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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- ISRCTNISRCTN no longer applicable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
- ACRONYMInterTrain (Interpretation Training in Depression)
- hypothesisWe expect that a positivity training, based on Interpretation Bias Modification (IBM) while making use of field imagery, can reduce general levels of depression in patients with Major Depressive Disorder (MDD).
- 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.

Intervention group
The intervention group will be encouraged to make use of field imagery (first perspective) throughout the intervention.

In the auditory sessions, the intervention group will listen to 64 positively constrained training paragraphs, which each last 13 seconds at most. Each scenario described in the paragraph starts ambiguously with respect to the outcome, yet becomes clearly positive towards the end of the paragraph. Participants close their eyes while listening to the training paragraph and imagine themselves in the scenario as if actively involved in the situation and seeing it through their own eyes (i.e. field perspective imagery).

In the picture-word sessions, this group will view 64 positively constrained picture-word combinations. The pictures consist of neutral everyday situations and are presented in combination with a word of positive valence. After presentation the participant is asked to combine the picture and word to form a mental image.

Control group
The control group will be encouraged to make use of verbal thinking and analysis throughout the intervention.

In the auditory sessions, the intervention group will listen to 64 neutral training paragraphs, which each last 13 seconds at most. Each scenario described in the paragraph is uambiguous with respect to the outcome. Participants keep their eyes on the screen while listening to the training paragraph and verbally analyse each scenario by asking themselves “how”, “what”, or “why” questions about the presented story.

In the picture-word sessions, this group will view 64 neutrally constrained picture-word combinations. The pictures consist of neutral everyday situations and are presented in combination with a descriptive word that is reflected in the scenario. After presentation the participant is asked to combine the picture and word to analyse the combination. Again after each picture-word combination participants are asked to verbally analyse each scenario by asking themselves “how”, “what”, and “why” questions about the presented combination.
- 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 summaryInterpretation biases are implied in the onset and maintenance of major depressive disorder (MDD). Experimental research shows that interpretation biases can be re-trained using simple computer tasks through Interpretation Bias Modification (IBM). In IBM, the aim is to modify the interpretation biases of depressed patients from negative to positive and consequently improve their depressive symptoms levels and achieve remission. Depressed people tend to show a deficit in generating positive prospective imagery, which hampers positive interpretations and limits chances to alter negative interpretation biases. Importantly, our IBM training incorporates mental imagery: imagining oneself in the presented (positive) scenarios in the IBM tasks.

In this single blind, randomised controlled trial, our main objective is to evaluate the (cost-)effectiveness of imagery-based Interpretation Bias Modification (IBM) for patients with MDD in the outpatient mental health care setting compared to usual care.
- 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 - 1-okt-2017


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