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Detection and Treatment of Depression in Patients Admitted to the General Hospital

Primary Purpose

Depressive Disorder, Depression

Status
Unknown status
Phase
Phase 2
Locations
Netherlands
Study Type
Interventional
Intervention
Cognitive Behavioural Therapy
Sponsored by
Radboud University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depressive Disorder focused on measuring Intervention Studies, Randomized Controlled Trials, Cognitive Therapy, Hospitals, General, Prevalence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Depressive Disorder

Exclusion Criteria:

  • Severe Physical Disfunction
  • Severe Cognitive Disfunction
  • Speech and/or Hearing Disorder
  • Limited knowledge of the Dutch language

Sites / Locations

  • Radboud University Nijmegen Medical CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

1

2

Arm Description

Cognitive Behavioural Therapy

Treatment as Usual

Outcomes

Primary Outcome Measures

Depressive Disorder Physical symptoms

Secondary Outcome Measures

- Functional impairment (RAND 36) - Cost-effectiveness (TiC-P) - Quality of Life (EQ5D)

Full Information

First Posted
August 27, 2007
Last Updated
December 24, 2008
Sponsor
Radboud University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00521911
Brief Title
Detection and Treatment of Depression in Patients Admitted to the General Hospital
Study Type
Interventional

2. Study Status

Record Verification Date
December 2008
Overall Recruitment Status
Unknown status
Study Start Date
August 2007 (undefined)
Primary Completion Date
December 2008 (Anticipated)
Study Completion Date
December 2008 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Radboud University Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Depression is a common disorder among patients with a somatic illness admitted to the general hospital. Patients with depression do worse in terms of their somatic symptoms or functioning that those without depression. They also stay in the hospital for longer. That is the reason that we are interested to know whether patients with depression do better if their depression is recognised earlier and treated appropriately. We would like to find out which questionnaires are most suitable in clinical practice to help pick up patients with a depression. In addition, we would like to know whether a short-term psychological treatment of depression would be of any help. We hope to be able to show that this treatment would not only result in a reduction of depressive symptoms, but also in a better and quicker recovery of the somatic illness. The treatment will consist of 6 to 9 weekly sessions of one hour, conducted by a cognitive behavioural assistant. Initially, the treatment will take place in the hospital. When patients are discharged, treatment sessions will continue at home. The treatment will focus on things like recognising and challenging unhelpful thoughts, planning of activities, and testing out of predictions by setting up behavioural experiments. Three monthly booster sessions will be offered to help patients to maintain their gains and prevent relapse. We will reassess the symptoms of the patients at three and six months after the end of treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorder, Depression
Keywords
Intervention Studies, Randomized Controlled Trials, Cognitive Therapy, Hospitals, General, Prevalence

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Cognitive Behavioural Therapy
Arm Title
2
Arm Type
No Intervention
Arm Description
Treatment as Usual
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioural Therapy
Primary Outcome Measure Information:
Title
Depressive Disorder Physical symptoms
Time Frame
9 months
Secondary Outcome Measure Information:
Title
- Functional impairment (RAND 36) - Cost-effectiveness (TiC-P) - Quality of Life (EQ5D)
Time Frame
9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Depressive Disorder Exclusion Criteria: Severe Physical Disfunction Severe Cognitive Disfunction Speech and/or Hearing Disorder Limited knowledge of the Dutch language
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Matthijs W. Beltman, MSc
Phone
+31 (0)24 3668008
Email
mw.beltman@psy.umcn.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne EM Speckens, PhD, MD
Organizational Affiliation
Radboud University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Radboud University Nijmegen Medical Centre
City
Nijmegen
State/Province
Gelderland
ZIP/Postal Code
6500 HB
Country
Netherlands
Individual Site Status
Recruiting

12. IPD Sharing Statement

Links:
URL
http://www.umcn.nl
Description
Radboud University Nijmegen Medical Centre

Learn more about this trial

Detection and Treatment of Depression in Patients Admitted to the General Hospital

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