- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04137367
A Personalized Approach to Effects of Affective Bias Modification on Symptom Change and Rumination
June 9, 2022 updated by: Nils Inge Landrø, University of Oslo
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
101
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Oslo, Norway, 0317
- Department of Psychology
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Active Affective Bias Modification
Computer based Affective Bias Modification
|
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.
Other Names:
|
Sham Comparator: Sham Affective Bias Modification
Computer based sham Affective Bias Modification
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Self-reported depressive symptoms: Becks Depression Inventory-II
Time Frame: At 6 months follow-up
|
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.
|
At 6 months follow-up
|
State rumination: Brief State Rumination Inventory
Time Frame: At baseline and two weeks follow up
|
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.
|
At baseline and two weeks follow up
|
State rumination: Brief State Rumination Inventory
Time Frame: At two weeks follow up.
|
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.
|
At two weeks follow up.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Affective bias: Dot-probe task
Time Frame: From baseline to two weeks follow up
|
Change in reaction time to probes in the location of the positive facial stimuli.
|
From baseline to two weeks follow up
|
Symptom network change: experience sampling of depressive symptoms
Time Frame: From two weeks prior to baseline to two weeks after two weeks follow up.
|
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.
|
From two weeks prior to baseline to two weeks after two weeks follow up.
|
Symptom network: experience sampling of depressive symptoms
Time Frame: At two weeks prior to baseline.
|
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.
|
At two weeks prior to baseline.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Nils Inge Landrø, Dr.Philos, University of Oslo
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 19, 2019
Primary Completion (Actual)
April 3, 2022
Study Completion (Actual)
April 3, 2022
Study Registration Dates
First Submitted
October 10, 2019
First Submitted That Met QC Criteria
October 21, 2019
First Posted (Actual)
October 24, 2019
Study Record Updates
Last Update Posted (Actual)
June 10, 2022
Last Update Submitted That Met QC Criteria
June 9, 2022
Last Verified
June 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019/FO249225
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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