Clinical trial · Interventional
Self-Management for Anxiety, Depression and Somatoform Disorders
Self-Management Support in Primary Care
NCT01726387CI-TRIAL-00031550SMADScompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anxiety Depression (Mild or Not Persistent) | — | UNRESOLVED | — |
| Major Depressive Disorder, Single Episode, Unspecified | — | UNRESOLVED | — |
| Neurotic, Stress-related and Somatoform Disorders | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Psychosocial Counseling | Behavioral | — | UNRESOLVED |
| Usual Care | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Psychosocial Counseling
- description
- 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.
- interventionNames
- Behavioral: Psychosocial Counseling
- type
- PLACEBO_COMPARATOR
- label
- Usual Care
- description
- Depending on the conditions, patients get usual care of their general practitioner.
- interventionNames
- Behavioral: Usual Care
Primary outcomes (1)
- measure
- General Self-Efficacy Scale (GSE)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Patients scoring \>= 5 on the Patient Health Questionnaire (German Version), corresponding to a probable or established diagnosis of Anxiety, Depression or Somatoform Disorder Exclusion Criteria: * Negation of Inclusion Criteria
References
Publications (7)
- BACKGROUNDZimmermann 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. PMID 24387048
- 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.
- RESULTZimmermann 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. PMID 26135280
- RESULTZimmermann 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. PMID 27611093
- RESULTGrochtdreis 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.