Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000900617
Ethics application status
Approved
Date submitted
13/08/2014
Date registered
25/08/2014
Date last updated
1/08/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The Managing Anger Trial: Examining the efficacy of a treatment for anger for serving Australian Defence members
Scientific title
In Defence members with problematic anger in the context of Posttraumatic Stress Disorder (PTSD), is a novel anger treatment effective in reducing the symptoms of anger
Secondary ID [1] 285163 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
anger 292754 0
Posttraumatic Stress Disorder 292804 0
Condition category
Condition code
Mental Health 293045 293045 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A novel anger focused intervention for Defence members who are also experiencing PTSD has been developed. This structured, Cognitive Behavioural Therapy (CBT) -based treatment is delivered by Defence psychologists in one-on-one sessions. One hour sessions are delivered once a week, for a period of 12 weeks.
Intervention code [1] 290015 0
Treatment: Other
Intervention code [2] 290065 0
Behaviour
Comparator / control treatment
There is no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 292916 0
Anger as assessed by the STAXI-2, DAR-5 and NAS-PI
Timepoint [1] 292916 0
Pre-treatment, post-treatment and 3 month follow-up
Secondary outcome [1] 309929 0
PTSD as assessed by the CAPS and PCL
Timepoint [1] 309929 0
Pre-treatment, post-treatment, 3 month follow-up
Secondary outcome [2] 309934 0
Alcohol use as assessed by the MINI and AUDIT
Timepoint [2] 309934 0
Pre-treatment, post-treatment and 3 month followup
Secondary outcome [3] 309935 0
Depression as assessed by the MINI and the HADS
Timepoint [3] 309935 0
Pre-treatment, post-treatment and 3 month follow-up
Secondary outcome [4] 309936 0
Anxiety as assessed by the HADS
Timepoint [4] 309936 0
Pre-treatment, post-treatment, 3 month follow-up

Eligibility
Key inclusion criteria
Identified PTSD
Problematic anger
Available to engage in 12 sessions of treatment
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Significant alcohol dependence/abuse
Psychosis
Threat to self and/or others
Has engaged recently in focussed anger treatment

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)
This trial will be advertised to participants, and participants will volunteer to participate.
Allocation will not be concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will not be used
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Based on preliminary data from the small number of existing studies in this area, 30 clients has been shown to be sufficient to demonstrate a moderate to large clinical effect. Sample power calculations based on treatment response from a previous trial (Moreland 2010) suggest a sample size of n=30 is required to detect a 10 point difference on mean anger scores (as measured by the STAXI-2) at follow-up, with power set at 96% and p set at 0.05. The reduction of 10 points on the STAXI in Moreland 2010 was associated with a large clinical effect size.

Frequency statistics will be used to describe the incidence of disorders within the sample. Correlation analyses will be used to examine the relationship between variables. T-tests, repeated measures multivariate analyses and hedges’ g effect size analyses will be used to examine treatment effects.

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
8/09/2014
Actual
26/08/2014
Date of last participant enrolment
Anticipated
19/12/2014
Actual
31/03/2015
Date of last data collection
Anticipated
Actual
17/08/2015
Sample size
Target
30
Accrual to date
Final
12
Recruitment in Australia
Recruitment state(s)
NSW,QLD

Funding & Sponsors
Funding source category [1] 289776 0
Government body
Name [1] 289776 0
Department of Defence
Country [1] 289776 0
Australia
Primary sponsor type
Individual
Name
Professor David Forbes
Address
Australian Centre for Posttraumatic Mental Health
Level 3, 161 Barry St
Carlton
VIC, 3053
Country
Australia
Secondary sponsor category [1] 288465 0
None
Name [1] 288465 0
Address [1] 288465 0
Country [1] 288465 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291506 0
Australian Defence Human Research Ethics Committee
Ethics committee address [1] 291506 0
Ethics committee country [1] 291506 0
Australia
Date submitted for ethics approval [1] 291506 0
Approval date [1] 291506 0
01/07/2014
Ethics approval number [1] 291506 0
758-14

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

Contacts
Principal investigator
Name 50678 0
Prof David Forbes
Address 50678 0
Australian Centre for Posttraumatic Mental Health
Level 3, 161 Barry St
Carlton
VIC, 3053
Country 50678 0
Australia
Phone 50678 0
+61 03 9035 5599
Fax 50678 0
Email 50678 0
[email protected]
Contact person for public queries
Name 50679 0
Tracey Varker
Address 50679 0
Australian Centre for Posttraumatic Mental Health
Level 3, 161 Barry St
Carlton
VIC, 3053
Country 50679 0
Australia
Phone 50679 0
61390367526
Fax 50679 0
Email 50679 0
[email protected]
Contact person for scientific queries
Name 50680 0
David Forbes
Address 50680 0
Australian Centre for Posttraumatic Mental Health
Level 3, 161 Barry St
Carlton
VIC, 3053
Country 50680 0
Australia
Phone 50680 0
+61 03 9035 5599
Fax 50680 0
Email 50680 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.