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van CCT (UK)

van CCT (UK)

Attention Bias Modification (ABM) for Major Depressive Disorder

- candidate number22485
- NTR NumberNTR5285
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR20-jul-2015
- Secondary IDsNL45720.091.13 Commissie Mensgebonden Onderzoek regio Arnhem – Nijmegen (UMC St Radboud)
- Public TitleAttention Bias Modification (ABM) for Major Depressive Disorder
- Scientific TitleAttention Bias Modification Training for Major Depressive Disorder: A Randomized Controlled Trial
- ACRONYMCogniTrain (Cognitieve Trainingen bij Depressie)
- hypothesisWe expect that a positivity training based on attention bias modification (ABM), can induce (1) a positive attentional bias (i.e., relatively more attention for positive than for negative stimuli), (2) attenuates stress reactivity (3) and reduces general levels of depression in patients with Major Depressive Disorder (MDD).
- Healt Condition(s) or Problem(s) studiedMajor depressive disorder (MDD)
- Inclusion criteria• A diagnosis of major depressive disorder, first or recurrent according to the DSM- IV-TR, as assessed with the MINI Neuropsychiatric Interview
• Age: between 18-65 years
- 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 the computer tasks
• Acute suicidal risk
• No sufficient command of Dutch language to participate in the study
• No regular access to a computer at home
• Lack of experience with the use of computers (based on subjective estimation of the patient).
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 2-okt-2014
- planned closingdate2-okt-2017
- Target number of participants126
- InterventionsAttention Bias Modification (ABM)

A computerized, cognitive bias modification (CBM) training for attention (i.e., Attention Bias Modification) is offered eight times during a period of two weeks (i.e., 4 weekly sessions). As ABM paradigm, the dot-probe task is used. On each trial during this task, two pictures (always one positive and one negative picture) are displayed next to each other for 1000-1500 ms. Thereafter, a probe (i.e., an arrow pointing up versus down) appears behind one of the pictures. Participants have to identify the probe as quickly as possible. Each session contains 210 trials and takes about 20 minutes. Besides the first, all training sessions are completed via the internet, at participant’s home.

Positivity training:
In the positivity training the probe replaces the positive pictures in 90% of the cases and the negative pictures in 10 % of the cases. Hence, patients are trained to attend to positive pictures and to avoid negative pictures.

Control training:
In the control condition, patients receive a sham-training, during which the probe appears equally often behind positive and negative pictures, hence attentional bias is only assessed, but not modified.
- Primary outcome• Attentional bias (dot-probe task)
• Depression level as assessed by the Inventory of Depressive Symptomatology self-report (IDS-SR)
• Emotional vulnerability in response to a speech task as measured by the Spielberger State Anxiety Inventory (STAI-S) and the Positive and Negative Affect Scale (PANAS)
- Secondary outcome• Attentional control, as measured by the classical Stroop task
• Attentional bias for verbal positive and negative information (‘emotional Stroop task’),
• Ruminative Response Scale (RRS-NL)
• Positive and Negative Affect (PANAS)
• Prospective Imagery Task (PIT)
• Resilience Scale (RS)
• Number of sessions of out-patient therapy needed
• Credibility/Expectancy Questionnaire (CEQ)
• Quality of life (EuroQol; EQ-5D) and costs/ health care utilization (Trimbos/iMTA questionnaire; TicP)
• Diagnostic status of depression according to the DSM-IV-TR as assessed by the MINI Neuropsychiatric Interview
- TimepointsPrimary outcome measures:
• Attentional bias – Dot-probe task (pre to post)
• Depression level – IDS-SR (pre to post, 1 & 6 months follow-up)
• Emotional vulnerability in response to a speech task (post)

Secondary outcome measures:
• Classical & emotional Stroop task (pre to post)
• RRS-NL (pre to post, 1 & 6 months follow-up)
• PANAS (pre to post, 1 & 6 months follow-up)
• PIT (pre to post)
• RS (pre to post & 6 months follow-up)
• Number of sessions of out-patient therapy needed (follow-up)
• CEQ (after the first training session)
• EQ-5D (pre to post, 1, 6 & 12 months follow-up)
• TicP (pre & 12 months follow-up)
• Diagnostic status of depression according to the DSM-IV-TR as assessed by the MINI Neuropsychiatric Interview (pre & 12 months follow-up)
- Trial web site
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESJunior Researcher Gina Ferrari
- CONTACT for SCIENTIFIC QUERIESJunior Researcher Gina Ferrari
- Sponsor/Initiator Pro Persona
- Funding
(Source(s) of Monetary or Material Support)
Fund = Initiator = Sponsor
- Publications
- Brief summaryAttention bias modification aims at targeting the attentional bias often found in depression (a difficulty to disengage attention from negative information), by training participants΄ attention away from negative and towards positive stimuli. Studies provide preliminary evidence that ABM can modify cognitive biases in depressed samples (in mild and remitted depression) and may be of therapeutic value by reducing symptoms. In this double blind, randomized controlled trial, we primarily aim to investigate whether, in clinically depressed patients, (1) a positive attentional bias (i.e., relatively more attention for positive than for negative stimuli) can be induced and if the training attenuates (2) stress reactivity (3) and general levels of depression.
- Main changes (audit trail)
- RECORD20-jul-2015 - 9-sep-2017

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