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

June 10, 2013 updated by: D. Meuldijk, Leiden University Medical Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

182

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Other: Treatment As Usual
Control group, TAU
Other: Treatment As Usual
Other: Treatment As Usual

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
approximately 3 years (start: march 2010).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
approximately 3 years (start: march 2010).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Leiden University Medical Center

Collaborators

Rivierduinen, Centre for Personality disorders Jelgersma

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

September 8, 2011

First Submitted That Met QC Criteria

July 17, 2012

First Posted (Estimate)

July 18, 2012

Study Record Updates

Last Update Posted (Estimate)

June 11, 2013

Last Update Submitted That Met QC Criteria

June 10, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P09.146/NL29380.058.09 (Other Identifier: CME LUMC/Toetsingonline ABR-formulier)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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