The Effect of Attention Bias Modification Training on Reducing Depressive Symptoms
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Attentional bias modification training 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%. 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). |
Behavioral: 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.
|
| Placebo Comparator: 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. |
Behavioral: 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.
|
| No Intervention: blank control Participants only complete assessment at each point time. |
Outcome Measures
Primary Outcome Measures
- Depressive Symptoms Measured by Beck Depression Inventory-II [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.
Secondary Outcome Measures
- Anxiety and Rumination Symptoms Measured by State-Trait Anxiety Inventory-Trait(STAI-T) and Rumination Response Style（RRS） [From baseline to post-training, 2-, 4-, 8-week, 3- , 7-month follow-ups after training]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
- A score of 14 or higher on the Beck Depression Inventory-II
Exclusion criteria :
-
a current episode of MDD, bipolar disorder, schizophrenia or organic mental disorder;
-
any concurrent psychotherapy;
-
any concurrent psychotropic medication.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Psychology, Hunan Normal University | Changsha | Hunan | China | 400081 |
Sponsors and Collaborators
- Hunan Normal University
Investigators
- Principal Investigator: Wenhui Yang, Ph.D, Department of Psychology, Hunan Normal University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- XJK011AXL002
Study Results
Participant Flow
| Recruitment Details | The training sessions were held in Hunan Normal University from September 14 - October 1, 2011. |
|---|---|
| Pre-assignment Detail | Participants were randomly assigned to one of the three conditions by a computer-generated random assignment. Randomization was stratified by depression severity and gender. |
| Arm/Group Title | Attentional Bias Modification Training | Placebo Training | Blank Control |
|---|---|---|---|
| Arm/Group Description | 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 | 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. | Participants only complete assessment at each point time. |
| Period Title: Pretraining to Posttraining | |||
| STARTED | 27 | 27 | 23 |
| COMPLETED | 27 | 27 | 23 |
| NOT COMPLETED | 0 | 0 | 0 |
| Period Title: Pretraining to Posttraining | |||
| STARTED | 27 | 27 | 23 |
| COMPLETED | 23 | 20 | 18 |
| NOT COMPLETED | 4 | 7 | 5 |
Baseline Characteristics
| Arm/Group Title | Attentional Bias Modification Training | Placebo Training | Assessment-only Control | Total |
|---|---|---|---|---|
| Arm/Group Description | 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). | .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. | Participants only complete assessment at each point time. | Total of all reporting groups |
| Overall Participants | 27 | 27 | 23 | 77 |
| Age (years) [Mean (Standard Deviation) ] | ||||
| age |
19.44
(1.58)
|
19.52
(0.89)
|
19.57
(0.73)
|
19.57
(0.87)
|
| Age (Count of Participants) | ||||
| <=18 years |
3
11.1%
|
2
7.4%
|
1
4.3%
|
6
7.8%
|
| Between 18 and 65 years |
24
88.9%
|
25
92.6%
|
22
95.7%
|
71
92.2%
|
| >=65 years |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
20
74.1%
|
17
63%
|
18
78.3%
|
55
71.4%
|
| Male |
7
25.9%
|
10
37%
|
5
21.7%
|
22
28.6%
|
| Region of Enrollment (participants) [Number] | ||||
| China |
27
100%
|
27
100%
|
23
100%
|
77
100%
|
Outcome Measures
| Title | Depressive Symptoms Measured by Beck Depression Inventory-II |
|---|---|
| Description | 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. |
| Time Frame | From the baseline to posttraining, 2-, 4-, 8-week, 3-, 7-month follow-ups after training |
Outcome Measure Data
| Analysis Population Description |
|---|
| Some subjects dropped out of the study or could not be contacted. |
| Arm/Group Title | Attentional Bias Modification Training | Placebo Training | Blank Control |
|---|---|---|---|
| Arm/Group Description | 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). | 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. | Participants only complete assessment at each point time. |
| Measure Participants | 27 | 27 | 23 |
| BDI-II scores at baseline |
17.33
(3.81)
|
18.04
(4.11)
|
18.13
(5.18)
|
| BDI-II scores at posttraining |
10.96
(4.62)
|
16.78
(5.09)
|
18.13
(6.33)
|
| BDI-II scores 2-week follow-up;n=23,21,20 |
9.22
(4.81)
|
17.29
(6.40)
|
17.00
(4.60)
|
| 4-week follow-up;n=23,21,21 |
8.26
(3.97)
|
17.29
(6.40)
|
17.00
(4.60)
|
| 8-week follow-up;n=27,27,23 |
9.41
(4.56)
|
17.44
(4.56)
|
17.35
(5.02)
|
| 3-momth follow-up;n=27,27,21 |
9.56
(4.56)
|
14.41
(7.12)
|
13.38
(5.97)
|
| 7-month follow-up;n=23,20,18 |
8.95
(4.68)
|
13.20
(7.95)
|
10.56
(7.35)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Attentional Bias Modification Training, Placebo Training, Blank Control |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | .05 |
| Comments | ||
| Method | Mixed Models Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 3.98 | |
| Confidence Interval |
(2-Sided) 95% to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Anxiety and Rumination Symptoms Measured by State-Trait Anxiety Inventory-Trait(STAI-T) and Rumination Response Style（RRS） |
|---|---|
| Description | 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. |
| Time Frame | From baseline to post-training, 2-, 4-, 8-week, 3- , 7-month follow-ups after training |
Outcome Measure Data
| Analysis Population Description |
|---|
| Some subjects dropped out of the study or could not be contacted. |
| Arm/Group Title | Attentional Bias Modification Training | Placebo Training | Blank Control |
|---|---|---|---|
| Arm/Group Description | 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). | Participants complete 8 sessions of placebo training(PT) during a two-week period. | Participants only complete assessment at each point time. |
| Measure Participants | 27 | 27 | 23 |
| STAI-T score at postraining;n=27,27,23 |
44.52
(4.56)
|
50.81
(5.20)
|
51.35
(5.46)
|
| STAI-T score at 2-week follow-up;n=23,21,20 |
43.82
(4.21)
|
50.23
(7.48)
|
50.30
(5.51)
|
| STAI-T score at 4-week follow-up;n=23,21,21 |
44.39
(4.28)
|
50.05
(6.82)
|
50.05
(5.63)
|
| STAI-T score at 8-week follow-up;n=27,27,23 |
44.15
(4.67)
|
49.19
(6.14)
|
50.13
(5.74)
|
| STAI-T score at 3-month follow-up;n=27,27,21 |
44.74
(5.20)
|
47.41
(7.42)
|
46.82
(7.86)
|
| STAI-T score at 7-month follow-up;n=23,20,18 |
47.87
(5.31)
|
48.25
(6.38)
|
45.94
(6.79)
|
| RRS score at postraining;n=27,27,23 |
41.40
(5.44)
|
45.44
(8.08)
|
46.78
(6.27)
|
| RRS score at 2-week follow-up;n=23,21,20 |
41.22
(4.45)
|
45.52
(7.78)
|
46.50
(6.61)
|
| RRS score at 4-week follow-up;n=23,21,21 |
38.91
(4.16)
|
45.14
(7.47)
|
46.33
(6.26)
|
| RRS score at 8-week follow-up;n=27,27,23 |
39.07
(5.17)
|
44.29
(8.09)
|
45.57
(6.51)
|
| RRS score at 3-month follow-up;n=27,27,21 |
42.96
(6.08)
|
44.15
(8.11)
|
45.52
(7.37)
|
| RRS score at 7-month follow-up;n=23,20,18 |
43.43
(6.75)
|
46.75
(8.87)
|
44.22
(7.92)
|
Adverse Events
| Time Frame | 7-month | |||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||
| Arm/Group Title | Attentional Bias Modification Training | Placebo Training | Blank Control | |||
| Arm/Group Description | 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). | 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. | Participants only complete assessment at each point time. | |||
All Cause Mortality |
||||||
| Attentional Bias Modification Training | Placebo Training | Blank Control | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | |||
Serious Adverse Events |
||||||
| Attentional Bias Modification Training | Placebo Training | Blank Control | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/27 (0%) | 0/27 (0%) | 0/23 (0%) | |||
Other (Not Including Serious) Adverse Events |
||||||
| Attentional Bias Modification Training | Placebo Training | Blank Control | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/27 (0%) | 0/27 (0%) | 0/23 (0%) | |||
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Dr. Wenhui Yang |
|---|---|
| Organization | Hunan Normal University |
| Phone | +86 731 8873076 |
| yangwh110@163.com |
- XJK011AXL002