Condition category
Mental and Behavioural Disorders
Date applied
07/08/2014
Date assigned
22/10/2014
Last edited
29/07/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Somatisation is a condition where mental factors, such as stress, causes a person to suffer physical symptoms. These can include headaches, feeling tired and feeling sick. If the symptoms are experienced for a long time, or are particularly severe, the patient can be diagnosed as having a somatoform disorder. This condition is very common and is one of the main reasons why people visit their doctor or primary care physician (PCP). However, it can take a long time, up to 6 years, for patients to be properly diagnosed and treated (e.g. with psychotherapy). This delay causes distress to the patient and leads to high health care costs. Here, we plan to set up and evaluate a health network (Sofu-Net) designed to improve the diagnosis and management of somatoform disorder patients.

Who can participate?
Patients aged at least 18 within the recruitment area that, through filling in a short screening questionnaire, show signs of suffering from the disorder.

What does the study involve?
There are two stages to the study. In the first stage (Phase I) the Sofu-Net health network is set up. It involves the recruitment of a number of PCP practices, psychotherapists, specialized outpatient and inpatient clinics. It uses a standardized screening measure for somatic symptoms, a stepped-care treatment approach, and regular meetings of the network partners for the purpose of professional exchange and education. In order to test Sofu-Net, all patients that had been attending the PCP practices involved before the setup of the network are assessed on 2-3 consecutive days. Another group of patients are assessed in the same way 12 months later. The assessment is done using questionnaires, structured clinical telephone interviews, and PCP checklists. Patients are asked about somatic symptoms, and also any symptoms of anxiety or depression. Those that have severe somatic symptoms, or moderate symptoms along with anxiety or depression are categorized as “screening positive” and are included in the study and the subsequent telephone interview. The telephone interview is completed for purpose of standardized diagnosis. It also reports when patients start treatment. The PCP checklist assesses physical and psychological disorders of the “screening positive” patients. The performance of the Sofu-Net health network is tested by looking at the number of patients who admit their psychological distress to their PCPs, the percentage that are referred to/are engaged with/have attempted to initiate an appointment with a psychotherapist, the number that use available health care and the percentage of correct diagnosis of somatoform and functional disorders by PCP’s.

What are the possible benefits and risks of participating?
Patients participating in the study can benefit from early detection of somatoform and functional disorders/other psychological disorders. In addition, patients with somatoform and functional disorders can benefit from being referred to adequate treatment within a short time-period. There are no apparent risks from participating in the study.

Where is the study run from?
The study is part of the Hamburg Network for Mental Health “Psychenet”, a large health services research study to evaluate and improve mental health care service in the Hamburg metropolitan area. The study is conducted by the department of Psychosomatic Medicine and Psychotherapy, University Medical Centre Hamburg-Eppendorf (UKE).

When is the study starting and how long is it expected to run for?
Phase I: September 2011 to April 2013
Phase II: September 2013 to September 2014

Who is funding the study?
Federal Ministry of Education and Research (BMBF) (Germany)

Who is the main contact?
Prof. Bernd Löwe
b.loewe@uke.de

Trial website

http://www.psychenet.de/en/about-psychenet/sub-projects/somatoform-disorders.html

Contact information

Type

Scientific

Primary contact

Prof Bernd Löwe

ORCID ID

Contact details

Department of Psychosomatic Medicine and Psychotherapy
University Medical Center Hamburg-Eppendorf
Martinistr. 52
Gebäude/Building O25
Hamburg
20246
Germany
+49 (0)40 7410 59733
b.loewe@uke.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Health network somatoform and functional disorders: SOFU-NET (Subproject VIII)

Acronym

Sofu-Net

Study hypothesis

Phase I (Implementation of the network):
The health network for somatoform and functional disorders (Sofu-Net) will improve the diagnostic process and treatment recommendations for this patient population. In particular, the implementation of Sofu-Net will lead to:
1. An improvement in the diagnostic process
1.1. An increase in the number of patients who are discussing psychological distress with their PCP’s
1.2. An increase in the percentage of correct detection of somatoform and functional disorders by PCP’s
2. An increase in adequate treatment recommendations
2.1. An increase in the percentage of patients who are referred to a psychotherapist
3. A decrease in health care utilization
3.1. A decrease in the amount of appointments with PCP’s and specialized psychiatric and psychological services
3.2. An increase in attempts to initiate psychotherapy

Phase II (Controlled study):
Sofu-Net will improve the diagnostic process and treatment recommendations for patients attending a PCP practice within the network, when compared to patients who are attending a regular PCP practice. In particular, the implementation Sofu-Net will lead to:
1. An increase in the percentage of patients having commenced with appropriate treatment since the implementation of Sofu-Net/since the initial screening (i.e. 6 months post recruitment)
2. A decrease in severity of somatic symptoms as measured with the Patient Health Questionnaire 15 (PHQ-15)
3. A decrease in the amount of health care utilization and costs
4. A decrease in overall disability and comorbidity

Ethics approval

Medical Chamber Hamburg (Germany), 28/09/2011, ref. PV3728

Study design

Phase I: Pre-post intervention study evaluating the implementation of Sofu-Net
Phase II: Non-randomized, controlled, observer-blinded intervention study evaluating the effectiveness of Sofu-Net

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Other

Trial type

Diagnostic

Patient information sheet

Information with regards to the study can be found on the following website: http://www.psychenet.de/en/about-psychenet/sub-projects/somatoform-disorders.htmlPlease use the contact details below to request a patient information sheet

Condition

Somatoform and functional disorders; Comorbid symptoms of anxiety and depression

Intervention

Phase I:
1. The intervention involves the establishment of a health network (Sofu-Net) of PCPs, psychotherapists, inpatient clinics and an outpatient clinic, offering special consultations for patients with somatoform and functional disorders, to allow adequate diagnosis as well as timely and specialized treatment
2. In addition, awareness with regard to somatoform and functional disorders and its treatment options is fostered in the general public by circulating short films, advertising boards and post cards (part of another simultaneous subproject)
3. Time from pre- to post measurement is 12 months

Phase II:
1. Following the establishment of Sofu-Net, patients in PCP practices who are part of the health network are compared to patients in PCP practices outside the health network
2. Data collection was completed over the course of 12 months (September 2013 to September 2014)

Intervention type

Other

Phase

Phase I/II

Drug names

Primary outcome measures

Phase I:
At this stage of network implementation a hierarchy of primary and secondary outcomes is not defined. The following measures are considered equally important in order to evaluate the network:
1. Outcomes related to diagnostic processes:
1.1. The number of patients who are discussing psychological distress with their PCP’s
1.2. The percentage of correct detection of somatoform and functional disorders by PCP’s
2. Outcomes related to treatment recommendations:
2.1. The percentage of patients who are referred to a psychotherapist
3. Outcomes related to health care utilization
3.1. The amount of appointments with PCP’s and with specialized psychiatric and psychological services
3.2. Attempts to initiate psychotherapy

Phase II:
The effectiveness of Sofu-Net will be assessed with the following outcome measures:
1. Outcomes related to adequate treatment and symptom change:
1.1. The percentage of patients attending a Sofu-Net PCP practice who have commenced with appropriate treatment (i.e. psychotherapy) since implementation of Sofu-Net/since the initial screening 6 months post recruitment, when compared to the number of patients attending a regular PCP practice who have commenced with appropriate treatment at these points in time
1.2. Severity of somatic symptoms (PHQ-15)
2. Outcomes related to health care utilization:
2.1. The amount of health care utilization and costs (e.g., outpatient appointments, emergency appointments, inpatient appointments) in patients attending a Sofu-Net PCP practice when compared to health care utilization and costs in patients attending a regular PCP practice

Secondary outcome measures

Phase I:
See comment above: Primary outcome measures - Phase I

Phase II:
In addition to the primary outcomes, patients in the Sofu-Net PCP practices will be compared to patients in regular PCP practices with regards to their outcomes on the measures below:
1. The amount of sickness-leave and self-reported inability to work (measured in days)
2. Health anxiety (Whiteley Index-7; WI-7)
3. Depression (PHQ-9)
4. Anxiety (GAD-7)
5. Health related quality of life/Health status (European Quality of Life-5 Dimensions; EQ-5D)
6. Patient satisfaction with treatment
7. Comorbidity of somatoform and functional symptoms and other psychopathological symptoms as assessed with the PCP checklist

Overall trial start date

01/09/2011

Overall trial end date

01/09/2014

Reason abandoned

Eligibility

Participant inclusion criteria

Phase I and Phase II:
Inclusion criteria for screening questionnaire
1. Patients aged 18 years and above
2. Patients that attend one of the PCP practices that collaborate with Sofu-Net
3. Patients that give oral informed consent for screening
Inclusion criteria for further assessment
4. Patients that screen positive on the initial screening questionnaire for somatoform and functional disorders, i.e. patients with severe somatic symptoms (Patient Health Questionnaire-15; PHQ-15 sum score of ≥ 15 points) or with moderate somatoform/ functional symptoms (PHQ-15 sum score of 10-15 points) in combination with moderate symptoms of anxiety (Generalized Anxiety Disorder Scale-7; GAD-7 sum score of ≥ 10 points) and/or moderate symptoms of depression (Patient Health Questionnaire-9; PHQ-9 sum score of ≥ 10 points)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Phase I: n=352 Phase II: n=440

Participant exclusion criteria

Phase I and Phase II:
Exclusion criteria for screening questionnaire
1. Patients under the age of 18 years
2. Patients with insufficient language skills
Exclusion criteria for further assessment
3. Patients with severe physical impairments or severe psychological disorders that impede study participation
4. Patients with cognitive impairments
5. Patients with acute suicidal ideation

Recruitment start date

01/09/2011

Recruitment end date

01/09/2014

Locations

Countries of recruitment

Germany

Trial participating centre

University Medical Center Hamburg-Eppendorf
Hamburg
20246
Germany

Sponsor information

Organisation

Federal ministry of Education and Research (Bundesministerium für Bildung und Forschung) (BMBF) (Germany)

Sponsor details

Heinemannstraße 2
Bonn
53175
Germany
+49 (0) 228 - 99570
bmbf@bmbf.bund.de

Sponsor type

Government

Website

http://www.bmbf.de/en/

Funders

Funder type

Government

Funder name

Bundesministerium für Bildung und Forschung (AE 46-52)

Alternative name(s)

Federal Ministry of Education and Research, BMBF

Funding Body Type

government organisation

Funding Body Subtype

federal

Location

Germany

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/26721544

Publication citations

Additional files

Editorial Notes

29/07/2016: Publication reference added.