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interpretation Bias Modification (IBM) in patients with Major Depressive Disorder


- candidate number24658
- NTR NumberNTR5949
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR19-jul-2016
- Secondary IDsNL55683.091.15 Commissie Mensgebonden Onderzoek regio Arnhem – Nijmegen (UMC St Radboud)
- Public Titleinterpretation Bias Modification (IBM) in patients with Major Depressive Disorder
- Scientific TitleCost-effectiveness of Interpretation Bias Modification in patients with Major Depressive Disorder: a randomised controlled trial
- ACRONYM
- hypothesisThe hypothesis is not public yet, because of the quality of the study.
- Healt Condition(s) or Problem(s) studiedDepression
- Inclusion criteria-A diagnosis of major depressive disorder, first or recurrent according to the DSM- IV-TR (APA; American Psychiatric Association, 2000), as assessed with the MINI.
-18-65 years old.
-Waitlisted for treatment
-Provides informed consent
- Exclusion criteria-Any psychotic disorder (current or previous)
-Current mania or hypomania or a history of bipolar disorder
-Cognitive disabilities (IQ < 80)
-Visual disabilities that interfere with a computer task
-Acute suicidal risk
-No sufficient command of Dutch language to participate in the study
-Lack of sufficient experience with the use of computers (based on subjective estimation of the patient)
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jun-2017
- planned closingdate1-jun-2019
- Target number of participants198
- InterventionsInterpretation Bias Modification (IBM)

Patients will be offered IBM during the routine waitlist before CBT, followed by further indicated care. IBM entails 10 20-minute computer training sessions over the course of 4 weeks: 7 daily sessions during in week 1, followed by weekly sessions during the following 3 weeks. The first session will be completed at Pro Persona. All other sessions will be completed via the internet at home.

Both groups will receive a mixture of auditory and picture-word training sessions.

Not all of the information about the intervention is public yet, because of the quality of the study.
- Primary outcomeFor testing the main hypothesis, that IBM is able to reduce depressive symptom levels, the Beck’s Depression Inventory II (BDI) will be used.
- Secondary outcome-Depressive symptomatology (IDS-SR; as part of routine care).
-Current use of antidepressant medication (as part of the TiC-P questionnaire).
-Dysfunctional cognitions (17- item Dysfunctional Attitude Scale, DAS).
-Levels of anxiety (20-item Spielberger State-Trait Anxiety Inventory-Trait version, STAI).
-Prospective mental imagery (20-item Prospective Mental Imagery Task, PIT).
-Everyday use of imagery (12-item Spontaneous use of imagery scale, SUIS).
-Interpretation Bias (Ambiguous Scenarios Test, AST) -Expectancies with respect to the training (3-item expectancy questionnaire, EQ), derived from the expectancy/credibility questionnaire).
-Quality of life and costs, (the 5-item EuroQoL, EQ-5D) and Trimbos Institute and iMTA Cost questionnaire for Psychiatry (TiC-P).
-Diagnostic status of depression according to the DSM-IV-TR as assessed by the MINI.
-Patient satisfaction questionnaire.
-In depth patient satisfaction interviews with the 10 most content and the 10 most discontent participants according to the patient satisfaction questionnaire.
- TimepointsPrimary outcome measure
-BDI (baseline, 2 weeks, 1 month, 6 months, 12 months)

Secondary outcome measures
-AST (baseline, 2 weeks, 1 month)
-PIT (baseline, 1 month, 6 months)
-IDS-SR (baseline, 1 months, 6 months, 12 months)
-STAI (baseline, 1 month, 6 months)
-SUIS (baseline, 1 month, 6 months)
-DAS (baseline, 1 month, 6 months)
-EQ (baseline, 1 month)
-TIC-P (baseline, 1 month, 6 months, 12 months)
-EQ-5D (baseline, 1 month, 6 months, 12 months)
-MINI (baseline, 12 months)
-Patient satisfaction questionnaire (1 month, 6 months)
-Patient satisfaction interview (12 months)
-Demographic items (baseline, 1 month)
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Denise te Paste
- CONTACT for SCIENTIFIC QUERIES Denise te Paste
- Sponsor/Initiator Pro Persona, Trimbos-institute - Netherlands Institute of Mental Health and Addiction
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- Publications
- Brief summaryThe summary is not public yet, because of the quality of the study.
- Main changes (audit trail)1-okt-2017 -IK:
Change in inclusion criteria:

'-A diagnosis of major depressive disorder, first or recurrent according to the DSM- IV-TR (APA; American Psychiatric Association, 2000), as assessed with the MINI.
-18-65 years old.
-Waitlisted for treatment
-Provides informed consent'

replaced by:

'-A diagnosis of major depressive disorder, first or recurrent according to the DSM- IV-TR (APA; American Psychiatric Association, 2000), as assessed with the MINI.
-18-65 years old.
-Provides informed consent'


Change in interventions:

'Patients will be offered IBM during the routine waitlist before CBT, followed by further indicated care. IBM entails 10 20-minute computer training sessions over the course of 4 weeks: 7 daily sessions during in week 1, followed by weekly sessions during the following 3 weeks. The first session will be completed at Pro Persona. All other sessions will be completed via the internet at home.'

replaced by:

'Patients will be offered IBM when just starting their treatment (maximum of 4 sessions) or when waitlisted for treatment, accompanied or followed by further indicated care. IBM entails 10 20-minute computer training sessions over the course of 4 weeks: 7 daily sessions during in week 1, followed by weekly sessions during the following 3 weeks. The first session will be completed at Pro Persona. All other sessions will be completed via the internet at home.'
- RECORD19-jul-2016 - 12-jul-2018


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