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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Type of registration
Prospectively registered

Titles & IDs
Public title
Can placebo pills improve well-being even when you know you're taking a placebo?
Scientific title
Open-label placebo administration and well-being in healthy participants
Secondary ID [1] 291196 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Well-being 302101 0
Sleep quality 302102 0
Physical symptoms 302103 0
Condition category
Condition code
Alternative and Complementary Medicine 301724 301724 0 0
Other alternative and complementary medicine
Mental Health 301736 301736 0 0
Studies of normal psychology, cognitive function and behaviour

Study type
Description of intervention(s) / exposure
Open-label placebo administration (1 placebo pill per day versus 4 placebo pills per day) for 5 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).
Intervention code [1] 297200 0
Other interventions
Comparator / control treatment
No treatment control condition - control participants will not take placebo pills and will be observation only through completion of study questionnaires
Control group

Primary outcome [1] 301117 0
Psychological well-being (DASS-21; Lovibond & Lovibond, 1995; WEMWBS; Tennant et al., 2007)
Timepoint [1] 301117 0
Follow-up 6 days post-randomisation (at completion of the 5-day course of placebo pills)
Primary outcome [2] 301118 0
Sleep quality (PSQI, Buysse et al., 1989)
Timepoint [2] 301118 0
6 days post-randomisation (at completion of the 5-day course of placebo pills)
Primary outcome [3] 301119 0
Physical symptoms (SHC; Eriksen, Ihlebaek & Ursin, 1999)
Timepoint [3] 301119 0
6 days post-randomisation (at completion of the 5-day course of placebo pills)
Secondary outcome [1] 331773 0
Adherence to placebo treatment - assessed using brief self-report measures (number of pills missed, visual analog scale)
Timepoint [1] 331773 0
6 days post-randomisation (at completion of the 5-day course of placebo pills)

Key inclusion criteria
Participants will be healthy undergraduate students
Minimum age
18 Years
Maximum age
No limit
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
Lactose intolerance

Study design
Purpose of the study
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
Other design features
Not Applicable
Type of endpoint(s)
Statistical methods / analysis
3-way ANCOVA assessing primary outcomes across groups, controlling for baseline

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 15324 0
2052 - Unsw Sydney

Funding & Sponsors
Funding source category [1] 295641 0
Name [1] 295641 0
University of New South Wales
Address [1] 295641 0
School of Psychology
UNSW Sydney
NSW 2052
Country [1] 295641 0
Primary sponsor type
Dr Kate Faasse
School of Psychology
UNSW Sydney
NSW 2052
Secondary sponsor category [1] 294480 0
Name [1] 294480 0
Address [1] 294480 0
Country [1] 294480 0

Ethics approval
Ethics application status
Ethics committee name [1] 296958 0
Ethics committee address [1] 296958 0
Ethics committee country [1] 296958 0
Date submitted for ethics approval [1] 296958 0
Approval date [1] 296958 0
Ethics approval number [1] 296958 0

Brief summary
This study will investigate the role of dose in open-label placebo administration. 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 well-being and randomly assigned to one of three conditions: no-treatment control, low dose (1 pill per day), or high dose (4 pills per day) placebo administration.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 72542 0
Dr Kate Faasse
Address 72542 0
School of Psychology
UNSW Sydney
NSW 2052
Country 72542 0
Phone 72542 0
Fax 72542 0
Email 72542 0
Contact person for public queries
Name 72543 0
Dr Kate Faasse
Address 72543 0
School of Psychology
UNSW Sydney
NSW 2052
Country 72543 0
Phone 72543 0
Fax 72543 0
Email 72543 0
Contact person for scientific queries
Name 72544 0
Dr Kate Faasse
Address 72544 0
School of Psychology
UNSW Sydney
NSW 2052
Country 72544 0
Phone 72544 0
Fax 72544 0
Email 72544 0

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary