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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01989247
Enrollment
853
Registered
2013-11-20
Start date
2013-06-30
Completion date
2016-01-31
Last updated
2016-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Depression, Self Efficacy

Keywords

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

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.

Interventions

BEHAVIORALSelf-management programme

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

Sponsors

National Board of Health, Denmark
CollaboratorOTHER_GOV
Danish Committee for Health Education
CollaboratorOTHER
University of Aarhus
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Depressive Symptoms (Beck's Depression Inventory (BDI-II))Change from 1) Pre-randomization, to 2) Three months post-intervention
Self-efficacy (Personal control from The Revised Illness Perception Questionnaire (IPQ-R))Change from 1) Pre-randomization, to 2) Three months post-interventionOnly the following subscale from the IPQ-R is used: Personal Control
Self-efficacy (Chronic Disease Self-efficacy Scales - SECD-32 (Stanford Patient Education Research Center))Change from 1) Pre-randomization, to 2) Three months post-interventionOnly the following subscale is used: Obtain help from Community, Family, Friends Scale
State Anxiety (Spielbergers State-Trait Anxiety Inventory (STAI))Change from 1) Pre-randomization, to 2) Three months post-interventionOnly the State-anxiety subscale of the STAI is used

Secondary

MeasureTime frameDescription
Exercise Behaviors (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
Health related symptomsChange from 1) Pre-randomization, to 2) Three months post-interventionSelf 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).
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

MeasureTime frameDescription
Coping (The Brief Cope)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
Use of Health benefitsChange from 1) The full year prior to start of intervention, to 2) The three months period following the interventionData on health benefits will be obtained by a linkage with The Danish National Health Insurance Service Registry
Social Constraints (lepore)Change from 1) Pre-randomization, to 2) Three months post-interventionOnly the subscale refering to an important other was administered
Common Mental Disorder Questionaire (CMDQ)Change from 1) Pre-randomization, to 2) Three months post-interventionThe following subscales are included: Somatization SCL-SOM; SCL-ANX4; SCL-DEP6; SCL-8
Health Care UtilizationChange from 1) Pre-randomization, to 2) Three months post-interventionFirst 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.

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026