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

Not Applicable

Completed

• Conditions: Depression; Anxiety; Self Efficacy
• Interventions: Behavioral: Self-management programme

• Registration Number: NCT01989247
• Lead Sponsor: University of Aarhus

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.

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-11-14
• Study First Submitted QC: 2013-11-14
• Study First Posted: 2013-11-20
• Primary Completion: 2014-09
• Study Completion: 2016-01
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-07
• Last Update Posted: 2016-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 853

Inclusion Criteria

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

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Exclusion Criteria

• Potential suicidal behavior
• Potential aggressive behavior
• Significant cognitive impairment

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Self-management program	Self-management programme	Seven weekly sessions of a group-based self-management programme for people with anxiety and depressive symptoms

Primary Outcome Measures

Name	Time	Method
Depressive Symptoms (Beck's Depression Inventory (BDI-II))	Change from 1) Pre-randomization, to 2) Three months post-intervention
State Anxiety (Spielbergers State-Trait Anxiety Inventory (STAI))	Change from 1) Pre-randomization, to 2) Three months post-intervention	Only the State-anxiety subscale of the STAI is used
Self-efficacy (Chronic Disease Self-efficacy Scales - SECD-32 (Stanford Patient Education Research Center))	Change from 1) Pre-randomization, to 2) Three months post-intervention	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))	Change from 1) Pre-randomization, to 2) Three months post-intervention	Only the following subscale from the IPQ-R is used: "Personal Control"

Secondary Outcome Measures

Name	Time	Method
Exercise Behaviors (Stanford Patient Education Research Center)	Change from 1) Pre-randomization, to 2) Three months post-intervention
Health related symptoms	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).
Social/Role Activities Limitations Scale (Stanford Patient Education Research Center)	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))	Change from 1) Pre-randomization, to 2) Three months post-intervention
Sleep Quality (The Pittsburgh Sleep Quality Index)	Change from 1) Pre-randomization, to 2) Three months post-intervention

Trial Locations

Locations (37)

Nordfyn Municipality; 🇩🇰 Bogense, Denmark

Dragør Municipality; 🇩🇰 Dragør, Denmark

Ikast-Brande Municipality; 🇩🇰 Brande, Denmark

Herning Municipality; 🇩🇰 Herning, Denmark

Fredensborg Municipality; 🇩🇰 Kokkedal, Denmark

Aabenraa Municipality; 🇩🇰 Rødekro, Denmark

Roskilde Municipality; 🇩🇰 Roskilde, Denmark

Næstved Municipality; 🇩🇰 Næstved, Denmark

Odense Municipality; 🇩🇰 Odense, Denmark

Silkeborg Municipality; 🇩🇰 Silkeborg, Denmark

Slagelse Municipality; 🇩🇰 Slagelse, Denmark

Sorø Municipality; 🇩🇰 Sorø, Denmark

Rebild Municipality; 🇩🇰 Støvring, Denmark

Gladsaxe Municipality; 🇩🇰 Søborg, Denmark

Sønderborg Municipality; 🇩🇰 Sønderborg, Denmark

Varde Municipality; 🇩🇰 Varde, Denmark

Aalborg Municipality; 🇩🇰 Aalborg, Denmark

Gentofte Municipality; 🇩🇰 Charlottenlund, Denmark

Vesthimmerlands Municipality; 🇩🇰 Farsø, Denmark

Esbjerg Municipality; 🇩🇰 Esbjerg, Denmark

Frederikssund Municipality; 🇩🇰 Frederikssund, Denmark

Norddjurs Municipality; 🇩🇰 Grenå, Denmark

Haderslev Municipality; 🇩🇰 Haderslev, Denmark

Faxe Municipality; 🇩🇰 Haslev, Denmark

Helsingør Municipality; 🇩🇰 Helsingør, Denmark

Holbæk Municipality; 🇩🇰 Holbæk, Denmark

Tårnby Municipality; 🇩🇰 Kastrup, Denmark

Lyngby-Taarbæk Municipality; 🇩🇰 Kongens Lyngby, Denmark

Køge Municipality; 🇩🇰 Køge, Denmark

Hedensted Municipality; 🇩🇰 Løsning, Denmark

Syddjurs Municipality; 🇩🇰 Rønde, Denmark

Skanderborg Municipality; 🇩🇰 Skanderborg, Denmark

Solrød Municipality; 🇩🇰 Solrød Strand, Denmark

Vejen Municipality; 🇩🇰 Vejen, Denmark

Vejle Municipality; 🇩🇰 Vejle, Denmark

Viborg Municipality; 🇩🇰 Viborg, Denmark

Fredericia Municipality; 🇩🇰 Fredericia, Denmark