NCT01726387

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
364

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 3, 2012

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 14, 2012

Completed
4 months until next milestone

Study Start

First participant enrolled

March 1, 2013

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

February 6, 2018

Status Verified

February 1, 2018

Enrollment Period

2.5 years

First QC Date

November 3, 2012

Last Update Submit

February 2, 2018

Conditions

Anxiety Depression (Mild or Not Persistent)Major Depressive Disorder, Single Episode, UnspecifiedNeurotic, Stress-related and Somatoform Disorders

Outcome Measures

Primary Outcomes (1)

  • 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."

    Baseline, 8 Weeks, 12 Months

Secondary Outcomes (2)

  • Change in Symptom Score Patient's Health Questionnaire (German Version)

    Baseline, 8 Weeks, 12 Months

  • Health Related Quality of Life

    Baseline, 8 Weeks, 12 Months

Other Outcomes (1)

  • Coping with Illness scale

    Baseline, 8 Weeks, 12 Months

Study Arms (2)

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.

Behavioral: Psychosocial Counseling

Usual Care

PLACEBO COMPARATOR

Depending on the conditions, patients get usual care of their general practitioner.

Behavioral: Usual Care

Interventions

Psychosocial CounselingBEHAVIORAL

Depending on their condition, counseling assistants support patients in self-management support, enhancing self-efficacy, reducing psychological symptoms

Also known as: Minimal Psychological Intervention, Self-Management Support
Psychosocial Counseling
Usual CareBEHAVIORAL

Depending on the conditions, patients get usual care of their general practitioner

Usual Care

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients scoring \>= 5 on the Patient Health Questionnaire (German Version), corresponding to a probable or established diagnosis of Anxiety, Depression or Somatoform Disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Primary Care Practices

Hamburg, Germany

Location

Related Publications (7)

  • 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.

    PMID: 24387048BACKGROUND

  • Zimmermann T, Puschmann E, Bäter G, Carstens S, Scherer M. Selbstmanagement stärken bei psychosozialen Belastungen. Die Kerbe - Forum für soziale Psychiatrie 4, 24-26, 2012.

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    PMID: 26135280RESULT

  • Zimmermann 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: 27611093RESULT

  • Grochtdreis 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.

    PMID: 29353712RESULT

MeSH Terms

Conditions

Lymphoma, FollicularDepressive Disorder, MajorSomatoform Disorders

Condition Hierarchy (Ancestors)

Lymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesDepressive DisorderMood DisordersMental Disorders

Study Officials

  • Martin Scherer, Prof.

    UK Hamburg-Eppendorf (Germany), Department of Primary Medical Care

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 2012

First Posted

November 14, 2012

Study Start

March 1, 2013

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

February 6, 2018

Record last verified: 2018-02

Locations

DE(1)