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

NCT01989247 | Completed

• 1 other identifier: 1-1010-46/1
• Study Type: interventional
• Target: 853
• Locations: 1 country
• Sites: 37

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)

Conditions

Depression; Anxiety; Self Efficacy

Keywords

Depression; Anxiety; Randomized Controlled Trial; Self Care; Intervention Studies; Health Education

Outcome Measures

Primary Outcomes (4)

• 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))

  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))

  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))

  Only the following subscale from the IPQ-R is used: "Personal Control"

  Change from 1) Pre-randomization, to 2) Three months post-intervention

Secondary Outcomes (5)

• Sleep Quality (The Pittsburgh Sleep Quality Index)

  Change from 1) Pre-randomization, to 2) Three months post-intervention

• 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

• 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

Other Outcomes (6)

• Common Mental Disorder Questionaire (CMDQ)

  Change from 1) Pre-randomization, to 2) Three months post-intervention

• Well-being (WHO-5 Well Being Index)

  Change from 1) Pre-randomization, to 2) Three months post-intervention

• Coping (The Brief Cope)

  Change from: 1) Pre-randomization, to 2) Three months post-intervention

Study Arms (2)

Self-management program

EXPERIMENTAL

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

Behavioral: Self-management programme

Control group

NO INTERVENTION

Interventions

Self-management programme BEHAVIORAL

Seven weekly group-based sessions for people with anxiety and depressive symptoms

Self-management program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Aarhus: lead
• National Board of Health, Denmark: collaborator
• Danish Committee for Health Education: collaborator

Study Sites (37)

Aalborg Municipality

Aalborg, 9000, Denmark

Location

Nordfyn Municipality

Bogense, 5400, Denmark

Location

Ikast-Brande Municipality

Brande, 7330, Denmark

Location

Gentofte Municipality

Charlottenlund, 2920, Denmark

Location

Dragør Municipality

Dragør, 2791, Denmark

Location

Helsingør Municipality

Elsinore, 3000, Denmark

Location

Esbjerg Municipality

Esbjerg, 6700, Denmark

Location

Vesthimmerlands Municipality

Farsø, 9640, Denmark

Location

Fredericia Municipality

Fredericia, 7000, Denmark

Location

Frederikssund Municipality

Frederikssund, 3600, Denmark

Location

Norddjurs Municipality

Grenå, 8500, Denmark

Location

Haderslev Municipality

Haderslev, 6100, Denmark

Location

Faxe Municipality

Haslev, 4690, Denmark

Location

Herning Municipality

Herning, 7400, Denmark

Location

Holbæk Municipality

Holbæk, 4300, Denmark

Location

Tårnby Municipality

Kastrup, 2770, Denmark

Location

Fredensborg Municipality

Kokkedal, 2980, Denmark

Location

Lyngby-Taarbæk Municipality

Kongens Lyngby, 2800, Denmark

Location

Køge Municipality

Køge, 4600, Denmark

Location

Hedensted Municipality

Løsning, 8723, Denmark

Location

Næstved Municipality

Næstved, 4700, Denmark

Location

Odense Municipality

Odense, 5000, Denmark

Location

Roskilde Municipality

Roskilde, 4000, Denmark

Location

Aabenraa Municipality

Rødekro, 6230, Denmark

Location

Syddjurs Municipality

Rønde, 8410, Denmark

Location

Silkeborg Municipality

Silkeborg, 8600, Denmark

Location

Skanderborg Municipality

Skanderborg, 8660, Denmark

Location

Slagelse Municipality

Slagelse, 4200, Denmark

Location

Solrød Municipality

Solrød Strand, 2680, Denmark

Location

Sorø Municipality

Sorø, 4180, Denmark

Location

Rebild Municipality

Støvring, 9530, Denmark

Location

Gladsaxe Municipality

Søborg, 2860, Denmark

Location

Sønderborg Municipality

Sønderborg, 6400, Denmark

Location

Varde Municipality

Varde, 6800, Denmark

Location

Vejen Municipality

Vejen Municipality, 6600, Denmark

Location

Vejle Municipality

Vejle, 7100, Denmark

Location

Viborg Municipality

Viborg, 8800, Denmark

Location

MeSH Terms

Conditions

Depression; Anxiety Disorders; Health Education

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Adherence Interventions; Medication Adherence; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior

Study Officials

• Soren Christensen, MSc

  Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

• Mimi Y Mehlsen, PhD

  University of Aarhus

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Researcher

Study Record Dates

• First Submitted: November 14, 2013
• First Posted: November 20, 2013
• Study Start: June 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: January 1, 2016
• Last Updated: March 8, 2016

Record last verified: 2016-03

Locations

DK (37)