Depressive SymptomsNCT01628016
The Effect of Attention Bias Modification Training on Reducing Depressive Symptoms
A study testing a word dot-probe task for training procedure in people with Depressive Symptoms, run by Hunan Normal University at 1 site in China.
Trial summary
The purpose of this study is to test whether attention bias modification training is an effective neurobehavioral therapy to improve depressive symptoms.That is whether attention bias modification training is superior to placebo in reducing depressive symptoms over 1 year after training. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Depressive Symptoms
- What is being tested?
- a word dot-probe task for training procedure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 77 participants
- Where
- 1 siteChina
- Study dates
- Sep 2011to Jul 2013
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- A score of 14 or higher on the Beck Depression Inventory-II
Who cannot join
- a current episode of MDD, bipolar disorder, schizophrenia or organic mental disorder;
- any concurrent psychotherapy;
- any concurrent psychotropic medication.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Psychology, Hunan Normal University
Changsha, Hunan, 400081
About this study
Official title: A Randomized, Double-blind, Placebo-Controlled Evaluation of the Efficacy of Attentional Bias Modification Training in the Treatment of Depressive Symptoms
The purpose of this study is to test whether attention bias modification training is an effective neurobehavioral therapy to improve depressive symptoms.That is whether attention bias modification training is superior to placebo in reducing depressive symptoms over 1 year after training.
Read the detailed description
Attentional bias has been theorized to play a critical role in the onset and maintenance of depression. Attentional bias modification training (ABMT), an experimental paradigm that uses training to induce adaptive attentional bias, was developed to test the causal model and this has therapeutic implications in depression.To test the effect of ABMT on treatment of depressive symptoms, a randomized, double-blind, placebo and blank controlled trial is conducted in college students who are experiencing mild-to-severe symptoms of depression.
- Conditions
- Depressive Symptoms
- Being tested
- a word dot-probe task for training procedure
- Keywords
- depression, attention, training, modification
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
a word dot-probe task for training procedureBehavioural
In the word dot-probe task for training procedure of attention bias modification, 90% of the targets appeared at the neutral word position and 10% at the sad word position.In the placebo condition, the targets appeared with equal probability in the sad (50%) and neutral (50%) word positions.All participants in ABM and placebo conditions received eight 12-min training sessions over a 2-week period.During each session, participants completed 216 word dot-probe trials.
| Study group | Role | What they receive |
|---|---|---|
| Attentional bias modification training | Experimental | 1. Attention bias modification training (ABMT) is a modified dot probe task, in which a probe always appears in the location of neutral stimulus after the two stimuli (i.e. one is the depressive cue and the other is neutral) were simultaneously presented. In the ABMT,the probability that a probe appears in the location of neutral is 90%, and correspondingly,in the location of depressive stimuli is 10%.
2. ABMT intervention: Participants complete 8 sessions of attention bias modification training (ABMT) during a two-week period. Each session consists of 218 trials, and the time to complete a training session is 12 minutes (4 sessions a week, roughly one session every other day with for each session). Receives: Behavioral: a word dot-probe task for training procedure |
| Placebo training | Placebo comparator | Participants complete 8 sessions of placebo training(PT) during a two-week period. Placebo training is a classic dot probe task, in which a probe appears after either of the locations that the two stimuli (i.e. one is the depressive cue and the other is neutral) were presented, with the same frequencies. In the PT condition, each session also consists of 218 trials, and the time to complete a PT session is approximately 10 minutes as well. Receives: Behavioral: a word dot-probe task for training procedure |
| blank control | No intervention | Participants only complete assessment at each point time. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depressive Symptoms Measured by Beck Depression Inventory-II
Beck Depression Inventory-II(BDI-II) contains 21 items and rates the depressive symptoms for the past two weeks. Each question provides for a response of 0 to 3. A zero response means the depressive symptom is not present; a 1 means the symptom is present, a 2 means the symptom is moderate, and a 3 means the symptom is severe. The total BDI-II score is the sum of the individual items; total BDI-II scores can range from 0 to 63. Cutoff points developed by Beck, Steer, \& Brown (1997) for the total BDI-II are: 0 to 13, nondepressed; 14 to 19, mild depression; 20 to 28, moderate depression; 29 or more, severe depression.
Measured: From the baseline to posttraining, 2-, 4-, 8-week, 3-, 7-month follow-ups after training
Secondary outcomes (1)
Anxiety and Rumination Symptoms Measured by State-Trait Anxiety Inventory-Trait(STAI-T) and Rumination Response Style（RRS）
State-Trait Anxiety Inventory-Trait (STAI-T) measures the anxiety symptoms of the individuals who often feel.It consists of 20 items and each question provides for a response of 1 to 4. A 1 response means the anxiety symptom is not present; a 2 means the symptom is present but a little, a 3 means the symptom is usually present, and a 4 means the symptom lasts all the time. The total STAI-T score is the sum of the individual items; total STAI-T scores can range from 20 to 80. The higher values represent a worse outcome.
The RRS measures ruminative responses to depressed mood. The content of the items is related to depressive cognitions and their possible causes and consequences. The scale consists of 21items and each question provides for a response of 1 to 4. The total RRS scores can range from 21 to 84. The higher values represent a worse outcome.
Measured: From baseline to post-training, 2-, 4-, 8-week, 3- , 7-month follow-ups after training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2012 (estimated)
- Study startSep 2011
- Primary completionJul 2013
- Study completionJul 2013
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 (1)Papers the sponsor has linked to this study.
- Other trials for Depressive SymptomsStudies 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
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hunan Normal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wenhui Yang, Hunan Normal University
- Investigators
- Wenhui Yang, Ph.D, Principal investigator, Department of Psychology, Hunan Normal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01628016
- Sponsor's protocol ID
- XJK011AXL002
- Status last verified
- Aug 2020
- First submitted
- 9 Jun 2012
- Last updated
- 14 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Yang W, Ding Z, Dai T, Peng F, Zhang JX. Attention Bias Modification training in individuals with depressive symptoms: A randomized controlled trial. J Behav Ther Exp Psychiatry. 2015 Dec;49(Pt A):101-11. doi: 10.1016/j.jbtep.2014.08.005. Epub 2014 Sep 8.
PubMed 25245928
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-Controlled Evaluation of the Efficacy of Attentional Bias Modification Training in the Treatment of Depressive Symptoms
- ClinicalTrials.gov ID
- NCT01628016
- Acronym / sponsor ID
- XJK011AXL002
- Conditions
- Depressive Symptoms
- Keywords
- depression, attention, training, modification
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Hunan Normal UniversityUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 26 Jun 2012 (estimated)
- Results
- Posted 19 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to test whether attention bias modification training is an effective neurobehavioral therapy to improve depressive symptoms.That is whether attention bias modification training is superior to placebo in reducing depressive symptoms over 1 year after training.
Detailed description
Attentional bias has been theorized to play a critical role in the onset and maintenance of depression. Attentional bias modification training (ABMT), an experimental paradigm that uses training to induce adaptive attentional bias, was developed to test the causal model and this has therapeutic implications in depression.To test the effect of ABMT on treatment of depressive symptoms, a randomized, double-blind, placebo and blank controlled trial is conducted in college students who are experiencing mild-to-severe symptoms of depression.
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 |
|---|---|---|
| Attentional bias modification training | Experimental | Behavioral: a word dot-probe task for training procedure1. Attention bias modification training (ABMT) is a modified dot probe task, in which a probe always appears in the location of neutral stimulus after the two stimuli (i.e. one is the depressive cue and the other is neutral) were simultaneously presented. In the ABMT,the probability that a probe appears in the location of neutral is 90%, and correspondingly,in the location of depressive stimuli is 10%. 2. ABMT intervention: Participants complete 8 sessions of attention bias modification training (ABMT) during a two-week period. Each session consists of 218 trials, and the time to complete a training session is 12 minutes (4 sessions a week, roughly one session every other day with for each session). |
| Placebo training | Placebo comparator | Behavioral: a word dot-probe task for training procedureParticipants complete 8 sessions of placebo training(PT) during a two-week period. Placebo training is a classic dot probe task, in which a probe appears after either of the locations that the two stimuli (i.e. one is the depressive cue and the other is neutral) were presented, with the same frequencies. In the PT condition, each session also consists of 218 trials, and the time to complete a PT session is approximately 10 minutes as well. |
| blank control | No intervention | –Participants only complete assessment at each point time. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- A score of 14 or higher on the Beck Depression Inventory-II
Key exclusion criteria (3 listed)
- a current episode of MDD, bipolar disorder, schizophrenia or organic mental disorder;
- any concurrent psychotherapy;
- any concurrent psychotropic medication.
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 |
|---|---|---|
| a word dot-probe task for training procedureIn the word dot-probe task for training procedure of attention bias modification, 90% of the targets appeared at the neutral word position and 10% at the sad word position.In the placebo condition, the targets appeared with equal probability in the sad (50%) and neutral (50%) word positions.All participants in ABM and placebo conditions received eight 12-min training sessions over a 2-week period.During each session, participants completed 216 word dot-probe trials. | Behavioural | Attentional bias modification training, Placebo training |
Primary outcome
Depressive Symptoms Measured by Beck Depression Inventory-II
Time frame: From the baseline to posttraining, 2-, 4-, 8-week, 3-, 7-month follow-ups after training
Beck Depression Inventory-II(BDI-II) contains 21 items and rates the depressive symptoms for the past two weeks. Each question provides for a response of 0 to 3. A zero response means the depressive symptom is not present; a 1 means the symptom is present, a 2 means the symptom is moderate, and a 3 means the symptom is severe. The total BDI-II score is the sum of the individual items; total BDI-II scores can range from 0 to 63. Cutoff points developed by Beck, Steer, \& Brown (1997) for the total BDI-II are: 0 to 13, nondepressed; 14 to 19, mild depression; 20 to 28, moderate depression; 29 or more, severe depression.
1 secondary outcome
Anxiety and Rumination Symptoms Measured by State-Trait Anxiety Inventory-Trait(STAI-T) and Rumination Response Style（RRS）
Time frame: From baseline to post-training, 2-, 4-, 8-week, 3- , 7-month follow-ups after training
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25245928Yang W, Ding Z, Dai T, Peng F, Zhang JX. Attention Bias Modification training in individuals with depressive symptoms: A randomized controlled trial. J Behav Ther Exp Psychiatry. 2015 Dec;49(Pt A):101-11. doi: 10.1016/j.jbtep.2014.08.005. Epub 2014 Sep 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.
Wenhui Yang, Ph.D principal investigator
Department of Psychology, Hunan Normal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing a word dot-probe task for training procedure in people with Depressive Symptoms, run by Hunan Normal University at 1 site in China.
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 3 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 14 Aug 2020. 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 China. 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 19 Sep 2019). 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?
Depressive Symptoms Measured by Beck Depression Inventory-II (time frame: From the baseline to posttraining, 2-, 4-, 8-week, 3-, 7-month follow-ups after training). 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 NCT01628016, which also lists 1 linked publication.
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 14 Aug 2020.