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Trial registered on ANZCTR


Registration number
ACTRN12618001664235
Ethics application status
Approved
Date submitted
26/05/2016
Date registered
9/10/2018
Date last updated
26/06/2019
Date data sharing statement initially provided
26/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Trauma Treatment Trial; 'Triple T'
Scientific title
A randomized-controlled trial evaluating EEG neurofeedback training adjunct to trauma counselling for reducing posttraumatic symptoms in adults with a refugee background
Secondary ID [1] 296263 0
None
Universal Trial Number (UTN)
U1111-1183-2573
Trial acronym
Triple T
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Posttraumatic Stress Disorder (PTSD) 298310 0
Condition category
Condition code
Mental Health 298432 298432 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
There are two active arms to this trial;
Arm 1: Neurofeedback integrated with trauma counselling (NFT)
Arm 2: A ‘lifestyle enhancement intervention’ (LEI) involving trauma counselling, nutrition and exercise therapy

Both treatment arms will participate in 30 x 1 hour sessions, scheduled at two per week for 15 weeks. For NFT, each of the 30 sessions will include approximately 20mins of neurofeedback training integrated with 40 mins of counselling. LEI will involve a one hour session week in counselling (15 sessions) and one in a lifestyle enhancement session.

Both interventions will be delivered individually and face-to-face, onsite at STARTTS’s neurofeedback/counselling rooms. Adherence will be measured as number of sessions attended. Attendance, intervention and session length are recorded by the clinician as part of routine care.

NEUROFEEDBACK TRAINING is a non-invasive method of modifying brainwave patterns using principles of behavioural learning. Brain activity is measured using an electroencephalograph (EEG) and is shown to the trainee via a simple signal (visual or auditory) to indicate to them when their brain is producing the desired activity. Over sessions new patterns are strengthened, increasing mental flexibility for processing situations in a more self-serving way.

Training protocols are chosen based on a decision tree for symptoms, and informed by quantitative EEG. The default protocol will target the most prevalent presentation seen in PTSD of hyperarousal and involve reinforcement of alpha (8-10Hz) and right parietal and temporal regions. Neurofeedback therapy will be delivered by psychologists who have experience and training with neurofeedback and trauma counselling with this population.

LIFESTYLE ENHANCEMENT INTERVENTION was developed at STARTTS as a complement to standard counselling. They focus on improvement of lifestyle habits in diet, sleep and physical activity, through education, monitoring support and coaching, in order to improve physical health and psychological wellbeing.

TRAUMA FOCUSED COUNSELLING (part of both NFT and LEI arms)
Counselling delivered at STARTTS tailored for the special needs of refugees and draws on current research and clinical experience. A variety of therapy modalities will be used according to the presentation of the client and the background of the clinician. Methods include case management, psychoeducation, mindfulness, acceptance and commitment therapy, grief counselling and cognitive therapy.
Intervention code [1] 294431 0
Behaviour
Intervention code [2] 312598 0
Lifestyle
Intervention code [3] 312600 0
Treatment: Other
Comparator / control treatment
Lifestyle Enhancement Intervention (LEI)
The Lifestyle Enhancement Intervention (LEI), will involve one counselling session per week (total 15). Weekly counselling will be augmented by a second weekly session (total 15) spent with either a) an exercise therapist (~7 sessions) or b) a nutritionist (~7 sessions).

Body Activation: The body activation part of this program is designed to alleviate symptoms of trauma and improve well-being using physical activity. The sessions work with motivation, mindset and goal setting, heart-rate variability training, exercise, visualizations and muscular relaxation. The guiding therapeutic principle across sessions is for the client to gain knowledge and awareness of how their body has responded to trauma, and to learn techniques for self-regulating to reduce symptoms and improve general well-being. Client’s abilities and previous experience with physical activity is diverse. Appropriate lifestyle changes may range from walking and low impact activities to more energetic forms of exercise. An important aspect of this program is to empower and educate clients to be able to find and evaluate resources of their own in making sustainable lifestyle changes. Sessions focussing on physical activity will be one-on-one with a qualified exercise therapist with expertise in working with individuals with PTSD related to refugee experience.

Nutrition: The aim of nutritional intervention at STARTTS is to introduce (or reinforce) healthy eating habits people from refugee backgrounds to promote their physical and mental wellbeing as well as their self -awareness and self-care. This is done by providing information about the health benefit of foods that can enhance their diet and which can be introduced into meals that are culturally congruent with the client. Support and discussion about barriers to change and ongoing evaluation about changes are discussed in session. The nutritional intervention is tailored to each individual’s needs, based on their cultural, financial, physical and mental status. The nutritional intervention is provided by a qualified nutritionist (Diploma of Nutrition) who is an accredited member of professional associations.
Control group
Active

Outcomes
Primary outcome [1] 298442 0
Difference in PTSD symptoms (Harvard Trauma Questionnaire; Symptoms 1-16) between NFT and LEI groups
Timepoint [1] 298442 0
Week 16: Post-treatment. Week 28: Follow-up
Primary outcome [2] 307687 0
Difference in symptoms of anxiety and depression (Hopkins Symptom Checklist) between NFT and LEI groups
Timepoint [2] 307687 0
Week 16: Post-treatment. Week 28: Follow-up.
Secondary outcome [1] 324249 0
NFT versus LEI on cognitive control as indicated by the P300 NOGO ERP elicited by a Visual Continuous Performance Task, and associated behavioural responses
Timepoint [1] 324249 0
Week 16: Post-treatment
Secondary outcome [2] 324252 0
NFT versus LEI on emotion regulation as indicated by the VPP and P300 ERPs to fearful versus neutral facial expressions and self-reported difficulties in emotion regulation scale (DERS)
Timepoint [2] 324252 0
Week 16: Post-treatment

Eligibility
Key inclusion criteria
(1) Exposure to refugee related trauma (2) Meets DSM-V criteria for PTSD
Minimum age
21 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Suicidal intent, Psychotic, Substance use disorder

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 treatment seeking individuals attending trauma counselling services at STARTTS. Trial participants and all study personnel will be unaware of the next study group assignment in the allocation sequence. The allocation sequence will be generated by an offsite investigator who is not involved in consenting, screening or randomization. They will use an online system which will allow access by researchers at different sites when needed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomly assigned according to a block randomization schedule per four sites with a 2:2 allocation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
To assess the main outcome of PTSD (HTQ) symptom levels, the two treatment groups will be compared on post-intervention Week-15/16 scores using an independent groups t-test with significance level of p<.05, 2-tailed. A sample size of n=32 in each group will have 90% power to detect a difference in means of 0.5 (e.g. if M1=3.0 and M2=2.5) assuming that the common standard deviation is 0.6. This is congruent with a clinically meaningful difference, and with effect size estimates of symptom changes for neurofeedback for PTSD and psychotherapy for refugee PTSD. Our target is n=40 in each group to allow for a 20% drop-out rate.

Other variables will be analysed in this way using t-tests for continuous variables, and chi-squared tests for categorical variables.

It is expected that randomization will result in systematic group differences on base levels of variables and demographic variables. Where there are baseline differences in variables or difference in demographic variables, analyses will be re-run using ANCOVA/Regression to test the effect of the variable on the outcome measure.

Additional Analyses
1. There are five symptom domains of PTSD as measured by the HTQ; Intrusion, Numbing, Anxious arousal, Dysphoric arousal and Avoidance. Pending a significant change in overall symptoms, we will run a further analysis (ANOVA) to identify in which symptom sub-scale we see the largest changes associated with neurofeedback.
2. There are hypothesized subtypes of PTSD that have been validated by a factor analysis of scores on the HTQ subscales. We will use factor analysis to test how well this proposed factor structure fits the current sample. We will then investigate the strength of treatment response for each subtype e.g. dysphoric arousal, emotional numbing.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
11/07/2019
Actual
Date of last participant enrolment
Anticipated
31/10/2020
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
0
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 13291 0
2163 - Carramar
Recruitment postcode(s) [2] 24273 0
2165 - Fairfield
Recruitment postcode(s) [3] 24274 0
2144 - Auburn
Recruitment postcode(s) [4] 24275 0
2170 - Liverpool

Funding & Sponsors
Funding source category [1] 293684 0
Government body
Name [1] 293684 0
NSW Service for the Treatment and Rehabilitation of Torture and Trauma Survivors
Country [1] 293684 0
Australia
Primary sponsor type
Government body
Name
NSW Service for the Treatment and Rehabilitation of Torture and Trauma Survivors
Address
Street Address: 152 - 168 The Horsley Drive, Carramar NSW 2163
Postal Address: PO Box 203, Fairfield NSW 2165
Country
Australia
Secondary sponsor category [1] 300414 0
None
Name [1] 300414 0
Address [1] 300414 0
Country [1] 300414 0
Other collaborator category [1] 280381 0
University
Name [1] 280381 0
University of Sydney Medical School - Westmead
Address [1] 280381 0
Westmead Hospital
Hawkesbury Road
Westmead NSW 2145
Country [1] 280381 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295123 0
South Western Sydney Local Health District (SWSLHD)
Ethics committee address [1] 295123 0
Ethics committee country [1] 295123 0
Australia
Date submitted for ethics approval [1] 295123 0
28/09/2018
Approval date [1] 295123 0
01/02/2019
Ethics approval number [1] 295123 0
HE18/272

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

Contacts
Principal investigator
Name 65002 0
Dr Anna Watters
Address 65002 0
NSW STARTTS

Street Address: 152 - 168 The Horsley Drive, Carramar NSW 2163

Postal Address: PO Box 203, Fairfield NSW 2165
Country 65002 0
Australia
Phone 65002 0
+61 (0)2 9794 1900
Fax 65002 0
+61 (0)2 9794 1910
Email 65002 0
anna.watters@health.nsw.gov.au
Contact person for public queries
Name 65003 0
Mirjana Askovic
Address 65003 0
NSW STARTTS

Street Address: 152 - 168 The Horsley Drive, Carramar NSW 2163

Postal Address: PO Box 203, Fairfield NSW 2165
Country 65003 0
Australia
Phone 65003 0
+61 (0)2 9794 1900
Fax 65003 0
+61 (0)2 9794 1910
Email 65003 0
mirjana.askovic@health.nsw.gov.au
Contact person for scientific queries
Name 65004 0
Anthony Harris
Address 65004 0
Westmead Institute for Medical Research
176 Hawkesbury Rd, Westmead NSW 2145
Country 65004 0
Australia
Phone 65004 0
+61 (0)2 9845 668
Fax 65004 0
+61 (0)2 9635 7734
Email 65004 0
anthony.harris@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
we'd have to check if this is permissible


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.