Depression in the nursing home: a cluster-randomized study to probe the effectiveness of a novel case management approach to improve treatment (the DAVOS project)

Depression is the second most common psychiatric illness in old people. Up to 30% of nursing home residents suffer from minor or major depression. Although depressive disorders in old age can be improved and even cured with adequate therapy, they often go unnoticed in nursing home residents and remain untreated. This highlights a striking deficit in health care and might results not only in lower quality of life among those concerned but also in poor physical functioning, premature mortality and increased hospitalization rates. of an and stepped structural case management program to improve by a in recruit a study population of have no medical diagnosis of and inclusion in the Residents with a clinical disorders or other serious DAVOS is a controlled cluster-randomized study that employs a stepped-wedge design.

The stepped-wedge design allows comparisons to be made within and between the clusters, receiving and not receiving the intervention. Furthermore, insights can be obtained into whether and from when the complex intervention is effective (the separate modules of the intervention have already been demonstrated to be effective in previous randomized studies).
[ FIGURE 1] Setting and study population The recruitment of participants and implementation of the intervention will take place at 10 outpatient nursing home facilities with a total of more than 1,250 care places. This will be possible as a result of the cooperation with the two social services organizations (German: Frankfurter Verband für Alten-und Behindertenhilfe e.V.; Agaplesion Markus Diakonie gGmbH). Based on nursing home records (e.g., on known diagnoses and health status), the nursing home residents that are, in principle, suitable for participation in the study, will be approached by the previously appointed case managers. At this point, residents with a clinical diagnosis of dementia (ca. 50%), are unable to provide consent, or who have a known alcohol or substance related disorder will be excluded from participation. It can be assumed from previous research that about one third of the overall population (ca. 36%) will be eligible for participation in the study and will provide their consent ( Figure 2). The data of residents that agree to participate in the study will be collected at baseline and checked against the inclusion and exclusion criteria.
[ FIGURE 2] Residents over 60 years of age and without obvious signs of dementia, an addictive disorder, or another severe mental illness will be included in the study. Inclusion criteria for participation in the interventional modules as described below are the presence of a subsyndromal depressive disorder or clinical depression. It makes sense to include subsyndromal symptomatic depression because it is common in old age and defines an important target population for the use of secondary preventive measures. In any case diagnosis of subsyndromal or clinically manifest depression is based on ICD 10 criteria following the judgement of a psychotherapist who is licenced by a state board (in Germany: Approbierter Psychotherapeut). The establishment of a proper clinical diagnosis is already part of the intervention as described below.

Intervention
The case management program as well as the interventional modules are shown in Figure 3. The depression case managers play an important integrative role in the intervention, as they are at the interface between residents, nurses, physicians, and psychotherapists. The case managers are nurses selected by the management of the respective nursing homes, and who have been trained for this role before the intervention begins. In every participating nursing home two depression case managers are selected. Altogether 20 depression case managers are trained during the study. The case manager's tasks include the identification of suitable study participants, prompt presentation during the psychotherapeutic consultation hour (see below) in the case of positive screening of depression, and coordinate the treatment modules for the participants.
The trainings for case managers will include the following four elements: 1) communication of basic medical-psychological information on late-life depression, 2) use of the screening instrument, 3) information on how to deal with residents with depression and 4) the organization of project-related requirements.
Case managers will be supervised throughout the study.

[FIGURE 3]
The intervention is initiated by a screening applied to the participating residents using a modified version of the Depression Monitoring List (DeMoL) with integrated PHQ-D assessment [10]. The screening is performed by the depression case manager or by other members of the nursing staff under the supervision of the case manager. In case of positive screening the participant is referred to a psychotherapeutic consultation hour (in German: Psychotherapeutische Sprechstunde) in accordance with §92, paragraph 6a, German Social Code (in German: Sozialgesetzbuch) during which a board licenced psychological psychotherapists will provide a diagnostic assessment (according to ICD 10 criteria). As part of DAVOS, the psychotherapeutic consultation hour will be implemented as an "in house" service in the nursing home which is an innovative approach compared to the usual practice in the German health care system. The assessment in the psychotherapeutic consultation hour will conclude with recommendations for several interventions that are elaborated in accordance with the German S3 guideline, and the National Disease Management Guideline on Unipolar Depression [6], and are part of three interventional modules. Ranging from "watchful waiting", participation in basic intervention (module 1) and a recommendation for psychotherapy (module 3) to the involvement of the general practitioner or a specialist physician, e.g. psychiatrist (module 2), the measures will cover a wide spectrum of possible interventions: Module 1 (= basic intervention) consists of participation in group sessions that are offered to all participants with and without any symptoms of depression (including persons suffering from subsyndromal depressive disorders). Key components of this module are supportive and psychoeducative approaches (on the subjects of "successful ageing", "mindfulness" etc.). By preparing a weekly plan, for example, the residents are to be animated to participate in measures involving physical activity, as well as other social and leisure pursuits. The case managers initially assist to carry out this module but later take on full responsibility for it. The aim is to establish this basic intervention as part of the daily nursing routine and to encourage everyday companions and other nurses to use it after the intervention is over. The case managers are thus to adopt the role of multipliers.
Module 2 contains aspects of treatment that require the therapeutic involvement of the general practitioner in charge of the resident and/or a specialist physicians (such as exclusion or treatment of somatic causes of depression, drug therapy / antidepressants, interactions with other drugs, polypharmacy, hospital admissions etc.). The role of the case manager here is to prompt and coordinate appointments with the doctors in charge following recommendations derived from the psychotherapeutic consultation hour.

Module 3 covers participation in psychotherapeutic groups and, where applicable, individual
psychotherapy conducted by psychologists. The employed interventions include elements of cognitive behavioral therapy (e.g., planning pleasant daily activities, problem solving, mindfulness-based meditation and cognitive restructuring [6,[11][12][13][14][15]). Individual psychotherapy sessions will be provided if required, to residents with major depression, dysthymia, and adjustment disorders. Psychotherapy will partly be delivered by psychologists in clinical training from the outpatient clinic of the Department of Clinical Psychology and Psychotherapy at Goethe University Frankfurt. The psychologists will receive additional training in CBT for late-life depression [16] and mindfulnessbased cognitive therapy [14,15].
The psychologists' tasks are: 1) participation in regular meetings at the nursing home facilities with case managers to ensure exchange of information about cases and treatments, 2) conducting psychotherapeutic consultations in order to motivate the patient for psychotherapy and select a suitable setting, 3) conducting either individual or group CBT including elements of mindfulness-based meditation [6,[11][12][13][14][15]).
After two months, individuals who meet the inclusion criteria for the intervention but do not wish to participate will be contacted again and informed about the provided treatment.

Data collection
Questionnaires and psychometric instruments that have been validated in clinical and gerontology research will be used to collect data face-to-face. For this purpose, instruments have been selected that are well-established and time-efficient, but that simultaneously cover a wide range of outcomerelevant variables. Data collection will be mainly quantitative but also supplemented qualitative methods (e.g., interviews with case managers, focus groups). These qualitative data will be analyzed by the sequential analysis in dependence on Rosenthal [17] and the Grounded Theory [18].
Subsequently, paper-pencil data will be digitalized, checked and subjected to missing values analysis.
Questionnaires with more than 30% of values missing will not be included in the subsequent analysis.
An estimate of isolated missing values will be made, using, for example, the FIML (full information maximum likelihood algorithm).
The raters responsible for data collection are part of the study team but not involved in the intervention (e.g. psychotherapy). They will receive intensive training in using the deployed instruments (test methods, questionnaires). The exclusive use of standardized instruments will ensure the influence of individual raters is negligible and that the data is valid. During the trainings, the trustworthiness of the data collection process will also be controlled by calculating interrater reliability.

Outcomes
The prevalence of depressive disorders and the severity of depression symptoms (or any change in them) among nursing home residents are the primary outcomes of DAVOS. Secondary outcomes are quality of life, functional status (instrumental activities of daily living), social participation and the type, frequency and duration of any hospitalization during the observation period. In addition to collecting data on primary and secondary outcomes (T0 to T5), relevant personal and sociodemographic data will be collected at baseline (including family background, socioeconomic status, educational level, subjective health status [19], personality characteristics [20], cognitive status [21], current medication and somatic comorbidities). To minimize the stress of data assessment nursing home documentation can serve as additional data source. Some of the variables, such as health status and cognitive status, will be measured repeatedly at the T5 follow-up assessment. All instruments are well introduced, validated and have frequently been used in previous research. An overview of the instruments and associated validation references are given in Table 1.