Neutral and Positive Attention Bias Modification Training for Young Adults With Depressive Symptoms
Primary Purpose
Depressive Disorder
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Neutral ABMT
Positive ABMT
Sponsored by

About this trial
This is an interventional treatment trial for Depressive Disorder focused on measuring attention bias modification, positive attention bias, depressive symptoms, prevention
Eligibility 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.
Sites / Locations
- Department of Psychology, Hunan Normal University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Neutral ABMT
Positive ABMT
Arm Description
8-session-ABMT during a two-week period and 4-session-booster-ABMT during a two-week period
8-session-ABMT during a two-week period and 4-session-booster-ABMT during a two-week period
Outcomes
Primary Outcome Measures
Changes of attentional bias score
Attentional bias score tested by a typical dot-probe task
Changes of depressive symptoms
Depression symptoms tested by clinicians using the Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children (K-SADS)
Secondary Outcome Measures
Changes of self-reported depressive symptoms
Self-reported depressive symptoms assessed by Beck depression scale-second version (BDI-II)
Changes of self-reported rumination
Self-reported rumination assessed by Rumination Response Scale(RRS).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03971942
Brief Title
Neutral and Positive Attention Bias Modification Training for Young Adults With Depressive Symptoms
Official Title
Department of Psychology, Hunan Normal University
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
December 24, 2017 (Actual)
Primary Completion Date
January 22, 2019 (Actual)
Study Completion Date
March 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hunan Normal University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study intends to explore the therapeutic effects of the development of negative attention bias modifaction and positive attention bias on depressive symptoms and redundancy through two different attention training methods: (1) neutral attention training (when neutral and sad stimuli are presented simultaneously, attention is always directed towards neutral stimuli to correct negative attention bias) and (2) positive attention training (when neutral and positive stimuli are presented simultaneously, attention is always directed towards positive stimuli to develop positive attention bias).
Detailed Description
Attention Bias Modification Training was a modified dot-probe task. In the neutral attention bias, 90% of the targets in the training group appear in the neutral word position and 10% of the targets appear in the negative word position, while 50% of the targets in the placebo group appear in the neutral word position and 50% of the targets appear in the negative word position. In the positive attention bias, 90% of the targets in the training group appear in the positive word position and 10% of the targets appear in the neutral word position, while 90% of the targets in the placebo group appear in the neutral word position and 10% of the targets appear in the positive word position. The investigators assess attention bias scores, depressive symptoms, trait anxiety, rumination and self-report attention control ability at 1-week, 2-week, 4-week, 7-week, 3-month, 4-month, 5-month, 6-month and 12-month follow-ups after training.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorder
Keywords
attention bias modification, positive attention bias, depressive symptoms, prevention
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
68 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Neutral ABMT
Arm Type
Experimental
Arm Description
8-session-ABMT during a two-week period and 4-session-booster-ABMT during a two-week period
Arm Title
Positive ABMT
Arm Type
Experimental
Arm Description
8-session-ABMT during a two-week period and 4-session-booster-ABMT during a two-week period
Intervention Type
Behavioral
Intervention Name(s)
Neutral ABMT
Intervention Description
In the neutral attention bias, there are 108 pairs of neutral-negative words, 54 pairs of which are used in the training group and 54 pairs of which are used in the placebo group. The word pairs in each group are repeated 4 times, with a total of 216 trial. Participants received 8 sessions over 2 weeks (1 session every other day).In booster ABMT, participants received 4 sessions over 2 weeks (1 session every three days).90% of the targets in the training group appear in the neutral word position and 10% of the targets appear in the negative word position, while 50% of the targets in the placebo group appear in the neutral word position and 50% of the targets appear in the negative word position.
Intervention Type
Behavioral
Intervention Name(s)
Positive ABMT
Intervention Description
In the positive attention bias, there are 54 pairs of neutral-negative words, 27 pairs of which are used in the training group and 27 pairs of which are used in the placebo group. The word pairs in each group are repeated 8 times, with a total of 216 trial.Participants received 8 sessions over 2 weeks (1 session every other day). In booster ABMT, participants received 4 sessions over 2 weeks (1 session every three days).90% of the targets in the training group appear in the positive word position and 10% of the targets appear in the neutral word position, while 90% of the targets in the placebo group appear in the neutral word position and 10% of the targets appear in the positive word position.
Primary Outcome Measure Information:
Title
Changes of attentional bias score
Description
Attentional bias score tested by a typical dot-probe task
Time Frame
pre-training, post-training(2 weeks after pre-training), follow-ups(1-week,2-week,4-week,7-week,3-month( booster pre-training), 4-month (booster post-training), 5-month,6-month,12-month after post-training)
Title
Changes of depressive symptoms
Description
Depression symptoms tested by clinicians using the Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children (K-SADS)
Time Frame
pre-training, post-training(2 weeks after pre-training), follow-ups(1-week,2-week,4-week,7-week,3-month( booster pre-training), 4-month (booster post-training), 5-month,6-month,12-month after post-training)
Secondary Outcome Measure Information:
Title
Changes of self-reported depressive symptoms
Description
Self-reported depressive symptoms assessed by Beck depression scale-second version (BDI-II)
Time Frame
pre-training, post-training(2 weeks after pre-training), follow-ups(1-week,2-week,4-week,7-week,3-month( booster pre-training), 4-month (booster post-training), 5-month,6-month,12-month after post-training)
Title
Changes of self-reported rumination
Description
Self-reported rumination assessed by Rumination Response Scale(RRS).
Time Frame
pre-training, post-training(2 weeks after pre-training), follow-ups(1-week,2-week,4-week,7-week,3-month( booster pre-training), 4-month (booster post-training), 5-month,6-month,12-month after post-training)
10. Eligibility
Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Department of Psychology, Hunan Normal University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410081
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Neutral and Positive Attention Bias Modification Training for Young Adults With Depressive Symptoms
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