NCT02078258

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

January 14, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 5, 2014

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

March 28, 2019

Status Verified

March 1, 2019

Enrollment Period

1.3 years

First QC Date

January 14, 2014

Last Update Submit

March 26, 2019

Conditions

Keywords

depression,adolescent,attention bias,modification

Outcome Measures

Primary Outcomes (2)

  • Changes in depressive symptom number

    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

    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 Outcomes (2)

  • Change of Self-report symptoms

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

  • Diagnostic status of major depressive disorder

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

Study Arms (2)

Attentional bias modification training

EXPERIMENTAL

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

Placebo control

ACTIVE COMPARATOR

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

Interventions

ABMTBEHAVIORAL

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.

Attentional bias modification trainingPlacebo control

Eligibility Criteria

Age11 Years - 19 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Meet the major depression disorder's criteria

You may not qualify if:

  • bipolar disorder, schizophrenia or organic mental disorder;
  • any concurrent psychotherapy;
  • any concurrent psychotropic medication.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Psychology, Hunan Normal University

Changsha, Hunan, 400081, China

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Study Officials

  • Wenhui Yang, Ph.D, MD.

    Hunan Normal University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of Psychology

Study Record Dates

First Submitted

January 14, 2014

First Posted

March 5, 2014

Study Start

September 1, 2012

Primary Completion

January 1, 2014

Study Completion

July 1, 2015

Last Updated

March 28, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will share

All data can be shared with other researchers

Shared Documents
STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
Time Frame
after the completion and forever
Access Criteria
Only for research

Locations