search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


Internet-based treatment of depressive symptoms in tumor patients.


- candidate number10788
- NTR NumberNTR3223
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR28-dec-2011
- Secondary IDs2010/4804 KWF Kankerbestrijding
- Public TitleInternet-based treatment of depressive symptoms in tumor patients.
- Scientific TitleInternet-based treatment of depressive symptoms in patients with tumors inside or outside of the central nervous system.
- ACRONYM
- hypothesisDepression is a major health problem in glioma patients, with emotional, cognitive and physical sequelae. Depression in these patients may be associated with increased morbidity and even with poorer survival. In addition, depression is the most important independent predictor of health-related quality of life (HRQOL) in patients with brain tumors affecting not only patients but also their informal caregivers (i.e. partner, good friend, or family member). Treatment of depression usually includes a combination of psychotherapy, group therapy, and medications. Glioma patients, however, are not inclined to seek help for mental health problems. The internet is a medium which is used much easier by these patients. This project is aimed at the development of an internet-based intervention for glioma patients with mild to moderate depression. This type of intervention has been proven to be effective in adult non-cancer populations with mild to moderate depression, but not in glioma patients. Guided self-help over the internet has the possibility to deliver services to large groups of patients. In this sense the proposed intervention is an important addition to existing services in the Netherlands.
- Healt Condition(s) or Problem(s) studiedDepression, Low-grade glioma, Low-grade hematological malignancies
- Inclusion criteria1. >18 years of age;
2. Presence of either low-grade glioma (grade II) or low-grade hematological malignancies (NHL or CLL);
3. Mild to moderate depressive symptoms;
4. Internet access and e-mail address.
- Exclusion criteriaMajor depression, no depressive symptoms, or suicidal intent
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlNot applicable
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 29-nov-2011
- planned closingdate1-jun-2015
- Target number of participants150
- InterventionsGuided self-help internet intervention focusing on reducing depressive symptoms.

Fifty low-grade glioma patients will be included in the intervention group and 50 low-grade glioma patients will be included in the control group. They will be put on a three month waiting list after which they can also take part in the intervention. Furthermore, 50 patients with low-grade hematological malignancies whose disease does not include the central nervous system will form a control group. They will take part in the internet-intervention.

As web-based intervention we use an adapted version of the website “Allesondercontrole” (Everything under control), an intervention for brief problem-solving which is based on self-examination therapy. The intervention takes five weeks (approximately 15 hours of work in total). During that period, patients describe what they think is important in their lives, make a list of their problems and concerns, and divide these into three categories: unimportant problems (problems which are not related to what is important in their life), important and solvable (these are solved through a six-step procedure of problem-solving), and important but unsolvable (such as loosing someone through death); for each of these problems the patient makes a plan how to cope with this. Patients hand in homework assignments every week and receive feedback from a personal coach. The coach is not a therapist, but only supports the patient in working through the intervention.
- Primary outcomeChange in depressive symptoms as measured by the Center for Epidemiological Studies Depression Scale (CES-D).
- Secondary outcomeQuality of life, symptoms of fatigue, cognitive functioning and variables that may predict outcome (working alliance between coach and patient, client satisfaction, problem-solving skills).
- Timepoints0 weeks, 6 weeks, 3 months, 12 months.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr. M. Klein
- CONTACT for SCIENTIFIC QUERIESDr. M. Klein
- Sponsor/Initiator VU University Medical Center
- Funding
(Source(s) of Monetary or Material Support)
KWF Kankerbestrijding, Alpe d’HuZes Foundation
- PublicationsN/A
- Brief summaryIntroduction:
Depression is a major health problem in glioma patients, with emotional, cognitive, and physical sequelae. Depression in these patients may be associated with increased morbidity and even with poorer survival. In addition, depression is the most important independent predictor of health-related quality of life (HRQOL) in patients with brain tumours affecting not only patients but also their informal caregivers (i.e., partner, good friend, or family member). The etiology of depression may be due to tumour location, treatment, or patient response to the diagnosis. Treatment of depression usually includes a combination of psychotherapy, group therapy, and medications. Glioma patients, however, are not inclined to seek help for mental health problems. The internet is a medium which is used much easier by glioma patients to seek help for mental health problems. This project is aimed at the development of an internet-based intervention for glioma patients with mild to moderate depression. This type of intervention has been proven to be effective in adult non-cancer populations with mild to moderate depression, but not in glioma patients.

Objectives:
The primary study objectives are:
1. To estimate the prevalence of depressive symptoms in glioma patients;
2. To determine whether an internet-based guided self-help intervention is effective in reducing symptoms of depression in glioma patients;
3. To determine the impact of the intervention on the HRQOL of both glioma patients and their informal caregivers;
4. To evaluate the compliance and feasibility of the intervention in this patient population;
5. To evaluate the cost-effectiveness of the intervention.

Methods:
We will use an internet intervention based on problem-solving and self-examination therapy which has been proven to be effective, and adapt this intervention for use with glioma patients addressing depression. Glioma patients are guided by a coach to work through the intervention.
- Main changes (audit trail)
- RECORD28-dec-2011 - 18-jan-2012


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl