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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 26, 2014