anticipated
27/04/2020
Actual
28/05/2021
Date of last data collection
Anticipated
3/05/2020
Actual
2/06/2021
Sample size
Target
125
Accrual to date
Final
101
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 29403 0
2052 - Unsw Sydney

Funding & Sponsors
Funding source category [1] 305026 0
University
Name [1] 305026 0
University of New South Wales
Country [1] 305026 0
Australia
Primary sponsor type
Individual
Name
Dr Kate Faasse
Address
School of Psychology
UNSW Sydney
NSW 2052
Country
Australia
Secondary sponsor category [1] 305387 0
None
Name [1] 305387 0
Address [1] 305387 0
Country [1] 305387 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305421 0
University of New South Wales Human Research Ethics Committee c
Ethics committee address [1] 305421 0
Ethics committee country [1] 305421 0
Australia
Date submitted for ethics approval [1] 305421 0
Approval date [1] 305421 0
30/04/2019
Ethics approval number [1] 305421 0
3202
Ethics committee name [2] 305424 0
University of New South Wales Human Research Ethics Committee c
Ethics committee address [2] 305424 0
Ethics committee country [2] 305424 0
Australia
Date submitted for ethics approval [2] 305424 0
Approval date [2] 305424 0
14/02/2020
Ethics approval number [2] 305424 0
File 3202 (modification)

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 100326 0
Mr Marco Valerio
Address 100326 0
School of Psychology
UNSW Sydney
NSW 2052
Country 100326 0
Australia
Phone 100326 0
+61 404307163
Fax 100326 0
Email 100326 0
[email protected]
Contact person for public queries
Name 100327 0
Marco Valerio
Address 100327 0
School of Psychology
UNSW Sydney
NSW 2052
Country 100327 0
Australia
Phone 100327 0
+61 404307163
Fax 100327 0
Email 100327 0
[email protected]
Contact person for scientific queries
Name 100328 0
Marco Valerio
Address 100328 0
School of Psychology
UNSW Sydney
NSW 2052
Country 100328 0
Australia
Phone 100328 0
+61 404307163
Fax 100328 0
Email 100328 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.