NCT01643642

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
182

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

September 8, 2011

Completed
10 months until next milestone

First Posted

Study publicly available on registry

July 18, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

June 11, 2013

Status Verified

June 1, 2013

Enrollment Period

2.8 years

First QC Date

September 8, 2011

Last Update Submit

June 10, 2013

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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).

Secondary Outcomes (1)

  • Cost-effectiveness intervention

    approximately 3 years (start: march 2010).

Study Arms (2)

Cognitive behavioral treatment/farmacotherapy intervention

EXPERIMENTAL

Brief intervention; intake, cognitive behavioral treatment/farmacotherapy (SSRI) and ROM

Other: Cognitive behavioral treatment/farmacotherapy intervention

Treatment As Usual

OTHER

Control group, TAU

Other: Treatment As Usual

Interventions

Brief cognitive behavioral intervention/farmacotherapy; intake, treatment and ROM

Cognitive behavioral treatment/farmacotherapy intervention

Other: Treatment As Usual

Treatment As Usual

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rivierduinen

South Holland, Netherlands

Location

Related Publications (1)

  • Meuldijk D, Carlier IV, van Vliet IM, van Veen T, Wolterbeek R, van Hemert AM, Zitman FG. The clinical effectiveness of concise cognitive behavioral therapy with or without pharmacotherapy for depressive and anxiety disorders; a pragmatic randomized controlled equivalence trial in clinical practice. Contemp Clin Trials. 2016 Mar;47:131-8. doi: 10.1016/j.cct.2015.12.021. Epub 2016 Jan 5.

MeSH Terms

Conditions

Depressive DisorderAnxiety Disorders

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Mood DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Student

Study Record Dates

First Submitted

September 8, 2011

First Posted

July 18, 2012

Study Start

March 1, 2010

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

June 11, 2013

Record last verified: 2013-06

Locations