NCT04346771

Brief Summary

The purpose of this study is to test whether emotional working memory training and attention bias modification training are an effective neurobehavioral therapy to improve depressive symptoms.That is whether emotional working memory training is superior to attention bias modification training or not in reducing depressive symptoms over 1 year after training.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2019

Geographic Reach
1 country

1 active site

Status
unknown

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

December 18, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 12, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 15, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2021

Completed
Last Updated

April 15, 2020

Status Verified

April 1, 2020

Enrollment Period

1.1 years

First QC Date

April 12, 2020

Last Update Submit

April 12, 2020

Conditions

Depressive Symptoms

Keywords

DepressionCognitive controlEmotionWorking memoryCognitive biasEmotional regulation

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • 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)

Study Arms (2)

Maintaining Positive Working memory

EXPERIMENTAL

Maintaining positive working memory training is based on visual positive works n-back task.In this training, positive words are presented on the pictures of happy face.According to the rules, subjects are required to identify whether the word present currently is as the same type as the word presented n before then click the keys correspondingly.Each training session contains 15 blocks which are consisted with 20+n trails.

Behavioral: Working memory training

Positive Attention Bias Modification

PLACEBO COMPARATOR

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 10 sessions over 2 weeks. 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.

Behavioral: Positive ABMT

Interventions

Working memory trainingBEHAVIORAL

Participants complete 10 sessions of maintaining positive working memory training during a two-week period. Each session consists of 15 blocks.

Maintaining Positive Working memory
Positive ABMTBEHAVIORAL

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.

Positive Attention Bias Modification

Eligibility Criteria

Age16 Years - 21 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Meet the major and mild 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

MeSH Terms

Conditions

DepressionEmotional Regulation

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorSelf-ControlSocial Behavior

Study Officials

  • Wenhui Yang

    Department of Psychology, Hunan Normal University

    PRINCIPAL INVESTIGATOR

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

April 12, 2020

First Posted

April 15, 2020

Study Start

December 18, 2019

Primary Completion

January 10, 2021

Study Completion

January 10, 2021

Last Updated

April 15, 2020

Record last verified: 2020-04

Locations

CN(1)