Trial Outcomes & Findings for The Effect of Attention Bias Modification Training on Reducing Depressive Symptoms (NCT NCT01628016)
NCT ID: NCT01628016
Last Updated: 2020-08-14
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
77 participants
Primary outcome timeframe
From the baseline to posttraining, 2-, 4-, 8-week, 3-, 7-month follow-ups after training
Results posted on
2020-08-14
Participant Flow
The training sessions were held in Hunan Normal University from September 14 - October 1, 2011.
Participants were randomly assigned to one of the three conditions by a computer-generated random assignment. Randomization was stratified by depression severity and gender.
Participant milestones
| Measure |
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
|
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.
|
Blank Control
Participants only complete assessment at each point time.
|
|---|---|---|---|
|
Pretraining to Posttraining
STARTED
|
27
|
27
|
23
|
|
Pretraining to Posttraining
COMPLETED
|
27
|
27
|
23
|
|
Pretraining to Posttraining
NOT COMPLETED
|
0
|
0
|
0
|
|
Posttraining to 5 Follow-ups
STARTED
|
27
|
27
|
23
|
|
Posttraining to 5 Follow-ups
COMPLETED
|
23
|
20
|
18
|
|
Posttraining to 5 Follow-ups
NOT COMPLETED
|
4
|
7
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Effect of Attention Bias Modification Training on Reducing Depressive Symptoms
Baseline characteristics by cohort
| Measure |
Attentional Bias Modification Training
n=27 Participants
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).
|
Placebo Training
n=27 Participants
.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.
|
Assessment-only Control
n=23 Participants
Participants only complete assessment at each point time.
|
Total
n=77 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
age
|
19.44 years
STANDARD_DEVIATION 1.58 • n=5 Participants
|
19.52 years
STANDARD_DEVIATION 0.89 • n=7 Participants
|
19.57 years
STANDARD_DEVIATION 0.73 • n=5 Participants
|
19.57 years
STANDARD_DEVIATION 0.87 • n=4 Participants
|
|
Age, Categorical
<=18 years
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
24 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
71 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
55 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
|
Region of Enrollment
China
|
27 participants
n=5 Participants
|
27 participants
n=7 Participants
|
23 participants
n=5 Participants
|
77 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: From the baseline to posttraining, 2-, 4-, 8-week, 3-, 7-month follow-ups after trainingPopulation: Some subjects dropped out of the study or could not be contacted.
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.
Outcome measures
| Measure |
Attentional Bias Modification Training
n=27 Participants
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
n=27 Participants
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.
|
Blank Control
n=23 Participants
Participants only complete assessment at each point time.
|
|---|---|---|---|
|
Depressive Symptoms Measured by Beck Depression Inventory-II
BDI-II scores at baseline
|
17.33 units on a scale
Standard Deviation 3.81
|
18.04 units on a scale
Standard Deviation 4.11
|
18.13 units on a scale
Standard Deviation 5.18
|
|
Depressive Symptoms Measured by Beck Depression Inventory-II
BDI-II scores at posttraining
|
10.96 units on a scale
Standard Deviation 4.62
|
16.78 units on a scale
Standard Deviation 5.09
|
18.13 units on a scale
Standard Deviation 6.33
|
|
Depressive Symptoms Measured by Beck Depression Inventory-II
BDI-II scores 2-week follow-up;n=23,21,20
|
9.22 units on a scale
Standard Deviation 4.81
|
17.29 units on a scale
Standard Deviation 6.40
|
17.00 units on a scale
Standard Deviation 4.60
|
|
Depressive Symptoms Measured by Beck Depression Inventory-II
4-week follow-up;n=23,21,21
|
8.26 units on a scale
Standard Deviation 3.97
|
17.29 units on a scale
Standard Deviation 6.40
|
17.00 units on a scale
Standard Deviation 4.60
|
|
Depressive Symptoms Measured by Beck Depression Inventory-II
8-week follow-up;n=27,27,23
|
9.41 units on a scale
Standard Deviation 4.56
|
17.44 units on a scale
Standard Deviation 4.56
|
17.35 units on a scale
Standard Deviation 5.02
|
|
Depressive Symptoms Measured by Beck Depression Inventory-II
3-momth follow-up;n=27,27,21
|
9.56 units on a scale
Standard Deviation 4.56
|
14.41 units on a scale
Standard Deviation 7.12
|
13.38 units on a scale
Standard Deviation 5.97
|
|
Depressive Symptoms Measured by Beck Depression Inventory-II
7-month follow-up;n=23,20,18
|
8.95 units on a scale
Standard Deviation 4.68
|
13.20 units on a scale
Standard Deviation 7.95
|
10.56 units on a scale
Standard Deviation 7.35
|
SECONDARY outcome
Timeframe: From baseline to post-training, 2-, 4-, 8-week, 3- , 7-month follow-ups after trainingPopulation: Some subjects dropped out of the study or could not be contacted.
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.
Outcome measures
| Measure |
Attentional Bias Modification Training
n=27 Participants
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
n=27 Participants
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.
|
Blank Control
n=23 Participants
Participants only complete assessment at each point time.
|
|---|---|---|---|
|
Anxiety and Rumination Symptoms Measured by State-Trait Anxiety Inventory-Trait(STAI-T) and Rumination Response Style（RRS）
RRS score at postraining;n=27,27,23
|
41.40 units on a scale
Standard Deviation 5.44
|
45.44 units on a scale
Standard Deviation 8.08
|
46.78 units on a scale
Standard Deviation 6.27
|
|
Anxiety and Rumination Symptoms Measured by State-Trait Anxiety Inventory-Trait(STAI-T) and Rumination Response Style（RRS）
RRS score at 2-week follow-up;n=23,21,20
|
41.22 units on a scale
Standard Deviation 4.45
|
45.52 units on a scale
Standard Deviation 7.78
|
46.50 units on a scale
Standard Deviation 6.61
|
|
Anxiety and Rumination Symptoms Measured by State-Trait Anxiety Inventory-Trait(STAI-T) and Rumination Response Style（RRS）
RRS score at 4-week follow-up;n=23,21,21
|
38.91 units on a scale
Standard Deviation 4.16
|
45.14 units on a scale
Standard Deviation 7.47
|
46.33 units on a scale
Standard Deviation 6.26
|
|
Anxiety and Rumination Symptoms Measured by State-Trait Anxiety Inventory-Trait(STAI-T) and Rumination Response Style（RRS）
RRS score at 8-week follow-up;n=27,27,23
|
39.07 units on a scale
Standard Deviation 5.17
|
44.29 units on a scale
Standard Deviation 8.09
|
45.57 units on a scale
Standard Deviation 6.51
|
|
Anxiety and Rumination Symptoms Measured by State-Trait Anxiety Inventory-Trait(STAI-T) and Rumination Response Style（RRS）
RRS score at 3-month follow-up;n=27,27,21
|
42.96 units on a scale
Standard Deviation 6.08
|
44.15 units on a scale
Standard Deviation 8.11
|
45.52 units on a scale
Standard Deviation 7.37
|
|
Anxiety and Rumination Symptoms Measured by State-Trait Anxiety Inventory-Trait(STAI-T) and Rumination Response Style（RRS）
RRS score at 7-month follow-up;n=23,20,18
|
43.43 units on a scale
Standard Deviation 6.75
|
46.75 units on a scale
Standard Deviation 8.87
|
44.22 units on a scale
Standard Deviation 7.92
|
|
Anxiety and Rumination Symptoms Measured by State-Trait Anxiety Inventory-Trait(STAI-T) and Rumination Response Style（RRS）
STAI-T score at postraining;n=27,27,23
|
44.52 units on a scale
Standard Deviation 4.56
|
50.81 units on a scale
Standard Deviation 5.20
|
51.35 units on a scale
Standard Deviation 5.46
|
|
Anxiety and Rumination Symptoms Measured by State-Trait Anxiety Inventory-Trait(STAI-T) and Rumination Response Style（RRS）
STAI-T score at 2-week follow-up;n=23,21,20
|
43.82 units on a scale
Standard Deviation 4.21
|
50.23 units on a scale
Standard Deviation 7.48
|
50.30 units on a scale
Standard Deviation 5.51
|
|
Anxiety and Rumination Symptoms Measured by State-Trait Anxiety Inventory-Trait(STAI-T) and Rumination Response Style（RRS）
STAI-T score at 4-week follow-up;n=23,21,21
|
44.39 units on a scale
Standard Deviation 4.28
|
50.05 units on a scale
Standard Deviation 6.82
|
50.05 units on a scale
Standard Deviation 5.63
|
|
Anxiety and Rumination Symptoms Measured by State-Trait Anxiety Inventory-Trait(STAI-T) and Rumination Response Style（RRS）
STAI-T score at 8-week follow-up;n=27,27,23
|
44.15 units on a scale
Standard Deviation 4.67
|
49.19 units on a scale
Standard Deviation 6.14
|
50.13 units on a scale
Standard Deviation 5.74
|
|
Anxiety and Rumination Symptoms Measured by State-Trait Anxiety Inventory-Trait(STAI-T) and Rumination Response Style（RRS）
STAI-T score at 3-month follow-up;n=27,27,21
|
44.74 units on a scale
Standard Deviation 5.20
|
47.41 units on a scale
Standard Deviation 7.42
|
46.82 units on a scale
Standard Deviation 7.86
|
|
Anxiety and Rumination Symptoms Measured by State-Trait Anxiety Inventory-Trait(STAI-T) and Rumination Response Style（RRS）
STAI-T score at 7-month follow-up;n=23,20,18
|
47.87 units on a scale
Standard Deviation 5.31
|
48.25 units on a scale
Standard Deviation 6.38
|
45.94 units on a scale
Standard Deviation 6.79
|
Adverse Events
Attentional Bias Modification Training
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo Training
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Blank Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place