Secondary Prevention of Depression Applying an Experimental Attentional Bias Modification Procedure

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.

Study Overview

• Status: Completed
• Conditions: Major Depression
• Intervention / Treatment: Behavioral: Attention Bias Modification; Behavioral: Sham Attention Bias Modification

• Study Type: Interventional
• Enrollment (Actual): 350
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway, 0317
    • University of Oslo, Department of Psychology
  • Aust-Agder
    • Arendal, Aust-Agder, Norway, 4801
      • Sørlandet Hospital, Department of Psychiatry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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).

Secondary Outcome Measures

Outcome Measure	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).	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

Other Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: University of Oslo
• Collaborators: Diakonhjemmet Hospital; University of Oxford; Sorlandet Hospital HF
• Investigators: Principal Investigator: Nils I Landrø, Dr. Phil, University of Oslo

Publications and helpful links

General Publications

• Bø R, Kraft B, Jonassen R, Harmer CJ, Hilland E, Stiles TC, Haaland VØ, Aspesletten MEB, Sletvold H, Landrø 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.
• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Actual): October 1, 2016
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: December 14, 2015
• First Submitted That Met QC Criteria: January 14, 2016
• First Posted (Estimate): January 20, 2016

Study Record Updates

• Last Update Posted (Actual): April 26, 2019
• Last Update Submitted That Met QC Criteria: April 25, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder
• Other Study ID Numbers: NFR-229135