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Secondary Prevention of Depression Applying an Experimental Attentional Bias Modification Procedure

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ClinicalTrials.gov Identifier: NCT02658682
Recruitment Status : Completed
First Posted : January 20, 2016
Last Update Posted : April 26, 2019
Sponsor:
Collaborators:
University of Oxford
Sorlandet Hospital HF
Diakonhjemmet Hospital
Information provided by (Responsible Party):
Nils Inge Landrø, University of Oslo

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.


Condition or disease Intervention/treatment Phase
Major Depression Behavioral: Attention Bias Modification Behavioral: Sham Attention Bias Modification Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Secondary Prevention of Depression Applying an Experimental Attentional Bias Modification Procedure
Study Start Date : January 2015
Actual Primary Completion Date : October 2016
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ABM +
Attention Bias Modification
Behavioral: Attention Bias Modification
Computer based Attention Bias Modification

Sham Comparator: ABM -
Sham Attention Bias Modification
Behavioral: Sham Attention Bias Modification
Computer based Sham Attention Bias Modification




Primary Outcome Measures :
  1. Change in residual symptoms of depression. Self report. [ Time Frame: At baseline and immediately after ABM intervention (during first week after ABM). ]
    Beck Depression Inventory

  2. Change in residual symptoms of depression. Clinician rating [ Time Frame: At baseline and immediately after ABM intervention (during first week after ABM). ]
    Hamilton Depression Rating Scale


Secondary Outcome Measures :
  1. Recurrence of major depressive episodes [ Time Frame: Will be measured 12 month after baseline ]
    Measured by the MINI structured interview

  2. Changes in Emotion Regulation [ Time Frame: At baseline. ]
    Emotion Regulation Questionnaire (ERQ).

  3. Changes in Rumination [ Time Frame: At baseline and 12 months after intervention ]
    The Rumination Response Scale

  4. Changes in cortisol response. [ Time Frame: At baseline, immediately after ABM intervention and one month after intervention. ]
    Cortisol samples from saliva measured by diural variation (6 samples).

  5. Changes in symptoms of anxiety [ Time Frame: 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 ]
    Beck Anxiety Inventory


Other Outcome Measures:
  1. Automatic thoughts [ Time Frame: At baseline, immediately after ABM intervention (average one day), 1 month after intervention, 6 months after intervention and 12 months after intervention ]
    Automatic Thought Questionnaire (ATQ)

  2. Changes in perceived stress [ Time Frame: At baseline, immediately after ABM intervention (average one day), , 1 month after intervention, 6 months after intervention and 12 months after intervention ]
    Perceived Stress Scale (PSS).

  3. Meta cognitions [ Time Frame: At baseline and 12 months after intervention ]
    Positive and Negative Beliefs about Rumination scale (PBRS and NBRS)

  4. 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 [ Time Frame: Immediately after ABM intervention. ]
  5. 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 [ Time Frame: Immediately after ABM intervention. ]
  6. 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 [ Time Frame: Immediately after ABM intervention. ]
  7. Change in residual symptoms of depression. Self report [ Time Frame: One month after intervention, 6 months after intervention and 12 months after intervention ]
    Beck Depression Inventory

  8. Change in residual symptoms of depression. Clinical rating [ Time Frame: One month after intervention, 6 month after intervention and 12 month after intervention ]
    Hamilton Depression Rating Scale

  9. Primary outcome measures will be modified by the degree of attentional change during the ABM intervention. [ Time Frame: Immediately after the ABM intervention ]
  10. Primary outcome measures will be modified by executive functioning [ Time Frame: At baseline ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02658682


Locations
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Norway
Sørlandet Hospital, Department of Psychiatry
Arendal, Aust-Agder, Norway, 4801
University of Oslo, Department of Psychology
Oslo, Norway, 0317
Sponsors and Collaborators
University of Oslo
University of Oxford
Sorlandet Hospital HF
Diakonhjemmet Hospital
Investigators
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Principal Investigator: Nils I Landrø, Dr. Phil University of Oslo

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Nils Inge Landrø, Professor, University of Oslo
ClinicalTrials.gov Identifier: NCT02658682     History of Changes
Other Study ID Numbers: NFR-229135
First Posted: January 20, 2016    Key Record Dates
Last Update Posted: April 26, 2019
Last Verified: April 2019

Additional relevant MeSH terms:
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Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders