Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000722291
Ethics application status
Approved
Date submitted
19/08/2009
Date registered
24/08/2009
Date last updated
9/07/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
The Effectiveness of Behavioural Activation treatment with high worriers
Scientific title
For high level worriers, is Behaviour Activation treatment more effective than waitlist control to reduce excessive worrying
Secondary ID [1] 252165 0
NIL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Worrying 243544 0
Condition category
Condition code
Mental Health 239841 239841 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The treatment includes eight two hour sessions over eight weeks and will be conducted in a group format. Two therapists will be present at each session. A treatment manual will be adapted for Worry treatment based on the Behavioural Activation handbook, Overcoming Depression one step at a time (Addis, M & Martell, C., 2004). The primary focus of Behavioural Activation (BA) treatment is in the use of functional analysis to provide individuals with psychosocial education to differentiate between helpful or unhelpful thinking. Individuals are then coached to shift towards more adaptive thinking styles. BA starts in functional analysis focusing on assessment and treatment of avoidance behaviours- variability of (1) Worry (e.g., differences between helpful and unhelpful thinking about problems); (2) Associated behaviours and (3) Counter-worry behaviours such as effective engagement in tasks. This detailed analysis of context and function is then used to help clients: (1) Recognize warning signs for worry; (2) Develop alternative strategies and contingency plans; some helpful alternative behaviour include allowing worry to cue the clients to take action, attending to their experience, etc.; (3) Alter environmental and behavioural contingencies maintaining worry.
Intervention code [1] 241151 0
Treatment: Other
Comparator / control treatment
Participants in the waitlist group will not receive any intervention at all until directly after the 6 week intervention period
Control group
Active

Outcomes
Primary outcome [1] 240608 0
Mean Penn State Worry Questionnaire (PSWQ, Meyer et al., 1990) score
Timepoint [1] 240608 0
Timepoints: at baseline, at treatment termination and 3 months after treatment termination
Secondary outcome [1] 257242 0
Depression Anxiety Stress Scales (DASS; Lovibond & Lovibond, 1993)
Timepoint [1] 257242 0
Timepoints: at baseline, at treatment termination and 3 months after treatment termination
Secondary outcome [2] 257243 0
Social Problem Solving Inventory- Revised Short form (SPSI-R:S, D' Zurilla et al., 2002)
Timepoint [2] 257243 0
Timepoints: at baseline, at treatment termination and 3 months after treatment termination

Eligibility
Key inclusion criteria
High to moderate scores on Penn State Worry Questionnaire (PSWQ, Meyer et al., 1990)
Minimum age
18 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Active psychosis, current suicide ideation and unmanaged substance dependence/abuse

Study design
Purpose of the study
Educational / counselling / training
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
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
Recruiting
Date of first participant enrolment
Anticipated
28/09/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 237517 0
Self funded/Unfunded
Name [1] 237517 0
Xi Liu
Country [1] 237517 0
Australia
Funding source category [2] 237518 0
University
Name [2] 237518 0
Department of Psychology
Country [2] 237518 0
Australia
Primary sponsor type
Individual
Name
Xi Liu
Address
Rm 313, C3A Department of Psychology, Macquarie University. North Ryde. NSW 2109
Country
Australia
Secondary sponsor category [1] 236996 0
Individual
Name [1] 236996 0
Prof. Ron Rapee
Address [1] 236996 0
C3A721, Department of Psychology, Macquarie University
North Ryde
NSW 2109
Country [1] 236996 0
Australia
Other collaborator category [1] 825 0
Individual
Name [1] 825 0
Dr Junwen Chen
Address [1] 825 0
School of Psychology
Flinders University
GPO Box 2100 Adelaide, SA 5001
AUSTRALIA
Country [1] 825 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 243650 0
Macquarie University Ethics Secretariat
Ethics committee address [1] 243650 0
Ethics committee country [1] 243650 0
Australia
Date submitted for ethics approval [1] 243650 0
25/06/2009
Approval date [1] 243650 0
Ethics approval number [1] 243650 0
HE31JUL2009-M00046

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

Contacts
Principal investigator
Name 30068 0
Address 30068 0
Country 30068 0
Phone 30068 0
Fax 30068 0
Email 30068 0
Contact person for public queries
Name 13315 0
Xi Liu
Address 13315 0
Rm 313, C3A Department of Psychology, Macquarie University. North Ryde. NSW 2109
Country 13315 0
Australia
Phone 13315 0
+61403804738
Fax 13315 0
Email 13315 0
[email protected]
Contact person for scientific queries
Name 4243 0
Xi Liu
Address 4243 0
Rm 313, C3A Department of Psychology, Macquarie University. North Ryde. NSW 2109
Country 4243 0
Australia
Phone 4243 0
+61403804738
Fax 4243 0
Email 4243 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.