Mental health specialist video consultations versus treatment as usual in patients with depression or anxiety disorders in primary care: study protocol for an individually randomised superiority trial (the PROVIDE-C trial)

Abstract

Background Most people with mental disorders, including those with severe and chronic disorders, are treated solely by their general practitioner (GP). Nevertheless, specialised mental health care may be required for specific patients. Notably, the accessibility of mental health specialist care is mainly complicated by (a) long waiting times for an appointment with specialists, (b) long travel distances to specialists, particularly in rural and remote areas, and (c) patients’ reservations about mental health specialist care (including fear of being stigmatised by seeking such care). To mitigate those barriers, technology-based integrated care models have been proposed. The purpose of this study is to examine the effectiveness and cost-effectiveness of a mental health specialist video consultations model versus treatment as usual in patients with depression or anxiety disorders in primary care. Methods In an individually randomised, prospective, two-arm superiority trial with parallel group design, N = 320 patients with anxiety and/or depressive disorder will be recruited in general practices in Germany. The intervention includes a newly developed treatment model based on video consultations with focus on diagnostics, treatment planning, and short-term intervention by mental health specialists. We will systematically compare the effectiveness, cost-effectiveness, and adverse effects of this new model with usual care by the GP: the primary outcome is the absolute change in the mean depressive and anxiety symptom severity measured on the Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS) from baseline to 6 months after baseline assessment. Follow-up in both groups will be conducted by blinded outcome assessors at 6 months and 12 months after baseline. The main analysis will be based on the intention-to-treat principle. We will optimise the likelihood of treatment effectiveness by strict inclusion criteria for patients, enhanced intervention integrity, and conducting a process evaluation. Discussion To the best of our knowledge, this is the first confirmatory study on a video-based, integrated care model for the treatment of anxiety and depressive disorders in GP patients in Germany. Trial registration ClinicalTrials.gov, United States National Institutes of Health NCT04316572. Prospectively registered on 20 March 2020.

Higher Acceptance of Videotelephonic Counseling Formats in Psychosomatic Medicine in Times of the COVID-19 Pandemic

“…Some comments from the free text modules read: "On site I feel more undisturbed and am not so quickly distracted, " "Conversation is more personal and therefore problems are easier to address, " "Contact on site is best because you can explain and present your issues better." Lastly, as shown also in previous studies (25,26) there is a great acceptance and broad agreement regarding tele-counseling in both men and women. In terms of "hurdles" the comparison did not detect differences between the three counseling formats.…”

Psychiatric treatment conducted via telemedicine versus in-person consultations in mood, anxiety and personality disorders: a protocol for a systematic review and meta-analysis

“…[7][8][9] Currently, there are a number of large ongoing trials comparing TM to in-person (IP) in populations of depression, anxiety, obsessive-compulsive disorder and perinatal women. [10][11][12] The use of TM in mental health services has several potential advantages such as making psychiatric services more accessible and flexible, reducing the cost of transport and time, reducing stigma, promoting patient autonomy and providing an opportunity for people with mental health difficulties to engage with services if they find it challenging to attend IP consultations. 13 14 There are also some potential disadvantages of TM, which include concerns about data security, technical obstacles, questions regarding the efficacy of interventions grounded in TM, which patient groups TM is most suitable for, concerns about establishing good working alliances, maintaining treatment engagement and the allocation of resources of trained clinicians.…”

“… 7–9 Currently, there are a number of large ongoing trials comparing TM to in-person (IP) in populations of depression, anxiety, obsessive–compulsive disorder and perinatal women. 10–12 …”

Health providers’ experiences with mental health specialist video consultations in primary care: a qualitative study nested within a randomised feasibility trial

“…Trial outcomes focused on feasibility, patient-reported outcomes and cost-effectiveness. The trial design and the intervention are described in the study protocol for the feasibility 17 and the main trial, respectively 22 as well as in the intervention manual (https:// bit. ly/ 32VAvI9).…”