Depressive Disorder, Major Clinical Trial
Official title:
Department of Psychology, Hunan Normal University
Verified date | May 2019 |
Source | Hunan Normal University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 30 |
Est. completion date | March 26, 2019 |
Est. primary completion date | March 26, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 16 Years to 20 Years |
Eligibility |
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). |
Country | Name | City | State |
---|---|---|---|
China | Department of Psychology, Hunan Normal University | Changsha | Hunan |
Lead Sponsor | Collaborator |
---|---|
Hunan Normal University |
China,
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. — View Citation
Yang W, Zhang JX, Ding Z, Xiao L. Attention Bias Modification Treatment for Adolescents With Major Depression: A Randomized Controlled Trial. J Am Acad Child Adolesc Psychiatry. 2016 Mar;55(3):208-18.e2. doi: 10.1016/j.jaac.2015.12.005. Epub 2015 Dec 23. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 ) | |
Primary | 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 ) | |
Primary | 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 | 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 ) | |
Secondary | 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 ) | |
Secondary | 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 ) |
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