Self-Management for Anxiety, Depression and Somatoform Disorders

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

364 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2015-09-30

Brief Summary

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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.

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Detailed Description

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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

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Psychosocial Counseling

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.

Group Type EXPERIMENTAL

Psychosocial Counseling

Intervention Type BEHAVIORAL

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

Usual Care

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

Group Type PLACEBO_COMPARATOR

Usual Care

Intervention Type BEHAVIORAL

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

Interventions

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Psychosocial Counseling

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

Intervention Type BEHAVIORAL

Usual Care

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

Intervention Type BEHAVIORAL

Other Intervention Names

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Minimal Psychological Intervention Self-Management Support

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No