Search

Background: Depression and panic disorders have high prevalence rates in primary care. Given the crucial role of general practitioners in diagnosing and treating mental disorders, the two-arm cluster-randomized, controlled PREMA trial was designed. PREMA was aimed at investigating a new intervention combining cognitive behavioral therapy, case management and eHealth components for patients with depression and/or panic disorder with or without agoraphobia in primary care practices in Germany. This qualitative study, embedded in the PREMA trial, explores primary healthcare professionals' lived experiences in using the new treatment program. Using a qualitative design, we conducted eleven interviews with general practitioners and medical assistants from Hesse, Germany, between July 2021 and March 2022. For both groups we relied on a semi-structured interview guide covering the following subjects: study procedures, implementation, practicality, and individual components of the treatment program. Interviews were audio-recorded, transcribed verbatim and analyzed by two researchers using content analysis. A deductive-inductive approach was used for the analysis according to Kuckartz. Results: We narratively summarized the facilitators and barriers from two different stakeholders across five key themes regarding experiences of feasibility and practicability of the new treatment program: study instruction materials, individual components of the treatment program, practicality, target population, and benefits of the treatment program. Facilitators to become familiar with the study include study instruction materials that are easy to understand and not too complex, considering the limited time resources available; barriers included text-heavy instruction materials, lack of collegial exchange, and issues especially with digital materials also involved access and log-in difficulties on the online platform. Facilitators for using the treatment program include the combination of face-to-face consultations and the use of an online platform, enabling a structured approach and regularity; barriers included patients feeling unsupported in performing anxiety exercises independently at home. For practicality, the professional skills of medical assistants and their central role as points of contact for patients facilitated the implementation; barriers included time-intensive organization and planning of monitoring phone calls and consultations. Regarding the target population, general practitioners and medical assistants state that the treatment program would be most appropriate for patients with mild to moderate depression and for those waiting for psychotherapeutic treatment; it would be less suitable for older patients, and those with negative attitudes towards technological tools. For benefits of the program, facilitating factors included free and low-threshold access to the online platform and strengthening the relationship between medical assistants and patients; barriers included a preference for in-person conversations and the inability of some people to use online applications. Conclusions: The complexity of the new treatment program and the associated high workload underline the need for further adjustments to the treatment approach. Team-based care and the expanded responsibilities of medical assistants demonstrated promising results. Trial registration: The study was registered in the German Clinical Trials Register (DRKS00016622) on February 22, 2019. [ABSTRACT FROM AUTHOR]

Background: Mental disorders are prevalent and cause considerable burden of disease. Exercise has been shown to be efficacious to treat major depressive disorders, insomnia, panic disorder with and without agoraphobia and post traumatic stress disorder (PTSD). Methods: This pragmatic, two arm, multi-site randomised controlled trial will evaluate the efficacy and cost-effectiveness of the manualized, group-based six-months exercise intervention "ImPuls", among physically inactive patients with major depressive disorders, insomnia, panic disorder, agoraphobia and PTSD within a naturalistic outpatient context in Germany. A minimum of 375 eligible outpatients from 10 different study sites will be block-randomized to either ImPuls in addition to treatment as usual (TAU) or TAU only. ImPuls will be conducted by trained exercise therapists and delivered in groups of six patients. The program will combine (a) moderate to vigorous aerobic exercise carried out two-three times a week for at least 30 min with (b) behavior change techniques for sustained exercise behavior change. All outcomes will be assessed pre-treatment, post-treatment (six months after randomization) and at follow-up (12 months after randomization). Primary outcome will be self-reported global symptom severity assessed with the Brief Symptom Inventory (BSI-18). Secondary outcomes will be accelerometry-based moderate to vigorous physical activity, self-reported exercise, disorder-specific symptoms, quality-adjusted life years (QALY) and healthcare costs. Intention-to-treat analyses will be conducted using mixed models. Cost-effectiveness and cost-utility analysis will be conducted using incremental cost-effectiveness and cost-utility ratios. Discussion: Despite its promising therapeutic effects, exercise programs are currently not provided within the outpatient mental health care system in Germany. This trial will inform service providers and policy makers about the efficacy and cost-effectiveness of the group-based exercise intervention ImPuls within a naturalistic outpatient health care setting. Group-based exercise interventions might provide an option to close the treatment gap within outpatient mental health care settings. Trial registration: The study was registered in the German Clinical Trials Register (ID: DRKS00024152, 05/02/2021). [ABSTRACT FROM AUTHOR]