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Attention Bias Modification Treatment for Major Depressive Disorder in Adolescents

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ClinicalTrials.gov Identifier: NCT02078258
Recruitment Status : Completed
First Posted : March 5, 2014
Last Update Posted : March 28, 2019
Sponsor:
Information provided by (Responsible Party):
Wenhui Yang, Hunan Normal University

Brief Summary:
In this study, we test whether a two-week 8-session neutral attention bias modification (ABM) training and a two-week 4-session positive ABM could reduce depressive symptoms relative to placebo controls in adolescents with major depressive disorder at posttraining and follow-ups during one year.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder, Single Episode, Unspecified Behavioral: ABMT Not Applicable

Detailed Description:
Depression is a common health problem in adolescents. Negative attentional bias has been theorized to play a critical role in the onset and maintenance of depression, suggesting that reduction of such biases may treat symptoms of depression. Recent studies have shown that attention bias modification(ABM) training could reduce depressive symptoms in both dysphoria and previously depressed adult patients.To test the effectiveness of ABM training on the treatment of depressive symptoms in depressed adolescents, we designed a randomized, double-blind, placebo controlled trial in adolescents with major depressive disorder(MDD).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Attention Bias Modification Treatment for Major Depressive Disorder in Adolescents: A Randomized Controlled Trial
Study Start Date : September 2012
Actual Primary Completion Date : January 2014
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine


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.

Behavioral: ABMT
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.

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).
Behavioral: ABMT
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.




Primary Outcome Measures :
  1. Changes in depressive symptom number [ Time Frame: baseline, 7-week, 6-month follow-up ]
    Depressive symptom accounts measured by Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children.

  2. Changes in depressive severity [ Time Frame: baseline, 7-week, 6-month follow-up ]
    depressive severity measured by the construct interview of the Schedule for Affective Disorders and Schizophrenia for School-Age Children(K-SADS)


Secondary Outcome Measures :
  1. 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)

  2. Diagnostic status of major depressive disorder [ Time Frame: baseline, 7-week, 6-month follow-up ]
    Assessed by the diagnostic interview of the Schedule for Affective Disorders and Schizophrenia for School-Age Children



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Ages Eligible for Study:   11 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02078258


Locations
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China, Hunan
Department of Psychology, Hunan Normal University
Changsha, Hunan, China, 400081
Sponsors and Collaborators
Hunan Normal University
Investigators
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Study Director: Wenhui Yang, Ph.D, MD. Hunan Normal University

Publications of Results:
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Responsible Party: Wenhui Yang, Department of Psychology, Hunan Normal University
ClinicalTrials.gov Identifier: NCT02078258     History of Changes
Other Study ID Numbers: 1
First Posted: March 5, 2014    Key Record Dates
Last Update Posted: March 28, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All data can be shared with other researchers
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Analytic Code
Time Frame: after the completion and forever
Access Criteria: Only for research

Keywords provided by Wenhui Yang, Hunan Normal University:
depression,adolescent,attention bias,modification

Additional relevant MeSH terms:
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Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms