Anxiety Depression (Mild or Not Persistent)SMADSNCT01726387
Self-Management for Anxiety, Depression and Somatoform Disorders
A study testing Psychosocial Counseling in people with Anxiety Depression (Mild or Not Persistent) and Major Depressive Disorder, Single Episode, Unspecified, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
Trial summary
Anxiety, Depression and Somatoform disorders are highly prevalent in primary care. Very often these conditions remain undiscovered and/or untreated. In order to ease this urgent health care problem in the future, the investigators conduct a cluster-randomized controlled trial, implementing a tandem working cooperation… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anxiety Depression (Mild or Not Persistent), Major Depressive Disorder, Single Episode, Unspecified, Neurotic, Stress-related and Somatoform Disorders
- What is being tested?
- Psychosocial Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 364 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2013to Sep 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scoring >= 5 on the Patient Health Questionnaire (German Version), corresponding to a probable or established diagnosis of Anxiety, Depression or Somatoform Disorder
Who cannot join
- Negation of Inclusion Criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Self-Management Support in Primary Care
Anxiety, Depression and Somatoform disorders are highly prevalent in primary care. Very often these conditions remain undiscovered and/or untreated.
In order to ease this urgent health care problem in the future, the investigators conduct a cluster-randomized controlled trial, implementing a tandem working cooperation between a nurse practitioner (Counseling Assistant - CA) and a general practitioner (GP) on-site its own practise.
The CA's task is to enhance the patients abilities to engage in a better self-management of their psychological symptoms and complaints, to enhance self-efficacy and empower the patients to tackle problems of daily living.
Read the detailed description
Anxiety, Depression and Somatoform disorders are highly prevalent in primary care. Very often these conditions remain undiscovered and/or untreated. Managing it is time-consuming and communication-intensive. Furthermore, the management is restraint by the high contact-frequencies in primary care practices in Germany.
In order to ease this urgent health care problem in the future, the investigators conduct a cluster-randomized controlled trial, implementing a tandem working cooperation between a nurse practitioner (Counseling Assistant - CA) and a general practitioner (GP) on-site its own practise.
The CA's task is to enhance the patients abilities to engage in a better self-management of their psychological symptoms and complaints, to enhance self-efficacy and empower the patients to tackle problems of daily living.
- Conditions
- Anxiety Depression (Mild or Not Persistent), Major Depressive Disorder, Single Episode, Unspecified, Neurotic, Stress-related and Somatoform Disorders
- Being tested
- Psychosocial Counseling, Usual Care
- Medical subject headings
- Lymphoma, Follicular, Depressive Disorder, Major, Somatoform Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychosocial CounselingBehavioural
Also called Minimal Psychological Intervention, Self-Management Support
Depending on their condition, counseling assistants support patients in self-management support, enhancing self-efficacy, reducing psychological symptoms
Usual CareBehavioural
Depending on the conditions, patients get usual care of their general practitioner
| Study group | Role | What they receive |
|---|---|---|
| Psychosocial Counseling | Experimental | A Counseling Assistant offers a low-threshold intervention (self-management support, counseling, active guidance). This nurse practitioner collaborates extensively with the general practitioner, re-adjusting the intervention in order to meet the patient's needs. Receives: Behavioral: Psychosocial Counseling |
| Usual Care | Placebo comparator | Depending on the conditions, patients get usual care of their general practitioner. Receives: Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
General Self-Efficacy Scale (GSE)
GSE assesses a general sense of perceived self-efficacy. It predicts coping with daily hassles as well as adaptation after experiencing all kinds of stressful life events.
http://userpage.fu-berlin.de/%7Ehealth/engscal.htm "The construct of Perceived Self-Efficacy reflects an optimistic self-belief (Schwarzer, 1992). This is the belief that one can perform a novel or difficult tasks, or cope with adversity -- in various domains of human functioning. Perceived self-efficacy facilitates goal-setting, effort investment, persistence in face of barriers and recovery from setbacks. It can be regarded as a positive resistance resource factor. Ten items are designed to tap this construct. Each item refers to successful coping and implies an internal-stable attribution of success. Perceived self-efficacy is an operative construct, i.e., it is related to subsequent behavior and, therefore, is relevant for clinical practice and behavior change."
Measured: Baseline, 8 Weeks, 12 Months
Secondary outcomes (2)
Change in Symptom Score Patient's Health Questionnaire (German Version)
Reducing the symptoms score in the "Patient's Health Questionnaire (German Version)". Reducing symptom score per scale -2,5 units comparing group mean of the intervention group and the group mean of the control group, power 80%, probability 0,05. Effect size d=0,5.
Measured: Baseline, 8 Weeks, 12 Months
Health Related Quality of Life
Enhancing the health related quality of life in the patients using EQ-5D
http://www.euroqol.org/ EQ-5D (European-Quality-of-Life-5-Dimensions): "Descriptive system of health-related quality of life states consisting of five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take one of three responses. The responses record three levels of severity (no problems/some or moderate problems/extreme problems) within a particular EQ-5D dimension."
Measured: Baseline, 8 Weeks, 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2012 (estimated)
- Study startMar 2013
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Anxiety Depression (Mild or Not Persistent)Studies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 364 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Collaborators
- German Federal Ministry of Education and Research
- Responsible party
- Sponsor
- Investigators
- Martin Scherer, Prof., Principal investigator, UK Hamburg-Eppendorf (Germany), Department of Primary Medical Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01726387
- Sponsor's protocol ID
- SMADS
- Acronym
- SMADS
- Status last verified
- Feb 2018
- First submitted
- 3 Nov 2012
- Last updated
- 6 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Zimmermann T, Puschmann E, Ebersbach M, Daubmann A, Steinmann S, Scherer M. Effectiveness of a primary care based complex intervention to promote self-management in patients presenting psychiatric symptoms: study protocol of a cluster-randomized controlled trial. BMC Psychiatry. 2014 Jan 3;14:2. doi: 10.1186/1471-244X-14-2.
PubMed 24387048Zimmermann T, Puschmann E, Bäter G, Carstens S, Scherer M. Selbstmanagement stärken bei psychosozialen Belastungen. Die Kerbe - Forum für soziale Psychiatrie 4, 24-26, 2012.
Zimmermann T, Puschmann E, Porzelt S, Ebersbach M, Ernst A, Thomsen T, Scherer M. Selbstmanagementförderung in der ambulanten Versorgung. Programm einer niedrigschwelligen, komplexen, psychosozialen Intervention durch Pflegekräfte in der Hausarztpraxis. Zeitschrift für Allgemeinmedizin, 91, 11, 456-462, 2015.
Porzelt S, Zimmermann T, Ernst A, Puschmann E, Scherer M. Wie Pflegekräfte in der hausärztlichen Versorgung Patienten mit psychischen Beschwerden gezielt unterstützen können. Pflegewissenschaft, 18(7-8): 355-361, 2016.
Zimmermann T, Puschmann E, Porzelt S, Ebersbach M, Ernst A, Thomsen P, Scherer M. [Promoting Self-Management in Primary Care - the Association of Motivation for Change, Self-Efficacy and Psychological Distress Prior to the Onset of Intervention]. Psychiatr Prax. 2015 Jul;42 Suppl 1:S44-8. doi: 10.1055/s-0034-1387686. Epub 2015 Jul 2. German.
PubMed 26135280Zimmermann T, Puschmann E, van den Bussche H, Wiese B, Ernst A, Porzelt S, Daubmann A, Scherer M. Collaborative nurse-led self-management support for primary care patients with anxiety, depressive or somatic symptoms: Cluster-randomised controlled trial (findings of the SMADS study). Int J Nurs Stud. 2016 Nov;63:101-111. doi: 10.1016/j.ijnurstu.2016.08.007. Epub 2016 Aug 21.
PubMed 27611093Grochtdreis T, Zimmermann T, Puschmann E, Porzelt S, Dams J, Scherer M, Konig HH. Cost-utility of collaborative nurse-led self-management support for primary care patients with anxiety, depressive or somatic symptoms: A cluster-randomized controlled trial (the SMADS trial). Int J Nurs Stud. 2018 Apr;80:67-75. doi: 10.1016/j.ijnurstu.2017.12.010. Epub 2017 Dec 29.
PubMed 29353712
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-Management Support in Primary Care
- ClinicalTrials.gov ID
- NCT01726387
- Acronym / sponsor ID
- SMADS / SMADS
- Conditions
- Anxiety Depression (Mild or Not Persistent), Major Depressive Disorder, Single Episode, Unspecified, Neurotic, Stress-related and Somatoform Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 364 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Collaborators
- German Federal Ministry of Education and Research
- Study start
- Mar 2013
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 14 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Anxiety, Depression and Somatoform disorders are highly prevalent in primary care. Very often these conditions remain undiscovered and/or untreated.
In order to ease this urgent health care problem in the future, the investigators conduct a cluster-randomized controlled trial, implementing a tandem working cooperation between a nurse practitioner (Counseling Assistant - CA) and a general practitioner (GP) on-site its own practise.
The CA's task is to enhance the patients abilities to engage in a better self-management of their psychological symptoms and complaints, to enhance self-efficacy and empower the patients to tackle problems of daily living.
Detailed description
Anxiety, Depression and Somatoform disorders are highly prevalent in primary care. Very often these conditions remain undiscovered and/or untreated. Managing it is time-consuming and communication-intensive. Furthermore, the management is restraint by the high contact-frequencies in primary care practices in Germany.
In order to ease this urgent health care problem in the future, the investigators conduct a cluster-randomized controlled trial, implementing a tandem working cooperation between a nurse practitioner (Counseling Assistant - CA) and a general practitioner (GP) on-site its own practise.
The CA's task is to enhance the patients abilities to engage in a better self-management of their psychological symptoms and complaints, to enhance self-efficacy and empower the patients to tackle problems of daily living.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Psychosocial Counseling | Experimental | Behavioral: Psychosocial CounselingA Counseling Assistant offers a low-threshold intervention (self-management support, counseling, active guidance). This nurse practitioner collaborates extensively with the general practitioner, re-adjusting the intervention in order to meet the patient's needs. |
| Usual Care | Placebo comparator | Behavioral: Usual CareDepending on the conditions, patients get usual care of their general practitioner. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients scoring >= 5 on the Patient Health Questionnaire (German Version), corresponding to a probable or established diagnosis of Anxiety, Depression or Somatoform Disorder
Key exclusion criteria (1 listed)
- Negation of Inclusion Criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychosocial CounselingAlso: Minimal Psychological Intervention, Self-Management SupportDepending on their condition, counseling assistants support patients in self-management support, enhancing self-efficacy, reducing psychological symptoms | Behavioural | Psychosocial Counseling |
| Usual CareDepending on the conditions, patients get usual care of their general practitioner | Behavioural | Usual Care |
Primary outcome
General Self-Efficacy Scale (GSE)
Time frame: Baseline, 8 Weeks, 12 Months
GSE assesses a general sense of perceived self-efficacy. It predicts coping with daily hassles as well as adaptation after experiencing all kinds of stressful life events. http://userpage.fu-berlin.de/%7Ehealth/engscal.htm "The construct of Perceived Self-Efficacy reflects an optimistic self-belief (Schwarzer, 1992). This is the belief that one can perform a novel or difficult tasks, or cope with adversity -- in various domains of human functioning. Perceived self-efficacy facilitates goal-setting, effort investment, persistence in face of barriers and recovery from setbacks. It can be regarded as a positive resistance resource factor. Ten items are designed to tap this construct. Each item refers to successful coping and implies an internal-stable attribution of success. Perceived self-efficacy is an operative construct, i.e., it is related to subsequent behavior and, therefore, is relevant for clinical practice and behavior change."
2 secondary outcomes
Change in Symptom Score Patient's Health Questionnaire (German Version)
Time frame: Baseline, 8 Weeks, 12 Months
Health Related Quality of Life
Time frame: Baseline, 8 Weeks, 12 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2018.
- Background: PubMed 24387048Zimmermann T, Puschmann E, Ebersbach M, Daubmann A, Steinmann S, Scherer M. Effectiveness of a primary care based complex intervention to promote self-management in patients presenting psychiatric symptoms: study protocol of a cluster-randomized controlled trial. BMC Psychiatry. 2014 Jan 3;14:2. doi: 10.1186/1471-244X-14-2.
- BackgroundZimmermann T, Puschmann E, Bäter G, Carstens S, Scherer M. Selbstmanagement stärken bei psychosozialen Belastungen. Die Kerbe - Forum für soziale Psychiatrie 4, 24-26, 2012.
- BackgroundZimmermann T, Puschmann E, Porzelt S, Ebersbach M, Ernst A, Thomsen T, Scherer M. Selbstmanagementförderung in der ambulanten Versorgung. Programm einer niedrigschwelligen, komplexen, psychosozialen Intervention durch Pflegekräfte in der Hausarztpraxis. Zeitschrift für Allgemeinmedizin, 91, 11, 456-462, 2015.
- BackgroundPorzelt S, Zimmermann T, Ernst A, Puschmann E, Scherer M. Wie Pflegekräfte in der hausärztlichen Versorgung Patienten mit psychischen Beschwerden gezielt unterstützen können. Pflegewissenschaft, 18(7-8): 355-361, 2016.
- Results publication: PubMed 26135280Zimmermann T, Puschmann E, Porzelt S, Ebersbach M, Ernst A, Thomsen P, Scherer M. [Promoting Self-Management in Primary Care - the Association of Motivation for Change, Self-Efficacy and Psychological Distress Prior to the Onset of Intervention]. Psychiatr Prax. 2015 Jul;42 Suppl 1:S44-8. doi: 10.1055/s-0034-1387686. Epub 2015 Jul 2. German.
- Results publication: PubMed 27611093Zimmermann T, Puschmann E, van den Bussche H, Wiese B, Ernst A, Porzelt S, Daubmann A, Scherer M. Collaborative nurse-led self-management support for primary care patients with anxiety, depressive or somatic symptoms: Cluster-randomised controlled trial (findings of the SMADS study). Int J Nurs Stud. 2016 Nov;63:101-111. doi: 10.1016/j.ijnurstu.2016.08.007. Epub 2016 Aug 21.
- Results publication: PubMed 29353712Grochtdreis T, Zimmermann T, Puschmann E, Porzelt S, Dams J, Scherer M, Konig HH. Cost-utility of collaborative nurse-led self-management support for primary care patients with anxiety, depressive or somatic symptoms: A cluster-randomized controlled trial (the SMADS trial). Int J Nurs Stud. 2018 Apr;80:67-75. doi: 10.1016/j.ijnurstu.2017.12.010. Epub 2017 Dec 29.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Scherer, Prof. principal investigator
UK Hamburg-Eppendorf (Germany), Department of Primary Medical Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychosocial Counseling in people with Anxiety Depression (Mild or Not Persistent) and Major Depressive Disorder, Single Episode, Unspecified, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
General Self-Efficacy Scale (GSE) (time frame: Baseline, 8 Weeks, 12 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01726387, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2018.