Transmural Collaborative Care: Depression and Anxiety disorders with concomitant physical symptoms.

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.

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.

Baseline measurements take place before inclusion (T0), follow up at 3 months (T1), 6 months (T2), 9 months (T3) and 12 months (T4).

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.