Clinical trial NCT02658682: Secondary Prevention of Depression Applying an Experimental Attentional Bias Modification Procedure
Official title: Secondary Prevention of Depression Applying an Experimental Attentional Bias Modification Procedure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depression
Lead sponsor: University of Oslo
Sponsor class: OTHER
Collaborators: name: University of Oxford
name: Sorlandet Hospital HF
name: Diakonhjemmet Hospital
First posted: 2016-01-20
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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.

Primary outcomes:
measure: Change in residual symptoms of depression. Self report.
timeFrame: At baseline and immediately after ABM intervention (during first week after ABM).
measure: Change in residual symptoms of depression. Clinician rating
timeFrame: At baseline and immediately after ABM intervention (during first week after ABM).
Secondary outcomes:
measure: Recurrence of major depressive episodes
timeFrame: Will be measured 12 month after baseline
measure: Changes in Emotion Regulation
timeFrame: At baseline.
measure: Changes in Rumination
timeFrame: At baseline and 12 months after intervention
measure: Changes in cortisol response.
timeFrame: At baseline, immediately after ABM intervention and one month after intervention.
measure: Changes in symptoms of anxiety
timeFrame: 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
Other outcomes:
measure: Automatic thoughts
timeFrame: At baseline, immediately after ABM intervention (average one day), 1 month after intervention, 6 months after intervention and 12 months after intervention
measure: Changes in perceived stress
timeFrame: At baseline, immediately after ABM intervention (average one day), , 1 month after intervention, 6 months after intervention and 12 months after intervention
measure: Meta cognitions
timeFrame: At baseline and 12 months after intervention
measure: 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
timeFrame: Immediately after ABM intervention.
measure: 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
timeFrame: Immediately after ABM intervention.
measure: 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
timeFrame: Immediately after ABM intervention.
measure: Change in residual symptoms of depression. Self report
timeFrame: One month after intervention, 6 months after intervention and 12 months after intervention
measure: Change in residual symptoms of depression. Clinical rating
timeFrame: One month after intervention, 6 month after intervention and 12 month after intervention
measure: Primary outcome measures will be modified by the degree of attentional change during the ABM intervention.
timeFrame: Immediately after the ABM intervention
measure: Primary outcome measures will be modified by executive functioning
timeFrame: At baseline
Locations:
city: Arendal
country: Norway
facility: Sørlandet Hospital, Department of Psychiatry
state: Aust-Agder
city: Oslo
country: Norway
facility: University of Oslo, Department of Psychology
Study officials:
affiliation: University of Oslo
name: Nils I Landrø, Dr. Phil
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.