None listed
Conditions
Brief summary
Psychological distress after TBI is high and Acceptance and Commitment Therapy (ACT) has been used effectively to treat this distress using the ACT-Adjust program. Access problems to psychologists in Australia in rural and regional areas are limited and this is exacerbated for individuals with a TBI accessing appropriately trained and skilled psychologists. Video consulting is one solution to improve access and though ACT has been delivered by this media, there is currently no evidence base to support the delivery of psychological therapy by video consulting to individuals with a TBI. This study will examine the effectiveness of ACT-Adjust delivered by video consulting to individuals with a TBI, promoting improved access for those living in regional and remote areas of Australia and having a TBI.
Interventions
A phase one three-armed non-inferiority randomised controlled trial comparing the efficacy of delivering an evidence-based psychological treatment (ACT-Adjust) to treat psychological distress in individuals with a severe traumatic brain injury (TBI) via video consulting (VC; Arm 1), with face-to-face delivery (FtF; Arm 2) and a wait list control group (Arm 3). ACT-Adjust is a manualised nine-session treatment program that is specifically tailored to individuals who have sustained a TBI and will be provided on an individual basis to participants. This treatment intervention consists of 7 x 1 hour weekly sessions. In addition to the intervention, an initial assessment session will take place approximately one week prior to the commencement of the intervention, and two follow-up sessions will be held; Session 8 two weeks after session 7; and session 9 which will occur 4 weeks after session 8. Overall the program encompasses 10 sessions which includes one assessment session to complete measures and a total of 9 sessions of treatment. The treatment is based on Acceptance and Commitment Therapy (ACT) which is a third wave cognitive behavioural therapy. ACT has an strong evidence base across a number of psychological conditions and has been previously delivered to individuals with a TBI and mixed psychological distress (depression, anxiety, stress). The current project is based on this previously trialled intervention (ACT-Adjust) which was only 7 sessions and delivered in a group modality. The current intervention has been modified for individual delivery and the exercises considered by a review panel for their appropriateness to be delivered by video consulting. An additional two sessions have been included to strengthen relapse prevention.The modified therapist manual and a separate client workbook will be available once the clinical trial commences through both the researchers and the funder, icare. The content of the sessions involves didactic education, interactive exercises including mindfulness activities, completion of worksheets and other activities that support ACT. This includes defusion, values identification and goal setting for committed action. Each session of the intervention focuses on a component on the ACT model with values work and mindfulness activities included in each session. Participants will be asked to complete activities at home and sent reminders by SMS (text messaging by mobile phone) to complete these tasks. Home tasks will include brief mindfulness exercises (from 2 mins to 6 mins by 3 times per week) which were taught in the preceding week and an activity relating to the previous weeks content e.g. a defusion activity which will take 5-10 minutes. Sessions 8 and 9 will set activities unique to each client identified as a committed action in service of identified values. This will be different for each client and set as a structure goal. The first session incorporates education about the intervention and assists the participant in identification of their current issues and coping strategies. A suicide risk assessment is undertaken as a component of the intervention when the normalacy of suffering is covered as part of the ACT treatment. Coping mechanisms include a better understanding of human suffering, allowing space to accept uncontrollable situations and mindfulness to bring the participant into the present moment. Behavioural activation will occur as goal setting will be established in conjunction with participants' values. The interventions will be delivered by registered psychologists who are trained to provide the ACT-Adjust intervention. Psychologists will use the ACT-Adjust therapist manual to deliver the treatment and participants in the treatment groups will each be provided with the ACT-Adjust client workbook. Participants allocated to Arm 1 (therapy via video consulting) of the trial will use either an electronic tablet or personal computer to access treatment via video consulting, either from home or a preferred location. Participants allocated to Arm 2 of the trial will attend therapy sessions at a local health clinic. Delivery of the ACT-Adjust intervention will be recorded and assessed by a blind external assessor for treatment fidelity.
Sponsors
Study design
Eligibility
Inclusion criteria
(i) having sustained a severe TBI (post-traumatic amnesia =>7 days) after 18 years of age; (ii) being between 18 and 65 years old and less than five years post-injury; (iii) having sufficient cognitive and linguistic capacity to complete self-report measures and participate in the program; and (iv) reporting a clinically significant level of psychological distress (Depression>13, Anxiety>9 and Stress>18; Depression Anxiety Stress Scales 21-item; DASS) (Lovibond & Lovibond, 1995).
Exclusion criteria
(i) having a severe psychiatric illness, including psychotic disorder or substance addiction as determined by the medical file, self-report or consultation with the rehabilitation team; (ii) currently undergoing psychological intervention;