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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Depression, Anxiety, Self Efficacy

Intervention / Treatment
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* Behavioral: Self-management programme


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Self-management program<br>Seven weekly sessions of a group-based self-management programme for people with anxiety and depressive symptoms | Behavioral: Self-management programme<br>* Seven weekly group-based sessions for people with anxiety and depressive symptoms<br>|
| No Intervention: Control group<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Depression, Anxiety, Randomized Controlled Trial, Self Care, Intervention Studies, Health Education