Dataset Information

Mental Health Specialist Video Consultations Versus Treatment-as-Usual for Patients With Depression or Anxiety Disorders in Primary Care: Randomized Controlled Feasibility Trial.

ABSTRACT:

Background

Most people affected by depression or anxiety disorders are treated solely by their primary care physician. Access to specialized mental health care is impeded by patients' comorbidity and immobility in aging societies and long waiting times at the providers' end. Video-based integrated care models may leverage limited resources more efficiently and provide timely specialized care in primary care settings.

Objective

The study aims to evaluate the feasibility of mental health specialist video consultations with primary care patients with depression or anxiety disorders.

Methods

Participants were recruited by their primary care physicians during regular practice visits. Patients who had experienced at least moderate symptoms of depression and/or anxiety disorders were considered eligible for the study. Patients were randomized into 2 groups receiving either treatment-as-usual as provided by their general practitioner or up to 5 video consultations conducted by a mental health specialist. Video consultations focused on systematic diagnosis and proactive monitoring using validated clinical rating scales, the establishment of an effective working alliance, and a stepped-care algorithm within integrated care adjusting treatments based on clinical outcomes. Feasibility outcomes were recruitment, rate of loss to follow-up, acceptability of treatment, and attendance at sessions. Effectiveness outcomes included depression (Patient Health Questionnaire-9), anxiety (Generalized Anxiety Disorder-7), burden of specific somatic complaints (Somatic Symptom Disorder-B Criteria Scale-12), recovery (Recovery Assessment Scale-German [RAS-G]), and perception of chronic illness care (Patient Assessment of Chronic Illness Care), which were measured at baseline and 16 weeks postallocation by assessors blinded to the group allocation.

Results

A total of 50 patients with depression and/or anxiety disorders were randomized, 23 in the intervention group and 27 in the treatment-as-usual group. The recruitment yield (number randomized per number screened) and the consent rate (number randomized per number eligible) were 69% (50/73) and 86% (50/58), respectively. Regarding acceptability, 87% (20/23) of the participants in the intervention group completed the intervention. Of the 108 planned video consultations, 102 (94.4%) were delivered. Follow-up rates were 96% (22/23) and 85% (23/27) for the intervention and control groups, respectively. The change from baseline scores at postmeasurement for the No Domination by Symptoms domain of recovery (RAS-G) was somewhat higher in the intervention group than in the control group (Mann-Whitney U test: rank-biserial r=0.19; 95% CI -0.09 to 0.46; P=.18). We did not detect any notable differences between the intervention and control groups in terms of other effectiveness outcomes. We did not observe any serious adverse events related to the trial.

Conclusions

The intervention and study procedures were found to be feasible for patients, primary care practice staff, and mental health specialists. A sufficiently powered pragmatic trial on mental health specialist video consultations should be conducted to investigate their effectiveness in routine care.

Trial registration

German Clinical Trials Register DRKS00015812; https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00015812.

SUBMITTER: Tonnies J

PROVIDER: S-EPMC7998325 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:IntroductionMost people suffering from depression and anxiety disorders are entirely treated in primary care. Due to growing challenges in ageing societies, for example, patients' immobility and multimorbidity, the transition to specialised care becomes increasingly difficult. Although the co-location of general practitioners and mental health specialists improves the access to psychosocial care, integrated in-person approaches are not practical for rural and single-doctor practices with limited personnel and financial resources. Treating primary care patients via internet-based video consultations by remotely located mental health specialists bears the potential to overcome structural barriers and provide low-threshold care. The aim of this randomised controlled feasibility trial is to investigate the feasibility of implementing of mental health specialist video consultations in primary care practices.Methods and analysisFifty primary care patients with significant depression and/or anxiety symptomatology will be randomised in two groups receiving either the treatment as usual as provided by their general practitioner or up to five video consultations conducted by a mental health specialist. The video consultations focus on (1) systematic diagnosis plus proactive monitoring using validated clinical rating scales, (2) the establishment of an effective working alliance and (3) a stepped-care algorithm within integrated care adjusting treatments based on clinical outcomes. We will investigate the following outcomes: effectiveness of the recruitment strategies, patient acceptance of randomisation, practicability of the technical and logistical processes related to implementing video consultations in the practices' workflows, feasibility of the data collection and clinical parameters.Ethics and disseminationThis trial has undergone ethical scrutiny and has been approved by the Medical Faculty of the University of Heidelberg Ethics Committee (S-634/2018). The findings will be disseminated to the research community through presentations at conferences and publications in scientific journals. This feasibility trial will prepare the ground for a large-scale, fully powered randomised controlled trial.Trial registration numberDRKS00015812.

Project description:BackgroundMost 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.MethodsIn 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.DiscussionTo 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 registrationClinicalTrials.gov, United States National Institutes of Health NCT04316572 . Prospectively registered on 20 March 2020.

Project description:ObjectiveDespite available effective treatments for mental health disorders, few patients in need receive even the most basic care. Integrated telepsychiatry services may be a viable option to increase access to mental healthcare. The aim of this qualitative process evaluation embedded in a randomised controlled feasibility trial was to explore health providers' experiences with a mental healthcare model integrating mental health specialist video consultations (MHSVC) and primary care.MethodsA qualitative process evaluation focusing on MHSVC in primary care was conducted. In 13 semistructured interviews, we assessed the experience of all mental health specialists, primary care physicians and medical assistants who participated in the trial. A thematic analysis, focusing on the implementation, mechanisms of impact and context, was applied to investigate the data.ResultsConsidering (1) the implementation, participants evaluated the consultations as feasible, easy to use and time saving. Concerning (2) the mechanisms of impact, the consultations were regarded as effective for patients. Providers attributed the patients' improvements to two key aspects: the familiarity of the primary care practice and the fast access to specialist mental healthcare. Mental health specialists observed trustful therapeutic alliances emerging and described their experience as comparable to same-room care. However, compared with same-room care, specialists perceived the video consultations as more challenging and sometimes more exhausting due to the additional effort required for establishing therapeutic alliances. Regarding (3) the intervention's context, shorter travel distances for patients positively affected the implementation, while technical failures, that is, poor Internet connectivity, emerged as the main barrier.ConclusionsMHSVCs in primary care are feasible and successful in improving access to mental healthcare for patients. To optimise engagement and comfort of both patients and health providers, future work should focus on empirical determinants for establishing robust therapeutic alliances with patients receiving MHSVC (eg, leveraging non-verbal cues for therapeutic purposes).Trial registration numberDRKS00015812; Results.

Project description:IntroductionGeneral practitioners (GP) report increasing difficulties in referring patients with somatic symptom disorder (SSD) in specialised psychosocial care. Barriers are structural conditions of the respective healthcare system and patients' reservations against receiving specialised psychosocial care. As patients with SSD often predominantly assume somatic influencing factors for the development and maintenance of their somatic complaints, close collaboration between the GP and mental health specialist (MHS) seems particularly important. Integrating internet-based video consultations by remotely located MHS and primary care can improve effective treatment of patients with SSD by overcoming structural barriers and provide low-threshold and timely care. The aim of this randomised controlled feasibility trial is to investigate the feasibility of implementing MHS video consultations in primary care practices.Methods and analysisFifty primary care patients with SSD will be individually randomised in two groups receiving either enhanced treatment as usual as provided by their GP (control group) or two versus five video consultations conducted by an MHS additionally to enhanced treatment as usual. The video consultations focus on (a) diagnostic clarification, (b) the development of a biopsychosocial disorder model, and (c) development of a treatment plan against the background of a stepped-care algorithm based on clinical outcomes. We will investigate the following outcomes: effectiveness of the recruitment strategies, patient acceptance of randomisation, practicability of the technical and logistical processes related to implementing video consultations in the practices' workflows, feasibility of the data collection and clinical parameters.Ethics and disseminationThis trial has undergone ethical scrutiny and has been approved by the Medical Faculty of the University of Heidelberg Ethics Committee (S-620/2021). The findings will be disseminated to the research community through presentations at conferences and publications in scientific journals. This feasibility trial will prepare the ground for a large-scale, fully powered randomised controlled trial.Trial registration numberDRKS00026075.

Project description:BACKGROUND:Due to limited access to specialist services, most patients with common mental disorders (depression or anxiety, or both) usually receive treatment in primary care. More recently, innovative technology-based care models (eg, video consultations) have been proposed to facilitate access to specialist services. Against this background, the PROVIDE (Improving Cross-Sectoral Collaboration Between Primary and Psychosocial Care: An Implementation Study on Video Consultations) project aims to improve the provision of psychosocial care through implementing video consultations integrated into routine primary care. OBJECTIVE:From the patients' perspective, this qualitative preimplementation study explored (1) anticipated benefits from and (2) barriers to implementing mental health specialist video consultations embedded in primary care services and (3) prerequisites for interacting with therapists via video consultations. METHODS:Using a purposive (ie, stratified) sampling strategy, we recruited 13 patients from primary care practices and a tertiary care hospital (psychosomatic outpatient clinic) for one-off semistructured interviews. In a computer-assisted thematic analysis, we inductively (bottom-up) derived key themes concerning the practicability of mental health specialist video consultations. To validate our results, we discussed our findings with the interviewees as part of a systematic member checking. RESULTS:Overall, we derived 3 key themes and 10 subthemes. Participants identified specific benefits in 2 areas: the accessibility of mental health specialist care (shorter waiting times: 11/13, 85%; lower threshold for seeking specialist mental health care: 6/13, 46%; shorter travel distances: 3/13, 23%); and the environment in primary care (familiar travel modalities, premises, and employees: 5/13, 38%). The main barriers to the implementation of mental health video consultations from the patients' perspective were the lack of face-to-face contact (13/13, 100%) and technical challenges (12/13, 92%). Notably, participants' prerequisites for interacting with therapists (12/13, 92%) did not seem to differ much from those concerning face-to-face contacts. CONCLUSIONS:Mental health service users mostly welcomed mental health specialist video consultations in primary care. Taking a pragmatic stance, service users, who are often frustrated about uncoordinated care, particularly valued the embedment of the consultations in the familiar environment of the primary care practice. With respect to interventional studies and implementation, our findings underscore the need to minimize technical disruptions during video consultations and to ensure optimal resemblance to face-to-face settings (eg, by training therapists in consistently reacting to nonverbal cues). TRIAL REGISTRATION:German Clinical Trials Register DRKS00012487; https://tinyurl.com/uhg2one.

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Project description:Background:Enhancing the capacity to experience positive affect could help improve recovery across a range of areas of mental health. Experimental psychopathology research indicates that a computerized cognitive training paradigm involving generation of positive mental imagery can increase state positive affect, and more recent clinical studies have suggested that this training could be used as an adjunct treatment module to target symptoms related to positive affect deficits, specifically anhedonia. The current study investigates the feasibility of adding a positive mental imagery computerized training module to treatment for patients in inpatient mental health settings, with a focus on increasing positive affect and reducing anhedonia. The positive mental imagery training (PMIT) is added to treatment as usual (TAU) in the inpatient setting, and compared to TAU alone, or TAU plus an alternative cognitive training module not hypothesized to increase positive affect, cognitive control training (CCT). Methods:The study is a feasibility randomized controlled trial with three parallel arms. Up to 90 patients admitted to inpatient mental health treatment clinics in Germany will be randomized to PMIT?+?TAU, CCT?+?TAU, or TAU on a 1:1:1 ratio. PMIT or CCT consist of an introductory session followed by up to 8 full training sessions over 2 weeks. All three arms (including TAU) include regular completion of mood measures over the 2-week period. Outcome measures are completed pre and post this 2-week training/monitoring period, and at 2-week follow-up. Data will be presented in the form of both raw means and standardized effect sizes, with 95% confidence intervals, for both intention-to-treat and per-protocol samples. Discussion:The study will inform feasibility of conducting a fully powered randomized controlled trial investigating the addition of the positive mental imagery training as a treatment adjunct to inpatient treatments for mental health, including potential refinement of study procedures, inclusion/exclusion criteria, and preliminary indications of the likely range of effect sizes. Trial registration:clinicaltrials.gov, NCT02958228 (date registered: 4 November 2016).

Project description:BackgroundDepression and anxiety frequently coexist with chronic musculoskeletal pain and can negatively impact patients' responses to standard orthopedic treatments. Nevertheless, mental health is not routinely addressed in the orthopedic care setting. If effective, a digital mental health intervention may be a feasible and scalable method of addressing mental health in an orthopedic setting.ObjectiveWe aimed to compare 2-month changes in mental and physical health between orthopedic patients who received a digital mental health intervention in addition to usual orthopedic care, those who received usual orthopedic care only (without a specific mental health intervention), and those who received in-person care with a psychologist as part of their orthopedic treatment plan.MethodsIn this single-center retrospective cohort study involving ancillary analysis of a pilot feasibility study, 2-month self-reported health changes were compared between a cohort of orthopedic patients who received access to a digital mental health intervention (Wysa) and 2 convenience sample comparison cohorts (patients who received usual orthopedic care without a specific mental health intervention and patients who received in-person care with a psychologist as part of their orthopedic treatment plan). All patients were 18 years or older and reported elevated symptoms of depression or anxiety at an orthopedic clinic visit (Patient-Reported Outcomes Measurement Information System [PROMIS] Depression or Anxiety score ≥55). The digital intervention was a multi-component mobile app that used chatbot technology and text-based access to human counselors to provide cognitive behavioral therapy, mindfulness training, and sleep tools, among other features, with an emphasis on behavioral activation and pain acceptance. Outcomes of interest were between-cohort differences in the 2-month longitudinal changes in PROMIS Depression and Anxiety scores (primary outcomes) and PROMIS Pain Interference and Physical Function scores (secondary outcomes).ResultsAmong 153 patients (mean age 55, SD 15 years; 128 [83.7%] female; 51 patients per cohort), patients who received the digital mental health intervention showed clinically meaningful improvements at the 2-month follow-up for all PROMIS measures (mean longitudinal improvement 2.8-3.7 points; P≤.02). After controlling for age and BMI, the improvements in PROMIS Depression, Pain Interference, and Physical Function were meaningfully greater than longitudinal changes shown by patients who received usual orthopedic care (mean between-group difference 2.6-4.8 points; P≤.04). Improvements in PROMIS Physical Function were also meaningfully greater than longitudinal changes shown by patients who received in-person psychological counseling (mean between-group difference 2.4 points; P=.04).ConclusionsPatients who received a digital mental health intervention as part of orthopedic care reported greater 2-month mean improvements in depression, pain interference, and physical function than patients who received usual orthopedic care. They also reported a greater mean improvement in physical function and comparable improvements in depression, anxiety, and pain interference compared with orthopedic patients who received in-person psychological counseling.