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Secondary Prevention of Depression Applying an Experimental Attentional Bias Modification Procedure

Secondary Prevention of Depression Applying an Experimental Attentional Bias Modification Procedure

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02658682
Enrollment
350
Registered
2016-01-20
Start date
2015-01-31
Completion date
2017-12-31
Last updated
2019-04-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Depression

Brief summary

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.

Interventions

BEHAVIORALAttention Bias Modification

Computer based Attention Bias Modification

Computer based Sham Attention Bias Modification

Sponsors

University of Oxford
CollaboratorOTHER
Sorlandet Hospital HF
CollaboratorOTHER_GOV
Diakonhjemmet Hospital
CollaboratorOTHER
University of Oslo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* Nondepressed subjects (based on the MINI structured interview) with a history of major depression

Exclusion criteria

* Current or past neurological illness, bipolar disorder, psychosis or drug addiction.

Design outcomes

Primary

MeasureTime frameDescription
Change in residual symptoms of depression. Self report.At baseline and immediately after ABM intervention (during first week after ABM).Beck Depression Inventory
Change in residual symptoms of depression. Clinician ratingAt baseline and immediately after ABM intervention (during first week after ABM).Hamilton Depression Rating Scale

Secondary

MeasureTime frameDescription
Changes in RuminationAt baseline and 12 months after interventionThe Rumination Response Scale
Recurrence of major depressive episodesWill be measured 12 month after baselineMeasured by the MINI structured interview
Changes in symptoms of anxietyAt baseline, immediately after ABM intervention (during first week after ABM intervention), 1 month after intervention, 6 months after intervention and 12 months after interventionBeck Anxiety Inventory
Changes in cortisol response.At baseline, immediately after ABM intervention and one month after intervention.Cortisol samples from saliva measured by diural variation (6 samples).
Changes in Emotion RegulationAt baseline.Emotion Regulation Questionnaire (ERQ).

Other

MeasureTime frameDescription
Change in residual symptoms of depression. Clinical ratingOne month after intervention, 6 month after intervention and 12 month after interventionHamilton Depression Rating Scale
Automatic thoughtsAt baseline, immediately after ABM intervention (average one day), 1 month after intervention, 6 months after intervention and 12 months after interventionAutomatic Thought Questionnaire (ATQ)
Primary outcome measures will be modified by executive functioningAt baseline
Primary outcome measures will be modified by the degree of attentional change during the ABM intervention.Immediately after the ABM intervention
Changes in perceived stressAt baseline, immediately after ABM intervention (average one day), , 1 month after intervention, 6 months after intervention and 12 months after interventionPerceived Stress Scale (PSS).
Meta cognitionsAt baseline and 12 months after interventionPositive and Negative Beliefs about Rumination scale (PBRS and NBRS)
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 conditionImmediately 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 conditionImmediately 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 conditionImmediately after ABM intervention.
Change in residual symptoms of depression. Self reportOne month after intervention, 6 months after intervention and 12 months after interventionBeck Depression Inventory

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026