F32 F33 F34.1
Conditions
Interventions
Group 1: In addition to the usual treatment provided by the GP, patients in the intervention group receive support by a trained care manager experienced in the field of health care over a period of 12
Sponsors
Universitätsklinikum Freiburg Klinik für Psychiatrie und Psychotherapie
Eligibility
Sex/Gender
All
Age
60 Years to No maximum
Inclusion criteria
Inclusion criteria: • age: = 60 • major depression of moderate severety (PHQ-9 score 10-14) • willingness and possibility to partake in telephone calls and personal meetings with the care manager on a regular basis • willingness to take part in three written surveys (questionnaires) and to be contacted by members of the data management team via telephone • signing of the patient consent form after having been sufficiently informed about the trial (informed consent)
Exclusion criteria
Exclusion criteria: • alcohol, drug or pharmaceutical abuse • significant cognitive impairment (e.g., dementia) • treatment of depression by a clinical specialist (e.g., psychiatrist, psychotherapist) at time of inclusion • bipolar disorder • psychotic symptoms/ severe behavioral symptoms • risk of suicide at time of inclusion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome variable is the PHQ-9 score (Kroenke et al. 2001) as a measure of change in the depressive symptoms over the course of the trial. The PHQ-9 questionnaire is the 9-item depression module of the "Patient Health Questionnaire" which has proven to be a valid instrument for the population of older people with depression in international trials. Along the lines of similar trials (Unützer et al. 2002; IJiff et al. 2007; Gensichen et al. 2009), the change of symptoms in terms of a "response to treatment" is defined as a decrease of symptoms (PHQ-9 score) by 50% or more. Remission is defined as a reduction of the PHQ-9 score to a score of 4 or less. The PHQ-9 will be assessed at the involvement of the patient, after 6 months and after 12 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary outcome variables encompass measures used to calculate the cost-effectiveness of the intervention including resource utilization ("Fragebogen zur Inanspruchnahme medizinischer und nicht-medizinischer Versorgungsleistungen" FIMA) and health-related quality of life (EQ-5D; EuroQol Group 1990). Comorbidities (modification of the "Comorbidity Disease Index" CDI; Rigler et al. 2002), anxiety (GAD-7; Spitzer et al. 2006), and pain (modification of the "Graded Chronic Pain Scale" CPG; Klasen et al. 2004) will be assessed as well as the individual psychological resilience (short version of the "Resilience Scale" RS-13; Leppert et al. 2008), problem solving skills (PLF), relevant socio-demographic data, and depression-related behavioral variables (modified questions by Ludman et al. 2003). At the involvement of the patient all secondaryoutcome variables will be assessed. After 6 months all variables except the "CDI" will be collected. After 12 months again all secondary outcome variables will be assessed. | — |
Countries
Germany
Contacts
Public ContactFrederike Bjerregaard
Universitätsklinikum Freiburg Klinik für Psychiatrie und Psychotherapie
Outcome results
None listed