Attention Bias Modification Treatment for Young Adults With Major Depressive Disorder

Study Overview
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Brief Summary
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In this study, the investigators test whether a 4-week 12-session attention bias modification treatment (ABMT) could reduce depressive symptoms relative to placebo controls in young adults with major depressive disorder at post-training and 3-month follow-ups. Meanwhile, the investigators also test whether a 2-week 4-session ABMT booster training for every three months could reduce residual depressive symptoms and recurrences relative to placebo controls for 1-year follow-up

Detailed Description
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Attention Bias Modification Training 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. 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. 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.

Official Title
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Department of Psychology, Hunan Normal University

Conditions
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Depressive Disorder, Major

Intervention / Treatment
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* Behavioral: Attention bias modification


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The presence of definite and probable MDD (i.e., at least 1 core symptom plus 3 further depressive symptoms present for at least 2 weeks) diagnoses Exclusion Criteria: a diagnosis of bipolar disorder, schizophrenia, or mood disorder due to a general medical condition or substance-induced mood disorder; and any concurrent treatment (i.e., psychotherapy and/or pharmacotherapy).

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Particpants are assigned to active ABM treatment or placebo training
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Attention bias modification treatment<br>12-session of ABMT | Behavioral: Attention bias modification<br>* The ABM training task was a variation of the computerized visual dot-probe task. During the training, each session includes 54 neutral-sad word pairs presenting 6 times (6 × 54=324 trials) during 20-minute. Participants received 12 sessions over 4 weeks (1 session every other day). In the active ABMT, 90% of the probes appeared at the neutral position and 10% at the sad position. At the placebo ABMT, 50% of the probes appeared at the neutral position and 50% at the sad position.<br>|
| Placebo Comparator: Placebo controls<br>12-session of placebo(i.e.,sham) training | Behavioral: Attention bias modification<br>* The ABM training task was a variation of the computerized visual dot-probe task. During the training, each session includes 54 neutral-sad word pairs presenting 6 times (6 × 54=324 trials) during 20-minute. Participants received 12 sessions over 4 weeks (1 session every other day). In the active ABMT, 90% of the probes appeared at the neutral position and 10% at the sad position. At the placebo ABMT, 50% of the probes appeared at the neutral position and 50% at the sad position.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of attention bias score | Attention bias score changes tested by a typical dot-probe task | pre-training, post-training(4 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 ) | 
| Changes of depressive symptoms | Depression symptoms tested by clinicians using Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children (K-SADS) | pre-training, post-training(4 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 ) | 
| Changes of severity of depression | The severity of depression tested by clinicians using the 17-Item Hamilton Depression Rating Scale (HAM-D) | pre-training, post-training(4 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 Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of self-reported depressive symptoms | Self-reported depressive symptoms assessed by Beck depression scale-second version (BDI-II), and trait anxiety assessed by State Trait Anxiety Inventory-Trait(STAI-T), rumination assessed by Rumination Response Scale(RRS). | pre-training, post-training(4 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 ) | 
| Changes of self-reported trait anxiety | self-reported trait anxiety assessed by State Trait Anxiety Inventory-Trait(STAI-T) | pre-training, post-training(4 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 ) | 
| Changes of self-reported rumination | Self-reported rumination assessed by Rumination Response Scale(RRS). | pre-training, post-training(4 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 ) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Attenion bias modification, major depression, treatment