Depressive DisorderK&KNCT01643642
Cost- Effectiveness Study of Brief Interventions for Mood and Anxiety Disorders
A study testing Cognitive behavioral treatment/farmacotherapy intervention and Treatment As Usual in people with Depressive Disorder and Anxiety Disorder, run by Leiden University Medical Center at 1 site in Netherlands.
Trial summary
This study compares both clinical effectiveness and cost-effectiveness of a brief, intensified therapy and diagnostic method for patients with mood and/or anxiety disorders with Treatment As Usual (TAU) at five outpatient Mental Healthcare Centers in the Netherlands. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Depressive Disorder, Anxiety Disorder
- What is being tested?
- Cognitive behavioral treatment/farmacotherapy intervention and Treatment As Usual
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- 1 siteNetherlands
- Study dates
- Mar 2010to Dec 2012
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male of female adolescents
- Adolescents aged between 18 to 65 year
- Adolescents main complaint: Mild to moderate anxiety and/or mood disorders with or without psychiatric and/or somatic co-morbidity
- Adolescents with proper understanding of the Dutch language.
Who cannot join
- Adolescents with current psychotic or bipolar traits,
- Adolescents with homicidal or suicidal risk
- Adolescents with severe social disfunctioning
- No proper understanding of the Dutch language
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Efficacy and Cost-effectiveness Study of a Brief Interventions for Mood and Anxiety Disorders: Brief Intake, Treatment and Routine Outcome Monitoring (ROM)
This study compares both clinical effectiveness and cost-effectiveness of a brief, intensified therapy and diagnostic method for patients with mood and/or anxiety disorders with Treatment As Usual (TAU) at five outpatient Mental Healthcare Centers in the Netherlands.
- Conditions
- Depressive Disorder, Anxiety Disorder
- Being tested
- Cognitive behavioral treatment/farmacotherapy intervention, Treatment As Usual
- Medical subject headings
- Depressive Disorder, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive behavioral treatment/farmacotherapy interventionOther
Brief cognitive behavioral intervention/farmacotherapy; intake, treatment and ROM
Treatment As UsualOther
Other: Treatment As Usual
| Study group | Role | What they receive |
|---|---|---|
| Cognitive behavioral treatment/farmacotherapy intervention | Experimental | Brief intervention; intake, cognitive behavioral treatment/farmacotherapy (SSRI) and ROM Receives: Other: Cognitive behavioral treatment/farmacotherapy intervention |
| Treatment As Usual | Other | Control group, TAU Receives: Other: Treatment As Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of the intervention
Effectiveness of the intervention is investigated by the main questionnaires: Web Screening Questionnaire (WSQ) and Brief Symptom Inventory (BSI) as conducted by ROM
Measured: approximately 3 years (start: march 2010).
Secondary outcomes (1)
Cost-effectiveness intervention
Cost-effectiveness is explored by an open questionnaire Trimbos/iMTA Questionnaire for Cost Associated with Psychiatric Illness (TIC-P).
Additionally patient and therapist satisfaction about the intervention is explored.
Measured: approximately 3 years (start: march 2010).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2012 (estimated)
- Study startMar 2010
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Leiden University Medical CenterThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- GGZ Rivierduinen
- Responsible party
- Principal investigator, D. Meuldijk, Leiden University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01643642
- Sponsor's protocol ID
- P09.146/NL29380.058.09
- Other IDs
- P09.146/NL29380.058.09
- Acronym
- K&K
- Status last verified
- Jun 2013
- First submitted
- 8 Sep 2011
- Last updated
- 11 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Meuldijk D, Carlier IV, van Vliet IM, van Veen T, Wolterbeek R, van Hemert AM, Zitman FG. The clinical effectiveness of concise cognitive behavioral therapy with or without pharmacotherapy for depressive and anxiety disorders; a pragmatic randomized controlled equivalence trial in clinical practice. Contemp Clin Trials. 2016 Mar;47:131-8. doi: 10.1016/j.cct.2015.12.021. Epub 2016 Jan 5.
PubMed 26762883
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Efficacy and Cost-effectiveness Study of a Brief Interventions for Mood and Anxiety Disorders: Brief Intake, Treatment and Routine Outcome Monitoring (ROM)
- ClinicalTrials.gov ID
- NCT01643642
- Acronym / sponsor ID
- K&K / P09.146/NL29380.058.09
- Conditions
- Depressive Disorder, Anxiety Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Collaborators
- GGZ Rivierduinen
- Study start
- Mar 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 18 Jul 2012 (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.
This study compares both clinical effectiveness and cost-effectiveness of a brief, intensified therapy and diagnostic method for patients with mood and/or anxiety disorders with Treatment As Usual (TAU) at five outpatient Mental Healthcare Centers in the Netherlands.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive behavioral treatment/farmacotherapy intervention | Experimental | Other: Cognitive behavioral treatment/farmacotherapy interventionBrief intervention; intake, cognitive behavioral treatment/farmacotherapy (SSRI) and ROM |
| Treatment As Usual | Other | Other: Treatment As UsualControl group, TAU |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male of female adolescents
- Adolescents aged between 18 to 65 year
- Adolescents main complaint: Mild to moderate anxiety and/or mood disorders with or without psychiatric and/or somatic co-morbidity
- Adolescents with proper understanding of the Dutch language.
Key exclusion criteria (4 listed)
- Adolescents with current psychotic or bipolar traits,
- Adolescents with homicidal or suicidal risk
- Adolescents with severe social disfunctioning
- No proper understanding of the Dutch language
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 |
|---|---|---|
| Cognitive behavioral treatment/farmacotherapy interventionBrief cognitive behavioral intervention/farmacotherapy; intake, treatment and ROM | Other | Cognitive behavioral treatment/farmacotherapy intervention |
| Treatment As UsualOther: Treatment As Usual | Other | Treatment As Usual |
Primary outcome
Effectiveness of the intervention
Time frame: approximately 3 years (start: march 2010).
Effectiveness of the intervention is investigated by the main questionnaires: Web Screening Questionnaire (WSQ) and Brief Symptom Inventory (BSI) as conducted by ROM
1 secondary outcome
Cost-effectiveness intervention
Time frame: approximately 3 years (start: march 2010).
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 11 Jun 2013.
- Derived from this study: PubMed 26762883Meuldijk D, Carlier IV, van Vliet IM, van Veen T, Wolterbeek R, van Hemert AM, Zitman FG. The clinical effectiveness of concise cognitive behavioral therapy with or without pharmacotherapy for depressive and anxiety disorders; a pragmatic randomized controlled equivalence trial in clinical practice. Contemp Clin Trials. 2016 Mar;47:131-8. doi: 10.1016/j.cct.2015.12.021. Epub 2016 Jan 5.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive behavioral treatment/farmacotherapy intervention and Treatment As Usual in people with Depressive Disorder and Anxiety Disorder, run by Leiden University Medical Center at 1 site in Netherlands.
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 4 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 11 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. 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?
Effectiveness of the intervention (time frame: approximately 3 years (start: march 2010).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01643642, which also lists 1 linked publication.
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 11 Jun 2013; AzTrials last refreshed its copy on 6 Nov 2026.