None listed
Conditions
Brief summary
This study will use sham placebo treatments, ostensibly a benzodiazepine medicines being tested to assess their effectiveness for experimentally-induced anxiety, to assess the influence of choice of treatment (no choice, choice of 2 treatments, choice of 10 treatments) on the nocebo effect (assessed via self-reported physical symptoms that are described as benzodiazepine side effects). To assess the development and magnitude of the nocebo effect, placebo-treated participants will be compared to a no treatment control condition. It is hypothesised that a nocebo effect will be seen across the three groups of placebo-treated participants. It is also hypothesised that, compared to the no choice group, the 2 choice group will report lower physical symptoms scores, and the 10 choice group will report higher or at least equivalent physical symptoms scores.
Interventions
There are 2 exposures in this study. First exposure to a placebo treatment described as a benzodiazepine (actually containing only lactose), compared to no exposure i.e. no treatment. Second, exposure to 1 of 3 treatment choice conditions (no choice of placebo treatments, choice of 2 placebo treatments, choice of 10 placebo treatments). Thus, participants will be randomly assigned to 1 of 4 conditions: 1) No treatment control, 2) No choice of placebo treatment, 3) Choice between two placebo trea
There are 2 exposures in this study. First exposure to a placebo treatment described as a benzodiazepine (actually containing only lactose), compared to no exposure i.e. no treatment. Second, exposure to 1 of 3 treatment choice conditions (no choice of placebo treatments, choice of 2 placebo treatments, choice of 10 placebo treatments). Thus, participants will be randomly assigned to 1 of 4 conditions: 1) No treatment control, 2) No choice of placebo treatment, 3) Choice between two placebo treatments, 4) Choice between ten placebo treatments. All participants will be asked to complete an experimental anxiety induction (straw breathing task) in order to ostensibly assess the impact of the benzodiazepine (actually placebo) on anxiety. The intervention will be delivered by a university research student, in the research rooms of the UNSW Psychology Clinic.
Sponsors
Dr Kate Faasse
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Able to ingest ingredients of placebo capsules (lactose, gelatin). In line with cover story of a benzodiazepine treatment, participants must also not have any contraindications for benzodiazepine use or previous adverse reaction.
Exclusion criteria
Unable to consume gelatine or lactose. Self-reported anxiety assessed as severe or extremely severe by DASS-21 anxiety subscale.
Outcome results
None listed