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Clinical Trials/NCT01989247
NCT01989247
Completed
Not Applicable

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

University of Aarhus37 sites in 1 country853 target enrollmentJune 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Depression
Sponsor
University of Aarhus
Enrollment
853
Locations
37
Primary Endpoint
Depressive Symptoms (Beck's Depression Inventory (BDI-II))
Status
Completed
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 2013
End Date
January 2016
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Søren Christensen

Senior Researcher

University of Aarhus

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

Outcomes

Primary Outcomes

Depressive Symptoms (Beck's Depression Inventory (BDI-II))

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

State Anxiety (Spielbergers State-Trait Anxiety Inventory (STAI))

Time Frame: 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))

Time Frame: 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))

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

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

Secondary Outcomes

  • Social/Role Activities Limitations Scale (Stanford Patient Education Research Center)(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)
  • 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)
  • Health related symptoms(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)

Study Sites (37)

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