DepressionNCT01989247
How to Cope With Anxiety and Depression. A Randomized Controlled Trial.
A study testing Self-management programme in people with Depression and Anxiety, run by University of Aarhus at 37 sites in Denmark.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, Anxiety, Self Efficacy
- What is being tested?
- Self-management programme
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 853 participants
- Where
- 37 sitesDenmark
- Study dates
- Jun 2013to Jan 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >= 18 years of age
- Suffering from anxiety and/or depressive symptoms
- Voluntary participation
Who cannot join
- Potential suicidal behavior
- Potential aggressive behavior
- Significant cognitive impairment
Trial locations and contacts
37 sites in 1 country.
37 sites in 1 country
Denmark37 sites
Aalborg Municipality
Aalborg, 9000
Nordfyn Municipality
Bogense, 5400
Ikast-Brande Municipality
Brande, 7330
Gentofte Municipality
Charlottenlund, 2920
Dragør Municipality
Dragør, 2791
Helsingør Municipality
Elsinore, 3000
Esbjerg Municipality
Esbjerg, 6700
Vesthimmerlands Municipality
Farsø, 9640
Fredericia Municipality
Fredericia, 7000
Frederikssund Municipality
Frederikssund, 3600
Norddjurs Municipality
Grenå, 8500
Haderslev Municipality
Haderslev, 6100
Faxe Municipality
Haslev, 4690
Herning Municipality
Herning, 7400
Holbæk Municipality
Holbæk, 4300
Tårnby Municipality
Kastrup, 2770
Køge Municipality
Køge, 4600
Fredensborg Municipality
Kokkedal, 2980
Lyngby-Taarbæk Municipality
Kongens Lyngby, 2800
Hedensted Municipality
Løsning, 8723
Næstved Municipality
Næstved, 4700
Odense Municipality
Odense, 5000
Aabenraa Municipality
Rødekro, 6230
Syddjurs Municipality
Rønde, 8410
Roskilde Municipality
Roskilde, 4000
Silkeborg Municipality
Silkeborg, 8600
Skanderborg Municipality
Skanderborg, 8660
Slagelse Municipality
Slagelse, 4200
Gladsaxe Municipality
Søborg, 2860
Solrød Municipality
Solrød Strand, 2680
Sønderborg Municipality
Sønderborg, 6400
Sorø Municipality
Sorø, 4180
Rebild Municipality
Støvring, 9530
Varde Municipality
Varde, 6800
Vejen Municipality
Vejen Municipality, 6600
Vejle Municipality
Vejle, 7100
Viborg Municipality
Viborg, 8800
About this study
Official title: Self-management of Depression and Anxiety. A Randomized Controlled Trial.
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)
Read the 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.
- Conditions
- Depression, Anxiety, Self Efficacy
- Being tested
- Self-management programme
- Keywords
- Depression, Anxiety, Randomized Controlled Trial, Self Care, Intervention Studies, Health Education
- Medical subject headings
- Depression, Anxiety Disorders, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-management programmeBehavioural
Seven weekly group-based sessions for people with anxiety and depressive symptoms
| Study group | Role | What they receive |
|---|---|---|
| Self-management program | Experimental | Seven weekly sessions of a group-based self-management programme for people with anxiety and depressive symptoms Receives: Behavioral: Self-management programme |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depressive Symptoms (Beck's Depression Inventory (BDI-II))
Measured: 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
Measured: 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"
Measured: 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"
Measured: Change from 1) Pre-randomization, to 2) Three months post-intervention
Secondary outcomes (5)
Sleep Quality (The Pittsburgh Sleep Quality Index)
Measured: Change from 1) Pre-randomization, to 2) Three months post-intervention
Exercise Behaviors (Stanford Patient Education Research Center)
Measured: 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).
Measured: Change from 1) Pre-randomization, to 2) Three months post-intervention
Social/Role Activities Limitations Scale (Stanford Patient Education Research Center)
Measured: 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))
Measured: Change from 1) Pre-randomization, to 2) Three months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2013 (estimated)
- Study startJun 2013
- Primary completionSep 2014
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 853 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- National Board of Health, Denmark, Danish Committee for Health Education
- Responsible party
- Principal investigator, Søren Christensen, University of Aarhus
- Investigators
- Soren Christensen, MSc, Principal investigator, Aarhus University HospitalMimi Y Mehlsen, PhD, Study director, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01989247
- Sponsor's protocol ID
- 1-1010-46/1
- Status last verified
- Mar 2016
- First submitted
- 14 Nov 2013
- Last updated
- 8 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-management of Depression and Anxiety. A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT01989247
- Acronym / sponsor ID
- 1-1010-46/1
- Conditions
- Depression, Anxiety, Self Efficacy
- Keywords
- Depression, Anxiety, Randomized Controlled Trial, Self Care, Intervention Studies, Health Education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 853 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- National Board of Health, Denmark, Danish Committee for Health Education
- Study start
- Jun 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 20 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self-management program | Experimental | Behavioral: Self-management programmeSeven weekly sessions of a group-based self-management programme for people with anxiety and depressive symptoms |
| Control group | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- >= 18 years of age
- Suffering from anxiety and/or depressive symptoms
- Voluntary participation
Key exclusion criteria (3 listed)
- Potential suicidal behavior
- Potential aggressive behavior
- Significant cognitive impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-management programmeSeven weekly group-based sessions for people with anxiety and depressive symptoms | Behavioural | Self-management program |
Primary outcome
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"
5 secondary outcomes
Sleep Quality (The Pittsburgh Sleep Quality Index)
Time frame: Change from 1) Pre-randomization, to 2) Three months post-intervention
Exercise Behaviors (Stanford Patient Education Research Center)
Time frame: Change from 1) Pre-randomization, to 2) Three months post-intervention
Health related symptoms
Time frame: Change from 1) Pre-randomization, to 2) Three months post-intervention
Social/Role Activities Limitations Scale (Stanford Patient Education Research Center)
Time frame: 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))
Time frame: Change from 1) Pre-randomization, to 2) Three months post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Soren Christensen, MSc principal investigator
Aarhus University Hospital
Mimi Y Mehlsen, PhD study director
University of Aarhus
37 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-management programme in people with Depression and Anxiety, run by University of Aarhus at 37 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depressive Symptoms (Beck's Depression Inventory (BDI-II)) (time frame: Change from 1) Pre-randomization, to 2) Three months post-intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2016.