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Attention Bias Modification Treatment for Young Adults With Major Depressive Disorder

Primary Purpose

Depressive Disorder, Major

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Attention bias modification
Sponsored by
Hunan Normal University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depressive Disorder, Major focused on measuring Attenion bias modification, major depression, treatment

Eligibility Criteria

16 Years - 20 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • The presence of definite and probable MDD (i.e., at least 1 core symptom plus 3 further depressive symptoms present for at least 2 weeks) diagnoses

Exclusion Criteria:

  • a diagnosis of bipolar disorder, schizophrenia, or mood disorder due to a general medical condition or substance-induced mood disorder; and any concurrent treatment (i.e., psychotherapy and/or pharmacotherapy).

Sites / Locations

  • Department of Psychology, Hunan Normal University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Attention bias modification treatment

Placebo controls

Arm Description

12-session of ABMT

12-session of placebo(i.e.,sham) training

Outcomes

Primary Outcome Measures

Changes of attention bias score
Attention bias score changes tested by a typical dot-probe task
Changes of depressive symptoms
Depression symptoms tested by clinicians using Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children (K-SADS)
Changes of severity of depression
The severity of depression tested by clinicians using the 17-Item Hamilton Depression Rating Scale (HAM-D)

Secondary Outcome Measures

Changes of self-reported depressive symptoms
Self-reported depressive symptoms assessed by Beck depression scale-second version (BDI-II), and trait anxiety assessed by State Trait Anxiety Inventory-Trait(STAI-T), rumination assessed by Rumination Response Scale(RRS).
Changes of self-reported trait anxiety
self-reported trait anxiety assessed by State Trait Anxiety Inventory-Trait(STAI-T)
Changes of self-reported rumination
Self-reported rumination assessed by Rumination Response Scale(RRS).

Full Information

First Posted
January 31, 2018
Last Updated
May 31, 2019
Sponsor
Hunan Normal University
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1. Study Identification

Unique Protocol Identification Number
NCT03971903
Brief Title
Attention Bias Modification Treatment for Young Adults With Major Depressive Disorder
Official Title
Department of Psychology, Hunan Normal University
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
December 24, 2017 (Actual)
Primary Completion Date
March 26, 2019 (Actual)
Study Completion Date
March 26, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hunan Normal University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
In this study, the investigators test whether a 4-week 12-session attention bias modification treatment (ABMT) could reduce depressive symptoms relative to placebo controls in young adults with major depressive disorder at post-training and 3-month follow-ups. Meanwhile, the investigators also test whether a 2-week 4-session ABMT booster training for every three months could reduce residual depressive symptoms and recurrences relative to placebo controls for 1-year follow-up
Detailed Description
Attention Bias Modification Training was a modified dot-probe task, in which 90% of the targets appeared at the neutral word position and 10% at the sad word position. The placebo training procedure is a classic dot-probe task in which the targets appeared with equal probability in the sad (50%) and neutral (50%) word positions. The investigators assess attention bias scores, depressive symptoms, trait anxiety, rumination and self-report attention control ability at 1-week, 2-week, 4-week,7-week,3-month,4-month, 5-month, 6-month and 12-month follow-ups after training.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorder, Major
Keywords
Attenion bias modification, major depression, treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Particpants are assigned to active ABM treatment or placebo training
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Attention bias modification treatment
Arm Type
Experimental
Arm Description
12-session of ABMT
Arm Title
Placebo controls
Arm Type
Placebo Comparator
Arm Description
12-session of placebo(i.e.,sham) training
Intervention Type
Behavioral
Intervention Name(s)
Attention bias modification
Intervention Description
The ABM training task was a variation of the computerized visual dot-probe task. During the training, each session includes 54 neutral-sad word pairs presenting 6 times (6 × 54=324 trials) during 20-minute. Participants received 12 sessions over 4 weeks (1 session every other day). In the active ABMT, 90% of the probes appeared at the neutral position and 10% at the sad position. At the placebo ABMT, 50% of the probes appeared at the neutral position and 50% at the sad position.
Primary Outcome Measure Information:
Title
Changes of attention bias score
Description
Attention bias score changes tested by a typical dot-probe task
Time Frame
pre-training, post-training(4 weeks after pre-training), follow-ups(1-week,2-week,4-week,7-week,3-month(booster pre-training),4-month(booster post-training),5-month,6-month,12-month after post-training )
Title
Changes of depressive symptoms
Description
Depression symptoms tested by clinicians using Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children (K-SADS)
Time Frame
pre-training, post-training(4 weeks after pre-training), follow-ups(1-week,2-week,4-week,7-week,3-month(booster pre-training),4-month(booster post-training),5-month,6-month,12-month after post-training )
Title
Changes of severity of depression
Description
The severity of depression tested by clinicians using the 17-Item Hamilton Depression Rating Scale (HAM-D)
Time Frame
pre-training, post-training(4 weeks after pre-training), follow-ups(1-week,2-week,4-week,7-week,3-month(booster pre-training),4-month(booster post-training),5-month,6-month,12-month after post-training )
Secondary Outcome Measure Information:
Title
Changes of self-reported depressive symptoms
Description
Self-reported depressive symptoms assessed by Beck depression scale-second version (BDI-II), and trait anxiety assessed by State Trait Anxiety Inventory-Trait(STAI-T), rumination assessed by Rumination Response Scale(RRS).
Time Frame
pre-training, post-training(4 weeks after pre-training), follow-ups(1-week,2-week,4-week,7-week,3-month(booster pre-training),4-month(booster post-training),5-month,6-month,12-month after post-training )
Title
Changes of self-reported trait anxiety
Description
self-reported trait anxiety assessed by State Trait Anxiety Inventory-Trait(STAI-T)
Time Frame
pre-training, post-training(4 weeks after pre-training), follow-ups(1-week,2-week,4-week,7-week,3-month(booster pre-training),4-month(booster post-training),5-month,6-month,12-month after post-training )
Title
Changes of self-reported rumination
Description
Self-reported rumination assessed by Rumination Response Scale(RRS).
Time Frame
pre-training, post-training(4 weeks after pre-training), follow-ups(1-week,2-week,4-week,7-week,3-month(booster pre-training),4-month(booster post-training),5-month,6-month,12-month after post-training )

10. Eligibility

Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The presence of definite and probable MDD (i.e., at least 1 core symptom plus 3 further depressive symptoms present for at least 2 weeks) diagnoses Exclusion Criteria: a diagnosis of bipolar disorder, schizophrenia, or mood disorder due to a general medical condition or substance-induced mood disorder; and any concurrent treatment (i.e., psychotherapy and/or pharmacotherapy).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wenhui Yang, Ph.D
Organizational Affiliation
Hunan Normal University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Psychology, Hunan Normal University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410081
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
After completion, all the data can be shared
IPD Sharing Time Frame
After 2020 and forever
IPD Sharing Access Criteria
Just for research
Citations:
PubMed Identifier
25245928
Citation
Yang W, Ding Z, Dai T, Peng F, Zhang JX. Attention Bias Modification training in individuals with depressive symptoms: A randomized controlled trial. J Behav Ther Exp Psychiatry. 2015 Dec;49(Pt A):101-11. doi: 10.1016/j.jbtep.2014.08.005. Epub 2014 Sep 8.
Results Reference
background
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 Young Adults With Major Depressive Disorder

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