Combining Antidepressants and Attention Bias Modification in Depression

NCT05503966 | Recruiting DMC

• 1 other identifier: 273292
• Study Type: interventional
• Target: 246
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Major Depressive Disorder; Attentional Bias Modification; Primary Health Care

Outcome Measures

Primary Outcomes (2)

• Hamilton Depression Rating Scale

  Clinician rated depressive symptoms. Range (0-50). Higher score indicate more depressive symptoms

  8 weeks after baseline.

• Beck Depression Inventory II

  Self rated depressive symptoms. Range (0-63). Higher score indicate more depressive symptoms

  8 weeks after baseline.

Secondary Outcomes (29)

• Beck Depression Inventory II

  Follow-up 12 weeks after baseline.

• Beck Depression Inventory II

  Follow-up 6 months after baseline

• Generalized Anxiety Disorder-7

  8 weeks after baseline.

• Generalized Anxiety Disorder-7

  12 weeks after baseline.

• Generalized Anxiety Disorder-7

  6 months after baseline

Study Arms (3)

Positive ABM

EXPERIMENTAL

The ABM intervention will be initiated two weeks after antidepressant treatment started (baseline) and continues with two daily sessions for two weeks.

Behavioral: Attentional Bias Modification

No ABM

ACTIVE COMPARATOR

This group will in addition to TAU complete the schedule of intermediate assessments as in the ABM group, but no ABM , thus controlling for the aspects of the ABM group that are additional to TAU (increased engagement in cognitive activity and repeated assessment over time), but not including the training component itself (SSRI Active comparison group).

Behavioral: Attentional Bias Modification

TAU

NO INTERVENTION

Patients allocated to this group will be assessed at baseline and at the primary end-point as well after 12 weeks and 6 months follow-up. They will not complete any instruments during the intervention period to prevent the effect of some cognitive activity and provide a more ecologically valid version of TAU as it happens in primary care.

Interventions

Attentional Bias Modification BEHAVIORAL

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.

Also known as: ABM

No ABM; Positive ABM

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Major Depressive Disorder
• BDI II \> 14
• Age 18 - 65 years
• Ability to understand and speak a Scandinavian language
• Willingness and ability to give informed consent

You may not qualify if:

• Current or past neurological illness
• Traumatic brain injury
• Current alcohol and/or substance dependency disorders
• Psychotic disorders
• Bipolar disorder type 1,
• Developmental disorders and mental retardation.

Sponsors & Collaborators

• University of Oslo: lead
• University of Oxford: collaborator

Study Sites (1)

Jan Ivar Røssberg

Oslo, Nydalen, Postboks 4959, Norway

RECRUITING

MeSH Terms

Conditions

Depressive Disorder; Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders

Study Officials

• Jan I Røssberg, PhD

  Universitetet i Oslo/Oslo universitetssykehus

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jan I Røssberg, PhD

CONTACT

+47 47876866; j.i.rossberg@medisin.uio.no

Nils I Landrø, PhD

CONTACT

+47 95038479; n.i.landro@psykologi.uio.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: The study is a three-armed, double-blinded, pragmatic randomized controlled trial comparing the efficacy of ABM as add-on to treatment with antidepressants (SSRI ABM group) in primary care compared to standard antidepressant treatment (SSRI TAU group). The third group will in addition to TAU be engaged in answering all the questionnaires and perform all the tasks, but without ABM, thus controlling for being engaged in some cognitive activity (SSRI Active comparison group).

Study Record Dates

• First Submitted: August 9, 2022
• First Posted: August 17, 2022
• Study Start: September 22, 2022
• Primary Completion: March 30, 2025
• Study Completion: December 30, 2025
• Last Updated: March 28, 2025

Record last verified: 2024-05

Locations

NO (1)