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ID
Source
Brief title
Health condition
Physical symptoms, major depressive disorder, generalized anxiety disorder, panic disorder.
Lichamelijke klachten, depressie, gegeneraliseerde angststoornis, paniekstoornis.
Sponsors and support
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
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
Intervention
Outcome measures
Primary outcome
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 outcome
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).
Background summary
Background:
Concomitant physical symptoms frequently complicate the treatment of common mental disorders. The objective of this study is to investigate effects and costs of a Transmural Collaborative stepped Care model with Consultation Letter (TCCCL) to the General Practitioner (GP), versus Care As Usual (CAU), for patients with concomitant physical symptoms in Major Depressive Disorder (MDD), Generalized Anxiety Disorder (GAD) and Panic Disorder (PD) who are referred by GPs to the mental health outpatient clinic.
Methods/design:
Study design: Two armed cluster randomized controlled trial with randomization between referring GP practices. Follow up at 3, 6, 9 and 12 months.
Study population: Patients referred to the mental health outpatient clinic who at baseline screening fulfil criteria for 5 or more concomitant physical symptoms in MDD/GAD/PD.
Intervention:
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 Treatment (CBT) with self help manual for physical symptoms;
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.
Sample size calculation/data analysis:
In order to be able to detect a clinical relevant difference of 1/2 SD with the CAU on the continuous measure of the ‘Lichamelijke Klachten Vragenlijst’ (LKV), considering that we want to perform multilevel analysis and estimating 30% loss to follow up, we must include 2 x 87 patients to attain 2 x 67 completers (alpha 0,5; power 0,90). Multilevel analysis will be performed with the GPs in the first and the patient outcomes in the second hierarchical level. Intention to treat analysis will be performed with multilevel analysis and imputation for missing data.
Outcome measures:
Primary outcome measure is reduction of physical symptoms as measured in the LKV and MDD/GAD/PD symptoms as measured in the PHQ9 and GAD7.
Economic evaluation:
The aim of this economic evaluation is to assess the cost effectiveness of TCCCL in a transmural model of treatment in mental health outpatient clinic and primary care of MDD, GAD or PD with 5 or more concomitant physical symptoms. The economic evaluation will be undertaken from a societal perspective. Hence, all relevant effects and costs due to resource utilisation within the healthcare (direct medical costs) and costs due to production losses (productivity costs) will be included.
Time schedule:
Preparation: 6 months. Inclusion and intervention phase: 24 months. Follow up: 12 months. Data analysis and writing: 6 months. The study will last 4 years.
Discussion:
In this study, the transmural collaborative stepped care intervention for MDD/GAD/PD with concomitant physical symptoms will be evaluated for (cost-)effectiveness in comparison with care as usual. Patients start treatment in the mental health outpatient setting, and receive good follow up when they are referred back to the GP care, with a consultation letter, in the primary care setting. Results of this study will contribute to treatment options for a complex group of patients. Results are expected in 2015. We hypothesize that the transmural collaborative stepped care intervention will be more cost-effective than care as usual.
Study objective
Concomitant physical symptoms frequently complicate the treatment of common mental disorders. The objective of this study is to investigate effects and costs of a Transmural Collaborative stepped Care model with Consultation Letter (TCCCL) to the General Practitioner (GP), versus Care As Usual (CAU), for patients with concomitant physical symptoms in Major Depressive Disorder (MDD), Generalized Anxiety Disorder (GAD) and Panic Disorder (PD) who are referred by GPs to the mental health outpatient clinic. We hypothesize that the transmural collaborative stepped care intervention will be more cost-effective than care as usual.
Study design
Baseline measurements take place before inclusion (T0), follow up at 3 months (T1), 6 months (T2), 9 months (T3) and 12 months (T4).
Intervention
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 Treatment (CBT) with self help manual for physical symptoms;
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 half hour up to an hour. The minimal duration of the treatment is 6 weeks, the maximal duration is 24 weeks.
Controls will receive care as usual.
Lage witsiebaan 4
Jonna Eck van der Sluijs, van
Tilburg 5042 DA
The Netherlands
+31 (0)88 0161616
J.vanEckvanderSluijs@ggzbreburg.nl
Lage witsiebaan 4
Jonna Eck van der Sluijs, van
Tilburg 5042 DA
The Netherlands
+31 (0)88 0161616
J.vanEckvanderSluijs@ggzbreburg.nl
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
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
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL2878 |
| NTR-old | NTR3023 |
| CCMO | NL37505.097.11 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
| OMON | NL-OMON35190 |