The primary objective of this research is to compare sustained abstinence of the blended smoking cessation treatment (BSCT) with the face-to-face treatment as usual (TAU). Secondary objectives are to explore mechanisms underlying smoking cessation,…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Addiction
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome parameter is sustained abstinence at 15 months from the
start of the smoking cessation treatment. Abstinence is defined as having
salivary cotinine levels < 20ng/mL. Participants with a cotinine-value of >
20ng/mL are regarded as smokers as well as participants who are lost to
follow-up.
Secondary outcome
Secondery outcome parameters are:
Internet Skills
Smoking status
Nicotine dependence (Fagerström)
Smoking history
Attitude
Self-efficacy
Readiness to change
Stop Smoking History
Social support
Alcohol (mis)use
Substance (mis)use
MAP-HSS + special complaints of smokers
DASS21
Quality of Life (Euroqol 5D)
Middle evaluation of treatment
Long term evaluation of treatment
Adherence
Exhaled CO
User experience
Background summary
Cigarette smoking causes a wide range of diseases. Smoking cessation can
significantly reduce the risk of developing smoking-related diseases. Several
face-to-face and online treatments have proven to be effective. Tailoring and
interactivity play an important role in successful cessation treatment.
Blending of online and face-to-face treatment that allows for tailoring and
interactivity is expected to improve cessation treatment. To the best of our
knowledge this will be the first study comparing a face-to-face smoking
cessation treatment and a blended online version derived from an face-to-face
treatment and an online addiction treatment.
Study objective
The primary objective of this research is to compare sustained abstinence of
the blended smoking cessation treatment (BSCT) with the face-to-face treatment
as usual (TAU). Secondary objectives are to explore mechanisms underlying
smoking cessation, give advice for further improvement of smoking cessation,
and to explore the benefit of blended treatment concerning patients
satisfaction and treatment costs.
Study design
The study is a randomized controlled non-inferiority-trial with parallel group
design. Patients will be randomly assigned to either the BSCT or TAU group
based on a computer generated randomization list.
Intervention
Both TAU and BSCT are based on the following evidence-based techniques: (1)
pharmacotherapy, (2) cognitive behavioural therapy (CBT), (3) motivational
interviewing, (4) self-control techniques and self-monitoring, and (5) relapse
prevention. Both treatments will consist of 10 sessions within six months. All
TAU sessions take place the outpatient smoking cessation clinic (*Stoppen met
roken poli*; SRP) while BSCT sessions will partly take place at SRP (five
sessions) and online via rokendebaas.nl (five sessions).
Study burden and risks
The possibility of smoking cessation outweighs the minimal/eligible risks of
(online) counselling in a controlled setting. BSCT may prove to be an
alternative treatment option for smokers experiencing problems with quitting
smoking, and a potentially greater number of individuals will be able to
increase their chances of sustained cessation aided by BSCT. The data
collection will mostly be done using online questionnaires. ). Approximately 10
participants of the blended treatment group will be asked to take part in
additional interviews (45 min). Compared to the usual smoking cessation
treatment there will be no additional burden (e.g. physical examination) for
this research except the cotinine salvia measurement at the 15 month follow up.
M.H. Tromplaan 28
Enschede 48431 AB
NL
M.H. Tromplaan 28
Enschede 48431 AB
NL
Listed location countries
Age
Inclusion criteria
willing to quit smoking,
aged 18 or older,
current daily smoker
able to access internet websites and to receive emails
Exclusion criteria
not able to read or write Dutch language
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL50944.044.14 |
| OMON | NL-OMON27150 |