Cost- Effectiveness Study of Brief Interventions for Mood and Anxiety Disorders

Depressive Disorder Clinical Trial

— 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01643642
• Other study ID #: P09.146/NL29380.058.09
• Secondary ID: P09.146/NL29380.
• Status: Completed
• Phase: N/A
• First received: September 8, 2011
• Last updated: June 10, 2013
• Start date: March 2010
• Est. completion date: December 2012

Study information

• Verified date: June 2013
• Source: Leiden University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 182
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety Disorder
• Anxiety Disorders
• Depression
• Depressive Disorder
• Disease

Intervention

Other:
• Cognitive behavioral treatment/farmacotherapy intervention
Brief cognitive behavioral intervention/farmacotherapy; intake, treatment and ROM
• Treatment As Usual
Other: Treatment As Usual

Locations

Country	Name	City	State
Netherlands	Rivierduinen	South Holland

Sponsors (2)

Lead Sponsor	Collaborator
Leiden University Medical Center	Rivierduinen, Centre for Personality disorders Jelgersma

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	approximately 3 years (start: march 2010).	No
Secondary	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.	approximately 3 years (start: march 2010).	No