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Cost- Effectiveness Study of Brief Interventions for Mood and Anxiety Disorders (K&K)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01643642
First Posted: July 18, 2012
Last Update Posted: June 11, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Rivierduinen, Centre for Personality disorders Jelgersma
Information provided by (Responsible Party):
D. Meuldijk, Leiden University Medical Center
  Purpose
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.

Condition Intervention
Depressive Disorder Anxiety Disorder Other: Cognitive behavioral treatment/farmacotherapy intervention Other: Treatment As Usual

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by D. Meuldijk, Leiden University Medical Center:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • Cost-effectiveness intervention [ Time Frame: approximately 3 years (start: march 2010). ]

    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.



Enrollment: 182
Study Start Date: March 2010
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cognitive behavioral treatment/farmacotherapy intervention
Brief intervention; intake, cognitive behavioral treatment/farmacotherapy (SSRI) and ROM
Other: Cognitive behavioral treatment/farmacotherapy intervention
Brief cognitive behavioral intervention/farmacotherapy; intake, treatment and ROM
Treatment As Usual
Control group, TAU
Other: Treatment As Usual
Other: Treatment As Usual

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01643642


Locations
Netherlands
Rivierduinen
South Holland, Netherlands
Sponsors and Collaborators
Leiden University Medical Center
Rivierduinen, Centre for Personality disorders Jelgersma
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: D. Meuldijk, PhD Student, Leiden University Medical Center
ClinicalTrials.gov Identifier: NCT01643642     History of Changes
Other Study ID Numbers: P09.146/NL29380.058.09
P09.146/NL29380.058.09 ( Other Identifier: CME LUMC/Toetsingonline ABR-formulier )
First Submitted: September 8, 2011
First Posted: July 18, 2012
Last Update Posted: June 11, 2013
Last Verified: June 2013

Additional relevant MeSH terms:
Disease
Anxiety Disorders
Depressive Disorder
Depression
Pathologic Processes
Mental Disorders
Mood Disorders
Behavioral Symptoms