Clinical trial NCT01989247: 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
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Anxiety
Self Efficacy
Keywords: Depression
Anxiety
Randomized Controlled Trial
Self Care
Intervention Studies
Health Education
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: National Board of Health, Denmark
name: Danish Committee for Health Education
First posted: 2013-11-20
Enrollment: 853
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Depressive Symptoms (Beck's Depression Inventory (BDI-II))
timeFrame: Change from 1) Pre-randomization, to 2) Three months post-intervention
measure: State Anxiety (Spielbergers State-Trait Anxiety Inventory (STAI))
timeFrame: Change from 1) Pre-randomization, to 2) Three months post-intervention
measure: Self-efficacy (Chronic Disease Self-efficacy Scales - SECD-32 (Stanford Patient Education Research Center))
timeFrame: Change from 1) Pre-randomization, to 2) Three months post-intervention
measure: Self-efficacy ("Personal control" from "The Revised Illness Perception Questionnaire" (IPQ-R))
timeFrame: Change from 1) Pre-randomization, to 2) Three months post-intervention
Secondary outcomes:
measure: Sleep Quality (The Pittsburgh Sleep Quality Index)
timeFrame: Change from 1) Pre-randomization, to 2) Three months post-intervention
measure: Exercise Behaviors (Stanford Patient Education Research Center)
timeFrame: Change from 1) Pre-randomization, to 2) Three months post-intervention
measure: Health related symptoms
timeFrame: Change from 1) Pre-randomization, to 2) Three months post-intervention
measure: Social/Role Activities Limitations Scale (Stanford Patient Education Research Center)
timeFrame: Change from 1) Pre-randomization, to 2) Three months post-intervention
measure: Self-efficacy ("Control/Manage Depression Scale from: "Chronic Disease Self-efficacy Scales - SECD-32 (Stanford Patient Education Research Center))
timeFrame: Change from 1) Pre-randomization, to 2) Three months post-intervention
Other outcomes:
measure: Common Mental Disorder Questionaire (CMDQ)
timeFrame: Change from 1) Pre-randomization, to 2) Three months post-intervention
measure: Well-being (WHO-5 Well Being Index)
timeFrame: Change from 1) Pre-randomization, to 2) Three months post-intervention
measure: Coping (The Brief Cope)
timeFrame: Change from: 1) Pre-randomization, to 2) Three months post-intervention
measure: Health Care Utilization
timeFrame: Change from 1) Pre-randomization, to 2) Three months post-intervention
measure: Social Constraints (lepore)
timeFrame: Change from 1) Pre-randomization, to 2) Three months post-intervention
measure: Use of Health benefits
timeFrame: Change from 1) The full year prior to start of intervention, to 2) The three months period following the intervention
Locations:
city: Aalborg
country: Denmark
facility: Aalborg Municipality
city: Bogense
country: Denmark
facility: Nordfyn Municipality
city: Brande
country: Denmark
facility: Ikast-Brande Municipality
city: Charlottenlund
country: Denmark
facility: Gentofte Municipality
city: Dragør
country: Denmark
facility: Dragør Municipality
city: Esbjerg
country: Denmark
facility: Esbjerg Municipality
city: Farsø
country: Denmark
facility: Vesthimmerlands Municipality
city: Fredericia
country: Denmark
facility: Fredericia Municipality
city: Frederikssund
country: Denmark
facility: Frederikssund Municipality
city: Grenå
country: Denmark
facility: Norddjurs Municipality
city: Haderslev
country: Denmark
facility: Haderslev Municipality
city: Haslev
country: Denmark
facility: Faxe Municipality
city: Helsingør
country: Denmark
facility: Helsingør Municipality
city: Herning
country: Denmark
facility: Herning Municipality
city: Holbæk
country: Denmark
facility: Holbæk Municipality
city: Kastrup
country: Denmark
facility: Tårnby Municipality
city: Kokkedal
country: Denmark
facility: Fredensborg Municipality
city: Kongens Lyngby
country: Denmark
facility: Lyngby-Taarbæk Municipality
city: Køge
country: Denmark
facility: Køge Municipality
city: Løsning
country: Denmark
facility: Hedensted Municipality
city: Næstved
country: Denmark
facility: Næstved Municipality
city: Odense
country: Denmark
facility: Odense Municipality
city: Roskilde
country: Denmark
facility: Roskilde Municipality
city: Rødekro
country: Denmark
facility: Aabenraa Municipality
city: Rønde
country: Denmark
facility: Syddjurs Municipality
city: Silkeborg
country: Denmark
facility: Silkeborg Municipality
city: Skanderborg
country: Denmark
facility: Skanderborg Municipality
city: Slagelse
country: Denmark
facility: Slagelse Municipality
city: Solrød Strand
country: Denmark
facility: Solrød Municipality
city: Sorø
country: Denmark
facility: Sorø Municipality
city: Støvring
country: Denmark
facility: Rebild Municipality
city: Søborg
country: Denmark
facility: Gladsaxe Municipality
city: Sønderborg
country: Denmark
facility: Sønderborg Municipality
city: Varde
country: Denmark
facility: Varde Municipality
city: Vejen
country: Denmark
facility: Vejen Municipality
city: Vejle
country: Denmark
facility: Vejle Municipality
city: Viborg
country: Denmark
facility: Viborg Municipality
Study officials:
affiliation: Aarhus University Hospital
name: Soren Christensen, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Aarhus
name: Mimi Y Mehlsen, PhD
role: STUDY_DIRECTOR
References: