A Personalized Approach to Effects of Affective Bias Modification on Symptom Change and Rumination

University of Oslo

Status: Completed

Conditions: Major Depressive Disorder

Treatments: Behavioral: Sham Affective bias modification; Behavioral: Affective bias modification

Study type: Interventional

Funder types: Other

Identifiers

NCT04137367

2019/FO249225

Details and patient eligibility

About

This study evaluates the effect of a computerized intervention for depressive symptoms called Affective Bias Modification (ABM). A third of the patients will receive active ABM, a third will receive sham ABM and a third will undergo assessment only. The study will investigate if rumination mediates the effect of the intervention and investigate if specific symptom profiles affect the effect of the intervention.

Full description

A main aim of the project is to investigate how the effects of an ABM intervention on depressive symptoms are mediated by transdiagnostic rumination and how characteristics of the symptom network moderate these effects. The Affective Bias Modification Task (ABM) will be applied in a randomized controlled, double blind clinical trial with 6 months follow-up. Personalized networks are generated from prospective assessment of depression-related processes at baseline and follow-ups. Patients (n = 150) will be recruited from out-patient clinics at Diakonhjemmet Hospital, and randomized into one of three conditions: active, sham and assessment only. Patients aged 18-65 with depression (major depressive disorder) or bipolar disorder 2, with or without comorbid anxiety and/or alcohol use disorder will be included. The main hypothesis is that subjects who are in the active ABM group will exhibit less tendency for stress related (state) rumination compared to those in the placebo group. Active vs placebo ABM will decrease depressive symptoms (6 months) and this effect will be mediated by the change in state rumination. Densely connected symptom network and high strength centrality of rumination at baseline will moderate the effect of ABM. By combining mechanisms research with a personalized symptom network approach, this study will be in the forefront of understanding how a drug-free treatment option works and for whom it works best.

Enrollment: 108 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Current or remitted Major Depressive Disorder, with or without anxiety, with or without alcohol use disorder

Exclusion criteria

• Neurological disorder, mania, and/or psychosis.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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108 participants in 3 patient groups

Active Affective Bias Modification

Experimental group

Description:

Computer based Affective Bias Modification

Treatment:

Behavioral: Affective bias modification

Sham Affective Bias Modification

Sham Comparator group

Description:

Computer based sham Affective Bias Modification

Treatment:

Behavioral: Sham Affective bias modification

Assesment only

No Intervention group

Description:

Only assessments are conducted