Study Design and Participants
This prospective uncontrolled observational cohort study examined data from people who enrolled in a MindSpot treatment course between 1st January 2013 and 31st December 2019. MindSpot does not target people with BD and consequently the screening assessment has not included questions about that diagnosis or about symptoms of the disorder. However, we know that people with BD have used MindSpot, including several who have swung to the manic phase of the disorder while completing the course, and the screening assessment does include questions about medication. For the purposes of this study the clinic records of all the patients who reported taking Lithium were then examined for the stated reason for taking Lithium and whether there was confirmation of the diagnosis of BD by a psychiatrist. Treatment with Lithium is not a sensitive method of detecting BD, because an increasing number of people with bipolar disorder are treated with other mood stabilisers and antipsychotic medication, or remain undiagnosed (12). However, in Australia the prescription of Lithium is fairly specific for the diagnosis of BD, although Lithium is also sometimes prescribed as an adjuvant treatment for treatment resistant major depression and for mood instability without a clear diagnosis of BD. Hence, demographic information, completion rates, satisfaction and symptom scores at baseline and after treatment of the patients enrolled in a MindSpot course who reported taking Lithium (n=124), and who then had entries in their medical records either confirming the diagnosis of BD or the reason for taking Lithium (n=88, confirmed diagnosis of BD n=83, prescribed Lithium for other reasons n=5) were examined. Information confirming the reason for taking Lithium was not available for the remaining patients either because the clinicians did not ask or record the reason, or because the patients chose self directed treatment, with little or no clinician contact, which was available for part of the study period. The outcomes for patients taking Lithium and those with confirmed BD were then compared with those of all patients who commenced a treatment course in the first seven years of operation (N=21,745).
The MindSpot assessment, the nature and delivery of the treatment courses, and the procedure for maintaining patient safety in remote treatment are described in detail elsewhere (30, 31, 33). MindSpot delivers seven digital treatment courses, which were developed and validated in a series of randomized controlled trials at the Macquarie University online research clinic, the eCentreClinic (www.ecentreclinic.org). Four of these are based on transdiagnostic principles, recognising that people often simultaneously experience symptoms of anxiety and depression, and that common psychological skills are used to treat these symptoms. They are Mood Mechanic (for ages 18 – 25 years), the Wellbeing Course (26 – 65 years), Wellbeing Plus (over 65 years of age), and the Indigenous Wellbeing Course (for Aboriginal and Torres Strait Islander people) (30, 34-37). These four interventions are evidence-based psychological treatment programs that include psycho-education about mediators and moderators of symptoms, cognitive therapy, behavioural activation, graded exposure, sleep training, communication and interpersonal skills, problem solving, and relapse prevention (38, 39). MindSpot also offers disorder-specific courses for Obsessive Compulsive Disorder, Post Traumatic Stress Disorder, and chronic pain. Patients can choose a treatment course based on their presenting symptoms and age, and since the majority were adults seeking assessment and treatment for anxiety and depression, most elected to enrol in the Wellbeing Course.
All courses consist of five lessons delivered over eight weeks. Each lesson comprises a series of slides that presents the principles of psychological treatment for the target symptoms in text and images, using principles of instructional design comprising both didactic and case-based learning (40). Courses are delivered online with weekly support from a therapist, either by phone, secure email (private messaging), or both. The therapist time required per patient per course was between 1.5 and 3 hours (41), which includes all contact with patients, reading and responding to patient messages, administration and therapist supervision during treatment and follow-up. Materials are available online, although up to 10% of patients elected to receive course materials in a printed workbook, sent by post. For part of the period in which this study was conducted, an entirely self-guided version of the Wellbeing Course was offered, the results of which will be reported separately elsewhere. Clinic services are provided at no cost to participants.
Symptoms at baseline and at completion were measured using the Kessler 10-Item Scale (K-10) as a measure of general psychological distress (42), the Patient Health Questionnaire 9-Item (PHQ-9) for depression (43) and the Generalized Anxiety Disorder Scale 7-Item (GAD-7) for symptoms of generalized anxiety (44). Course completion and response to questions about patient satisfaction were also reported.
To account for missing data, estimated means obtained from Generalised estimating equation (GEE) models were used for post-treatment scores, for both the bipolar sample and the clinic benchmarks. (32) Treatment effect sizes from assessment to post-treatment were measured using Cohen’s d, percentage change in symptom scores from assessment to post treatment, and an estimate of the number needed to treat (NNT) to achieve a 50% improvement in symptoms of depression are also reported. Deterioration rates were calculated based on an increase in the PHQ-9 and GAD-7 scores from baseline to post treatment of 6 and 5 respectively. Data were analysed using SPSS version 21.0. A significance level of .05 was used for all analyses.