None listed
Conditions
Brief summary
Converging evidence has shown that treatment choice can enhance the deceptive placebo effect for a range of conditions, such as pain. The current study aims to test whether treatment choice can facilitate the effect of open-label placebo (OLP) on chronic pain in a randomized controlled trial. Participants will be randomized to one of the three conditions: Choice, No Choice and Natural History. Both Choice and No Choice will receive OLP treatment and use their OLP treatment twice every day for two weeks while Natural History will not receive any treatment. Critically, the Choice group will be given the opportunity to choose a treatment between two options and decide when to use their treatment every day, whereas the No Choice group will be assigned a treatment and must use their treatment once in the morning and once in the evening. We hypothesize that (1) OLP will reduce chronic pain relative to Natural History; (2) choice over OLP treatment will enhance the OLP effect relative to No Choice.
Interventions
Participants with chronic pain will be randomized to one of three groups: Choice, No Choice and Natural History. Participants randomized to Choice and No Choice groups will receive an open-label placebo (OLP) treatment and will be asked to use their treatment twice every day for two weeks. Those randomized to Natural History will not receive any treatment.
The Choice group will be given the opportunity to choose their OLP treatment between oral pills and nasal spray before the two-week treatment
Participants with chronic pain will be randomized to one of three groups: Choice, No Choice and Natural History. Participants randomized to Choice and No Choice groups will receive an open-label placebo (OLP) treatment and will be asked to use their treatment twice every day for two weeks. Those randomized to Natural History will not receive any treatment. The Choice group will be given the opportunity to choose their OLP treatment between oral pills and nasal spray before the two-week treatment period and decide when to take each of two doses every day. The No Choice group will be assigned a OLP treatment by the researcher and must use the treatment once in the morning and once in the evening every day for two weeks. Treatment adherence will be assessed by self-report after the two-week treatment period.
Sponsors
The University of Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Age 18 and above • Self-reported persistent pain on more days than not for at least three months • Self-reported current pain intensity of moderate or greater severity (evidenced by a score of > 3 (/10) on a pain intensity numeric rating scale, PI-NRS). • Willingness to provide written informed consent • Willingness to participate and comply with the study protocol • Fluent in English • Competent to give consent
Exclusion criteria
• Current serious illness that requires therapy, where pain is not the primary symptom • Serious psychiatric illness (e.g., bipolar disorder, schizophrenia) • Drug or alcohol addiction • Currently pregnant
Outcome results
None listed