Attention Bias Modification Treatment for Major Depressive Disorder in Adolescents

March 26, 2019 updated by: Wenhui Yang, Hunan Normal University

Attention Bias Modification Treatment for Major Depressive Disorder in Adolescents: A Randomized Controlled Trial

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.

Study Overview

Status

Completed

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Hunan
      • Changsha, Hunan, China, 400081
        • Department of Psychology, Hunan Normal University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 years to 19 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
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).
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.

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
Depressive symptom accounts measured by Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children.
baseline, 7-week, 6-month follow-up
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)
baseline, 7-week, 6-month follow-up

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)
baseline, 7-week, 6-, 12-month follow-up
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
baseline, 7-week, 6-month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Wenhui Yang, Ph.D, MD., Hunan Normal University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

January 14, 2014

First Submitted That Met QC Criteria

March 4, 2014

First Posted (Estimate)

March 5, 2014

Study Record Updates

Last Update Posted (Actual)

March 28, 2019

Last Update Submitted That Met QC Criteria

March 26, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All data can be shared with other researchers

IPD Sharing Time Frame

after the completion and forever

IPD Sharing Access Criteria

Only for research

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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