- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02078258
Attention Bias Modification Treatment for Major Depressive Disorder in Adolescents
Attention Bias Modification Treatment for Major Depressive Disorder in Adolescents: A Randomized Controlled Trial
Study Overview
Status
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:
- Meet the major depression disorder's criteria
Exclusion Criteria:
- 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 |
---|---|
Experimental: Attentional bias modification training
Attention bias modification training (ABMT) is a a variation of attention tasks to modify attentional biases, in which a probe always appears in the location of relatively positive stimuli after the two stimuli, one neutral and one emotional, were simultaneously presented. Participants complete 8 sessions (320 trials each with 20 minutes) over two weeks of neutral ABMT to shift attention toward neutral, in which a probe appeared in the location of neutral with 90% probability, and sadness-related with 10% probality. At a 9-week follow-up, participants completed 4 more sessions (480 trials each with 30 minutes)over two weeks of positive ABMT to shift attention toward positive words,in which a probe appeared in the location of 67% positive or 33% neutral. |
During a two-week period, 8 sessions of a modified dot probe task for attentional bias modification training (ABMT) condition, 8 sessions of a classic dot probe task for placebo training (PT) condition.
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Active Comparator: Placebo control
The placebo ABMT was identical to the active ABMT, but shifted toward neutral (50%) or sad (50%) stimuli equally often (i.e., 50/50 training).
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During a two-week period, 8 sessions of a modified dot probe task for attentional bias modification training (ABMT) condition, 8 sessions of a classic dot probe task for placebo training (PT) condition.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in depressive symptom number
Time Frame: baseline, 7-week, 6-month follow-up
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Depressive symptom accounts measured by Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children.
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baseline, 7-week, 6-month follow-up
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Changes in depressive severity
Time Frame: baseline, 7-week, 6-month follow-up
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depressive severity measured by the construct interview of the Schedule for Affective Disorders and Schizophrenia for School-Age Children(K-SADS)
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baseline, 7-week, 6-month follow-up
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of Self-report symptoms
Time Frame: baseline, 7-week, 6-, 12-month follow-up
|
symptoms measured by the Center for Epidemiological Studies Depression Scale (CES-D), State-Trait Anxiety Inventory-Trait(STAI-T),Rumination Response Style(RRS),Suicidal Ideation Questionnaire(SIQ)
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baseline, 7-week, 6-, 12-month follow-up
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Diagnostic status of major depressive disorder
Time Frame: baseline, 7-week, 6-month follow-up
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Assessed by the diagnostic interview of the Schedule for Affective Disorders and Schizophrenia for School-Age Children
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baseline, 7-week, 6-month follow-up
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Wenhui Yang, Ph.D, MD., Hunan Normal University
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ANALYTIC_CODE
- CSR
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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