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Trial registered on ANZCTR


Registration number
ACTRN12618001664235p
Ethics application status
Submitted, not yet approved
Date submitted
26/05/2016
Date registered
9/10/2018
Date last updated
9/10/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating an EEG neurofeedback intervention for posttraumatic stress disorder in adult refugees
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
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; ‘neurofeedback therapy’. Arm 2: A ‘lifestyle enhancement intervention’ 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. 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.

For Neurofeedback Therapy (NFT), each of the 30 sessions will include approximately 20mins of neurofeedback training integrated with 40 mins of counselling.

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 symptoms and whole-brain quantitative EEG recordings. The most common protocols used as interventions for trauma, hyperarousal and anxiety, involve enhancing Sensory Motor Rhythm (SMR) (12-15Hz across the sensory-motor cortex or Cz/C4) or alpha activity (8-10Hz, right parietal and temporal regions). Current best practice suggests that treatment protocols should be personalized to address specific deviating EEG patterns.

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.

Neurofeedback therapy will be delivered by psychologists who have experience and training with neurofeedback and trauma counselling with this population.
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
Group difference in posttraumatic stress symptom severity post-intervention measured using the Harvard Trauma Questionnaire, Part 4: Symptoms (1-16)
Timepoint [1] 298442 0
1. Pre-intervention (Week-0); 2. Week-5; 3. Week-10; 4. Post-intervention (Week-15/16); 5. Follow-up (Week-28)
Primary outcome [2] 307687 0
Group difference in anxiety and depression symptoms post-intervention measured using the Hopkins Symptom Questionnaire
Timepoint [2] 307687 0
1. Pre-intervention (Week-0); 2. Week-5; 3. Week-10; 4. Post-intervention (Week-15/16); 5. Follow-up (Week-28)
Primary outcome [3] 307688 0
Group difference in sleep quality post-intervention measured using the Insomnia Severity Index
Timepoint [3] 307688 0
1. Pre-intervention (Week-0); 2. Week-5; 3. Week-10; 4. Post-intervention (Week-15/16); 5. Follow-up (Week-28)
Secondary outcome [1] 324136 0
Group differences in functioning post-intervention as measured by the Sheehan Disability Scale
Timepoint [1] 324136 0
1. Pre-intervention (Week-0); 2. Post-intervention (Week-15/16); 3. Follow-up (Week-28)
Secondary outcome [2] 324247 0
Group differences in resting state power spectra post-intervention as measured using EEG (eyes-open, eyes closed)
Timepoint [2] 324247 0
1. Pre-intervention (Week-0); 2. Post-intervention (Week-15/16); 3. Follow-up (Week-28)
Secondary outcome [3] 324249 0
Group differences in cognitive control indicated by a) EEG measured event-related potentials (ERPs) and b) behavioural performance, recorded simultaneously while completing a Visual Continuous Performance Task. This task also probes working memory, sustained attention, and response to novelty.
Timepoint [3] 324249 0
1. Pre-intervention (Week-0); 2. Post-intervention (Week-15/16); 3. Follow-up (Week-28)
Secondary outcome [4] 324251 0
Group differences in cognitive control post-intervention measured using backwards digit span
Timepoint [4] 324251 0
1. Pre-intervention (Week-0); 2. Post-intervention (Week-15/16); 3. Follow-up (Week-28)
Secondary outcome [5] 324252 0
Group differences in emotion processing post-intervention measured using event-related potential (ERPs) elicited by facial expressions of emotion (fear, sadness, anger, disgust, happiness and neutral) presented during EEG recording.
Timepoint [5] 324252 0
1. Pre-intervention (Week-0); 2. Post-intervention (Week-15/16); 3. Follow-up (Week-28)

Eligibility
Key inclusion criteria
(1) Exposure to refugee related trauma (2) Meet criteria for PTSD
Minimum age
21 Years
Maximum age
65 Years
Gender
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, generated by an online data-management application (Redcap).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
The research personnel administering the symptom, functioning and neurocognitive/EEG assessments will be blinded to the arm of the study the participant is enrolled in.
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
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
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
Address [1] 293684 0
Street Address: 152 - 168 The Horsley Drive, Carramar NSW 2163
Postal Address: PO Box 203, Fairfield NSW 2165
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
Submitted, not yet approved
Ethics committee name [1] 295123 0
South Western Sydney Local Health District (SWSLHD)
Ethics committee address [1] 295123 0
Liverpool Hospital, NSW 1871
Postal address: Locked Bag 7103 Liverpool BC NSW 1871
Ethics committee country [1] 295123 0
Australia
Date submitted for ethics approval [1] 295123 0
28/09/2018
Approval date [1] 295123 0
Ethics approval number [1] 295123 0

Summary
Brief summary
Background summary: Refugees experience a higher incidence of posttraumatic stress disorder (PTSD) and increased levels of chronicity. Effective treatment is a challenge worldwide and is likely to require a multifaceted approach. Neurofeedback (EEG biofeedback) is utilized to enable individuals to modulate and retrain brain electrical activity through training new pathways of activation that can increase the brain’s capacity to self-regulate. STARTTS’ neurofeedback program was developed to complement counselling for refugee related PTSD and has had good clinical success. However, evidence from a randomized controlled trial is needed.

Objectives: The primary aim of this project is to examine the efficacy of neurofeedback training for alleviating chronic posttraumatic stress symptoms in adult refugees. We hypothesize a reduction in symptoms, accompanied by changes in functional brain activity reflecting improved cognitive control and emotion regulation.

Study Plan: Willing and eligible, existing STARTTS clients will be randomized to participate in neurofeedback integrated with counselling (NFT) or to an active control “lifestyle enhancement intervention” (LEI) involving sessions focusing on nutrition and physical activity in addition to counselling. Both interventions will involve 30 bi-weekly sessions over 15 weeks. A total of eighty participants will be enrolled over two years and will complete questionnaire and EEG assessments pre- and post-intervention and at 3-month follow-up.
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
Dr Anna Watters
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
anna.watters@health.nsw.gov.au
Contact person for scientific queries
Name 65004 0
Dr Anna Watters
Address 65004 0
NSW STARTTS

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

Postal Address: PO Box 203, Fairfield NSW 2165
Country 65004 0
Australia
Phone 65004 0
+61 (0)2 9794 1900
Fax 65004 0
+61 (0)2 9794 1910
Email 65004 0
anna.watters@health.nsw.gov.au

No information has been provided regarding IPD availability
Summary results
No Results