The Effect of Emotional Working Memory Training on Preventing Depression Occurrence

April 14, 2020 updated by: Wenhui Yang, Hunan Normal University

A Randomized, Double-blind, Placebo-Controlled Evaluation of the Efficacy of Emotional Working Memory Training in the Prevention Treatment of Depressive Symptoms

The purpose of this study is to test whether emotional working memory training and attention bias modification training are an effective neurobehavioral therapy to prevent the occurrence of depression .That is whether emotional working memory training and attention bias modification training are superior to placebo in preventing the occurrence of depression over 1 year after training.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Attentional bias has been theorized to play a critical role in the onset and maintenance of depression. Attentional bias modification training (ABMT), an experimental paradigm that uses training to induce adaptive attentional bias, was developed to test the causal model and this has therapeutic implications in depression.To test the effect of ABMT on treatment of depressive symptoms, a randomized, double-blind, placebo and blank controlled trial is conducted in college students who are experiencing mild-to-severe symptoms of depression.

Study Type

Interventional

Enrollment (Actual)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hunan
      • Changsha, Hunan, China, 400081
        • Department of Psychology, Hunan Normal University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 21 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • A current episode of MDD, bipolar disorder, schizophrenia or organic mental disorder;
  • Any concurrent psychotherapy;
  • Any concurrent psychotropic medication.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: maintaining positive working memory training
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: maintaining positive working memory training
Participants complete 10 sessions of maintaining positive working memory training during a two-week period. Each session consists of 15 blocks.
EXPERIMENTAL: repressing negative working memory training
Repressing negative working memory training is a dual n-back task containing visual and auditory stimulus.Both two types of stimulus are negative.In this training, subjects are required to identify whether the location of picture presented on the screen or the word appeared in the headphone is the same as the picture or the word presented n before, then react with typing correspondingly.Each training session contains 16 blocks which are consisted with 20+n trails.
Behavioral: repressing negative working memory training
Participants complete 10 sessions of repressing negative working memory training during a two-week period. Each session consists of 15 blocks.
EXPERIMENTAL: Positive ABMT
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
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.
PLACEBO_COMPARATOR: Positive placebo ABMT
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. 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.
Behavioral: Positive placebo ABMT
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes of depressive symptoms
Time Frame: 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)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes of self-reported depressive symptoms
Time Frame: 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)
Self-reported depressive symptoms assessed by Beck depression scale-second version (BDI-II)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hunan Normal University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 18, 2019

Primary Completion (ANTICIPATED)

January 10, 2021

Study Completion (ANTICIPATED)

January 10, 2021

Study Registration Dates

First Submitted

April 12, 2020

First Submitted That Met QC Criteria

April 14, 2020

First Posted (ACTUAL)

April 15, 2020

Study Record Updates

Last Update Posted (ACTUAL)

April 15, 2020

Last Update Submitted That Met QC Criteria

April 14, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EMOTION2 2019

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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