Depressive DisorderPhase 2NCT00521911
Detection and Treatment of Depression in Patients Admitted to the General Hospital
A Phase 2 study testing Cognitive Behavioural Therapy in people with Depressive Disorder and Depression, run by Radboud University Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depressive Disorder, Depression
- What is being tested?
- Cognitive Behavioural Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteNetherlands
- Study dates
- Aug 2007to Dec 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Depressive Disorder
Who cannot join
- Severe Physical Disfunction
- Severe Cognitive Disfunction
- Speech and/or Hearing Disorder
- Limited knowledge of the Dutch language
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Radboud University Nijmegen Medical Centre
Nijmegen, Gelderland, 6500 HB
About this study
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
- Being tested
- Cognitive Behavioural Therapy
- Keywords
- Intervention Studies, Randomized Controlled Trials, Cognitive Therapy, Hospitals, General, Prevalence
- Medical subject headings
- Depressive Disorder, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioural TherapyBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Cognitive Behavioural Therapy Receives: Behavioral: Cognitive Behavioural Therapy |
| 2 | No intervention | Treatment as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depressive Disorder Physical symptoms
Measured: 9 months
Secondary outcomes (1)
- Functional impairment (RAND 36) - Cost-effectiveness (TiC-P) - Quality of Life (EQ5D)
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2007 (estimated)
- Study startAug 2007
- Primary completionDec 2008 (estimated)
- Study completionDec 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Anne EM Speckens, PhD, MD, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00521911
- Sponsor's protocol ID
- PROJECT9999
- Status last verified
- Dec 2008
- First submitted
- 27 Aug 2007
- Last updated
- 25 Dec 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection and Treatment of Depression in Patients Admitted to the General Hospital
- ClinicalTrials.gov ID
- NCT00521911
- Acronym / sponsor ID
- PROJECT9999
- Conditions
- Depressive Disorder, Depression
- Keywords
- Intervention Studies, Randomized Controlled Trials, Cognitive Therapy, Hospitals, General, Prevalence
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- Aug 2007
- Primary completion
- Dec 2008 (estimated)
- Study completion
- Dec 2008 (estimated)
- First posted
- 28 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Behavioral: Cognitive Behavioural TherapyCognitive Behavioural Therapy |
| 2 | No intervention | –Treatment as Usual |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Depressive Disorder
Key exclusion criteria (4 listed)
- Severe Physical Disfunction
- Severe Cognitive Disfunction
- Speech and/or Hearing Disorder
- Limited knowledge of the Dutch language
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavioural Therapy | Behavioural | 1 |
Primary outcome
Depressive Disorder Physical symptoms
Time frame: 9 months
1 secondary outcome
- Functional impairment (RAND 36) - Cost-effectiveness (TiC-P) - Quality of Life (EQ5D)
Time frame: 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Dec 2008.
- Radboud University Nijmegen Medical CentreLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne EM Speckens, PhD, MD principal investigator
Radboud University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cognitive Behavioural Therapy in people with Depressive Disorder and Depression, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Dec 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Matthijs W. Beltman, MSc (+31 (0)24 3668008, mw.beltman@psy.umcn.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depressive Disorder Physical symptoms (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Dec 2008.