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

This study has been completed.
Sponsor:
Collaborator:
Rivierduinen, Centre for Personality disorders Jelgersma
Information provided by (Responsible Party):
D. Meuldijk, Leiden University Medical Center
ClinicalTrials.gov Identifier:
NCT01643642
First received: September 8, 2011
Last updated: June 10, 2013
Last verified: June 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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 Leiden University Medical Center:

Primary Outcome Measures:
  • Effectiveness of the intervention [ Time Frame: approximately 3 years (start: march 2010). ] [ Designated as safety issue: No ]
    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). ] [ Designated as safety issue: No ]

    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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01643642

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

No publications provided

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
Study First Received: September 8, 2011
Last Updated: June 10, 2013
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

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

ClinicalTrials.gov processed this record on April 15, 2014