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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2008 by Radboud University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Radboud University
ClinicalTrials.gov Identifier:
NCT00521911
First received: August 27, 2007
Last updated: December 24, 2008
Last verified: December 2008
  Purpose

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.


Condition Intervention Phase
Depressive Disorder
Depression
Behavioral: Cognitive Behavioural Therapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Radboud University:

Primary Outcome Measures:
  • Depressive Disorder Physical symptoms [ Time Frame: 9 months ]

Secondary Outcome Measures:
  • - Functional impairment (RAND 36) - Cost-effectiveness (TiC-P) - Quality of Life (EQ5D) [ Time Frame: 9 months ]

Estimated Enrollment: 60
Study Start Date: August 2007
Estimated Study Completion Date: December 2008
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Cognitive Behavioural Therapy
Behavioral: Cognitive Behavioural Therapy
No Intervention: 2
Treatment as Usual

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Depressive Disorder

Exclusion Criteria:

  • Severe Physical Disfunction
  • Severe Cognitive Disfunction
  • Speech and/or Hearing Disorder
  • Limited knowledge 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: NCT00521911

Contacts
Contact: Matthijs W. Beltman, MSc +31 (0)24 3668008 mw.beltman@psy.umcn.nl

Locations
Netherlands
Radboud University Nijmegen Medical Centre Recruiting
Nijmegen, Gelderland, Netherlands, 6500 HB
Sponsors and Collaborators
Radboud University
Investigators
Principal Investigator: Anne EM Speckens, PhD, MD Radboud University
  More Information

Additional Information:
No publications provided

Responsible Party: Anne EM Speckens, PhD, MD, Radboud University Medical Center
ClinicalTrials.gov Identifier: NCT00521911     History of Changes
Other Study ID Numbers: PROJECT9999
Study First Received: August 27, 2007
Last Updated: December 24, 2008
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Radboud University:
Intervention Studies
Randomized Controlled Trials
Cognitive Therapy
Hospitals, General
Prevalence

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 28, 2014