Overview

This trial is active, not recruiting.

Condition major depression
Treatments attention bias modification, sham attention bias modification
Sponsor University of Oslo
Collaborator University of Oxford
Start date January 2015
End date October 2016
Trial size 350 participants
Trial identifier NCT02658682, NFR-229135

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose prevention
Arm
(Experimental)
Attention Bias Modification
attention bias modification
Computer based Attention Bias Modification
(Sham Comparator)
Sham Attention Bias Modification
sham attention bias modification
Computer based Sham Attention Bias Modification

Primary Outcomes

Measure
Change in residual symptoms of depression. Self report.
time frame: At baseline and immediately after ABM intervention (during first week after ABM).
Change in residual symptoms of depression. Clinician rating
time frame: At baseline and immediately after ABM intervention (during first week after ABM).

Secondary Outcomes

Measure
Recurrence of major depressive episodes
time frame: Will be measured 12 month after baseline
Changes in Emotion Regulation
time frame: At baseline.
Changes in Rumination
time frame: At baseline and 12 months after intervention
Changes in cortisol response.
time frame: At baseline, immediately after ABM intervention and one month after intervention.
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

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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.

Additional Information

Official title Secondary Prevention of Depression Applying an Experimental Attentional Bias Modification Procedure
Principal investigator Nils I Landrø, Dr. Phil
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by University of Oslo.