ABSTRACT
Background: We conducted the first non-inferiority, randomised controlled trial to determine whether lifestyle therapy is non-inferior to psychotherapy with respect to mental health outcomes and costs when delivered via online videoconferencing. Methods: An individually randomised, group treatment design with computer-generated block randomisation was used. Between May 2021-April 2022, 182 adults with a Distress Questionnaire-5 score = ≥8 (indicative depression) were recruited from a tertiary mental health service in regional Victoria, Australia and surrounds. Participants were assigned to six 90-min sessions over 8-weeks using group-based, online videoconferencing comprising: (1) lifestyle therapy (targeting nutrition, physical activity) with a dietitian and exercise physiologist (n = 91) or (2) psychotherapy (Cognitive Behavioural Therapy) with psychologists (n = 91). The primary outcome was Patient Health Questionnaire-9 (PHQ-9) depression at 8-weeks (non-inferiority margin ≤2) using Generalised Estimating Equations (GEE). Cost-minimisation analysis estimated the mean difference in total costs from health sector and societal perspectives. Outcomes were assessed by blinded research assistants using Computer Assisted Telephone Interviews. Results are presented per-protocol (PP) and Intention to Treat (ITT) using beta coefficients with 95% Confidence Intervals (CIs). Findings: The sample was 80% women (mean: 45-years [SD:13.4], mean PHQ-9:10.5 [SD:5.7]. An average 4.2 of 6 sessions were completed, with complete data for n = 132. Over 8-weeks, depression reduced in both arms (PP: Lifestyle (n = 70) mean difference:-3.97, 95% CIs:-5.10, -2.84; and Psychotherapy (n = 62): mean difference:-3.74, 95% CIs:-5.12, -2.37; ITT: Lifestyle (n = 91) mean difference:-4.42, 95% CIs: -4.59, -4.25; Psychotherapy (n = 91) mean difference:-3.82, 95% CIs:-4.05, -3.69) with evidence of non-inferiority (PP GEE ß:-0.59; 95% CIs:-1.87, 0.70, n = 132; ITT GEE ß:-0.49, 95% CIs:-1.73, 0.75, n = 182). Three serious adverse events were recorded. While lifestyle therapy was delivered at lower cost, there were no differences in total costs (health sector adjusted mean difference: PP AUD$156 [95% CIs -$182, $611, ITT AUD$190 [95% CIs -$155, $651] ]; societal adjusted mean difference: PP AUD$350 [95% CIs:-$222, $1152] ITT AUD$ 408 [95% CIs -$139, $1157]. Interpretation: Remote-delivered lifestyle therapy was non-inferior to psychotherapy with respect to clinical and cost outcomes. If replicated in a fully powered RCT, this approach could increase access to allied health professionals who, with adequate training and guidelines, can deliver mental healthcare at comparable cost to psychologists. Funding: This trial was funded by the Australian Medical Research Future Fund (GA133346) under its Covid-19 Mental Health Research Grant Scheme.
ABSTRACT
BACKGROUND: COVID-19 required mental health services to quickly switch from face-to-face service delivery to telehealth (telephone and videoconferencing). This evaluation explored implementation of a telehealth mental health response in a regional public mental health provider. METHODS: A mixed methods approach, combining service use data, brief satisfaction surveys, and qualitative interviews/focus groups was undertaken. Number and types of contacts from de-identified mental health service data were compared between April-May 2020 and April-May 2019. Mental health consumers and providers completed brief online satisfaction surveys after videoconferencing sessions. Attitudes and perspectives on the implementation of telehealth were further explored by applying a descriptive qualitative framework to the analysis of interview and focus group data supplied by consumers and providers. Template thematic analysis was used to elucidate key themes relating to the barriers and enablers of telehealth uptake and future implementation recommendations. RESULTS: Total contacts decreased by 13% from 2019 to 2020. Face-to-face contacts decreased from 55% of total in 2019 to 24% in 2020. In 2019, 45% of contacts were by telephone, increasing to 70% in 2020. Only four videoconferencing contacts were made in 2019; increasing to 886 in 2020. Consumer surveys (n = 26) rated videoconferencing as good or excellent for technical quality (92%), overall experience (86%), and satisfaction with personal comfort (82%). Provider surveys (n = 88) rated technical quality as good or excellent (68%) and 86% could achieve assessment/treatment goals with videoconferencing. Provider focus groups/interviews (n = 32) identified that videoconferencing was well-suited to some clinical tasks. Consumers interviewed (n = 6) endorsed the ongoing availability of telehealth within a blended approach to service delivery. Both groups reflected on videoconferencing limitations due to infrastructure (laptops, phones, internet access), cumbersome platform and privacy concerns, with many reverting to telephone use. CONCLUSIONS: While videoconferencing increased, technical and other issues led to telephone being the preferred contact method. Satisfaction surveys indicated improvement opportunities in videoconferencing. Investment in user-friendly platforms, telehealth infrastructure and organisational guidelines are needed for successful integration of videoconferencing in public mental health systems.
ABSTRACT
BACKGROUND: There is increasing recognition of the substantial burden of mental health disorders at an individual and population level, including consequent demand on mental health services. Lifestyle-based mental healthcare offers an additional approach to existing services with potential to help alleviate system burden. Despite the latest Royal Australian New Zealand College of Psychiatrists guidelines recommending that lifestyle is a 'first-line', 'non-negotiable' treatment for mood disorders, few such programs exist within clinical practice. Additionally, there are limited data to determine whether lifestyle approaches are equivalent to established treatments. Using an individually randomised group treatment design, we aim to address this gap by evaluating an integrated lifestyle program (CALM) compared to an established therapy (psychotherapy), both delivered via telehealth. It is hypothesised that the CALM program will not be inferior to psychotherapy with respect to depressive symptoms at 8 weeks. METHODS: The study is being conducted in partnership with Barwon Health's Mental Health, Drugs & Alcohol Service (Geelong, Victoria), from which 184 participants from its service and surrounding regions are being recruited. Eligible participants with elevated psychological distress are being randomised to CALM or psychotherapy. Each takes a trans-diagnostic approach, and comprises four weekly (weeks 1-4) and two fortnightly (weeks 6 and 8) 90-min, group-based sessions delivered via Zoom (digital video conferencing platform). CALM focuses on enhancing knowledge, behavioural skills and support for improving dietary and physical activity behaviours, delivered by an Accredited Exercise Physiologist and Accredited Practising Dietitian. Psychotherapy uses cognitive behavioural therapy (CBT) delivered by a Psychologist or Clinical Psychologist, and Provisional Psychologist. Data collection occurs at baseline and 8 weeks. The primary outcome is depressive symptoms (assessed via the Patient Health Questionnaire-9) at 8 weeks. Societal and healthcare costs will be estimated to determine the cost-effectiveness of the CALM program. A process evaluation will determine its reach, adoption, implementation and maintenance. DISCUSSION: If the CALM program is non-inferior to psychotherapy, this study will provide the first evidence to support lifestyle-based mental healthcare as an additional care model to support individuals experiencing psychological distress. TRIAL REGISTRATION: Australia and New Zealand Clinical Trials Register (ANZCTR): ACTRN12621000387820 , Registered 8 April 2021.