Physical symptoms, major depressive disorder, generalized anxiety disorder, panic disorder. Lichamelijke klachten, depressie, gegeneraliseerde angststoornis, paniekstoornis.
Conditions
Interventions
The TCCCL model combines several modules that were proven effective separately in patients with physical symptoms and in patients with MDD/GAD/PD, in a stepped care model:
1. Cognitive Behavioural Tr
2. Problem Solving Treatment (PST) for MDD/GAD/PD
3. Graded activity guided by a physiotherapist
4. Antidepressant medication
5. Consultation Letter with diagnosis and treatment advice to the GP.
Patients will visit the mental health outpatient clinic twice a week and the physiotherapist once a week. Each visit will last a
Sponsors
GGZ Breburg
Postbus 770
5000 AT Tilburg
The Netherlands
Tel: +31 (0)88 0161616
Fax: +31 (0)88 0161199
info@ggzbreburg.nl
Bezoekadres: Lage witsiebaan 4, 5042DA Tilburg, The Netherlands
Eligibility
Inclusion criteria
Inclusion criteria: Of the referred patients, all patients that present with both five physical symptoms and a common mental disorder, namely MDD, GAD or PD, are eligible for the study. MDD is operationalized as a score of 10 or more on the Patients Health Questionnaire depression subscale (PHQ9) on the ROM; GAD and PD are operationalized as a score of 10 or more on the GAD7, and we speak of increased physical symptoms when the patient reports five or more physical symptoms on a validated self-report questionnaire (Physical Symptoms Questionnaire, in Dutch ‘Lichamelijke Klachten Vragenlijst’; LKV) as that number of symptoms was found to be associated with poor functioning by Escobar e.a. The diagnosis of MDD, GAD or PD should be confirmed in the clinical interview that follows the ROM. If the diagnosis is not confirmed in the clinical interview, but the patient does have a score of 10 or more on the PHQ9 or GAD7, the patient will also be included. The data of these patients will form a subgroup in the analysis. All the described patients are asked informed consent and if they agree, are enrolled in the study. Although women suffer from (medically unexplained) physical symptoms, MDD and anxiety disorders more often than men, both sexes will be sufficiently represented in the sample to consider gender as a variable in the analysis. The same holds for age and cultural background.
Exclusion criteria
Exclusion criteria: Patients are excluded from the study if they are less than 18 years old, have insufficient knowledge of Dutch to fill in the questionnaires, or are suicidal, psychotic or suffering from dementia.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Baseline measurements: The PHQ9, the GAD7 and the LKV. The Mini International Neuropsychiatric Interview (MINI) for classification of symptoms. Primary outcome measure is reduction of physical symptoms as measured by the LKV, as this is considered crucial to attain improvement on the concomitant common mental disorder as well. The CBS questionnaire will be used to distinguish between medically explained and medically unexplained physical symptoms. | — |
Secondary
| Measure | Time frame |
|---|---|
| Besides the LKV, the number and intensity of functional somatic complaints a patient is experiencing is assessed with the PHQ15. Improvement of the concomitant common mental disorder is another outcome measure: Response in symptoms of MDD, GAD or PD as measured with the PHQ9, respectively GAD7 (score below 10), as well as general functioning assessed with Short Form 36 Health Survey (SF36) and EuroQol-D5 (EQ-D5). Coping strategies will be measured by the Dutch version of the Coping Inventory for Stressful Situations (CISS-NL). Adherence and compliance are also evaluated. Contentment of the patient about the GP is measured with the Patient-Doctor Relationship Questionnaire (PDRQ9). The consultation letter will be evaluated with the GPs; they will be asked if they have followed the advises and if the consider them to be useful. The influence of pain is measured with the Brief Pain Inventory (BPI). Health care use is assessed by the Scale for Medical Utilisation of Health Services. Chronic medical illness is assessed with a central bureau of statistics (CBS) questionnaire. Moreover, direct and indirect costs as well as productivity costs will be assessed with the Trimbos/iMTA questionnaire for Costs associated with Psychiatric Illness (TiC-P). | — |
Contacts
Public ContactJonna Eck van der Sluijs, van
GGZ Breburg Lage witsiebaan 4
Outcome results
None listed