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| Name | Class |
|---|---|
| University of Oxford | OTHER |
| Sorlandet Hospital HF | OTHER_GOV |
| Diakonhjemmet Hospital | OTHER |
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Depression (Major Depressive Disorder; MDD) has been dubbed "the common cold among the mental illnesses" and it is also a highly recurrent disorder. Secondary prevention has been identified as a key goal in the long-term management of depression. High recurrence rate suggests that there are specific vulnerability factors that increase people's risk for developing repeated episodes of the disorder. Preventive strategies should identify and ameliorate these factors to reduce the individual's risk of subsequent episodes. Biased attention for emotional stimuli is central to the cognitive model where increased sensitivity to negative cues is believed to fuel the negative thoughts and feelings in depression and play a key role in maintaining the illness. Selective biases in attention can be modified by a simple computerized technique; The Attention Bias Modification Task (ABM). This project aims to investigate whether ABM can reduce surrogate and clinical markers of relapse in a large group highly vulnerable to depressive episodes. The effects of ABM, immediately after the two weeks intervention, on three key risk factors for depression will be studied: Residual symptoms, cortisol awakening response and emotion regulation strategies. The participants will be followed up after 1 month, 6 months and 12 months. The hypothesis that ABM will reduce subsequent episodes of low mood over the following 12 months in this group in a manner predicted by early changes in these risk factors will be investigated. It will also be tested if such effects in the lab may be dependent on candidate genes which affect serotonin reuptake and which have been implicated in malleability and emotional learning. Effects on underlying neural correlates of emotion regulation will be studied in an fMRI experiment in a sub-sample and which will also be stratified by serotonin transporter genotype (see also NCT02931487). The predictive value of meta cognitions related to rumination and the possible mediating effects of automatic thoughts and perceived stress will also be investigated in a sub group (see also NCT02648165).
The characterization of the cognitive, genetic and neural mechanisms underlying the ABM effect will have key implications for future treatment development and combination with other treatment modalities like pharmacotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABM + | Experimental | Attention Bias Modification |
|
| ABM - | Sham Comparator | Sham Attention Bias Modification |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Attention Bias Modification | Behavioral | Computer based Attention Bias Modification |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in residual symptoms of depression. Self report. | Beck Depression Inventory | At baseline and immediately after ABM intervention (during first week after ABM). |
| Change in residual symptoms of depression. Clinician rating | Hamilton Depression Rating Scale | At baseline and immediately after ABM intervention (during first week after ABM). |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence of major depressive episodes | Measured by the MINI structured interview | Will be measured 12 month after baseline |
| Changes in Emotion Regulation | Emotion Regulation Questionnaire (ERQ). |
| Measure | Description | Time Frame |
|---|---|---|
| Automatic thoughts | Automatic Thought Questionnaire (ATQ) | At baseline, immediately after ABM intervention (average one day), 1 month after intervention, 6 months after intervention and 12 months after intervention |
| Changes in perceived stress |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nils I Landrø, Dr. Phil | University of Oslo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sørlandet Hospital, Department of Psychiatry | Arendal | Aust-Agder | 4801 | Norway | ||
| University of Oslo, Department of Psychology |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39111231 | Derived | Bo R, Kraft B, Skilbrei A, Jonassen R, Harmer CJ, Landro NI. Inhibition moderates the effect of attentional bias modification for reducing residual depressive symptoms: A randomized sham-controlled clinical trial. J Behav Ther Exp Psychiatry. 2024 Dec;85:101982. doi: 10.1016/j.jbtep.2024.101982. Epub 2024 Aug 2. | |
| 37579884 | Derived |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| Sham Attention Bias Modification |
| Behavioral |
Computer based Sham Attention Bias Modification |
|
| At baseline. |
| Changes in Rumination | The Rumination Response Scale | At baseline and 12 months after intervention |
| Changes in cortisol response. | Cortisol samples from saliva measured by diural variation (6 samples). | At baseline, immediately after ABM intervention and one month after intervention. |
| Changes in symptoms of anxiety | Beck Anxiety Inventory | At baseline, immediately after ABM intervention (during first week after ABM intervention), 1 month after intervention, 6 months after intervention and 12 months after intervention |
Perceived Stress Scale (PSS).
| At baseline, immediately after ABM intervention (average one day), , 1 month after intervention, 6 months after intervention and 12 months after intervention |
| Meta cognitions | Positive and Negative Beliefs about Rumination scale (PBRS and NBRS) | At baseline and 12 months after intervention |
| 5-HTTLPR+A>G polymorphic variation divided by the triallelic functional "high expressive" versus "low expressive" genotype will moderat the effect of ABM on residual symptoms compared to neutral ABM placebo condition | Immediately after ABM intervention. |
| Brain Derived Neurotrophic Factor (BDNF) val66met polymorphic variation linked to Brian Derived Neurotrophic Factor (BDNF) variation will moderate the effect of ABM on residual symptoms compared to neutral ABM placebo condition | Immediately after ABM intervention. |
| A serotonergic cumulative Genetic score, including (5-HHTLPR, HTR1A 8rs6295) and HTR 2A (rs 6311) polymorphisms will moderate the effects of ABM on residual symptoms compared to neutral placebo condition | Immediately after ABM intervention. |
| Change in residual symptoms of depression. Self report | Beck Depression Inventory | One month after intervention, 6 months after intervention and 12 months after intervention |
| Change in residual symptoms of depression. Clinical rating | Hamilton Depression Rating Scale | One month after intervention, 6 month after intervention and 12 month after intervention |
| Primary outcome measures will be modified by the degree of attentional change during the ABM intervention. | Immediately after the ABM intervention |
| Primary outcome measures will be modified by executive functioning | At baseline |
| Oslo |
| 0317 |
| Norway |
| Bo R, Kraft B, Jonassen R, Pedersen ML, Harmer CJ, Landro NI. The long-term effects of ABM on symptom severity in patients with recurrent depression: A randomized sham-controlled trial. J Affect Disord. 2023 Nov 1;340:886-892. doi: 10.1016/j.jad.2023.08.024. Epub 2023 Aug 12. |
| 33984807 | Derived | Bo R, Kraft B, Jonassen R, Harmer CJ, Hilland E, Stiles TC, Haaland VO, Aspesletten MEB, Sletvold H, Landro NI. Symptom severity moderates the outcome of attention bias modification for depression: An exploratory study. J Psychiatr Res. 2021 Jun;138:528-534. doi: 10.1016/j.jpsychires.2021.04.027. Epub 2021 May 5. |
| 31068158 | Derived | Jonassen R, Harmer CJ, Hilland E, Maglanoc LA, Kraft B, Browning M, Stiles TC, Haaland VO, Berge T, Landro NI. Effects of Attentional Bias Modification on residual symptoms in depression: a randomized controlled trial. BMC Psychiatry. 2019 May 8;19(1):141. doi: 10.1186/s12888-019-2105-8. |