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Attention Bias Modification Treatment for Major Depressive Disorder in Adolescents

Primary Purpose

Major Depressive Disorder, Single Episode, Unspecified

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

ABMT

About this trial

This is an interventional treatment trial for Major Depressive Disorder, Single Episode, Unspecified focused on measuring depression，adolescent，attention bias，modification

Eligibility Criteria

11 Years - 19 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Department of Psychology, Hunan Normal University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Attentional bias modification training

Placebo control

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

Changes in depressive symptom number

Depressive symptom accounts measured by Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children.

Changes in depressive severity

depressive severity measured by the construct interview of the Schedule for Affective Disorders and Schizophrenia for School-Age Children(K-SADS)

Secondary Outcome Measures

Change of Self-report symptoms

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）

Diagnostic status of major depressive disorder

Assessed by the diagnostic interview of the Schedule for Affective Disorders and Schizophrenia for School-Age Children

Full Information

NCT ID

NCT02078258

First Posted

January 14, 2014

Last Updated

March 26, 2019

Sponsor

Hunan Normal University

1. Study Identification

Unique Protocol Identification Number

NCT02078258

Brief Title

Attention Bias Modification Treatment for Major Depressive Disorder in Adolescents

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2019

Overall Recruitment Status

Completed

Study Start Date

September 2012 (undefined)

Primary Completion Date

January 2014 (Actual)

Study Completion Date

July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hunan Normal University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Major Depressive Disorder, Single Episode, Unspecified

Keywords

depression，adolescent，attention bias，modification

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

45 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Attentional bias modification training

Arm Type

Experimental

Arm Description

Arm Title

Placebo control

Arm Type

Active Comparator

Arm Description

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).

Intervention Type

Behavioral

Intervention Name(s)

ABMT

Intervention Description

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 Measure Information:

Title

Changes in depressive symptom number

Description

Depressive symptom accounts measured by Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children.

Time Frame

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

Title

Changes in depressive severity

Description

depressive severity measured by the construct interview of the Schedule for Affective Disorders and Schizophrenia for School-Age Children(K-SADS)

Time Frame

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

Secondary Outcome Measure Information:

Title

Change of Self-report symptoms

Description

Time Frame

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

Title

Diagnostic status of major depressive disorder

Description

Assessed by the diagnostic interview of the Schedule for Affective Disorders and Schizophrenia for School-Age Children

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

11 Years

Maximum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Wenhui Yang, Ph.D, MD.

Organizational Affiliation

Hunan Normal University

Official's Role

Study Director

Facility Information:

Facility Name

Department of Psychology, Hunan Normal University

City

Changsha

State/Province

Hunan

ZIP/Postal Code

400081

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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

Citations:

PubMed Identifier

26903254

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.

Results Reference

result

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Attention Bias Modification Treatment for Major Depressive Disorder in Adolescents

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