NCT01628016

Brief Summary

The purpose of this study is to test whether attention bias modification training is an effective neurobehavioral therapy to improve depressive symptoms.That is whether attention bias modification training is superior to placebo in reducing depressive symptoms over 1 year after training.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
77

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2011

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 9, 2012

Completed
17 days until next milestone

First Posted

Study publicly available on registry

June 26, 2012

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
6.2 years until next milestone

Results Posted

Study results publicly available

September 19, 2019

Completed
Last Updated

August 14, 2020

Status Verified

August 1, 2020

Enrollment Period

1.8 years

First QC Date

June 9, 2012

Results QC Date

January 13, 2014

Last Update Submit

August 1, 2020

Conditions

Keywords

depressionattentiontrainingmodification

Outcome Measures

Primary Outcomes (1)

  • Depressive Symptoms Measured by Beck Depression Inventory-II

    Beck Depression Inventory-II(BDI-II) contains 21 items and rates the depressive symptoms for the past two weeks. Each question provides for a response of 0 to 3. A zero response means the depressive symptom is not present; a 1 means the symptom is present, a 2 means the symptom is moderate, and a 3 means the symptom is severe. The total BDI-II score is the sum of the individual items; total BDI-II scores can range from 0 to 63. Cutoff points developed by Beck, Steer, \& Brown (1997) for the total BDI-II are: 0 to 13, nondepressed; 14 to 19, mild depression; 20 to 28, moderate depression; 29 or more, severe depression.

    From the baseline to posttraining, 2-, 4-, 8-week, 3-, 7-month follow-ups after training

Secondary Outcomes (1)

  • Anxiety and Rumination Symptoms Measured by State-Trait Anxiety Inventory-Trait(STAI-T) and Rumination Response Style(RRS)

    From baseline to post-training, 2-, 4-, 8-week, 3- , 7-month follow-ups after training

Study Arms (3)

Attentional bias modification training

EXPERIMENTAL

1. Attention bias modification training (ABMT) is a modified dot probe task, in which a probe always appears in the location of neutral stimulus after the two stimuli (i.e. one is the depressive cue and the other is neutral) were simultaneously presented. In the ABMT,the probability that a probe appears in the location of neutral is 90%, and correspondingly,in the location of depressive stimuli is 10%. 2. ABMT intervention: Participants complete 8 sessions of attention bias modification training (ABMT) during a two-week period. Each session consists of 218 trials, and the time to complete a training session is 12 minutes (4 sessions a week, roughly one session every other day with for each session).

Behavioral: a word dot-probe task for training procedure

Placebo training

PLACEBO COMPARATOR

Participants complete 8 sessions of placebo training(PT) during a two-week period. Placebo training is a classic dot probe task, in which a probe appears after either of the locations that the two stimuli (i.e. one is the depressive cue and the other is neutral) were presented, with the same frequencies. In the PT condition, each session also consists of 218 trials, and the time to complete a PT session is approximately 10 minutes as well.

Behavioral: a word dot-probe task for training procedure

blank control

NO INTERVENTION

Participants only complete assessment at each point time.

Interventions

In the word dot-probe task for training procedure of attention bias modification, 90% of the targets appeared at the neutral word position and 10% at the sad word position.In the placebo condition, the targets appeared with equal probability in the sad (50%) and neutral (50%) word positions.All participants in ABM and placebo conditions received eight 12-min training sessions over a 2-week period.During each session, participants completed 216 word dot-probe trials.

Attentional bias modification trainingPlacebo training

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • A score of 14 or higher on the Beck Depression Inventory-II

You may not qualify if:

  • a current episode of MDD, 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, 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.

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Results Point of Contact

Title
Dr. Wenhui Yang
Organization
Hunan Normal University

Study Officials

  • Wenhui Yang, Ph.D

    Department of Psychology, Hunan Normal University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

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

June 9, 2012

First Posted

June 26, 2012

Study Start

September 1, 2011

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

August 14, 2020

Results First Posted

September 19, 2019

Record last verified: 2020-08

Locations