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

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Affective bias modification
Sham Affective bias modification
Sponsored by
University of Oslo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring Rumination, Attention bias modification, Transdiagnostic

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Department of Psychology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Active Affective Bias Modification

Sham Affective Bias Modification

Arm Description

Computer based Affective Bias Modification

Computer based sham Affective Bias Modification

Outcomes

Primary Outcome Measures

Self-reported depressive symptoms: Becks Depression Inventory-II
Self-reported depressive symptoms 6 months after the ABM intervention based on a 21-item scale. Each item is scored 0-3 (where scoring description is adapted to each item), yielding a score from 0-63.
State rumination: Brief State Rumination Inventory
Change in self-reported state rumination after stress induction on a 8 item scale. Each item is scored on a 0-100 Visual Analogue Scale, yielding a score from 0-800 will mediate the effect of ABM on depressive symptoms at six months follow up.
State rumination: Brief State Rumination Inventory
Self-reported state rumination after stress induction on a 8 item scale. Each item is scored on a 0-100 Visual Analogue Scale, yielding a score from 0-800.

Secondary Outcome Measures

Affective bias: Dot-probe task
Change in reaction time to probes in the location of the positive facial stimuli.
Symptom network change: experience sampling of depressive symptoms
Less densely connected network of self-reported symptoms and changed centrality of rumination based on a 9-item experience sampling questionnaire administrated five times/day for two periodes of fourteen days. Each item is scored on a 0-100 visual analogue scale.
Symptom network: experience sampling of depressive symptoms
Network density of self-reported symptoms and centrality of rumination prior to baseline will moderate the effect of ABM, based on a 9-item experience sampling questionnaire administrated five times/day for fourteen days. Each item is scored on a 0-100 visual analogue scale.

Full Information

First Posted
October 10, 2019
Last Updated
June 9, 2022
Sponsor
University of Oslo
Collaborators
Extrastiftelsen, Diakonhjemmet Hospital, University of Oxford
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1. Study Identification

Unique Protocol Identification Number
NCT04137367
Brief Title
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

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
November 19, 2019 (Actual)
Primary Completion Date
April 3, 2022 (Actual)
Study Completion Date
April 3, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Oslo
Collaborators
Extrastiftelsen, Diakonhjemmet Hospital, University of Oxford

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
Rumination, Attention bias modification, Transdiagnostic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
101 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active Affective Bias Modification
Arm Type
Experimental
Arm Description
Computer based Affective Bias Modification
Arm Title
Sham Affective Bias Modification
Arm Type
Sham Comparator
Arm Description
Computer based sham Affective Bias Modification
Intervention Type
Behavioral
Intervention Name(s)
Affective bias modification
Other Intervention Name(s)
Attention Bias Modification
Intervention Description
In the Affective bias modification (ABM) procedure, paired stimuli (e.g. a negative and a positive facial expression) are presented on a laptop screen, 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. Stimuli presentation time is 50% 500 ms and 50 % 1000 ms (evenly distributed throughout the task). In total, the ABM will comprise 90 trials of paired images of faces of different valences. In the active condition, the probe appears at the location of the most positive stimuli of each pair in 87 % of trials (encouraging a positive affective bias). Participants will do ABM in their homes (approx. 5 min.) twice a day for two weeks (28 sessions) using laptop computers provided by us.
Intervention Type
Behavioral
Intervention Name(s)
Sham Affective bias modification
Other Intervention Name(s)
Sham Attention bias modification
Intervention Description
In the Affective bias modification (ABM) procedure, paired stimuli (e.g. a negative and a positive facial expression) are presented on a laptop screen, 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. Stimuli presentation time is 50% 500 ms and 50 % 1000 ms (evenly distributed throughout the task). In total, the ABM will comprise 90 trials of paired images of faces of different valences. In the sham condition, the probe appears at the location of the most positive stimuli of each pair in 50 % of trials (no contingency between facial expressions shown and the probe location). Participants will do ABM in their homes (approx. 5 min.) twice a day for two weeks (28 sessions) using laptop computers provided by us.
Primary Outcome Measure Information:
Title
Self-reported depressive symptoms: Becks Depression Inventory-II
Description
Self-reported depressive symptoms 6 months after the ABM intervention based on a 21-item scale. Each item is scored 0-3 (where scoring description is adapted to each item), yielding a score from 0-63.
Time Frame
At 6 months follow-up
Title
State rumination: Brief State Rumination Inventory
Description
Change in self-reported state rumination after stress induction on a 8 item scale. Each item is scored on a 0-100 Visual Analogue Scale, yielding a score from 0-800 will mediate the effect of ABM on depressive symptoms at six months follow up.
Time Frame
At baseline and two weeks follow up
Title
State rumination: Brief State Rumination Inventory
Description
Self-reported state rumination after stress induction on a 8 item scale. Each item is scored on a 0-100 Visual Analogue Scale, yielding a score from 0-800.
Time Frame
At two weeks follow up.
Secondary Outcome Measure Information:
Title
Affective bias: Dot-probe task
Description
Change in reaction time to probes in the location of the positive facial stimuli.
Time Frame
From baseline to two weeks follow up
Title
Symptom network change: experience sampling of depressive symptoms
Description
Less densely connected network of self-reported symptoms and changed centrality of rumination based on a 9-item experience sampling questionnaire administrated five times/day for two periodes of fourteen days. Each item is scored on a 0-100 visual analogue scale.
Time Frame
From two weeks prior to baseline to two weeks after two weeks follow up.
Title
Symptom network: experience sampling of depressive symptoms
Description
Network density of self-reported symptoms and centrality of rumination prior to baseline will moderate the effect of ABM, based on a 9-item experience sampling questionnaire administrated five times/day for fourteen days. Each item is scored on a 0-100 visual analogue scale.
Time Frame
At two weeks prior to baseline.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nils Inge Landrø, Dr.Philos
Organizational Affiliation
University of Oslo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Psychology
City
Oslo
ZIP/Postal Code
0317
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.sv.uio.no/psi/english/research/projects/affective-bias-modification/
Description
Project web page

Learn more about this trial

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

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