Depressive Symptoms
Conditions
Keywords
depression, attention, training, modification
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.
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.
Interventions
BEHAVIORALa 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.
Sponsors
Hunan Normal University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* A score of 14 or higher on the Beck Depression Inventory-II
Exclusion criteria
: 1. a current episode of MDD, bipolar disorder, schizophrenia or organic mental disorder; 2. any concurrent psychotherapy; 3. any concurrent psychotropic medication.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Participant flow
Recruitment details
The training sessions were held in Hunan Normal University from September 14 - October 1, 2011.
Pre-assignment details
Participants were randomly assigned to one of the three conditions by a computer-generated random assignment. Randomization was stratified by depression severity and gender.
Participants by arm
| Arm | Count |
|---|---|
| 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). | 27 |
| 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. | 27 |
| Assessment-only Control Participants only complete assessment at each point time. | 23 |
| Total | 77 |
Baseline characteristics
| Characteristic | Attentional Bias Modification Training | Placebo Training | Assessment-only Control | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 3 Participants | 2 Participants | 1 Participants | 6 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 24 Participants | 25 Participants | 22 Participants | 71 Participants |
| Age, Continuous age | 19.44 years STANDARD_DEVIATION 1.58 | 19.52 years STANDARD_DEVIATION 0.89 | 19.57 years STANDARD_DEVIATION 0.73 | 19.57 years STANDARD_DEVIATION 0.87 |
| Region of Enrollment China | 27 participants | 27 participants | 23 participants | 77 participants |
| Sex: Female, Male Female | 20 Participants | 17 Participants | 18 Participants | 55 Participants |
| Sex: Female, Male Male | 7 Participants | 10 Participants | 5 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 27 | 0 / 27 | 0 / 23 |
| serious Total, serious adverse events | 0 / 27 | 0 / 27 | 0 / 23 |
Outcome results
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.
Time frame: From the baseline to posttraining, 2-, 4-, 8-week, 3-, 7-month follow-ups after training
Population: Some subjects dropped out of the study or could not be contacted.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Attentional Bias Modification Training | 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 |
| Attentional Bias Modification Training | 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 |
| Attentional Bias Modification Training | 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 |
| Attentional Bias Modification Training | 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 |
| Attentional Bias Modification Training | Depressive Symptoms Measured by Beck Depression Inventory-II | BDI-II scores at posttraining | 10.96 units on a scale | Standard Deviation 4.62 |
| Attentional Bias Modification Training | Depressive Symptoms Measured by Beck Depression Inventory-II | BDI-II scores at baseline | 17.33 units on a scale | Standard Deviation 3.81 |
| Attentional Bias Modification Training | 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 |
| Placebo Training | Depressive Symptoms Measured by Beck Depression Inventory-II | 7-month follow-up;n=23,20,18 | 13.20 units on a scale | Standard Deviation 7.95 |
| Placebo Training | Depressive Symptoms Measured by Beck Depression Inventory-II | BDI-II scores at baseline | 18.04 units on a scale | Standard Deviation 4.11 |
| Placebo Training | Depressive Symptoms Measured by Beck Depression Inventory-II | BDI-II scores at posttraining | 16.78 units on a scale | Standard Deviation 5.09 |
| Placebo Training | Depressive Symptoms Measured by Beck Depression Inventory-II | BDI-II scores 2-week follow-up;n=23,21,20 | 17.29 units on a scale | Standard Deviation 6.4 |
| Placebo Training | Depressive Symptoms Measured by Beck Depression Inventory-II | 4-week follow-up;n=23,21,21 | 17.29 units on a scale | Standard Deviation 6.4 |
| Placebo Training | Depressive Symptoms Measured by Beck Depression Inventory-II | 8-week follow-up;n=27,27,23 | 17.44 units on a scale | Standard Deviation 4.56 |
| Placebo Training | Depressive Symptoms Measured by Beck Depression Inventory-II | 3-momth follow-up;n=27,27,21 | 14.41 units on a scale | Standard Deviation 7.12 |
| Blank Control | Depressive Symptoms Measured by Beck Depression Inventory-II | BDI-II scores at baseline | 18.13 units on a scale | Standard Deviation 5.18 |
| Blank Control | Depressive Symptoms Measured by Beck Depression Inventory-II | 8-week follow-up;n=27,27,23 | 17.35 units on a scale | Standard Deviation 5.02 |
| Blank Control | Depressive Symptoms Measured by Beck Depression Inventory-II | BDI-II scores at posttraining | 18.13 units on a scale | Standard Deviation 6.33 |
| Blank Control | Depressive Symptoms Measured by Beck Depression Inventory-II | 7-month follow-up;n=23,20,18 | 10.56 units on a scale | Standard Deviation 7.35 |
| Blank Control | Depressive Symptoms Measured by Beck Depression Inventory-II | 3-momth follow-up;n=27,27,21 | 13.38 units on a scale | Standard Deviation 5.97 |
| Blank Control | Depressive Symptoms Measured by Beck Depression Inventory-II | 4-week follow-up;n=23,21,21 | 17.00 units on a scale | Standard Deviation 4.6 |
| Blank Control | Depressive Symptoms Measured by Beck Depression Inventory-II | BDI-II scores 2-week follow-up;n=23,21,20 | 17.00 units on a scale | Standard Deviation 4.6 |
p-value: 0.05Mixed Models Analysis
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.
Time frame: From baseline to post-training, 2-, 4-, 8-week, 3- , 7-month follow-ups after training
Population: Some subjects dropped out of the study or could not be contacted.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Attentional Bias Modification Training | 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 |
| Attentional Bias Modification Training | 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 |
| Attentional Bias Modification Training | 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 |
| Attentional Bias Modification Training | 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 |
| Attentional Bias Modification Training | 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 |
| Attentional Bias Modification Training | 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 |
| Attentional Bias Modification Training | 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 |
| Attentional Bias Modification Training | 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 |
| Attentional Bias Modification Training | 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 |
| Attentional Bias Modification Training | 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 |
| Attentional Bias Modification Training | 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 |
| Attentional Bias Modification Training | 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 5.2 |
| Placebo Training | 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 | 45.44 units on a scale | Standard Deviation 8.08 |
| Placebo Training | 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 | 50.81 units on a scale | Standard Deviation 5.2 |
| Placebo Training | 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 | 50.23 units on a scale | Standard Deviation 7.48 |
| Placebo Training | 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 | 50.05 units on a scale | Standard Deviation 6.82 |
| Placebo Training | 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 | 49.19 units on a scale | Standard Deviation 6.14 |
| Placebo Training | 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 | 47.41 units on a scale | Standard Deviation 7.42 |
| Placebo Training | 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 | 48.25 units on a scale | Standard Deviation 6.38 |
| Placebo Training | 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 | 46.75 units on a scale | Standard Deviation 8.87 |
| Placebo Training | 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 | 45.52 units on a scale | Standard Deviation 7.78 |
| Placebo Training | 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 | 45.14 units on a scale | Standard Deviation 7.47 |
| Placebo Training | 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 | 44.29 units on a scale | Standard Deviation 8.09 |
| Placebo Training | 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 | 44.15 units on a scale | Standard Deviation 8.11 |
| Blank Control | 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 | 46.82 units on a scale | Standard Deviation 7.86 |
| Blank Control | 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 | 51.35 units on a scale | Standard Deviation 5.46 |
| Blank Control | 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 | 46.33 units on a scale | Standard Deviation 6.26 |
| Blank Control | 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 | 50.13 units on a scale | Standard Deviation 5.74 |
| Blank Control | 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 | 44.22 units on a scale | Standard Deviation 7.92 |
| Blank Control | 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 | 45.57 units on a scale | Standard Deviation 6.51 |
| Blank Control | 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 | 50.30 units on a scale | Standard Deviation 5.51 |
| Blank Control | 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 | 46.78 units on a scale | Standard Deviation 6.27 |
| Blank Control | 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 | 50.05 units on a scale | Standard Deviation 5.63 |
| Blank Control | 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 | 45.94 units on a scale | Standard Deviation 6.79 |
| Blank Control | 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 | 45.52 units on a scale | Standard Deviation 7.37 |
| Blank Control | 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 | 46.50 units on a scale | Standard Deviation 6.61 |