Major Depressive DisorderNCT04137367
A Personalized Approach to Effects of Affective Bias Modification on Symptom Change and Rumination
A study testing Affective bias modification in people with Major Depressive Disorder, run by University of Oslo at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Affective bias modification
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 1 siteNorway
- Study dates
- 19 Nov 2019to 3 Apr 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Current or remitted Major Depressive Disorder, with or without anxiety, with or without alcohol use disorder
Who cannot join
- Neurological disorder, mania, and/or psychosis.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Major Depressive Disorder
- Being tested
- Affective bias modification, Sham Affective bias modification
- Keywords
- Rumination, Attention bias modification, Transdiagnostic
- Medical subject headings
- Depressive Disorder, Major, Rumination Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Affective bias modificationBehavioural
Also called Attention 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.
Sham Affective bias modificationBehavioural
Also called Sham Attention 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.
| Study group | Role | What they receive |
|---|---|---|
| Active Affective Bias Modification | Experimental | Computer based Affective Bias Modification Receives: Behavioral: Affective bias modification |
| Sham Affective Bias Modification | Sham comparator | Computer based sham Affective Bias Modification Receives: Behavioral: Sham Affective bias modification |
| Assesment only | No intervention | Only assessments are conducted |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 6 months follow-up
State Rumination: Brief State Rumination Inventory (BSRI)
Change in self-reported state rumination after the stress induction from pre to post intervention on a 8 item scale. Difference score: BSRI post intervention - BRSI Baseline. A negative score means reduction in state rumination over the intervention. Each item is scored on a 0-100 Visual Analogue Scale. The total score divided by 8 to provide the mean item total score, hence the min= 0 and max = 100 for each of the BSRI assessment time points. It was hypothesized that change in state rumination over the intervention period would mediate the effect of ABM on depressive symptoms at six months follow up.
Measured: At baseline and two weeks 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, which is reported divided by 8 to provide a mean total item score. Hence the min= 0 and max = 100. A higher score indicates more state rumination.
Measured: At two weeks follow up.
Secondary outcomes (3)
Affective Bias: Dot-probe Task
Change in reaction time in milliseconds to probes in the location of the positive facial stimuli compared to probes in the location of the negative stimuli. Positive number implies reduction in negative bias.
Measured: From baseline to two weeks follow up
Symptom Network Change: Experience Sampling of Depressive Symptoms
Changed centrality of rumination in networks estimated based on a 9-item experience sampling questionnaire of self-reported depressive symptoms scored on a 0-100 visual analogue scale (higher value, more symptoms; reversing interest, positive affect and activity; Kraft et al., 2023, Psychiatry Research Communications). Two person-specific networks (pre and post-intervention) were estimated using the var1-function in the R package psychonetrics, with full-information maximum likelihood estimator, based on the experience sampling questionnaires that were administrated 5 times/day for 14 days before and after the intervention. Centrality of rumination in these networks were calculated using qgraph (Epskamp et al., 2012) and standardized. Change in rumination centrality was calculated as difference between rumination centrality in the two estimated networks, and higher number indicate increased centrality of rumination (post-pre).
Measured: From two weeks prior to baseline to two weeks after the two-week intervention.
Symptom Network: Experience Sampling of Depressive Symptoms
Centrality of rumination in networks based on a 9-item experience sampling questionnaire of self-reported depressive symptoms scored on a 0-100 visual analogue scale (higher value, more symptoms; reversing interest, positive affect and activity; Kraft et al., 2023, Psychiatry Research Communications). Person-specific networks were estimated using the var1-function in the R package psychonetrics, with full-information maximum likelihood estimator, based on the experience sampling questionnaires that were administrated 5 times/day for 14 days after the two-week intervention. Centrality of rumination in this network was calculated using qgraph (Epskamp et al., 2012) and standardized. Higher number indicate higher centrality of rumination.
Measured: Two weeks after the two-week intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2019
- Study start19 Nov 2019
- Primary completion3 Apr 2022
- Study completion3 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oslo
- Sponsor type
- University, hospital or other
- Collaborators
- Extrastiftelsen, Diakonhjemmet Hospital, University of Oxford
- Responsible party
- Principal investigator, Nils Inge Landrø, University of Oslo
- Investigators
- Nils Inge Landrø, Dr.Philos, Principal investigator, University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04137367
- Sponsor's protocol ID
- 2019/FO249225
- Status last verified
- Oct 2024
- First submitted
- 10 Oct 2019
- Last updated
- 5 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bo R, Kraft B, Joormann J, Jonassen R, Harmer CJ, Landro NI. Cognitive predictors of stress-induced mood malleability in depression. Anxiety Stress Coping. 2024 Mar;37(2):278-292. doi: 10.1080/10615806.2023.2255531. Epub 2023 Sep 11.
PubMed 37695740Bo R, Kraft B, Pedersen ML, Joormann J, Jonassen R, Osnes K, Harmer CJ, Landro NI. The effect of attention bias modification on depressive symptoms in a comorbid sample: a randomized controlled trial. Psychol Med. 2023 Oct;53(13):6389-6396. doi: 10.1017/S0033291722003956. Epub 2023 Jan 9.
PubMed 36617964
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Personalized Approach to Effects of Affective Bias Modification on Symptom Change and Rumination
- ClinicalTrials.gov ID
- NCT04137367
- Acronym / sponsor ID
- 2019/FO249225
- Conditions
- Major Depressive Disorder
- Keywords
- Rumination, Attention bias modification, Transdiagnostic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- University of OsloUniversity, hospital or other
- Collaborators
- Extrastiftelsen, Diakonhjemmet Hospital, University of Oxford
- Study start
- 19 Nov 2019 (actual)
- Primary completion
- 3 Apr 2022 (actual)
- Study completion
- 3 Apr 2022 (actual)
- First posted
- 24 Oct 2019 (actual)
- Results
- Posted 5 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Active Affective Bias Modification | Experimental | Behavioral: Affective bias modificationComputer based Affective Bias Modification |
| Sham Affective Bias Modification | Sham comparator | Behavioral: Sham Affective bias modificationComputer based sham Affective Bias Modification |
| Assesment only | No intervention | –Only assessments are conducted |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Current or remitted Major Depressive Disorder, with or without anxiety, with or without alcohol use disorder
Key exclusion criteria (1 listed)
- Neurological disorder, mania, and/or psychosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Affective bias modificationAlso: Attention Bias ModificationIn 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. | Behavioural | Active Affective Bias Modification |
| Sham Affective bias modificationAlso: Sham Attention bias modificationIn 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. | Behavioural | Sham Affective Bias Modification |
Primary outcome
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.
State Rumination: Brief State Rumination Inventory (BSRI)
Time frame: At baseline and two weeks follow up.
Change in self-reported state rumination after the stress induction from pre to post intervention on a 8 item scale. Difference score: BSRI post intervention - BRSI Baseline. A negative score means reduction in state rumination over the intervention. Each item is scored on a 0-100 Visual Analogue Scale. The total score divided by 8 to provide the mean item total score, hence the min= 0 and max = 100 for each of the BSRI assessment time points. It was hypothesized that change in state rumination over the intervention period would mediate the effect of ABM on depressive symptoms at six months 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, which is reported divided by 8 to provide a mean total item score. Hence the min= 0 and max = 100. A higher score indicates more state rumination.
3 secondary outcomes
Affective Bias: Dot-probe Task
Time frame: 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 the two-week intervention.
Symptom Network: Experience Sampling of Depressive Symptoms
Time frame: Two weeks after the two-week intervention.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37695740Bo R, Kraft B, Joormann J, Jonassen R, Harmer CJ, Landro NI. Cognitive predictors of stress-induced mood malleability in depression. Anxiety Stress Coping. 2024 Mar;37(2):278-292. doi: 10.1080/10615806.2023.2255531. Epub 2023 Sep 11.
- Derived from this study: PubMed 36617964Bo R, Kraft B, Pedersen ML, Joormann J, Jonassen R, Osnes K, Harmer CJ, Landro NI. The effect of attention bias modification on depressive symptoms in a comorbid sample: a randomized controlled trial. Psychol Med. 2023 Oct;53(13):6389-6396. doi: 10.1017/S0033291722003956. Epub 2023 Jan 9.
- Project web pageLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nils Inge Landrø, Dr.Philos principal investigator
University of Oslo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Affective bias modification in people with Major Depressive Disorder, run by University of Oslo at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-reported Depressive Symptoms: Becks Depression Inventory-II (time frame: At 6 months follow-up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04137367, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2025; AzTrials last refreshed its copy on 6 Nov 2026.