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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Attentional bias modification training | Experimental |
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| 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. |
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| blank control | No Intervention | Participants only complete assessment at each point time. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| a word dot-probe task for training procedure | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From the baseline to posttraining, 2-, 4-, 8-week, 3-, 7-month follow-ups after training |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion criteria :
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| Name | Affiliation | Role |
|---|---|---|
| Wenhui Yang, Ph.D | Department of Psychology, Hunan Normal University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Psychology, Hunan Normal University | Changsha | Hunan | 400081 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25245928 | Derived | 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. |
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Participants were randomly assigned to one of the three conditions by a computer-generated random assignment. Randomization was stratified by depression severity and gender.
The training sessions were held in Hunan Normal University from September 14 - October 1, 2011.
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| ID | Title | Description |
|---|---|---|
| FG000 | Attentional Bias Modification Training | 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). a word dot-probe task for training procedure: 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 |
| FG001 | Placebo Training | 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. a word dot-probe task for training procedure: 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. |
| FG002 | Blank Control | Participants only complete assessment at each point time. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Pretraining to Posttraining |
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| Posttraining to 5 Follow-ups |
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| ID | Title | Description |
|---|---|---|
| BG000 | Attentional Bias Modification Training | Participants complete 8 sessions of attention bias modification training (ABMT) during a two-week period. The task was a modified dot-probe task, in which 90% of the targets appeared at the neutral word position and 10% at the sad word position. 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). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Some subjects dropped out of the study or could not be contacted. | Posted | Mean | Standard Deviation | units on a scale | From the baseline to posttraining, 2-, 4-, 8-week, 3-, 7-month follow-ups after training |
|
7-month
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Attentional Bias Modification Training | 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). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Wenhui Yang | Hunan Normal University | +86 731 8873076 | yangwh110@163.com |
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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|
| From baseline to post-training, 2-, 4-, 8-week, 3- , 7-month follow-ups after training |
| NOT COMPLETED |
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| BG001 | Placebo Training | .Participants complete 8 sessions of placebo training(PT) during a two-week period.The placebo training procedure is a classic dot probe task in which the targets appeared with equal probability in the sad (50%) and neutral (50%) word positions.Each session consists of 218 trials, and the time to complete a PT session is approximately 12 minutes as well.The stimuli is identical to ABM condition. |
| BG002 | Assessment-only Control | Participants only complete assessment at each point time. |
| BG003 | Total | Total of all reporting groups |
| years |
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| Age, Categorical | Classification of age features | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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The training procedure of attention bias modification is a modified dot-probe task,in which 90% of the targets appeared at the neutral word position and 10% at the sad word position. 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). |
| OG001 | Placebo Training | Placebo training procedure is a classic dot probe task, in which the targets appeared with equal probability in the sad (50%) and neutral (50%) word positions.Participants complete 8 sessions of placebo training(PT) during a two-week period and each session consists of 218 trials.The stimuli was identical to the ABM condition. |
| OG002 | Blank Control | Participants only complete assessment at each point time. |
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| Secondary | 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. | Some subjects dropped out of the study or could not be contacted. | Posted | Mean | Standard Deviation | units on a scale | From baseline to post-training, 2-, 4-, 8-week, 3- , 7-month follow-ups after training |
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| 0 |
| 27 |
| 0 |
| 27 |
| EG001 | Placebo Training | 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. | 0 | 27 | 0 | 27 |
| EG002 | Blank Control | Participants only complete assessment at each point time. | 0 | 23 | 0 | 23 |
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| STAI-T score at 2-week follow-up;n=23,21,20 |
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| STAI-T score at 4-week follow-up;n=23,21,21 |
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| STAI-T score at 8-week follow-up;n=27,27,23 |
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| STAI-T score at 3-month follow-up;n=27,27,21 |
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| STAI-T score at 7-month follow-up;n=23,20,18 |
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| RRS score at postraining;n=27,27,23 |
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| RRS score at 2-week follow-up;n=23,21,20 |
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| RRS score at 4-week follow-up;n=23,21,21 |
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| RRS score at 8-week follow-up;n=27,27,23 |
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| RRS score at 3-month follow-up;n=27,27,21 |
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| RRS score at 7-month follow-up;n=23,20,18 |
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