Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001092381
Ethics application status
Approved
Date submitted
25/07/2017
Date registered
27/07/2017
Date last updated
28/06/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Are pills enough? The influence of information on open-label placebo effects in healthy volunteers
Scientific title
Open-label placebo administration, treatment information, and wellbeing in healthy participants
Secondary ID [1] 292520 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Negative emotional state 304161 0
Positive mental wellbeing 304162 0
Physical symptoms 304163 0
Sleep quality 304164 0
Condition category
Condition code
Alternative and Complementary Medicine 303491 303491 0 0
Other alternative and complementary medicine
Mental Health 303492 303492 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, with either standard RCT placebo information versus enhanced open-label placebo information) 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).

Enhanced information will follow 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.

Standard RCT information is similar to that typically provided in RCT studies involving a placebo control condition. Namely, placebos will be described as typically being used as a control treatment, with the capsules containing inert ingredients that have no active physiological effect.

Information will be provided verbally to both groups during an initial half hour face-to-face research session. Information provision will take 5 to 10 minutes. At the end of this session, participants will be given lactose-filled vegetarian gelatin placebo capsules to take for the next 5 days.
Intervention code [1] 298704 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] 302867 0
Negative emotional state: depression, anxiety, and stress symptoms (DASS-21; Lovibond & Lovibond, 1995)
Timepoint [1] 302867 0
Follow-up 6 days post-randomisation (at completion of the 5-day course of placebo pills)
Primary outcome [2] 302868 0
Physical symptoms (SHC; Eriksen, Ihlebaek & Ursin, 1999)
Timepoint [2] 302868 0
6 days post-randomisation (at completion of the 5-day course of placebo pills)
Primary outcome [3] 302869 0
Sleep quality (ISI, Morin, Belleville, Belanger, & Ivers, 2011)
Timepoint [3] 302869 0
6 days post-randomisation (at completion of the 5-day course of placebo pills)
Secondary outcome [1] 337269 0
Adherence to placebo treatment - assessed using brief self-report measures (number of pills missed, visual analog scale). On the VAS scale, 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 [1] 337269 0
6 days post-randomisation (at completion of the 5-day course of placebo pills)
Secondary outcome [2] 337350 0
Positive mental wellbeing (WEMWBS; Tennant et al., 2007) - this is a fourth primary outcome.
Timepoint [2] 337350 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
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

Regression analyses assessing the influence of expectations about and adherence to placebo treatment on primary outcomes, controlling for baseline

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
31/07/2017
Actual
1/08/2017
Date of last participant enrolment
Anticipated
29/09/2017
Actual
7/05/2018
Date of last data collection
Anticipated
4/10/2017
Actual
13/05/2018
Sample size
Target
90
Accrual to date
Final
108
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 16715 0
2052 - Unsw Sydney

Funding & Sponsors
Funding source category [1] 297089 0
University
Name [1] 297089 0
University of New South Wales
Country [1] 297089 0
Australia
Primary sponsor type
Individual
Name
Dr Kate Faasse
Address
School of Psychology
UNSW Sydney
NSW 2052
Country
Australia
Secondary sponsor category [1] 296097 0
None
Name [1] 296097 0
Address [1] 296097 0
Country [1] 296097 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298267 0
UNSW HREAP-C
Ethics committee address [1] 298267 0
Ethics committee country [1] 298267 0
Australia
Date submitted for ethics approval [1] 298267 0
14/07/2017
Approval date [1] 298267 0
20/07/2017
Ethics approval number [1] 298267 0
File 2770 (modification)

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

Contacts
Principal investigator
Name 76530 0
Dr Kate Faasse
Address 76530 0
School of Psychology
UNSW Sydney
NSW 2052
Country 76530 0
Australia
Phone 76530 0
+61293850364
Fax 76530 0
Email 76530 0
[email protected]
Contact person for public queries
Name 76531 0
Kate Faasse
Address 76531 0
School of Psychology
UNSW Sydney
NSW 2052
Country 76531 0
Australia
Phone 76531 0
+61293850364
Fax 76531 0
Email 76531 0
[email protected]
Contact person for scientific queries
Name 76532 0
Kate Faasse
Address 76532 0
School of Psychology
UNSW Sydney
NSW 2052
Country 76532 0
Australia
Phone 76532 0
+61293850364
Fax 76532 0
Email 76532 0
[email protected]

No information has been provided regarding IPD availability


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.