Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000314921
Ethics application status
Not yet submitted
Date submitted
22/03/2011
Date registered
24/03/2011
Date last updated
24/03/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
The Behavioural Activation Treatment for Smoking Cessation
Scientific title
Behavioural Activation for a community sample in the treatment of smoking cessation
Secondary ID [1] 259829 0
Nil
Secondary ID [2] 259854 0
Nil
Universal Trial Number (UTN)
U1111-1120-2249
Trial acronym
The BASC Project
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Smoking 265403 0
Condition category
Condition code
Public Health 265580 265580 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Behavioural Activation for Smoking Cessation. The treatment protocol was based on the Brief Behavioral Activation Treatment for Depression Revised Manual (Lejuez, Hopko, Acierno, Daughters & Pagoto, 2011). Ten weekly individual therapy sessions of 1 hour duration, of brief behavioural activation commencing with a functional analysis of smoking behaviour to create individualised treatment plans for participants. The individualised treatment plans will take into account each participants values and goals for treatment for example, one participant may wish to stop smoking during working hours whilst another may wish to quit because they are worried about the impact it will have on their children.
Intervention code [1] 264255 0
Behaviour
Intervention code [2] 264272 0
Treatment: Other
Comparator / control treatment
This study is an ABA design and each participant serves as their own control. This research is an ABA design as there is a 2 week baseline period (A), a 10 week intervention period (B) after which the intervention is withdrawn (A).
During the A phases participants are required to keep a smoking diary and collect their cigarette butts, whilst in the intervention period participants are required to attend the clinic for their individual behavioural activation therapy sessions.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 262367 0
Number of cigarettes smoked as assessed by a smoking diary and butt jar.
Timepoint [1] 262367 0
Each week for 14 weeks includes baseline (2 weeks), intervention period (10 weeks) and withdrawal period (2 weeks).
Secondary outcome [1] 273639 0
Mood as assessed by the DASS.
Timepoint [1] 273639 0
Each week for 14 weeks includes baseline (2 weeks), intervention period (10 weeks) and withdrawal period (2 weeks).
Secondary outcome [2] 273640 0
Nicotine Dependence as assessed by the Fagerstrom Test for Nicotine Dependence.
Timepoint [2] 273640 0
Each week for 14 weeks includes baseline (2 weeks), intervention period (10 weeks) and withdrawal period (2 weeks).
Secondary outcome [3] 273641 0
Nicotine Dependence as assessed by the Fagerstrom Test for Nicotine Dependence.
Timepoint [3] 273641 0
Each week for 14 weeks includes baseline (2 weeks), intervention period (10 weeks) and withdrawal period (2 weeks).
Secondary outcome [4] 273642 0
Demographic variables as assessed by a questionnaire- includes age, gender, educational status.
Timepoint [4] 273642 0
Baseline (week 1)
Secondary outcome [5] 273643 0
Smoking variables as assessed by a questionnaire- includes age onset, number of cigarettes smoked per day, brand/dose of cigarettes etc.
Timepoint [5] 273643 0
Baseline (week 1)

Eligibility
Key inclusion criteria
Inclusion criteria:
*Aged over 18 years of age-
*Participants need to currently smoke at least ten cigarettes per day.
*Participants must be able to communicate in English.
*Participants must be able to commit to attending weekly sessions (up to 1 hour) at the Murdoch Psychology Clinic for a period of 10 weeks.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria:
*Participants aged under 18 years of age-
*Participants who do not currently smoke at least ten cigarettes per day.
*Participants who are unable to communicate in English.
*Participants who are unable to commit to attending weekly sessions (up to 1 hour) at the Murdoch Psychology Clinic for a period of 10 weeks.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 264722 0
Self funded/Unfunded
Name [1] 264722 0
Sarah Hegarty
Country [1] 264722 0
Australia
Primary sponsor type
Individual
Name
Sarah Hegarty
Address
Murdoch University
South Street
Murdoch
W.A. 6150
Country
Australia
Secondary sponsor category [1] 263848 0
None
Name [1] 263848 0
Address [1] 263848 0
Country [1] 263848 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 266709 0
Murdoch University Human Research Ethics Committee
Ethics committee address [1] 266709 0
Ethics committee country [1] 266709 0
Australia
Date submitted for ethics approval [1] 266709 0
22/03/2011
Approval date [1] 266709 0
Ethics approval number [1] 266709 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32368 0
Address 32368 0
Country 32368 0
Phone 32368 0
Fax 32368 0
Email 32368 0
Contact person for public queries
Name 15615 0
Sarah Hegarty
Address 15615 0
School of Psychology
Murdoch University
South Street
Murdoch
W.A. 6150
Country 15615 0
Australia
Phone 15615 0
+61 438 994 448
Fax 15615 0
Email 15615 0
[email protected]
Contact person for scientific queries
Name 6543 0
Sarah Hegarty
Address 6543 0
School of Psychology
Murdoch University
South Street
Murdoch
W.A. 6150
Country 6543 0
Australia
Phone 6543 0
+61 438 994 448
Fax 6543 0
Email 6543 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.