What’s in a name: a study protocol for a randomised controlled trial to identify the influence of diagnostic labels for mild depression and acute bronchitis on intended medication use.

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12616001393448

Enrollment

1600

Registered

2016-10-07

Start date

2016-10-31

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The current study will conduct a randomised controlled trial via an online survey. Recruitment will be conducted by Survey Sampling International (SSI) in order to obtain the desired 1600 participants. The current study aims to identify whether individuals given a diagnostic label for either a psychological (“mild depression”), or physiological condition (“acute bronchitis”) are more likely to decide to take medication than if given a symptomatic description only. We hypothesise that a higher proportion of those provided with a diagnostic label will decide to take medication for that condition, than those given a symptomatic description.

Interventions

Participants will be presented with one of four case scenarios. Case scenarios (which include the label) will be presented via a web-based survey using the online survey platform Qualtrics. Following randomisation to either “mild depression” or “acute bronchitis”, participants will receive either a scenario with a “diagnostic label' (e.g. "mild depression" or "acute bronchitis") or “symptomatic label" (e.g "the symptoms you are experiencing"). All scenarios: (1) describe symptoms of the allocated condition; (2) offer medication as a treatment option (i.e. SSRIs for “mild depression” and antibiotics for “acute bronchitis”); and (3) contain evidence-based information on the potential harms and benefits of medications for the relevant condition. The time required to complete the scenario and assessment is approximately 10 minutes.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Healthy volunteers

Yes

Inclusion criteria

We will recruit adults who can understand written English and provide informed consent, and who live in one of three English speaking, developed countries that have fee-for-service healthcare environments (Australia, Ireland, and Canada) and do not have direct consumer advertising.

Exclusion criteria

We will exclude those with current depression or acute bronchitis.

Outcome results