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UW6762002 Bachelor of Counselling With Honours
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Question:
A feasibility trial of an internet-delivered psychological intervention to manage mental health and functional outcomes in neurological disorders
Introduction
Mental health difficulties are highly prevalent across neurological disorders, with meta-analytic data indicating rates of anxiety and depressive disorders are as high as approximately 20 to 30% in people with epilepsy [1], multiple sclerosis (MS) [2], Parkinson's disease [3,4] and acquired brain injury [5]. Across neurological disorders poor mental health is associated with poor quality of life, greater disability, poor treatment response, poor prognosis and disease progression [6–8]. In addition, some studies indicate that up to 30 to 50% of people with neurological disorders will experience significant cognitive difficulties [9–12], including problems with attention, memory and executivefunction.

These cognitive difficulties are also highly disabling [13,14] can exacerbate mental health difficulties and complicate their treatment [15].There is some evidence psychological interventions based on cognitive behavior therapy (CBT) can improve mental health outcomes (e.g., depression, anxiety) [16,17], and interventions based on compensatory cognitive rehabilitation can improve cognitive outcomes (e.g., memory complaints) [18], in patients with both acquired and chronic neurological disorders. Despite this, there are numerous barriers preventing access to effective psychological care for the majority of these patients, including a lack of specialists and services, high costs and travel restrictions [19]. One innovative approach for increasing access to psychologicalinterventions is delivery via the internet [20]. There is now substantial evidence for the effectiveness and acceptability of these interventions for common mental health [21] and physical health conditions [22]. There have also been several trials in certain neurological disorders, which highlight the potential of this approach.

For instance, internetdelivered CBT based interventions have resulted in improvements in depression in epilepsy [23,24], multiple sclerosis [25] and Parkinson's disease [26]. The present study examines the feasibility of an innovative transdiagnostic internet-delivered psychological intervention, the Wellbeing Neuro Course. The course teaches adults with a variety of neurological disorders psychological skills to manage both their mental health and functional abilities. A single-group open-trial was employed to gain important feasibility, acceptability and efficacy data. It was hypothesized participants would report; (1) the intervention as acceptable, (2) significant improvements on primary outcomes of depression, anxiety and disability at post-intervention and 3-month follow-up; and (3) significant improvements on secondary functional outcomes of cognitive difficulties and fatigue.

Method

The trial was conducted via the online specialist research unit the eCentreClinic, Macquarie University, which offers free psychological interventions for common mental health and chronic health conditions via participation in clinical trials. Participants read details of the trial and made an application via the eCentreClinic website (www. ecentreclinic.org). This website can be located via online searches and is promoted by various health professionals and websites within Australia. Previous participants, who had consented to be emailed about the trial following their participation in an online national mental health survey [19] were sent a link to the website and details of the trial.

All participants self-referred and met the following inclusion criteria:

(1) Australian resident,

(2) ≥18 years of age, and

(3) received formal diagnosis of one of the targeted neurological disorders (epilepsy, multiple sclerosis (MS), Parkinson's disease (PD), or acquired brain injury (ABI)), with clinical management by a GP or neurologist,

(4) experiencing cognitive difficulties that impact day-to-day activities and quality of life;

(5) wanting to learn information and skills to limit the impact of neurological disorder on their emotional and cognitive wellbeing. Exclusion criteria were: (1) an inability to access or use a computer with the internet, (2) depression symptoms in the very severe range (indicated by a total score > 22 or a score > 2 on item 9 of the Patient Health Questionnaire 9-item [27], (3) acutely suicidal or recent history of attempted suicide or self-harm (i.e., last 12 months), (4) serious cognitive impairment indicative of dementia (< 21 on the Telephone Interview of Cognitive Status; TICS-M).

Cognitive Status

Analytic plan

Analyses were performed in SPSS version 25 (SPSS, Inc., Chicago, IL). Generalised estimation equation (GEE) modelling examined changes over time from baseline to 3-month follow-up [43]. Initial assessment data were employed as baseline from the primary outcomes and pre-intervention data for the secondary outcomes. GEE models specified a gamma with log link response scale to address skewness within the dependent variables [44] and an unstructured working correlation to account for different rates of change from pre-intervention to post-intervention (i.e., bulk of intervention effect), and postintervention to follow-up (i.e., maintenance). Pairwise comparisons examined the statistical significance of changes in the outcomes between time points.

Clinical significance was assessed in two ways. First, the estimated marginal means from the GEE analyses were used to calculate the average percentage change across time for each of the outcome variables with 95% confidence intervals. Second, Cohen's d effect sizes and 95% confidence intervals were calculated for the within-groups effects based on the estimated marginal means. To address missing values (only 7.6% post-intervention and 13.3% follow-up) a multiple imputations procedure was applied.

This process first considered evidence of systematic dropout probability and nonignorable mechanisms of missing data. [45] From the range of available patient and intervention variables, lesson completion was a single large predictor of missing data portability at post-intervention (Wald's = 21.863, p < .001, Nagelkerke R Square = 67.7%) and thus missing value imputations accounted (stratified) for this. Post hoc longitudinal GEE power analyses demonstrated that the sample of 100 was adequately powered to test changes as low as 12% in depression (PHQ-9), 18% in anxiety (GAD-7), and 11% in disability (WHODAS 2.0). Thus, the study was sufficiently powered.

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