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

NCT00521911 | Unknown Phase 2 DMC

• 1 other identifier: PROJECT9999
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Depressive Disorder; Depression

Keywords

Intervention Studies; Randomized Controlled Trials; Cognitive Therapy; Hospitals, General; Prevalence

Outcome Measures

Primary Outcomes (1)

• Depressive Disorder Physical symptoms

  9 months

Secondary Outcomes (1)

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

  9 months

Study Arms (2)

1

ACTIVE COMPARATOR

Cognitive Behavioural Therapy

Behavioral: Cognitive Behavioural Therapy

2

NO INTERVENTION

Treatment as Usual

Interventions

Cognitive Behavioural Therapy BEHAVIORAL

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Depressive Disorder

You may not qualify if:

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

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (1)

Radboud University Nijmegen Medical Centre

Nijmegen, Gelderland, 6500 HB, Netherlands

RECRUITING

Related Links

• Radboud University Nijmegen Medical Centre

MeSH Terms

Conditions

Depressive Disorder; Depression

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Anne EM Speckens, PhD, MD

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matthijs W. Beltman, MSc

CONTACT

+31 (0)24 3668008; mw.beltman@psy.umcn.nl

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 27, 2007
• First Posted: August 28, 2007
• Study Start: August 1, 2007
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: December 25, 2008

Record last verified: 2008-12

Locations

NL (1)