ANZCTR - Registration

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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]

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.

Condition category

Condition code

Mental Health

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]

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]

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]

Administered pre-treatment,post treatment and 1 month follow up post treatment

Primary outcome [2]

Primary Outcome 2: Anger Expression-In (AX-I) subscale on the STAXI-2 will measure the extent to which anger is suppressed.

Timepoint [2]