Major DepressionNCT02658682
Secondary Prevention of Depression Applying an Experimental Attentional Bias Modification Procedure
A study testing Attention Bias Modification in people with Major Depression, run by University of Oslo at 2 sites in Norway.
Trial summary
Depression (Major Depressive Disorder; MDD) has been dubbed "the common cold among the mental illnesses" and it is also a highly recurrent disorder. Secondary prevention has been identified as a key goal in the long-term management of depression. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depression
- What is being tested?
- Attention Bias Modification
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 350 participants
- Where
- 2 sitesNorway
- Study dates
- Jan 2015to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Nondepressed subjects (based on the MINI structured interview) with a history of major depression
Who cannot join
- Current or past neurological illness, bipolar disorder, psychosis or drug addiction.
Trial locations and contacts
2 sites in 1 country.
Norway2 sites
Sørlandet Hospital, Department of Psychiatry
Arendal, Aust-Agder, 4801
University of Oslo, Department of Psychology
Oslo, 0317
About this study
Depression (Major Depressive Disorder; MDD) has been dubbed "the common cold among the mental illnesses" and it is also a highly recurrent disorder. Secondary prevention has been identified as a key goal in the long-term management of depression. High recurrence rate suggests that there are specific vulnerability factors that increase people's risk for developing repeated episodes of the disorder. Preventive strategies should identify and ameliorate these factors to reduce the individual's risk of subsequent episodes. Biased attention for emotional stimuli is central to the cognitive model where increased sensitivity to negative cues is believed to fuel the negative thoughts and feelings in depression and play a key role in maintaining the illness. Selective biases in attention can be modified by a simple computerized technique; The Attention Bias Modification Task (ABM). This project aims to investigate whether ABM can reduce surrogate and clinical markers of relapse in a large group highly vulnerable to depressive episodes. The effects of ABM, immediately after the two weeks intervention, on three key risk factors for depression will be studied: Residual symptoms, cortisol awakening response and emotion regulation strategies. The participants will be followed up after 1 month, 6 months and 12 months. The hypothesis that ABM will reduce subsequent episodes of low mood over the following 12 months in this group in a manner predicted by early changes in these risk factors will be investigated. It will also be tested if such effects in the lab may be dependent on candidate genes which affect serotonin reuptake and which have been implicated in malleability and emotional learning. Effects on underlying neural correlates of emotion regulation will be studied in an fMRI experiment in a sub-sample and which will also be stratified by serotonin transporter genotype (see also NCT02931487). The predictive value of meta cognitions related to rumination and the possible mediating effects of automatic thoughts and perceived stress will also be investigated in a sub group (see also NCT02648165).
The characterization of the cognitive, genetic and neural mechanisms underlying the ABM effect will have key implications for future treatment development and combination with other treatment modalities like pharmacotherapy.
- Conditions
- Major Depression
- Being tested
- Attention Bias Modification, Sham Attention Bias Modification
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Attention Bias ModificationBehavioural
Computer based Attention Bias Modification
Sham Attention Bias ModificationBehavioural
Computer based Sham Attention Bias Modification
| Study group | Role | What they receive |
|---|---|---|
| ABM + | Experimental | Attention Bias Modification Receives: Behavioral: Attention Bias Modification |
| ABM - | Sham comparator | Sham Attention Bias Modification Receives: Behavioral: Sham Attention Bias Modification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in residual symptoms of depression. Self report.
Beck Depression Inventory
Measured: At baseline and immediately after ABM intervention (during first week after ABM).
Change in residual symptoms of depression. Clinician rating
Hamilton Depression Rating Scale
Measured: At baseline and immediately after ABM intervention (during first week after ABM).
Secondary outcomes (5)
Recurrence of major depressive episodes
Measured by the MINI structured interview
Measured: Will be measured 12 month after baseline
Changes in Emotion Regulation
Emotion Regulation Questionnaire (ERQ).
Measured: At baseline.
Changes in Rumination
The Rumination Response Scale
Measured: At baseline and 12 months after intervention
Changes in cortisol response.
Cortisol samples from saliva measured by diural variation (6 samples).
Measured: At baseline, immediately after ABM intervention and one month after intervention.
Changes in symptoms of anxiety
Beck Anxiety Inventory
Measured: At baseline, immediately after ABM intervention (during first week after ABM intervention), 1 month after intervention, 6 months after intervention and 12 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2016 (estimated)
- Study startJan 2015
- Primary completionOct 2016
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Major DepressionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oslo
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oxford, Sorlandet Hospital HF, Diakonhjemmet Hospital
- Responsible party
- Principal investigator, Nils Inge Landrø, University of Oslo
- Investigators
- Nils I Landrø, Dr. Phil, Principal investigator, University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02658682
- Sponsor's protocol ID
- NFR-229135
- Status last verified
- Apr 2019
- First submitted
- 14 Dec 2015
- Last updated
- 26 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Bo R, Kraft B, Skilbrei A, Jonassen R, Harmer CJ, Landro NI. Inhibition moderates the effect of attentional bias modification for reducing residual depressive symptoms: A randomized sham-controlled clinical trial. J Behav Ther Exp Psychiatry. 2024 Dec;85:101982. doi: 10.1016/j.jbtep.2024.101982. Epub 2024 Aug 2.
PubMed 39111231Bo R, Kraft B, Jonassen R, Pedersen ML, Harmer CJ, Landro NI. The long-term effects of ABM on symptom severity in patients with recurrent depression: A randomized sham-controlled trial. J Affect Disord. 2023 Nov 1;340:886-892. doi: 10.1016/j.jad.2023.08.024. Epub 2023 Aug 12.
PubMed 37579884Bo R, Kraft B, Jonassen R, Harmer CJ, Hilland E, Stiles TC, Haaland VO, Aspesletten MEB, Sletvold H, Landro NI. Symptom severity moderates the outcome of attention bias modification for depression: An exploratory study. J Psychiatr Res. 2021 Jun;138:528-534. doi: 10.1016/j.jpsychires.2021.04.027. Epub 2021 May 5.
PubMed 33984807Jonassen R, Harmer CJ, Hilland E, Maglanoc LA, Kraft B, Browning M, Stiles TC, Haaland VO, Berge T, Landro NI. Effects of Attentional Bias Modification on residual symptoms in depression: a randomized controlled trial. BMC Psychiatry. 2019 May 8;19(1):141. doi: 10.1186/s12888-019-2105-8.
PubMed 31068158
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Secondary Prevention of Depression Applying an Experimental Attentional Bias Modification Procedure
- ClinicalTrials.gov ID
- NCT02658682
- Acronym / sponsor ID
- NFR-229135
- Conditions
- Major Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- University of OsloUniversity, hospital or other
- Collaborators
- University of Oxford, Sorlandet Hospital HF, Diakonhjemmet Hospital
- Study start
- Jan 2015
- Primary completion
- Oct 2016 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 20 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Depression (Major Depressive Disorder; MDD) has been dubbed "the common cold among the mental illnesses" and it is also a highly recurrent disorder. Secondary prevention has been identified as a key goal in the long-term management of depression. High recurrence rate suggests that there are specific vulnerability factors that increase people's risk for developing repeated episodes of the disorder. Preventive strategies should identify and ameliorate these factors to reduce the individual's risk of subsequent episodes. Biased attention for emotional stimuli is central to the cognitive model where increased sensitivity to negative cues is believed to fuel the negative thoughts and feelings in depression and play a key role in maintaining the illness. Selective biases in attention can be modified by a simple computerized technique; The Attention Bias Modification Task (ABM). This project aims to investigate whether ABM can reduce surrogate and clinical markers of relapse in a large group highly vulnerable to depressive episodes. The effects of ABM, immediately after the two weeks intervention, on three key risk factors for depression will be studied: Residual symptoms, cortisol awakening response and emotion regulation strategies. The participants will be followed up after 1 month, 6 months and 12 months. The hypothesis that ABM will reduce subsequent episodes of low mood over the following 12 months in this group in a manner predicted by early changes in these risk factors will be investigated. It will also be tested if such effects in the lab may be dependent on candidate genes which affect serotonin reuptake and which have been implicated in malleability and emotional learning. Effects on underlying neural correlates of emotion regulation will be studied in an fMRI experiment in a sub-sample and which will also be stratified by serotonin transporter genotype (see also NCT02931487). The predictive value of meta cognitions related to rumination and the possible mediating effects of automatic thoughts and perceived stress will also be investigated in a sub group (see also NCT02648165).
The characterization of the cognitive, genetic and neural mechanisms underlying the ABM effect will have key implications for future treatment development and combination with other treatment modalities like pharmacotherapy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ABM + | Experimental | Behavioral: Attention Bias ModificationAttention Bias Modification |
| ABM - | Sham comparator | Behavioral: Sham Attention Bias ModificationSham Attention Bias Modification |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Nondepressed subjects (based on the MINI structured interview) with a history of major depression
Key exclusion criteria (1 listed)
- Current or past neurological illness, bipolar disorder, psychosis or drug addiction.
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 |
|---|---|---|
| Attention Bias ModificationComputer based Attention Bias Modification | Behavioural | ABM + |
| Sham Attention Bias ModificationComputer based Sham Attention Bias Modification | Behavioural | ABM - |
Primary outcome
Change in residual symptoms of depression. Self report.
Time frame: At baseline and immediately after ABM intervention (during first week after ABM).
Beck Depression Inventory
Change in residual symptoms of depression. Clinician rating
Time frame: At baseline and immediately after ABM intervention (during first week after ABM).
Hamilton Depression Rating Scale
5 secondary outcomes
Recurrence of major depressive episodes
Time frame: Will be measured 12 month after baseline
Changes in Emotion Regulation
Time frame: At baseline.
Changes in Rumination
Time frame: At baseline and 12 months after intervention
Changes in cortisol response.
Time frame: At baseline, immediately after ABM intervention and one month after intervention.
Changes in symptoms of anxiety
Time frame: At baseline, immediately after ABM intervention (during first week after ABM intervention), 1 month after intervention, 6 months after intervention and 12 months after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2019.
- Derived from this study: PubMed 39111231Bo R, Kraft B, Skilbrei A, Jonassen R, Harmer CJ, Landro NI. Inhibition moderates the effect of attentional bias modification for reducing residual depressive symptoms: A randomized sham-controlled clinical trial. J Behav Ther Exp Psychiatry. 2024 Dec;85:101982. doi: 10.1016/j.jbtep.2024.101982. Epub 2024 Aug 2.
- Derived from this study: PubMed 37579884Bo R, Kraft B, Jonassen R, Pedersen ML, Harmer CJ, Landro NI. The long-term effects of ABM on symptom severity in patients with recurrent depression: A randomized sham-controlled trial. J Affect Disord. 2023 Nov 1;340:886-892. doi: 10.1016/j.jad.2023.08.024. Epub 2023 Aug 12.
- Derived from this study: PubMed 33984807Bo R, Kraft B, Jonassen R, Harmer CJ, Hilland E, Stiles TC, Haaland VO, Aspesletten MEB, Sletvold H, Landro NI. Symptom severity moderates the outcome of attention bias modification for depression: An exploratory study. J Psychiatr Res. 2021 Jun;138:528-534. doi: 10.1016/j.jpsychires.2021.04.027. Epub 2021 May 5.
- Derived from this study: PubMed 31068158Jonassen R, Harmer CJ, Hilland E, Maglanoc LA, Kraft B, Browning M, Stiles TC, Haaland VO, Berge T, Landro NI. Effects of Attentional Bias Modification on residual symptoms in depression: a randomized controlled trial. BMC Psychiatry. 2019 May 8;19(1):141. doi: 10.1186/s12888-019-2105-8.
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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 I Landrø, Dr. Phil principal investigator
University of Oslo
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Attention Bias Modification in people with Major Depression, run by University of Oslo at 2 sites 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 26 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in residual symptoms of depression. Self report. (time frame: At baseline and immediately after ABM intervention (during first week after ABM).). The study lists 2 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 NCT02658682, which also lists 4 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 26 Apr 2019.