search
Back to results

The Effect of Emotional Working Memory Training on Preventing Depression Occurrence

Primary Purpose

Depressive Symptoms

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
maintaining positive working memory training
repressing negative working memory training
Positive ABMT
Positive placebo ABMT
Sponsored by
Hunan Normal University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depressive Symptoms focused on measuring Depression, Cognitive control, Emotion, Working memory, Cognitive bias, Emotional regulation

Eligibility Criteria

16 Years - 21 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Department of Psychology, Hunan Normal University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

maintaining positive working memory training

repressing negative working memory training

Positive ABMT

Positive placebo ABMT

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Changes of self-reported depressive symptoms
Self-reported depressive symptoms assessed by Beck depression scale-second version (BDI-II)

Full Information

First Posted
April 12, 2020
Last Updated
April 14, 2020
Sponsor
Hunan Normal University
search

1. Study Identification

Unique Protocol Identification Number
NCT04346784
Brief Title
The Effect of Emotional Working Memory Training on Preventing Depression Occurrence
Official Title
A Randomized, Double-blind, Placebo-Controlled Evaluation of the Efficacy of Emotional Working Memory Training in the Prevention Treatment of Depressive Symptoms
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 18, 2019 (Actual)
Primary Completion Date
January 10, 2021 (Anticipated)
Study Completion Date
January 10, 2021 (Anticipated)

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
No

5. Study Description

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 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Symptoms
Keywords
Depression, Cognitive control, Emotion, Working memory, Cognitive bias, Emotional regulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
110 (Actual)

8. Arms, Groups, and Interventions

Arm Title
maintaining positive working memory training
Arm Type
Experimental
Arm Description
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.
Arm Title
repressing negative working memory training
Arm Type
Experimental
Arm Description
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.
Arm Title
Positive ABMT
Arm Type
Experimental
Arm Description
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.
Arm Title
Positive placebo ABMT
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
maintaining positive working memory training
Intervention Description
Participants complete 10 sessions of maintaining positive working memory training during a two-week period. Each session consists of 15 blocks.
Intervention Type
Behavioral
Intervention Name(s)
repressing negative working memory training
Intervention Description
Participants complete 10 sessions of repressing negative working memory training during a two-week period. Each session consists of 15 blocks.
Intervention Type
Behavioral
Intervention Name(s)
Positive ABMT
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Positive placebo ABMT
Intervention Description
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
Primary Outcome Measure Information:
Title
Changes of depressive symptoms
Description
Depression symptoms tested by clinicians using the Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children (K-SADS)
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)
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)
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wenhui Yang, Ph.D
Organizational Affiliation
Department of Psychology, 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
400081
Country
China

12. IPD Sharing Statement

Learn more about this trial

The Effect of Emotional Working Memory Training on Preventing Depression Occurrence

We'll reach out to this number within 24 hrs