- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03971942
Neutral and Positive Attention Bias Modification Training for Young Adults With Depressive Symptoms
May 31, 2019 updated by: Wenhui Yang, Hunan Normal University
Department of Psychology, Hunan Normal University
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Attention Bias Modification Training was a modified dot-probe task.
In the neutral attention bias, 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.
In the positive attention bias, 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.
The investigators assess attention bias scores, depressive symptoms, trait anxiety, rumination and self-report attention control ability at 1-week, 2-week, 4-week, 7-week, 3-month, 4-month, 5-month, 6-month and 12-month follow-ups after training.
Study Type
Interventional
Enrollment (Actual)
68
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
-
-
Hunan
-
Changsha, Hunan, China, 410081
- 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 20 years (Child, Adult)
Accepts Healthy Volunteers
No
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 Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Neutral ABMT
8-session-ABMT during a two-week period and 4-session-booster-ABMT during a two-week period
|
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.
|
Experimental: Positive ABMT
8-session-ABMT during a two-week period and 4-session-booster-ABMT during a two-week period
|
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.
|
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)
|
Changes of attentional bias score
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)
|
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)
|
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)
|
Changes of self-reported rumination
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 rumination assessed by Rumination Response Scale(RRS).
|
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
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 24, 2017
Primary Completion (Actual)
January 22, 2019
Study Completion (Actual)
March 30, 2019
Study Registration Dates
First Submitted
March 26, 2019
First Submitted That Met QC Criteria
May 31, 2019
First Posted (Actual)
June 3, 2019
Study Record Updates
Last Update Posted (Actual)
June 3, 2019
Last Update Submitted That Met QC Criteria
May 31, 2019
Last Verified
May 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ABM2017
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
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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