Combining Antidepressants and Attention Bias Modification in Depression

Summary

Background: Major depressive disorder (MDD) is a highly prevalent psychiatric condition associated with significant disability, mortality and economic burden. A large proportion of MDD patients are treated in primary health care (PHC) in the municipalities and represent a challenging group. Attentional Bias Modification (ABM) training in combination with antidepressants (SSRIs) could be an effective treatment. The overall aim of this study is to test the hypothesis that adding an ABM procedure to regular treatment with antidepressants in PHC will result in further improvement of symptoms compared to treatment with antidepressants alone (treatment as usual, TAU) and as compared to an active comparison condition.

Methods: A total of 246 patients with a diagnosis of MDD will be included in this study. The study is a three-armed pragmatic randomized controlled trial comparing the efficacy of ABM as add-on to treatment with antidepressants in primary care (ABM condition) compared to standard antidepressant treatment (TAU condition). In a third group participants will complete the same schedule of intermediate assessments as the ABM condition in addition to TAU , but no ABM, thus controlling for the non-training-specific aspects of the ABM condition (SSRI Active comparison group).

Discussion:

The clinical outcome of this study may help develop easy accessible, low cost treatment of depression in PHC. Moreover, the study aims to broaden our knowledge of optimal treatment for patients with a MDD by providing adjunct treatment to facilitate recovery and long term gain

Conditions

• Depressive Disorder

Interventions

BEHAVIORAL

Attentional Bias Modification

The ABM task is based on a computerized visual Dot-probe task. In the dot-probe task paired stimuli of negative (angry and fearful), positive (happy) or neutral faces are presented, followed by one or two probes (dots) appearing in the spatial location of one of the stimuli. Participants are then required to press one of two buttons as quickly as possible to indicate the number of dots in the probe. In the ABM condition, probes are in the same locus as the more positive/less negative stimuli in 87% of the trials, as opposed to 13% with probes in the same locus as more negative/less positive stimuli. Thus, when completing the ABM, participants should learn to deploy their attention toward the relatively more positive stimuli, and in this way develop a more positive AB.

Sponsors & Collaborators

• University of Oxford

  collaborator OTHER

• University of Oslo

  lead OTHER

Principal Investigators

• Jan I Røssberg, PhD · Universitetet i Oslo/Oslo universitetssykehus

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-09-22

Primary Completion

2025-03-30

Completion

2025-12-30

Countries

• Norway

Study Locations