Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000387820
Ethics application status
Not yet submitted
Date submitted
21/03/2012
Date registered
4/04/2012
Date last updated
4/04/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
The effects of a 'Brief Behavioural Activation' Programme on Treatment Adherence for Chronic Pain Management.
Scientific title
Additional Effects of a Brief Behavioural Activation Programme on Treatment Adherence for People Undergoing the STEPS and PUMP programmes for Chronic Pain Management.
Secondary ID [1] 280188 0
Nil
Universal Trial Number (UTN)
U1111-1129-3255
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Pain 286123 0
Condition category
Condition code
Mental Health 286315 286315 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Brief Behavioural Activation:
A structured 12 week programme in which participants receive positive consequences for healthy behaviours/activities. This increases the likelihood that these behaviours will reoccur in the future. The programme works at increasing the behaviours/activities someone does that result in a positive consequence so the person is more likely to be involved in that behaviour/activity again. It includes goal setting, activity monitoring (24 hr monitoring) and activity scheduling. Involves a 1 hour weekly appointment to recieve instructions for goal seeting, activity monitoring and activity scheduling and to complete outcome measures. The Brief Behavioural Activation programme is administered in one-to-one, face-to-face appointments with a student psychologist, under the supervision of a registered psychologist.

Self-Training Educative Pain Sessions (STEPS) Programme:
An 8 hour course (4 hours on a tuesday 9-1pm and 4 hours on a thursday 9-1pm) provided by the Pain Medine Unit at Fremantle Hospital, giving patients with chronic pain a broad overview of options, current research, knowledge and skills for the management of persistent pain. Participants are offered the PUMP programme and it is up to them if they choose to attend the PUMP programme.

Pain Understanding and Management Programme (PUMP):
An intensive four week (Every morning from 9-1pm for a four week period) multidisciplinary pain management programmeme provided by the Pain Medicine Unit at Fremantle Hospital, designed to improve patient’s physical function and coping capacity when dealing with ongoing pain. Participants must complete the STEPS programme before attending the PUMP programme. Only participants who participate in the PUMP programme will be recieving the Brief Behavioural Activation programme. Participants who recieve the Brief Behavioural Activation programme will begin at the same time as starting the PUMP programme. Their appointment for the Brief Behavioural Activation will occur after the PUMP programme, so participants dont have to make an extra trip.
Intervention code [1] 284514 0
Behaviour
Intervention code [2] 284581 0
Treatment: Other
Comparator / control treatment
Treatment as usual (No Brief Behavioural Activation, just STEPS and PUMP)
Control group
Active

Outcomes
Primary outcome [1] 286785 0
Frequency and duration of increases in activities engaged (including treatment adherence). This is assessed through obtaining information on a patient 24 hour daily diary.
Timepoint [1] 286785 0
Baseline, during treatment (weekly), end of treatment and 3 month follow-up
Secondary outcome [1] 296658 0
Reduction in Depression, Anxiety and Stress Scale (DASS) scores
Timepoint [1] 296658 0
Baseline, during treatment (weekly), end of treatment and 3 month follow-up

Eligibility
Key inclusion criteria
Participants must be over 18 years of age, speak and understand English fluently, agree to have Brief Behavioural Activation Programme sessions audio recorded for assessment of treatment integrity, have a diagnosis of chronic pain, have been given individually specialised treatment instructions from medical practitioners ( e.g. medication, physiotherapy, psychology appointments, exercise; treatment adherence will vary between participants), be willing to communicate treatment instructions, not be receiving standardised treatment from other health professionals regarding treatment adherence and do not have any other diagnosed medical conditions.
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Under 18 years of age. Do not speak or understand english fluently. Do not agree to have sessions audio taped for treatment integrity. Do not have a diagnosis of Chronic Pain. Do not have treatment instructions. Are receiving a standardised treatment for treatment adherence.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
After attending the STEPS programme, participants who are selected for the PUMP programme are allocated to either just the PUMP programme or PUMP + Brief Behavioural Activation programmes.

Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software - through Excel.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
14/06/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 284939 0
University
Name [1] 284939 0
Murdoch University
Country [1] 284939 0
Australia
Primary sponsor type
University
Name
Murdoch University
Address
South Street campus
Murdoch University
90 South Street
Murdoch
Western Australia 6150
Country
Australia
Secondary sponsor category [1] 283813 0
Hospital
Name [1] 283813 0
Pain Medicine Unit, Fremantle Hospital
Address [1] 283813 0
Dalgety Street,
East Fremantle,
WA
6158
Country [1] 283813 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 286948 0
Ethics committee address [1] 286948 0
Ethics committee country [1] 286948 0
Date submitted for ethics approval [1] 286948 0
16/03/2012
Approval date [1] 286948 0
Ethics approval number [1] 286948 0

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

Contacts
Principal investigator
Name 33956 0
Address 33956 0
Country 33956 0
Phone 33956 0
Fax 33956 0
Email 33956 0
Contact person for public queries
Name 17203 0
Jacqueline Le Mesurier
Address 17203 0
South Street campus
Murdoch University
90 South Street
Murdoch
Western Australia 6150
Country 17203 0
Australia
Phone 17203 0
+61 0420939109
Fax 17203 0
Email 17203 0
[email protected]
Contact person for scientific queries
Name 8131 0
Jacqueline Le Mesurier
Address 8131 0
South Street campus
Murdoch University
90 South Street
Murdoch
Western Australia 6150
Country 8131 0
Australia
Phone 8131 0
+61 0420939109
Fax 8131 0
Email 8131 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.