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

March 7, 2016 updated by: Søren Christensen, University of Aarhus

Self-management of Depression and Anxiety. A Randomized Controlled Trial.

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

  • 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.

Study Type

Interventional

Enrollment (Actual)

853

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aalborg, Denmark, 9000
        • Aalborg Municipality
      • Bogense, Denmark, 5400
        • Nordfyn Municipality
      • Brande, Denmark, 7330
        • Ikast-Brande Municipality
      • Charlottenlund, Denmark, 2920
        • Gentofte Municipality
      • Dragør, Denmark, 2791
        • Dragør Municipality
      • Esbjerg, Denmark, 6700
        • Esbjerg Municipality
      • Farsø, Denmark, 9640
        • Vesthimmerlands Municipality
      • Fredericia, Denmark, 7000
        • Fredericia Municipality
      • Frederikssund, Denmark, 3600
        • Frederikssund Municipality
      • Grenå, Denmark, 8500
        • Norddjurs Municipality
      • Haderslev, Denmark, 6100
        • Haderslev Municipality
      • Haslev, Denmark, 4690
        • Faxe Municipality
      • Helsingør, Denmark, 3000
        • Helsingør Municipality
      • Herning, Denmark, 7400
        • Herning Municipality
      • Holbæk, Denmark, 4300
        • Holbæk Municipality
      • Kastrup, Denmark, 2770
        • Tårnby Municipality
      • Kokkedal, Denmark, 2980
        • Fredensborg Municipality
      • Kongens Lyngby, Denmark, 2800
        • Lyngby-Taarbæk Municipality
      • Køge, Denmark, 4600
        • Køge Municipality
      • Løsning, Denmark, 8723
        • Hedensted Municipality
      • Næstved, Denmark, 4700
        • Næstved Municipality
      • Odense, Denmark, 5000
        • Odense municipality
      • Roskilde, Denmark, 4000
        • Roskilde Municipality
      • Rødekro, Denmark, 6230
        • Aabenraa Municipality
      • Rønde, Denmark, 8410
        • Syddjurs municipality
      • Silkeborg, Denmark, 8600
        • Silkeborg municipality
      • Skanderborg, Denmark, 8660
        • Skanderborg Municipality
      • Slagelse, Denmark, 4200
        • Slagelse Municipality
      • Solrød Strand, Denmark, 2680
        • Solrød Municipality
      • Sorø, Denmark, 4180
        • Sorø municipality
      • Støvring, Denmark, 9530
        • Rebild Municipality
      • Søborg, Denmark, 2860
        • Gladsaxe Municipality
      • Sønderborg, Denmark, 6400
        • Sønderborg Municipality
      • Varde, Denmark, 6800
        • Varde Municipality
      • Vejen, Denmark, 6600
        • Vejen Municipality
      • Vejle, Denmark, 7100
        • Vejle Municipality
      • Viborg, Denmark, 8800
        • Viborg Municipality

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
Experimental: Self-management program
Seven weekly sessions of a group-based self-management programme for people with anxiety and depressive symptoms
Behavioral: Self-management programme
Seven weekly group-based sessions for people with anxiety and depressive symptoms

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Depressive Symptoms (Beck's Depression Inventory (BDI-II))
Time Frame: Change from 1) Pre-randomization, to 2) Three months post-intervention
Change from 1) Pre-randomization, to 2) Three months post-intervention
State Anxiety (Spielbergers State-Trait Anxiety Inventory (STAI))
Time Frame: Change from 1) Pre-randomization, to 2) Three months post-intervention
Only the State-anxiety subscale of the STAI is used
Change from 1) Pre-randomization, to 2) Three months post-intervention
Self-efficacy (Chronic Disease Self-efficacy Scales - SECD-32 (Stanford Patient Education Research Center))
Time Frame: Change from 1) Pre-randomization, to 2) Three months post-intervention
Only the following subscale is used: "Obtain help from Community, Family, Friends Scale"
Change from 1) Pre-randomization, to 2) Three months post-intervention
Self-efficacy ("Personal control" from "The Revised Illness Perception Questionnaire" (IPQ-R))
Time Frame: Change from 1) Pre-randomization, to 2) Three months post-intervention
Only the following subscale from the IPQ-R is used: "Personal Control"
Change from 1) Pre-randomization, to 2) Three months post-intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sleep Quality (The Pittsburgh Sleep Quality Index)
Time Frame: Change from 1) Pre-randomization, to 2) Three months post-intervention
Change from 1) Pre-randomization, to 2) Three months post-intervention
Exercise Behaviors (Stanford Patient Education Research Center)
Time Frame: Change from 1) Pre-randomization, to 2) Three months post-intervention
Change from 1) Pre-randomization, to 2) Three months post-intervention
Health related symptoms
Time Frame: Change from 1) Pre-randomization, to 2) Three months post-intervention

Self related overall health: Stanford Patient Education Research Center (1 item).

Fatigue: Visual Analogue Scale. Stanford Patient Education Research Center (1 Item).

Pain: Visual Analogue Scale. Stanford Patient Education Research Center (1 item).
Change from 1) Pre-randomization, to 2) Three months post-intervention
Social/Role Activities Limitations Scale (Stanford Patient Education Research Center)
Time Frame: Change from 1) Pre-randomization, to 2) Three months post-intervention
Change from 1) Pre-randomization, to 2) Three months post-intervention
Self-efficacy ("Control/Manage Depression Scale from: "Chronic Disease Self-efficacy Scales - SECD-32 (Stanford Patient Education Research Center))
Time Frame: Change from 1) Pre-randomization, to 2) Three months post-intervention
Change from 1) Pre-randomization, to 2) Three months post-intervention

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Common Mental Disorder Questionaire (CMDQ)
Time Frame: Change from 1) Pre-randomization, to 2) Three months post-intervention
The following subscales are included: Somatization SCL-SOM; SCL-ANX4; SCL-DEP6; SCL-8
Change from 1) Pre-randomization, to 2) Three months post-intervention
Well-being (WHO-5 Well Being Index)
Time Frame: Change from 1) Pre-randomization, to 2) Three months post-intervention
Change from 1) Pre-randomization, to 2) Three months post-intervention
Coping (The Brief Cope)
Time Frame: Change from: 1) Pre-randomization, to 2) Three months post-intervention
Change from: 1) Pre-randomization, to 2) Three months post-intervention
Health Care Utilization
Time Frame: Change from 1) Pre-randomization, to 2) Three months post-intervention
First two items from "Health Care Utilization" (Stanford Patient Education Research Center). Measured within the recent two months instead of six as used in the original scale.
Change from 1) Pre-randomization, to 2) Three months post-intervention
Social Constraints (lepore)
Time Frame: Change from 1) Pre-randomization, to 2) Three months post-intervention
Only the subscale refering to an "important other" was administered
Change from 1) Pre-randomization, to 2) Three months post-intervention
Use of Health benefits
Time Frame: Change from 1) The full year prior to start of intervention, to 2) The three months period following the intervention
Data on health benefits will be obtained by a linkage with The Danish National Health Insurance Service Registry
Change from 1) The full year prior to start of intervention, to 2) The three months period following the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Collaborators

National Board of Health, Denmark
Danish Committee for Health Education

Investigators

  • Principal Investigator: Soren Christensen, MSc, Aarhus University Hospital
  • Study Director: Mimi Y Mehlsen, PhD, University of Aarhus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

November 14, 2013

First Submitted That Met QC Criteria

November 14, 2013

First Posted (Estimate)

November 20, 2013

Study Record Updates

Last Update Posted (Estimate)

March 8, 2016

Last Update Submitted That Met QC Criteria

March 7, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1-1010-46/1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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