Zimmermann 2014.

Trial name or title	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
Methods	Cluster‐randomised controlled trial in primary care
Participants	340 participants will be enrolled in the study, 170 in either arm. Inclusion criteria are: a PHQ ≥ 5 on the anxiety, depression or somatoform scale, an age of 18‐65 years old, German literacy, fully able to give consent, sufficient auditory and visual capabilities and no current psychotherapeutic treatment
Interventions	Intervention group: a complex, low‐threshold intervention by an Advanced Practice Nurse (APN) using a mixture of case management and counselling techniques to promote self management Control group: usual care
Outcomes	Primary outcome: self efficacy, measured by the General Self‐Efficacy Scale (GSE), here used as a proxy for self management Secondary outcomes: PHQ‐D symptom load and questionnaires regarding coping with illness and health related quality of life. Outcome assessments will be applied 8 weeks and 12 months after the baseline assessment
Starting date	2014
Contact information	t.zimmermann@uke.uni‐hamburg.de
Notes	Design paper: 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 participants presenting psychiatric symptoms: study protocol of a cluster‐randomised controlled trial. BMC Psychiatry 2014;14:2. doi: 10.1186/1471‐244X‐14‐2 Trial registration: Clinicaltrials.gov Identifier: NCT01726387. Results expected: 2015