Self-Management for Anxiety, Depression and Somatoform Disorders (SMADS)

Universitätsklinikum Hamburg-Eppendorf

Status: Completed

Conditions: Anxiety Depression (Mild or Not Persistent); Major Depressive Disorder, Single Episode, Unspecified; Neurotic, Stress-related and Somatoform Disorders

Treatments: Behavioral: Usual Care; Behavioral: Psychosocial Counseling

Study type: Interventional

Funder types: Other

Identifiers

NCT01726387

SMADS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 364 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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364 participants in 2 patient groups, including a placebo group

Psychosocial Counseling

Experimental group

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.

Treatment:

Behavioral: Psychosocial Counseling

Usual Care

Placebo Comparator group

Description:

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

Treatment:

Behavioral: Usual Care