How to Cope With Anxiety and Depression. A Randomized Controlled Trial.

NCT ID: NCT01989247

Last Updated: 2016-03-08

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

853 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2016-01-31

Brief Summary

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The purpose of this study is to investigate whether citizens experiencing symptoms of anxiety and depression will benefit from a self-management training program with respect to: 1) Self-efficacy, and 2) Symptoms of anxiety and depression, and 3) Self reported measures of Health Related Quality of Life (HRQoL)

Detailed Description

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* The intervention is a Danish adaption of The Chronic Disease Self-Management Program developed by The Stanford Patient Education Research Center, The Expert Patient Program Community Interest Company (EPPCIC), and The English National Health Service (NHS).
* The Danish adaptation has been performed by The Danish Committee for Health Education.

Conditions

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Depression Anxiety Self Efficacy

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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Self-management program

Seven weekly sessions of a group-based self-management programme for people with anxiety and depressive symptoms

Group Type EXPERIMENTAL

Self-management programme

Intervention Type BEHAVIORAL

Seven weekly group-based sessions for people with anxiety and depressive symptoms

Control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Self-management programme

Seven weekly group-based sessions for people with anxiety and depressive symptoms

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* \>= 18 years of age
* Suffering from anxiety and/or depressive symptoms
* Voluntary participation

Exclusion Criteria

* Potential suicidal behavior
* Potential aggressive behavior
* Significant cognitive impairment
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Board of Health, Denmark

OTHER_GOV

Sponsor Role collaborator

Danish Committee for Health Education

OTHER

Sponsor Role collaborator

University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Søren Christensen

Senior Researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Soren Christensen, MSc

Role: PRINCIPAL_INVESTIGATOR

Aarhus University Hospital

Mimi Y Mehlsen, PhD

Role: STUDY_DIRECTOR

University of Aarhus

Locations

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Aalborg Municipality

Aalborg, , Denmark

Site Status

Nordfyn Municipality

Bogense, , Denmark

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Ikast-Brande Municipality

Brande, , Denmark

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Gentofte Municipality

Charlottenlund, , Denmark

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Dragør Municipality

Dragør, , Denmark

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Helsingør Municipality

Elsinore, , Denmark

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Esbjerg Municipality

Esbjerg, , Denmark

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Vesthimmerlands Municipality

Farsø, , Denmark

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Fredericia Municipality

Fredericia, , Denmark

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Frederikssund Municipality

Frederikssund, , Denmark

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Norddjurs Municipality

Grenå, , Denmark

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Haderslev Municipality

Haderslev, , Denmark

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Faxe Municipality

Haslev, , Denmark

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Herning Municipality

Herning, , Denmark

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Holbæk Municipality

Holbæk, , Denmark

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Tårnby Municipality

Kastrup, , Denmark

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Fredensborg Municipality

Kokkedal, , Denmark

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Lyngby-Taarbæk Municipality

Kongens Lyngby, , Denmark

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Køge Municipality

Køge, , Denmark

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Hedensted Municipality

Løsning, , Denmark

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Næstved Municipality

Næstved, , Denmark

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Odense Municipality

Odense, , Denmark

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Roskilde Municipality

Roskilde, , Denmark

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Aabenraa Municipality

Rødekro, , Denmark

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Syddjurs Municipality

Rønde, , Denmark

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Silkeborg Municipality

Silkeborg, , Denmark

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Skanderborg Municipality

Skanderborg, , Denmark

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Slagelse Municipality

Slagelse, , Denmark

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Solrød Municipality

Solrød Strand, , Denmark

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Sorø Municipality

Sorø, , Denmark

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Rebild Municipality

Støvring, , Denmark

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Gladsaxe Municipality

Søborg, , Denmark

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Sønderborg Municipality

Sønderborg, , Denmark

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Varde Municipality

Varde, , Denmark

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Vejen Municipality

Vejen Municipality, , Denmark

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Vejle Municipality

Vejle, , Denmark

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Viborg Municipality

Viborg, , Denmark

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Countries

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Denmark

Other Identifiers

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1-1010-46/1

Identifier Type: -

Identifier Source: org_study_id

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