Patterns and processes of cognitive and behavioural changes in patients with COPD receiving smoking reduction treatment - The REDUQ II study

Smoking cessation is the most effective means of favourably modifying the
course of COPD. However, due to several failed quit attempts, many smoking COPD
patients are convinced that they are unable to quit smoking. Other avenues to
convince these patients to try again to quit smoking are therefore urgently
needed. One such strategy would be to prepare a patient for a new serious
cessation attempt by first successfully reducing the number of cigarettes
smoked per day. In the REDUQ study (P09-22/NL30620.044.09) such a smoking
reduction programme, which combines behavioural counselling with Nicotine
Replacement Therapy (NRT), is compared to a brief (placebo) self-help
intervention (a single information meeting on smoking reduction and cessation
combined with a self-help manual).
The main hypothesis of the REDUQ trial was that the smoking reduction
intervention leads to an increased likelihood of sustained abstinence after 18
months, compared to a the brief (placebo) self-help intervention. Intermediate
analyses have shown, however, that the reduction intervention has no effect on
the smoking cessation rate at 6 months follow-up (8%, 3 out of 36 patients)
compared to controls (10%, 4 out of 39). Moreover, the percentage of
participants who undertake at least one serious quit attempt during the first 6
months is, in contrast with our hypothesis (i.e. 75% of the experimental group
and 25% of the control group), comparable: 25% (3 out of 36 patients) of the
reduction intervention arm vs. 21% (8 out of 39 patients) in the control arm.
Extrapolating these outcomes to 12-month and 18-month follow-up, we expect no
significant differences between groups will be found.
Three conclusions can be drawn from the intermediate outcomes. First, by
offering COPD patients, unmotivated to quit, a reduction intervention, even a
brief one, an abstinence rate of up to 10% after six months is observed in this
sample. Second, a very brief reduction intervention appears to be able to
re-motivate a fairly high number of smoking COPD patients who were initially
unmotivated quit. And third, a considerably more intensive reduction
intervention does not seem to add to the effect of the brief reduction
intervention.
These conclusions support the initial idea that for smokers who have become
resistant to smoking cessation therapies (after repeated failures), offering a
reduction approach may have some beneficial effect. Yet, unclear is how to
explain the aforementioned conclusions. Can the quit attempts undertaken in the
brief intervention group be attributed to a re-motivating effect of trying
reduction first? And if so, by what mechanisms does the brief intervention
re-motivate some of the participants? We have no detailed data on the extent to
which participants in this arm even consider applying the reduction techniques
provided to them, whether they actually try to reduce their smoking, or whether
this precedes subsequent quit attempts. Also, data are lacking on the cognitive
changes these patients undergo during this phase, and which may help to explain
when re-motivation to quit occurs in some participants and what elicits this
change. Similarly, although many participants in the REDUQ intervention arm
initially do engage in a scheduled reduction process, it is unclear whether
this contributes to favourable changes in their expectations towards cessation.
And if so, why this does not elicit more (successful) quit attempts?
To gain a better insight into this issue, we need to collect more detailed
longitudinal data on the trajectories of smoking behaviour (and underlying
cognitions) of patients in the REDUQ trial than is currently provided for.
According to the REDUQ study protocol, patients receive measurements at
baseline and at 6, 12, and 18 months follow-up. However, to explain a lack of
treatment effects during the first six months, data on week-to-week changes in
their experiences and their behaviour are needed. A final group of 32 patients
is yet to be enrolled into the trial (see amendment 8 to REDUQ protocol), which
enables us to collect additional prospective data among these subjects.

The REDUQ II study will be conducted to help us to complete data on the
secondary endpoints of the REDUQ study (P09-22) and arrange and examine
relationships occurring between and among intervention elements of the REDUQ
study, behavioural and cognitive variables, and confounding and extraneous
variables, by means of a single case experimental design (SCED). The primary
objective of the SCED is to:
a) gain insight into the nature of the psychological processes (including
cognitive as well as behavioural changes) that participants experience during
the first six months of the trial;
b) assess whether these processes are casually related to smoking cessation
(attempts); and to what extent components of both interventions (i.e.,
reduction techniques, NRT use) contribute to successful reduction and quitting.

The main study question is: What are the psychological patterns and processes
of cognitive and behavioural change in patients with COPD receiving smoking
reduction treatment? In order to answer the main question, several sub
questions are formulated.
- Are there any patterns and processes of changes in the target variables of
the study (main study parameters: smoking status, motivation to quit,
self-efficacy, attitudes towards smoking (cessation)?
- When do these patterns and processes of change emerge?
- Are these patterns and processes of change unique for each participant in the
study
- Are the patterns and processes of change linked to (components of) the
smoking reduction intervention?
- Are the patterns and processes of change linked to other (independent)
variables (e.g. treatment adherence, social influence, NRT use, urges to
smoke)?
- Are there differences in patterns and processes of change between the
experimental and control group?

The protocol concerns a combination of a randomized controlled trial (RCT) on
the (cost)effectiveness of a smoking reduction intervention for patients with
COPD (see REDUQ study, P09-22) with an 18 month follow-up, and a randomized
single case experimental design (SCED) with seven to eight months follow-up in
patients with COPD.

In the RCT the cost-effectiveness of an intensive smoking reduction group
intervention and a self-help smoking reduction intervention will be compared.
In addition to the RCT, a single case experimental design (SCED) will be
conducted to explore patterns and processes of cognitive and behavioural
changes in COPD patients receiving smoking reduction treatment. A combination
of an ABA design and multiple-baseline design is applied.

Patients will be randomly assigned into one of eight study groups (i.e.,
experimental or control smoking reduction condition and one of four baseline
conditions) using a computer-generated schedule. Outcomes will be assessed at
baseline, during a 26-week period (*ABA phase*) with weekly repeated measures,
and six, 12 and 18 months after treatment start.

Participants of the REDUQ II receive the intervention offered in the REDUQ
study. The intervention has been described in detail in the REDUQ study
protocol (P09-22/NL30620.044.09)
In brief: patients in the intervention group receive an intensive
reduction-to-quit smoking programme, which combines behavioural counselling and
NRT. It consists of eight small-group sessions and four telephone contacts
between meetings. NRT is offered free of charge for a period of 12 weeks.
Patients in the control group receive one single information meeting on smoking
reduction and quitting, and a self-help manual with reduction strategies. As
soon as patients in both groups express readiness to quit, they will be
referred to an intensive smoking cessation programme.

The possibility of reducing or alleviating symptoms of COPD by smoking
cessation or reduction outweighs the (minimal) burden of participating in the
study. Smoking reduction counselling may prove to be an alternative treatment
option for COPD patients experiencing problems with quitting abruptly. Both
participants and non-participating patients can benefit from this study and its
outcome, but it is also possible that participants will not receive any benefit
from treatment. It is expected that there are no (extra) risks for patients
participating in the study.