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Clinical Trials/NCT03971903
NCT03971903
Completed
Not Applicable

Department of Psychology, Hunan Normal University

Hunan Normal University1 site in 1 country30 target enrollmentDecember 24, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Depressive Disorder, Major
Sponsor
Hunan Normal University
Enrollment
30
Locations
1
Primary Endpoint
Changes of depressive symptoms
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
December 24, 2017
End Date
March 26, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Hunan Normal University
Responsible Party
Principal Investigator
Principal Investigator

Wenhui Yang

Department of Psychology

Hunan Normal University

Eligibility Criteria

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).

Outcomes

Primary Outcomes

Changes of depressive symptoms

Time Frame: 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 )

Depression symptoms tested by clinicians using Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children (K-SADS)

Changes of attention bias score

Time Frame: 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 )

Attention bias score changes tested by a typical dot-probe task

Changes of severity of depression

Time Frame: 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 )

The severity of depression tested by clinicians using the 17-Item Hamilton Depression Rating Scale (HAM-D)

Secondary Outcomes

  • Changes of self-reported trait anxiety(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(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 depressive symptoms(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 ))

Study Sites (1)

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