Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000921886
Ethics application status
Approved
Date submitted
2/06/2021
Date registered
15/07/2021
Date last updated
15/07/2021
Date data sharing statement initially provided
15/07/2021
Date results provided
15/07/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Dialectical Behaviour Therapy (DBT) skills for men with anger problems
Scientific title
Feasibility, acceptability and preliminary outcomes associated with Dialectical Behaviour Therapy group skills training for men in New Zealand experiencing problems with anger.
Secondary ID [1] 304212 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anger 322071 0
Depressive symptoms 322072 0
Emotion dysregulation 322073 0
Condition category
Condition code
Mental Health 319789 319789 0 0
Other mental health disorders
Mental Health 319790 319790 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Six months of weekly 2-hour group sessions of dialectical behaviour therapy (DBT) skills training. The first hour of each group session involved mindfulness practice and review of homework assigned the week before. The second hour involved skills instruction, practice, homework assignment, and a closing mindfulness task. Group sessions included up to 10 participants at a time, and two group facilitators. The lead facilitator was a clinical psychologist and the co-facilitators were a registered psychologist and a clinical psychology trainee. No measure of treatment fidelity was used. Session attendance was tracked as an outcome.
Intervention code [1] 320666 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 327652 0
Drop out rate and session attendance via audit of study records
Timepoint [1] 327652 0
At the conclusion of the study.
Primary outcome [2] 327653 0
Qualitative feedback regarding acceptability of intervention via focus group and semi-structured interview.
Timepoint [2] 327653 0
At the conclusion of study
Primary outcome [3] 327654 0
Recruitment rate via audit of study records
Timepoint [3] 327654 0
At the conclusion of study
Secondary outcome [1] 396100 0
Change in Spielberger State-Trait Anger Inventory scores from before intervention to after intervention completion.
Timepoint [1] 396100 0
Baseline and end of intervention.
Secondary outcome [2] 396101 0
Change in Difficulty in Emotion Regulation Scale scores from before intervention to after intervention completion.
Timepoint [2] 396101 0
Baseline and end of intervention.
Secondary outcome [3] 396102 0
Change in Difficulty in Beck Depression Inventory scores from before intervention to after intervention completion.
Timepoint [3] 396102 0
Baseline and end of intervention.

Eligibility
Key inclusion criteria
Male gender, proficiency in spoken English, self-reported problems with anger and emotion dysregulation.
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Touching assessor in a threatening way during assessment screening. Florid psychosis or intellectual impairment that stops individual from providing informed consent.

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)
None.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
None.
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
Primary focus was to determine treatment acceptability and trial feasibility. We planned to obtain effect sizes for secondary outcomes.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/09/2008
Date of last participant enrolment
Anticipated
Actual
13/01/2009
Date of last data collection
Anticipated
Actual
7/04/2009
Sample size
Target
11
Accrual to date
Final
13
Recruitment outside Australia
Country [1] 23726 0
New Zealand
State/province [1] 23726 0
Auckland

Funding & Sponsors
Funding source category [1] 308583 0
Government body
Name [1] 308583 0
Auckland District Health Board
Country [1] 308583 0
New Zealand
Primary sponsor type
Individual
Name
Emily Cooney
Address
Otago University Wellington, 23a Mein st
Newtown, Wellington 6021
Country
New Zealand
Secondary sponsor category [1] 309578 0
None
Name [1] 309578 0
Address [1] 309578 0
Country [1] 309578 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308522 0
Northern X Health & Disability Ethics Committee
Ethics committee address [1] 308522 0
Ethics committee country [1] 308522 0
New Zealand
Date submitted for ethics approval [1] 308522 0
20/03/2008
Approval date [1] 308522 0
14/07/2008
Ethics approval number [1] 308522 0
NTX/08/04/038

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

Contacts
Principal investigator
Name 111002 0
Dr Emily Cooney
Address 111002 0
Otago University, Wellington
23a Mein St
Newtown
Wellington 6021
Country 111002 0
New Zealand
Phone 111002 0
+64274850899
Fax 111002 0
Email 111002 0
[email protected]
Contact person for public queries
Name 111003 0
Emily Cooney
Address 111003 0
Otago University, Wellington
23a Mein St
Newtown, Wellington 6021
Country 111003 0
New Zealand
Phone 111003 0
+64274850899
Fax 111003 0
Email 111003 0
[email protected]
Contact person for scientific queries
Name 111004 0
Emily Cooney
Address 111004 0
Otago University, Wellington
23a Mein St
Newtown, Wellington 6021
Country 111004 0
New Zealand
Phone 111004 0
+64274850899
Fax 111004 0
Email 111004 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data are unavailable


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.