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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
Date results information initially provided
17/12/2021
Type of registration
Prospectively registered
Titles & IDs
Public title
Influence of rituals on open-label placebo effect in healthy volunteers
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Scientific title
Open-label placebo administration, performing a ritual, and wellbeing in healthy participants
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Secondary ID [1]
300606
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Negative emotional states
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Poor sleep quality
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Low perceived well-being
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Perceived fatigue
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Condition category
Condition code
Alternative and Complementary Medicine
314619
314619
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0
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Other alternative and complementary medicine
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Mental Health
314620
314620
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0
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Studies of normal psychology, cognitive function and behaviour
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
316916
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Other interventions
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Comparator / control treatment
No treatment control condition - control participants will not take placebo pills and will be observed only through completion of study questionnaires
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Control group
Active
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Outcomes
Primary outcome [1]
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Negative emotional state: depression, anxiety, and stress symptoms (DASS-21; Lovibond & Lovibond, 1995)
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Assessment method [1]
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Timepoint [1]
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Follow-up 6 days post-randomisation (at completion of the 6-day course of placebo pills)
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Primary outcome [2]
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Sleep quality (ISI, Morin, Belleville, Belanger, & Ivers, 2011)
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Assessment method [2]
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Timepoint [2]
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6 days post-randomisation (at completion of the 6-day course of placebo pills)
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Primary outcome [3]
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Positive mental Well-Being (WEMWBS, Tennant et al., 2006)
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Assessment method [3]
322951
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Timepoint [3]
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6 days post-randomisation (at completion of the 6-day course of placebo pills)
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Secondary outcome [1]
380343
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Vigour and Fatigue (POMS, McNair, Droppleman, & Lorr, 1992) - This is a fourth primary outcome
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Assessment method [1]
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Timepoint [1]
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6 days post-randomisation (at completion of the 6-day course of placebo pills)
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Secondary outcome [2]
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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).
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Assessment method [2]
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Timepoint [2]
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6 days post-randomisation (at completion of the 6-day course of placebo pills)
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Eligibility
Key inclusion criteria
Participants will be healthy undergraduate students seeking to improve well-being.
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Minimum age
16
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
Lactose intolerance
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment via sealed opaque envelopes
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation table created by computer software (Excel)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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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.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
13/03/2020
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Actual
13/03/2020
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Date of last participant enrolment
Anticipated
27/04/2020
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Actual
28/05/2021
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Date of last data collection
Anticipated
3/05/2020
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Actual
2/06/2021
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Sample size
Target
125
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Accrual to date
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Final
101
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment postcode(s) [1]
29403
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2052 - Unsw Sydney
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Funding & Sponsors
Funding source category [1]
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University
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Name [1]
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University of New South Wales
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Address [1]
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School of Psychology
UNSW Sydney
NSW 2052
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Country [1]
305026
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Australia
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Primary sponsor type
Individual
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Name
Dr Kate Faasse
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Address
School of Psychology
UNSW Sydney
NSW 2052
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
305387
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Country [1]
305387
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
305421
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University of New South Wales Human Research Ethics Committee c
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Ethics committee address [1]
305421
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School of Psychology
UNSW Sydney
NSW 2052
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Ethics committee country [1]
305421
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Australia
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Date submitted for ethics approval [1]
305421
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Approval date [1]
305421
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30/04/2019
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Ethics approval number [1]
305421
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3202
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Ethics committee name [2]
305424
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University of New South Wales Human Research Ethics Committee c
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Ethics committee address [2]
305424
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School of Psychology
UNSW Sydney
NSW 2052
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Ethics committee country [2]
305424
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Australia
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Date submitted for ethics approval [2]
305424
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Approval date [2]
305424
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14/02/2020
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Ethics approval number [2]
305424
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File 3202 (modification)
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Summary
Brief summary
This study will investigate the role of rituals in open-label placebo effect. Recent studies have found that open-label placebo treatments are effective in improving symptoms of IBS, depression, ADHD, and low-back and migraine pain. These findings suggest the possibility of generating a placebo effect without deception. Participants will be recruited to take part in a study investigating the effect of open-label placebo administration on wellbeing and randomly assigned to one of three conditions: no-treatment control, placebo treatment, or placebo treatment taken performing a ritual procedure.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Mr Marco Valerio
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Address
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School of Psychology
UNSW Sydney
NSW 2052
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Country
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Australia
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Phone
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+61 404307163
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Mr Marco Valerio
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Address
100327
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School of Psychology
UNSW Sydney
NSW 2052
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Country
100327
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Australia
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Phone
100327
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+61 404307163
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Fax
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Email
100327
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[email protected]
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Contact person for scientific queries
Name
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Mr Marco Valerio
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Address
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School of Psychology
UNSW Sydney
NSW 2052
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Country
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Australia
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Phone
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+61 404307163
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Fax
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Email
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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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.
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