Clinical trial NCT04137367: A Personalized Approach to Effects of Affective Bias Modification on Symptom Change and Rumination
Official title: A Personalized Approach to Effects of Affective Bias Modification on Symptom Change and Rumination
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depressive Disorder
Keywords: Rumination
Attention bias modification
Transdiagnostic
Lead sponsor: University of Oslo
Sponsor class: OTHER
Collaborators: name: Extrastiftelsen
name: Diakonhjemmet Hospital
name: University of Oxford
First posted: 2019-10-24
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Self-reported Depressive Symptoms: Becks Depression Inventory-II
timeFrame: At 6 months follow-up
measure: State Rumination: Brief State Rumination Inventory (BSRI)
timeFrame: At baseline and two weeks follow up.
measure: State Rumination: Brief State Rumination Inventory
timeFrame: At two weeks follow up.
Secondary outcomes:
measure: Affective Bias: Dot-probe Task
timeFrame: From baseline to two weeks follow up
measure: Symptom Network Change: Experience Sampling of Depressive Symptoms
timeFrame: From two weeks prior to baseline to two weeks after the two-week intervention.
measure: Symptom Network: Experience Sampling of Depressive Symptoms
timeFrame: Two weeks after the two-week intervention.
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Department of Psychology
Study officials:
affiliation: University of Oslo
name: Nils Inge Landrø, Dr.Philos
role: PRINCIPAL_INVESTIGATOR
References: