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Trial registered on ANZCTR


Registration number
ACTRN12612000300875
Ethics application status
Approved
Date submitted
14/02/2012
Date registered
16/03/2012
Date last updated
21/08/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
"Dame Laran- Moris ne'ebe iha Dame" (Peace within - Peaceful life): An integrated (culture specific) therapeutic intervention for the management of Intermittent Explosive Disorder (IED) in Timor Leste (East Timor).
Scientific title
Examining the effectiveness of an integrated culture specific therapeutic intervention to reduce both the frequency and severity of Intermittent Explosive Disorder (IED) : A randomised waitlist control trial in Timor-Leste (East Timor)
Secondary ID [1] 280152 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Intermittent Explosive Disorder (IED) is an extreme form of anger attacks associated with aggression towards people and/or animals, and the destruction of property. 285833 0
Condition category
Condition code
Mental Health 286014 286014 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study is a waitlist controlled intervention. Sixty four participants will take part in the trial. Half of the participants (n=32) will be allocated to receive therapy immediately, the other half (n=32) will be allocated to a waitlist. Both groups will receive the same treatment.
The integrated therapy program consists of 7 individual therapy sessions (2 sessions per week) conducted over a 4 week period. Session length will range from 90 -120 minutes per session. Components of the integrated therapy program include: 1.Psycho education through self awareness including physical (somatic), cognitive, social, historical, and political representations of self, incorporating awareness on human rights and a sense of justice; 2.Trauma focused cognitive behaviour therapy, with modified narrative exposure based on the ‘life-line’ technique (Schauer, Neuner et al., 2004); and cognitive restructuring through pictorial representations of at least one story similar to the participant’s own history of trauma related anger and the symbolic representation of anger attacks and related trauma through the use of traditional “Timorese Dolls”; and 3.Cultural and traditional healing practices incorporating existing native healing practices and perspectives. Homework will be given at the end of each session, including anger and anxiety monitoring tools, deep breathing with progressive muscle relaxation exercises and mindfulness training.
In addition, culturally adapted assertiveness training for positive anger expression will be reinforced in homework assignments.
At the end of the 6th session, a traditional healing/reconciliation technique, that will involve participation of the clients’ ‘most trusted person’, will be recommended to the client by the therapist. The healing process is optional and will depend on the participant’s perspective of its value.
The healing process aims to reintegrate the participant back into the extended family and/or immediate community and will be conducted with the family of the participant as well as any parties affected by the participants’ anger. The participant is free to choose or exclude any potential family members or affected parties.
Participants assigned to immediate treatment will be assessed at three time points: pre treatment, post treatment completion, and 1 month post treatment completion. Participants assigned to the waitlist will also be assessed at 3 time points which will coincide with assessment time points for a person allocated to the immediate treatment group.

Therapy for the immediate treatment group will be provided by one therapist, Hewage ( PhD Candidate )who will be supervised by Professor Derrick Silove ( MBChB, MRANZCP) and Dr Susan Rees (PhD) of UNSW via Skype and/or telephone.
The therapist, who is the primary architect of the intervention and qualified Psychologist, has had extensive experience in the provision of psychotherapeutic interventions for over 1200 survivors of trauma with IED in the course of her standard work in the past 5 yrs in Timor Leste ( East Timor). A number of additional case workers from Timor Leste ( East Timor) will be trained by Hewage in the IED intervention. These case workers will provide the IED intervention to participants in the waitlist group with all of these sessions supervised by Hewage (PhD Candidate), Professor Derrick Silove ( MBChB, MRANZCP) and Dr Susan Rees (PhD) via direct observation,skype and/or telephone.
Intervention code [1] 284248 0
Behaviour
Comparator / control treatment
Waitlist control. Participants allocated to the waitlist will receive no treatment while acting as control for participants allocated to immediate treatment.The waitlist control partcipants will receive treatment once each one of them has completed all 3 assessments i.e pre treatment, post treatment completion and 1 month post treatment completion
Control group
Active

Outcomes
Primary outcome [1] 286502 0
Primary Outcome 1: Anger Expression -Out (AX-O) subscale on the State-Trait Anger Expression Inventory (STAXI-2) will measure the outward expression of anger and aggressive behaviour.
Timepoint [1] 286502 0
Administered pre-treatment,post treatment and 1 month follow up post treatment
Primary outcome [2] 286503 0
Primary Outcome 2: Anger Expression-In (AX-I) subscale on the STAXI-2 will measure the extent to which anger is suppressed.
Timepoint [2] 286503 0
Administered pre-treatment,post treatment and 1 month follow-up post treatment
Primary outcome [3] 286504 0
Primary Outcome 3: Anger Control-Out (AC-O) subscale on the STAXI-2 will measure the energy expended in controlling outward expressions of anger.
Timepoint [3] 286504 0
Administered pre-treatment,post treatment and 1 month follow-up post treatment
Secondary outcome [1] 296034 0
Primary Outcome 4 :Anger Control- In (AC-I) subscale on the STAXI-2 will measure how much energy a person expends in calming down and reducing anger.
Timepoint [1] 296034 0
Administered pre-treatment,post treatment and 1 month follow-up post treatment
Secondary outcome [2] 296035 0
Primary Outcome 5:Intermittent Explosive Disorder assessed by the culturally adapted East Timor Mental Health Epidemiological Needs Study (ETMHENS 11) module, a measure that corresponds with this diagnosis in the Diagnostic and Statistical Manual Edition 4.
Timepoint [2] 296035 0
Administered pre-treatment,post treatment and 1 month follow-up post treatment
Secondary outcome [3] 296036 0
Secondary Outcome 1: Trauma events experienced by participant will be measured by the Harvard Trauma Questionnaire (HTQ
Timepoint [3] 296036 0
Administered pre-treatment,post treatment and 1 month follow-up post treatment
Secondary outcome [4] 296037 0
Secondary Outcome 2:Emotional symptoms associated with trauma will be measured by the Harvard Trauma Questionnaire (HTQ).
Timepoint [4] 296037 0
Administered pre-treatment,post treatment and 1 month follow-up post treatment
Secondary outcome [5] 296038 0
Secondary Outcome 3: Symptoms of psychological distress will be measured by the Kessler Psychological Distress Scale (K10).
Timepoint [5] 296038 0
Administered pre-treatment,post treatment and 1 month follow-up post treatment
Secondary outcome [6] 296039 0
Secondary Outcome 4: Level of functional impairment assessed by the World Health Organization Disability Assessment Schedule (WHODAS).
Timepoint [6] 296039 0
Administered pre-treatment,post treatment and 1 month follow-up post treatment

Eligibility
Key inclusion criteria
1) Participant meets diagnostic criteria for Intermittent Explosive Disorder.
2) Participant has experienced at least 1 traumatic event over their lifetime
3) Participant is willing to take part in therapy
4) Participant is literate
5) Timorese nationals
6) Males and females
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Substance use problems, PTSD or depression are dominant
2) Psychosis
3) Dementia
4) Developmentally delayed

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)
Participants will be recruited from multiple sources including advertising in local papers, and referrals by NGO's, organisations such as the 12th of November Group (ex-torture victims group), government hospitals, clinics and private health practitioners. In addition, several workshops on ‘Anger Identification, Causes and Consequences of Anger Attacks’ will be conducted in the community by Hewage (Trial Investigator). Persons who meet the study criteria will be recruited from these workshops.
Participant allocation will be carried out by a staff member who is located off-site and not involved in recruitment or treatment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation will be used. The software package SAS will be used to generate the randomisation schedule. The staff member generating the randomisation schedule will be located off-site and not be involved in recruitment or treatment
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
Completed
Date of first participant enrolment
Anticipated
1/10/2012
Actual
5/11/2012
Date of last participant enrolment
Anticipated
11/02/2013
Actual
11/02/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
64
Accrual to date
Final
64
Recruitment outside Australia
Country [1] 4124 0
Timor-Leste
State/province [1] 4124 0

Funding & Sponsors
Funding source category [1] 284695 0
Government body
Name [1] 284695 0
National Health and Medical Research Council (NHMRC)
Country [1] 284695 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
School of Psychiatry, University of New South Wales, Anzac Parade. Kensington,Sydney NSW,2052
Country
Australia
Secondary sponsor category [1] 283597 0
None
Name [1] 283597 0
Address [1] 283597 0
Country [1] 283597 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286698 0
The University of New South Wales ( HREC )
Ethics committee address [1] 286698 0
Ethics committee country [1] 286698 0
Australia
Date submitted for ethics approval [1] 286698 0
29/06/2012
Approval date [1] 286698 0
25/09/2012
Ethics approval number [1] 286698 0
Ethics committee name [2] 286699 0
The Ethics Committee-Ministry of Health-Timor Leste
Ethics committee address [2] 286699 0
Ethics committee country [2] 286699 0
Timor-Leste
Date submitted for ethics approval [2] 286699 0
08/06/2012
Approval date [2] 286699 0
02/07/2012
Ethics approval number [2] 286699 0
MS-CHRD/V11/2012/75

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

Contacts
Principal investigator
Name 33764 0
Prof Derrick Silove
Address 33764 0
Center for Population Mental Health Research,Psychiatry Research and Teaching Unit, Faculty of Medicine, University of New South Wales; Level 1, Mental Health Centre, Liverpool Hospital, Liverpool NSW 2170, Australia
Country 33764 0
Australia
Phone 33764 0
+61296164311
Fax 33764 0
Email 33764 0
[email protected]
Contact person for public queries
Name 17011 0
Kalhari Hewage
Address 17011 0
Critical Incident Stress Management Unit-UNDSS
304 East 45th Street,FF-804
New York,NY 10017
Country 17011 0
United States of America
Phone 17011 0
+1917-209-9047
Fax 17011 0
Email 17011 0
[email protected]
Contact person for scientific queries
Name 7939 0
Kalhari Hewage
Address 7939 0
Critical Incident Stress Management Unit (CISMU),United Nations Dept of Safety and Security ( UNDSS),304 E 45th Street,FF-1800,New York,NY10017,USA
Country 7939 0
United States of America
Phone 7939 0
+1917-209-9047
Fax 7939 0
Email 7939 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
SourceTitleYear of PublicationDOI
EmbaseWait-list controlled study of a trauma-focused cognitive behavioral treatment for intermittent explosive disorder in Timor-Leste.2018https://dx.doi.org/10.1037/ort0000280
N.B. These documents automatically identified may not have been verified by the study sponsor.