Depressive DisorderCWSA-FinNCT00611052
Prevention of Adolescent Major Depression
A study testing the Adolescent Coping with Stress, Treatment as usual and usual health education in people with Depressive Disorder, run by Finnish Institute for Health and Welfare at 3 sites in Finland.
Trial summary
The main purpose of this study is to assess the effect of a cognitive group intervention on prevention of major depression in 14-15-year-old adolescents. Moreover, the effect on other selected mental health parameters are investigated. Read more about this study
- Who is it for?
- Ages 14 to 16 years
- Conditions the study is for
- Depressive Disorder
- What is being tested?
- the Adolescent Coping with Stress, Treatment as usual and usual health education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 3 sitesFinland
- Study dates
- Mar 2008to Dec 2013
- 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 14 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- mild to moderate level depressive symptoms (RBDI self-report scale)
- adequate knowledge of the Finnish language
- informed consent from the adolescent (all) and his/her parent (under 15 years)
- healthy controls comprise subjects with no depressive symptoms
Who cannot join
- ongoing major depression, dysthymia or bipolar disorder
- ongoing other severe psychiatric illness precluding group participation
- mental retardation
Trial locations and contacts
3 sites in 1 country.
Finland3 sites
Kuopio University Hospital and Kuopio University
Kuopio
Turku Primary Health care and Adolescent Psychiatric clinic
Turku
Vantaa Primary Health Care
Vantaa
About this study
Official title: "Adolescents Coping With Stress": Prevention of Adolescent Major Depression in School Health Care
The main purpose of this study is to assess the effect of a cognitive group intervention on prevention of major depression in 14-15-year-old adolescents. Moreover, the effect on other selected mental health parameters are investigated.
- Conditions
- Depressive Disorder
- Being tested
- the Adolescent Coping with Stress, Treatment as usual, usual health education
- Keywords
- Depressive Disorder, Depressive Disorder, Major, Mental Health, Prevention
- Medical subject headings
- Depressive Disorder, Depressive Disorder, Major, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the Adolescent Coping with StressBehavioural
A group cognitive intervention, manualized and highly structured. Includes 8 sessions (á 1.5 hours) and a booster session 6 months after termination of the actual intervention. Groups leaders are specifically trained for this course.
Treatment as usualBehavioural
The usual treatment received by the adolescent with mild to moderate self-reported depressive symptoms in school health care.
usual health educationOther
usual health education given by the school nurses, targeted for healthy controls with no depressive symptoms according to the self-report scale
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Group cognitive intervention (the Adolescent Coping with Stress) Receives: Behavioral: the Adolescent Coping with Stress |
| 2 | Active comparator | Treatment as usual Receives: Behavioral: Treatment as usual |
| 3 | Active comparator | Healthy controls, receive usual health education in school health care Receives: Other: usual health education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major depression (diagnostic interview) High level of depressive symptoms (self-report scale)
Measured: 3 months, 6 months, 12months, 24 months, 36 months
Secondary outcomes (1)
Suicidality (diagnostic interview, self-report scale)
Measured: 3 months, 6 months, 12 months, 24 months, 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2008 (estimated)
- Study startMar 2008
- Primary completionDec 2013
- Study completionDec 2013
Why it stopped: Unsuccessful recruitment, failed training of the group leaders leading into lack of study groups
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive DisorderStudies 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Finnish Institute for Health and Welfare
- Sponsor type
- Other government
- Collaborators
- University of Helsinki, University of Eastern Finland, Kuopio University Hospital, City of Vantaa, City of Kuopio, City of Turku
- Responsible party
- Principal investigator, Linnea Karlsson, Finnish Institute for Health and Welfare
- Investigators
- Mauri J Marttunen, Professor, Study director, National Institute for Health nd Welfare, Dept of Mental Health and Substance Abuse Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00611052
- Sponsor's protocol ID
- KTL423-0
- Acronym
- CWSA-Fin
- Status last verified
- Apr 2016
- First submitted
- 28 Jan 2008
- Last updated
- 20 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Adolescents Coping With Stress": Prevention of Adolescent Major Depression in School Health Care
- ClinicalTrials.gov ID
- NCT00611052
- Acronym / sponsor ID
- CWSA-Fin / KTL423-0
- Conditions
- Depressive Disorder
- Keywords
- Depressive Disorder, Depressive Disorder, Major, Mental Health, Prevention
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unsuccessful recruitment, failed training of the group leaders leading into lack of study groups
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Finnish Institute for Health and WelfareOther government
- Collaborators
- University of Helsinki, University of Eastern Finland, Kuopio University Hospital, City of Vantaa, City of Kuopio, City of Turku
- Study start
- Mar 2008
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 8 Feb 2008 (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 main purpose of this study is to assess the effect of a cognitive group intervention on prevention of major depression in 14-15-year-old adolescents. Moreover, the effect on other selected mental health parameters are investigated.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: the Adolescent Coping with StressGroup cognitive intervention (the Adolescent Coping with Stress) |
| 2 | Active comparator | Behavioral: Treatment as usualTreatment as usual |
| 3 | Active comparator | Other: usual health educationHealthy controls, receive usual health education in school health care |
Who may qualify
- Ages
- 14 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- mild to moderate level depressive symptoms (RBDI self-report scale)
- adequate knowledge of the Finnish language
- informed consent from the adolescent (all) and his/her parent (under 15 years)
- healthy controls comprise subjects with no depressive symptoms
Key exclusion criteria (3 listed)
- ongoing major depression, dysthymia or bipolar disorder
- ongoing other severe psychiatric illness precluding group participation
- mental retardation
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 |
|---|---|---|
| the Adolescent Coping with StressA group cognitive intervention, manualized and highly structured. Includes 8 sessions (á 1.5 hours) and a booster session 6 months after termination of the actual intervention. Groups leaders are specifically trained for this course. | Behavioural | 1 |
| Treatment as usualThe usual treatment received by the adolescent with mild to moderate self-reported depressive symptoms in school health care. | Behavioural | 2 |
| usual health educationusual health education given by the school nurses, targeted for healthy controls with no depressive symptoms according to the self-report scale | Other | 3 |
Primary outcome
Major depression (diagnostic interview) High level of depressive symptoms (self-report scale)
Time frame: 3 months, 6 months, 12months, 24 months, 36 months
1 secondary outcome
Suicidality (diagnostic interview, self-report scale)
Time frame: 3 months, 6 months, 12 months, 24 months, 36 months
Results and safety
The study was stopped early (reason given: Unsuccessful recruitment, failed training of the group leaders leading into lack of study groups). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 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.
Mauri J Marttunen, Professor study director
National Institute for Health nd Welfare, Dept of Mental Health and Substance Abuse Services
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing the Adolescent Coping with Stress, Treatment as usual and usual health education in people with Depressive Disorder, run by Finnish Institute for Health and Welfare at 3 sites in Finland.
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 4 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: stopped early, as of the sponsor's last update on 20 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Finland. 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 was stopped early (reason given: Unsuccessful recruitment, failed training of the group leaders leading into lack of study groups). Results are not available in the source record.
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?
Major depression (diagnostic interview) High level of depressive symptoms (self-report scale) (time frame: 3 months, 6 months, 12months, 24 months, 36 months). 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 20 Apr 2016.