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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01989247
• Other study ID #: 1-1010-46/1
• Status: Completed
• Phase: N/A
• First received: November 14, 2013
• Last updated: March 7, 2016
• Start date: June 2013
• Est. completion date: January 2016

Study information

• Verified date: March 2016
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: Ethics Committee
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 853
• Est. completion date: January 2016
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Depression
• Depressive Disorder
• Self Efficacy

Intervention

Behavioral:
• Self-management programme
Seven weekly group-based sessions for people with anxiety and depressive symptoms

Locations

Country	Name	City	State
Denmark	Aalborg Municipality	Aalborg
Denmark	Nordfyn Municipality	Bogense
Denmark	Ikast-Brande Municipality	Brande
Denmark	Gentofte Municipality	Charlottenlund
Denmark	Dragør Municipality	Dragør
Denmark	Esbjerg Municipality	Esbjerg
Denmark	Vesthimmerlands Municipality	Farsø
Denmark	Fredericia Municipality	Fredericia
Denmark	Frederikssund Municipality	Frederikssund
Denmark	Norddjurs Municipality	Grenå
Denmark	Haderslev Municipality	Haderslev
Denmark	Faxe Municipality	Haslev
Denmark	Helsingør Municipality	Helsingør
Denmark	Herning Municipality	Herning
Denmark	Holbæk Municipality	Holbæk
Denmark	Tårnby Municipality	Kastrup
Denmark	Køge Municipality	Køge
Denmark	Fredensborg Municipality	Kokkedal
Denmark	Lyngby-Taarbæk Municipality	Kongens Lyngby
Denmark	Hedensted Municipality	Løsning
Denmark	Næstved Municipality	Næstved
Denmark	Odense Municipality	Odense
Denmark	Aabenraa Municipality	Rødekro
Denmark	Syddjurs Municipality	Rønde
Denmark	Roskilde Municipality	Roskilde
Denmark	Silkeborg Municipality	Silkeborg
Denmark	Skanderborg Municipality	Skanderborg
Denmark	Slagelse Municipality	Slagelse
Denmark	Gladsaxe Municipality	Søborg
Denmark	Solrød Municipality	Solrød Strand
Denmark	Sønderborg Municipality	Sønderborg
Denmark	Sorø Municipality	Sorø
Denmark	Rebild Municipality	Støvring
Denmark	Varde Municipality	Varde
Denmark	Vejen Municipality	Vejen
Denmark	Vejle Municipality	Vejle
Denmark	Viborg Municipality	Viborg

Sponsors (3)

Lead Sponsor	Collaborator
University of Aarhus	Danish Committee for Health Education, National Board of Health, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Common Mental Disorder Questionaire (CMDQ)	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	No
Other	Well-being (WHO-5 Well Being Index)		Change from 1) Pre-randomization, to 2) Three months post-intervention	No
Other	Coping (The Brief Cope)		Change from: 1) Pre-randomization, to 2) Three months post-intervention	No
Other	Health Care Utilization	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	No
Other	Social Constraints (lepore)	Only the subscale refering to an "important other" was administered	Change from 1) Pre-randomization, to 2) Three months post-intervention	No
Other	Use of Health benefits	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	No
Primary	Depressive Symptoms (Beck's Depression Inventory (BDI-II))		Change from 1) Pre-randomization, to 2) Three months post-intervention	No
Primary	State Anxiety (Spielbergers State-Trait Anxiety Inventory (STAI))	Only the State-anxiety subscale of the STAI is used	Change from 1) Pre-randomization, to 2) Three months post-intervention	No
Primary	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"	Change from 1) Pre-randomization, to 2) Three months post-intervention	No
Primary	Self-efficacy ("Personal control" from "The Revised Illness Perception Questionnaire" (IPQ-R))	Only the following subscale from the IPQ-R is used: "Personal Control"	Change from 1) Pre-randomization, to 2) Three months post-intervention	No
Secondary	Sleep Quality (The Pittsburgh Sleep Quality Index)		Change from 1) Pre-randomization, to 2) Three months post-intervention	No
Secondary	Exercise Behaviors (Stanford Patient Education Research Center)		Change from 1) Pre-randomization, to 2) Three months post-intervention	No
Secondary	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).	Change from 1) Pre-randomization, to 2) Three months post-intervention	No
Secondary	Social/Role Activities Limitations Scale (Stanford Patient Education Research Center)		Change from 1) Pre-randomization, to 2) Three months post-intervention	No
Secondary	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	No