Skip to content

Trauma Treatment Trial; 'Triple T'

A randomized-controlled trial evaluating EEG neurofeedback training adjunct to trauma counselling for reducing posttraumatic symptoms in adults with a refugee background

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618001664235
Acronym
Triple T
Enrollment
0
Registered
2018-10-09
Start date
2019-07-11
Completion date
2020-10-31
Last updated
2019-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 cou

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.

Sponsors

NSW Service for the Treatment and Rehabilitation of Torture and Trauma Survivors
Lead SponsorGovernment body

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
21 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

(1) Exposure to refugee related trauma (2) Meets DSM-V criteria for PTSD

Exclusion criteria

Suicidal intent, Psychotic, Substance use disorder

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026