No registrations found.
ID
Source
Brief title
Health condition
Chronic Obstructive Pulmonary Disease (COPD), Smoking, Smoking cessation, Smoking reduction, Tobacco addiction, COPD, Lung emphysema, Chronic bronchitis, Nicotine dependence, Smoking reduction, single case experimental design (SCED).
Sponsors and support
Intervention
Outcome measures
Primary outcome
- (biochemically validated) smoking status
- motivation/intention to quit
- self-efficacy
- attitudes towards smoking cessation
Secondary outcome
- social influence
- desire or urge to smoke
- treatment adherence (scheduled reduced smoking)
- use of NRT and/or anti-smoking medication
Background summary
The REDUQ II study is an addendum study to the REDUQ trial (see NTR2227) and concerns a monocentre randomized single case experimental design (SCED). The study will be conducted to examine the patterns and processes of cognitive and behavioural changes in patients with COPD receiving smoking reduction treatment, offered during the REDUQ trial. The objective 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 REDUQ trial, and b) assess whether these processes are casually related to smoking cessation (attempts); and to what extent components of both interventions (intervention and control) i.e., reduction techniques, use of Nicotine Replacement Therapy (NRT), contribute to successful smoking reduction and quitting.
Study objective
-
Study design
-Baseline and 6, 12, 18-month follow-up, and
-Repeated (weekly) measures during a baseline phase (duration: 5-8 weeks), active treatment phase (duration: 13 weeks), and follow-up phase (5-8 weeks), with a total of 26 timepoints per patient.
Intervention
Participants of the REDUQ II study receive one of the two (experimental and control) smoking reduction treatments of the REDUQ study (see NTR2227).
Marcel Pieterse
Enschede 7500 AE
The Netherlands
+31 (0)53 4896066
m.e.pieterse@utwente.nl
Marcel Pieterse
Enschede 7500 AE
The Netherlands
+31 (0)53 4896066
m.e.pieterse@utwente.nl
Inclusion criteria
1. Clinical COPD, GOLD stage I-IV;
2. Age 40-80 years;
3. Smoking 10 or more cigarettes daily;
4. Motivated to reduce smoking;
5. Two or more failed lifetime quit attempts (abstinence > 24 hours).
Exclusion criteria
1. Motivated to quit smoking within 1 month from baseline (= ready to quit);
2. Not able to speak, read and write Dutch;
3. Contra-indication for the use of all forms of NRT;
4. Serious psychiatric morbidity (not only depressive symptoms);
5. Pregnancy.
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL3916 |
| NTR-old | NTR4087 |
| Other | - : REDUQ II / P13-23 / NL45791.044.13 / AF3.4.08.036 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |