NCT03971942

Brief Summary

This study intends to explore the therapeutic effects of the development of negative attention bias modifaction and positive attention bias on depressive symptoms and redundancy through two different attention training methods: (1) neutral attention training (when neutral and sad stimuli are presented simultaneously, attention is always directed towards neutral stimuli to correct negative attention bias) and (2) positive attention training (when neutral and positive stimuli are presented simultaneously, attention is always directed towards positive stimuli to develop positive attention bias).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2017

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

December 24, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 22, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 26, 2019

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 3, 2019

Completed
Last Updated

June 3, 2019

Status Verified

May 1, 2019

Enrollment Period

1.1 years

First QC Date

March 26, 2019

Last Update Submit

May 31, 2019

Conditions

Keywords

attention bias modificationpositive attention biasdepressive symptomsprevention

Outcome Measures

Primary Outcomes (2)

  • Changes of attentional bias score

    Attentional bias score tested by a typical dot-probe task

    pre-training, post-training(2 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)

  • Changes of depressive symptoms

    Depression symptoms tested by clinicians using the Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children (K-SADS)

    pre-training, post-training(2 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 Outcomes (2)

  • Changes of self-reported depressive symptoms

    pre-training, post-training(2 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)

  • Changes of self-reported rumination

    pre-training, post-training(2 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)

Study Arms (2)

Neutral ABMT

EXPERIMENTAL

8-session-ABMT during a two-week period and 4-session-booster-ABMT during a two-week period

Behavioral: Neutral ABMT

Positive ABMT

EXPERIMENTAL

8-session-ABMT during a two-week period and 4-session-booster-ABMT during a two-week period

Behavioral: Positive ABMT

Interventions

Neutral ABMTBEHAVIORAL

In the neutral attention bias, there are 108 pairs of neutral-negative words, 54 pairs of which are used in the training group and 54 pairs of which are used in the placebo group. The word pairs in each group are repeated 4 times, with a total of 216 trial. Participants received 8 sessions over 2 weeks (1 session every other day).In booster ABMT, participants received 4 sessions over 2 weeks (1 session every three days).90% of the targets in the training group appear in the neutral word position and 10% of the targets appear in the negative word position, while 50% of the targets in the placebo group appear in the neutral word position and 50% of the targets appear in the negative word position.

Neutral ABMT
Positive ABMTBEHAVIORAL

In the positive attention bias, there are 54 pairs of neutral-negative words, 27 pairs of which are used in the training group and 27 pairs of which are used in the placebo group. The word pairs in each group are repeated 8 times, with a total of 216 trial.Participants received 8 sessions over 2 weeks (1 session every other day). In booster ABMT, participants received 4 sessions over 2 weeks (1 session every three days).90% of the targets in the training group appear in the positive word position and 10% of the targets appear in the neutral word position, while 90% of the targets in the placebo group appear in the neutral word position and 10% of the targets appear in the positive word position.

Positive ABMT

Eligibility Criteria

Age16 Years - 20 Years
Sexall(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

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, 410081, China

Location

MeSH Terms

Conditions

Depressive DisorderDepression

Condition Hierarchy (Ancestors)

Mood DisordersMental DisordersBehavioral SymptomsBehavior

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

March 26, 2019

First Posted

June 3, 2019

Study Start

December 24, 2017

Primary Completion

January 22, 2019

Study Completion

March 30, 2019

Last Updated

June 3, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations