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

Primary Purpose

Depression, Anxiety, Self Efficacy

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Self-management programme
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Depression, Anxiety, Randomized Controlled Trial, Self Care, Intervention Studies, Health Education

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Aalborg Municipality
  • Nordfyn Municipality
  • Ikast-Brande Municipality
  • Gentofte Municipality
  • Dragør Municipality
  • Esbjerg Municipality
  • Vesthimmerlands Municipality
  • Fredericia Municipality
  • Frederikssund Municipality
  • Norddjurs Municipality
  • Haderslev Municipality
  • Faxe Municipality
  • Helsingør Municipality
  • Herning Municipality
  • Holbæk Municipality
  • Tårnby Municipality
  • Fredensborg Municipality
  • Lyngby-Taarbæk Municipality
  • Køge Municipality
  • Hedensted Municipality
  • Næstved Municipality
  • Odense Municipality
  • Roskilde Municipality
  • Aabenraa Municipality
  • Syddjurs Municipality
  • Silkeborg Municipality
  • Skanderborg Municipality
  • Slagelse Municipality
  • Solrød Municipality
  • Sorø Municipality
  • Rebild Municipality
  • Gladsaxe Municipality
  • Sønderborg Municipality
  • Varde Municipality
  • Vejen Municipality
  • Vejle Municipality
  • Viborg Municipality

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Self-management program

Control group

Arm Description

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

Outcomes

Primary Outcome Measures

Depressive Symptoms (Beck's Depression Inventory (BDI-II))
State Anxiety (Spielbergers State-Trait Anxiety Inventory (STAI))
Only the State-anxiety subscale of the STAI is used
Self-efficacy (Chronic Disease Self-efficacy Scales - SECD-32 (Stanford Patient Education Research Center))
Only the following subscale is used: "Obtain help from Community, Family, Friends Scale"
Self-efficacy ("Personal control" from "The Revised Illness Perception Questionnaire" (IPQ-R))
Only the following subscale from the IPQ-R is used: "Personal Control"

Secondary Outcome Measures

Sleep Quality (The Pittsburgh Sleep Quality Index)
Exercise Behaviors (Stanford Patient Education Research Center)
Health related symptoms
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).
Social/Role Activities Limitations Scale (Stanford Patient Education Research Center)
Self-efficacy ("Control/Manage Depression Scale from: "Chronic Disease Self-efficacy Scales - SECD-32 (Stanford Patient Education Research Center))

Full Information

First Posted
November 14, 2013
Last Updated
March 7, 2016
Sponsor
University of Aarhus
Collaborators
National Board of Health, Denmark, Danish Committee for Health Education
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1. Study Identification

Unique Protocol Identification Number
NCT01989247
Brief Title
How to Cope With Anxiety and Depression. A Randomized Controlled Trial.
Official Title
Self-management of Depression and Anxiety. A Randomized Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Aarhus
Collaborators
National Board of Health, Denmark, Danish Committee for Health Education

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Anxiety, Self Efficacy
Keywords
Depression, Anxiety, Randomized Controlled Trial, Self Care, Intervention Studies, Health Education

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
853 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Self-management program
Arm Type
Experimental
Arm Description
Seven weekly sessions of a group-based self-management programme for people with anxiety and depressive symptoms
Arm Title
Control group
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Self-management programme
Intervention Description
Seven weekly group-based sessions for people with anxiety and depressive symptoms
Primary Outcome Measure Information:
Title
Depressive Symptoms (Beck's Depression Inventory (BDI-II))
Time Frame
Change from 1) Pre-randomization, to 2) Three months post-intervention
Title
State Anxiety (Spielbergers State-Trait Anxiety Inventory (STAI))
Description
Only the State-anxiety subscale of the STAI is used
Time Frame
Change from 1) Pre-randomization, to 2) Three months post-intervention
Title
Self-efficacy (Chronic Disease Self-efficacy Scales - SECD-32 (Stanford Patient Education Research Center))
Description
Only the following subscale is used: "Obtain help from Community, Family, Friends Scale"
Time Frame
Change from 1) Pre-randomization, to 2) Three months post-intervention
Title
Self-efficacy ("Personal control" from "The Revised Illness Perception Questionnaire" (IPQ-R))
Description
Only the following subscale from the IPQ-R is used: "Personal Control"
Time Frame
Change from 1) Pre-randomization, to 2) Three months post-intervention
Secondary Outcome Measure Information:
Title
Sleep Quality (The Pittsburgh Sleep Quality Index)
Time Frame
Change from 1) Pre-randomization, to 2) Three months post-intervention
Title
Exercise Behaviors (Stanford Patient Education Research Center)
Time Frame
Change from 1) Pre-randomization, to 2) Three months post-intervention
Title
Health related symptoms
Description
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).
Time Frame
Change from 1) Pre-randomization, to 2) Three months post-intervention
Title
Social/Role Activities Limitations Scale (Stanford Patient Education Research Center)
Time Frame
Change from 1) Pre-randomization, to 2) Three months post-intervention
Title
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
Other Pre-specified Outcome Measures:
Title
Common Mental Disorder Questionaire (CMDQ)
Description
The following subscales are included: Somatization SCL-SOM; SCL-ANX4; SCL-DEP6; SCL-8
Time Frame
Change from 1) Pre-randomization, to 2) Three months post-intervention
Title
Well-being (WHO-5 Well Being Index)
Time Frame
Change from 1) Pre-randomization, to 2) Three months post-intervention
Title
Coping (The Brief Cope)
Time Frame
Change from: 1) Pre-randomization, to 2) Three months post-intervention
Title
Health Care Utilization
Description
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.
Time Frame
Change from 1) Pre-randomization, to 2) Three months post-intervention
Title
Social Constraints (lepore)
Description
Only the subscale refering to an "important other" was administered
Time Frame
Change from 1) Pre-randomization, to 2) Three months post-intervention
Title
Use of Health benefits
Description
Data on health benefits will be obtained by a linkage with The Danish National Health Insurance Service Registry
Time Frame
Change from 1) The full year prior to start of intervention, to 2) The three months period following the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Soren Christensen, MSc
Organizational Affiliation
Aarhus University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mimi Y Mehlsen, PhD
Organizational Affiliation
University of Aarhus
Official's Role
Study Director
Facility Information:
Facility Name
Aalborg Municipality
City
Aalborg
ZIP/Postal Code
9000
Country
Denmark
Facility Name
Nordfyn Municipality
City
Bogense
ZIP/Postal Code
5400
Country
Denmark
Facility Name
Ikast-Brande Municipality
City
Brande
ZIP/Postal Code
7330
Country
Denmark
Facility Name
Gentofte Municipality
City
Charlottenlund
ZIP/Postal Code
2920
Country
Denmark
Facility Name
Dragør Municipality
City
Dragør
ZIP/Postal Code
2791
Country
Denmark
Facility Name
Esbjerg Municipality
City
Esbjerg
ZIP/Postal Code
6700
Country
Denmark
Facility Name
Vesthimmerlands Municipality
City
Farsø
ZIP/Postal Code
9640
Country
Denmark
Facility Name
Fredericia Municipality
City
Fredericia
ZIP/Postal Code
7000
Country
Denmark
Facility Name
Frederikssund Municipality
City
Frederikssund
ZIP/Postal Code
3600
Country
Denmark
Facility Name
Norddjurs Municipality
City
Grenå
ZIP/Postal Code
8500
Country
Denmark
Facility Name
Haderslev Municipality
City
Haderslev
ZIP/Postal Code
6100
Country
Denmark
Facility Name
Faxe Municipality
City
Haslev
ZIP/Postal Code
4690
Country
Denmark
Facility Name
Helsingør Municipality
City
Helsingør
ZIP/Postal Code
3000
Country
Denmark
Facility Name
Herning Municipality
City
Herning
ZIP/Postal Code
7400
Country
Denmark
Facility Name
Holbæk Municipality
City
Holbæk
ZIP/Postal Code
4300
Country
Denmark
Facility Name
Tårnby Municipality
City
Kastrup
ZIP/Postal Code
2770
Country
Denmark
Facility Name
Fredensborg Municipality
City
Kokkedal
ZIP/Postal Code
2980
Country
Denmark
Facility Name
Lyngby-Taarbæk Municipality
City
Kongens Lyngby
ZIP/Postal Code
2800
Country
Denmark
Facility Name
Køge Municipality
City
Køge
ZIP/Postal Code
4600
Country
Denmark
Facility Name
Hedensted Municipality
City
Løsning
ZIP/Postal Code
8723
Country
Denmark
Facility Name
Næstved Municipality
City
Næstved
ZIP/Postal Code
4700
Country
Denmark
Facility Name
Odense Municipality
City
Odense
ZIP/Postal Code
5000
Country
Denmark
Facility Name
Roskilde Municipality
City
Roskilde
ZIP/Postal Code
4000
Country
Denmark
Facility Name
Aabenraa Municipality
City
Rødekro
ZIP/Postal Code
6230
Country
Denmark
Facility Name
Syddjurs Municipality
City
Rønde
ZIP/Postal Code
8410
Country
Denmark
Facility Name
Silkeborg Municipality
City
Silkeborg
ZIP/Postal Code
8600
Country
Denmark
Facility Name
Skanderborg Municipality
City
Skanderborg
ZIP/Postal Code
8660
Country
Denmark
Facility Name
Slagelse Municipality
City
Slagelse
ZIP/Postal Code
4200
Country
Denmark
Facility Name
Solrød Municipality
City
Solrød Strand
ZIP/Postal Code
2680
Country
Denmark
Facility Name
Sorø Municipality
City
Sorø
ZIP/Postal Code
4180
Country
Denmark
Facility Name
Rebild Municipality
City
Støvring
ZIP/Postal Code
9530
Country
Denmark
Facility Name
Gladsaxe Municipality
City
Søborg
ZIP/Postal Code
2860
Country
Denmark
Facility Name
Sønderborg Municipality
City
Sønderborg
ZIP/Postal Code
6400
Country
Denmark
Facility Name
Varde Municipality
City
Varde
ZIP/Postal Code
6800
Country
Denmark
Facility Name
Vejen Municipality
City
Vejen
ZIP/Postal Code
6600
Country
Denmark
Facility Name
Vejle Municipality
City
Vejle
ZIP/Postal Code
7100
Country
Denmark
Facility Name
Viborg Municipality
City
Viborg
ZIP/Postal Code
8800
Country
Denmark

12. IPD Sharing Statement

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

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