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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
ACTRN12617000253303
Ethics application status
Approved
Date submitted
16/02/2017
Date registered
20/02/2017
Date last updated
13/07/2017
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
Nil
Universal Trial Number (UTN)
U1111-1193-1778
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

Intervention/exposure
Study type
Interventional
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
Active

Outcomes
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)

Eligibility
Key inclusion criteria
Participants will be healthy undergraduate students
Minimum age
18 Years
Maximum age
No limit
Gender
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

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

Funding & Sponsors
Funding source category [1] 295641 0
University
Name [1] 295641 0
University of New South Wales
Address [1] 295641 0
School of Psychology
UNSW Sydney
NSW 2052
Country [1] 295641 0
Australia
Primary sponsor type
Individual
Name
Dr Kate Faasse
Address
School of Psychology
UNSW Sydney
NSW 2052
Country
Australia
Secondary sponsor category [1] 294480 0
None
Name [1] 294480 0
Address [1] 294480 0
Country [1] 294480 0

Ethics approval
Ethics application status
Approved
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
10/02/2017
Ethics approval number [1] 296958 0

Summary
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

Contacts
Principal investigator
Name 72542 0
Dr Kate Faasse
Address 72542 0
School of Psychology
UNSW Sydney
NSW 2052
Country 72542 0
Australia
Phone 72542 0
+61293850364
Fax 72542 0
Email 72542 0
k.faasse@unsw.edu.au
Contact person for public queries
Name 72543 0
Dr Kate Faasse
Address 72543 0
School of Psychology
UNSW Sydney
NSW 2052
Country 72543 0
Australia
Phone 72543 0
+61293850364
Fax 72543 0
Email 72543 0
k.faasse@unsw.edu.au
Contact person for scientific queries
Name 72544 0
Dr Kate Faasse
Address 72544 0
School of Psychology
UNSW Sydney
NSW 2052
Country 72544 0
Australia
Phone 72544 0
+61293850364
Fax 72544 0
Email 72544 0
k.faasse@unsw.edu.au

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