Back to resultsCost- Effectiveness Study of Brief Interventions for Mood and Anxiety Disorders (K&K)
Primary Purpose
Depressive Disorder, Anxiety Disorder
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Cognitive behavioral treatment/farmacotherapy intervention
Treatment As Usual
Sponsored by
About this trial
This is an interventional treatment trial for Depressive Disorder
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Sites / Locations
- Rivierduinen
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Cognitive behavioral treatment/farmacotherapy intervention
Treatment As Usual
Arm Description
Brief intervention; intake, cognitive behavioral treatment/farmacotherapy (SSRI) and ROM
Control group, TAU
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT01643642
First Posted
September 8, 2011
Last Updated
June 10, 2013
Sponsor
Leiden University Medical Center
Collaborators
Rivierduinen, Centre for Personality disorders Jelgersma
1. Study Identification
Unique Protocol Identification Number
NCT01643642
Brief Title
Cost- Effectiveness Study of Brief Interventions for Mood and Anxiety Disorders
Acronym
K&K
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)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Leiden University Medical Center
Collaborators
Rivierduinen, Centre for Personality disorders Jelgersma
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorder, Anxiety Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
182 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cognitive behavioral treatment/farmacotherapy intervention
Arm Type
Experimental
Arm Description
Brief intervention; intake, cognitive behavioral treatment/farmacotherapy (SSRI) and ROM
Arm Title
Treatment As Usual
Arm Type
Other
Arm Description
Control group, TAU
Intervention Type
Other
Intervention Name(s)
Cognitive behavioral treatment/farmacotherapy intervention
Intervention Description
Brief cognitive behavioral intervention/farmacotherapy; intake, treatment and ROM
Intervention Type
Other
Intervention Name(s)
Treatment As Usual
Intervention Description
Other: Treatment As Usual
Primary Outcome Measure Information:
Title
Effectiveness of the intervention
Description
Effectiveness of the intervention is investigated by the main questionnaires: Web Screening Questionnaire (WSQ) and Brief Symptom Inventory (BSI) as conducted by ROM
Time Frame
approximately 3 years (start: march 2010).
Secondary Outcome Measure Information:
Title
Cost-effectiveness intervention
Description
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.
Time Frame
approximately 3 years (start: march 2010).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
Facility Information:
Facility Name
Rivierduinen
City
South Holland
Country
Netherlands
12. IPD Sharing Statement
Citations:
PubMed Identifier
26762883
Citation
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.
Results Reference
derived
Learn more about this trial
Cost- Effectiveness Study of Brief Interventions for Mood and Anxiety Disorders
We'll reach out to this number within 24 hrs