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The Effect of Attention Bias Modification Training on Reducing Depressive Symptoms

NCT01628016 — Not applicable, Completed, 77 participants, Hunan Normal University

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A Randomized, Double-blind, Placebo-Controlled Evaluation of the Efficacy of Attentional Bias Modification Training in the Treatment of Depressive Symptoms

RegistryNCT01628016
StatusCompleted
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: triple, treatment
Enrollment77 (Actual)
SponsorHunan Normal University (Other)
ConditionsDepressive Symptoms
Interventionsa word dot-probe task for training procedure (Behavioral)
Datesstart 2011-09-01, primary completion 2013-07-01, completion 2013-07-01, first posted 2012-06-26, last updated 2020-08-14
Locations1 site in China

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All trials for Depressive Symptoms All trials of a word dot-probe task for training procedure

-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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
Attentional bias modification trainingExperimentalBehavioral: 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 trainingPlacebo comparatorBehavioral: 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 controlNo interventionParticipants only complete assessment at each point time.
  • 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.

+Outcome measures

Primary outcomes

  • 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 outcomes

  • 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

Sex: All, ages: 16 Years to any

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.

+Posted results

Participant flow

MilestoneAttentional Bias Modification TrainingPlacebo TrainingBlank Control
Started272723
Completed272723
Not completed000

Outcome results

  • Depressive Symptoms Measured by Beck Depression Inventory-II (Primary), Mean, units on a scale: Attentional Bias Modification Training 17.33 +/- 3.81; Placebo Training 18.04 +/- 4.11; Blank Control 18.13 +/- 5.18 (p .05)
  • Anxiety and Rumination Symptoms Measured by State-Trait Anxiety Inventory-Trait(STAI-T) and Rumination Response Style(RRS) (Secondary), Mean, units on a scale: Attentional Bias Modification Training 44.52 +/- 4.56; Placebo Training 50.81 +/- 5.20; Blank Control 51.35 +/- 5.46

Adverse events

Time frame: 7-month

ArmDeathsSerious adverse eventsOther adverse events
Attentional Bias Modification Training00/27 (0.0%)0/27 (0.0%)
Placebo Training00/27 (0.0%)0/27 (0.0%)
Blank Control00/23 (0.0%)0/23 (0.0%)

+Locations (1)

FacilityCityCountryStatus
Department of Psychology, Hunan Normal UniversityChangsha, HunanChina

+Publications

  • Results publication: 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. PMID 25245928

+Investigators

  • Wenhui Yang, Ph.D, Principal investigator, Department of Psychology, Hunan Normal University

My Notes