Self-management of Depression and Anxiety. A Randomized Controlled Trial.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Aarhus
- Enrollment
- 853
- Locations
- 37
- Primary Endpoint
- Depressive Symptoms (Beck's Depression Inventory (BDI-II))
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Self-management program
Seven weekly sessions of a group-based self-management programme for people with anxiety and depressive symptoms
Intervention: Self-management programme (Behavioral)
Control group
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
- 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)
- Sleep Quality (The Pittsburgh Sleep Quality Index)(Change from 1) Pre-randomization, to 2) Three months post-intervention)
Investigators
Søren Christensen
Senior Researcher
University of Aarhus