RecruitingACTRN12618001664235

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


Sponsor

NSW Service for the Treatment and Rehabilitation of Torture and Trauma Survivors

Enrollment

80 participants

Start Date

Jul 11, 2019

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 21 YearssMax Age: 65 Yearss

Plain Language Summary

Simplified for easier understanding

Refugees often experience extremely traumatic events before, during, and after displacement — including torture, violence, and profound loss. As a result, post-traumatic stress disorder (PTSD) is very common in refugee communities, and it tends to be chronic and difficult to treat. Standard trauma therapies can help, but they need to be adapted for refugees, who may have complex trauma histories and practical barriers to engagement. This study, run through STARTTS (NSW Service for the Treatment and Rehabilitation of Torture and Trauma Survivors), tests whether adding neurofeedback therapy to standard counselling is more effective than adding a lifestyle enhancement program (nutrition and physical activity education). Neurofeedback is a technique that trains the brain to regulate its own electrical activity through real-time feedback, and it has shown clinical promise for PTSD. Eighty participants will be randomly assigned to one of the two programs, each involving 30 twice-weekly sessions over 15 weeks. To be eligible you need to be a current STARTTS client aged 21 to 65 who has experienced refugee-related trauma and meets diagnostic criteria for PTSD. People with active suicidal intent, psychotic disorders, or substance use disorders are not eligible. The study will measure PTSD symptoms, brain activity patterns, and quality of life before, after, and three months following the program.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 an

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.


Locations(1)

NSW, Australia

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