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Behavioral activation using a smartphone application in patients with a major depressive disorder


- candidate number27084
- NTR NumberNTR6389
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR12-apr-2017
- Secondary IDsNL522562.058.15 METC LUMC
- Public TitleBehavioral activation using a smartphone application in patients with a major depressive disorder
- Scientific TitleBehavioral activation using a smartphone application in patients with a major depressive disorder
- ACRONYMBE POSITIVE
- hypothesisBehavioral activation using a smarthphone application is more effective than regular Cognitive Behavioral Therapy in patients with a major depressive disorder
- Healt Condition(s) or Problem(s) studiedDepressive Disorder , Behavioural therapy
- Inclusion criteria- Age 18-65 years
- Major Depressive Disorder (DSM-5, MINI+)
- In possession of a smartphone
- Indication for treatment with Pharmacotherapy
+ Cognitive Behavioral Treatment
- Exclusion criteria- Insufficient ability to understand Dutch
- Insufficient control of smartphone
- Severe psychiatric comorbidity
- Severe somatic comorbidity
- Severe problems in the social domain
- Alcohol or drug abuse
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-aug-2017
- planned closingdate1-aug-2019
- Target number of participants150
- InterventionsA smartphone application, supporting behavioral activation during the CBT treatment, lasting 16 weeks. The application allows setting personalized goals (physical activity, sleep, eat, etc.), gives insights in emotions (experience sampling) related to behavior.
These are delivered through (among others) goal-specific modules, logging activities, providing reports and visualizations, providing event-based notifications and reminders.
- Primary outcomeTime to remission on depressive symptoms
- Secondary outcome- Symptom reduction on the following domains: depressive symptoms, anxiety, anger,
anhedonia, quality of life and self-directedness.
- Cost-effectiviness
- Long term effects (6, 9 and 12 months)
- TimepointsPatients will be included and randomized before starting the CBT treatment.
T0: Inclusion - start treatment
Week 1-16: 16 CBT sessions (+ use application), with weekly questionnaires
Months 6, 9 and 12: Evaluation with questionnaires
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES Wouter Spoelman
- CONTACT for SCIENTIFIC QUERIES Wouter Spoelman
- Sponsor/Initiator PsyQ
- Funding
(Source(s) of Monetary or Material Support)
Health~Holland (previously known as Foundation LSH-TKI)
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD12-apr-2017 - 21-jun-2017


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