- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01628016
The Effect of Attention Bias Modification Training on Reducing Depressive Symptoms
A Randomized, Double-blind, Placebo-Controlled Evaluation of the Efficacy of Attentional Bias Modification Training in the Treatment of Depressive Symptoms
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Hunan
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Changsha, Hunan, China, 400081
- Department of Psychology, Hunan Normal University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Attentional bias modification training
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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.
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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.
|
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.
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No Intervention: blank control
Participants only complete assessment at each point time.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Depressive Symptoms Measured by Beck Depression Inventory-II
Time Frame: From the baseline to posttraining, 2-, 4-, 8-week, 3-, 7-month follow-ups after training
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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.
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From the baseline to posttraining, 2-, 4-, 8-week, 3-, 7-month follow-ups after training
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Anxiety and Rumination Symptoms Measured by State-Trait Anxiety Inventory-Trait(STAI-T) and Rumination Response Style(RRS)
Time Frame: From baseline to post-training, 2-, 4-, 8-week, 3- , 7-month follow-ups after training
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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. |
From baseline to post-training, 2-, 4-, 8-week, 3- , 7-month follow-ups after training
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- XJK011AXL002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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