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| Name | Class |
|---|---|
| Science and Technology Innovation Commission of Shenzhen Municipality | OTHER |
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The goal of this clinical trial is to test the effect and underlying mechanism of reconsolidation-based cognitive reappraisal for traumatic memories in patients with major depression disorder. The main questions it aims to answer are:
There are three sub-trials in this study. Participants in the first trial will learn the fear of emotional faces based on the Pavlovian conditioned fear learning paradigm. Using an inter-subject experimental design, the intervention will be divided into four groups (retrieval /non-retrieval, self-concerned cognitive reappraisal/context-concerned cognitive reappraisal). The researchers will compare the differences between the four groups on long-term memory tests to see if the cognitive reappraisal based on memory reconsolidation has effect on traumatic memory in the laboratory of depressed patients.
Participants in the second trial are given the same treatment as in the first, but with brain imaging equipment to gain brain imaging data. The researchers will compare the brain functional characteristics of the four groups in the long-term memory test, in order to explore the neural mechanism of the effect of cognitive reappraisal on traumatic memory intervention based on memory reconsolidation mechanism.
Participants in the third trial are divided into two groups (retrieval + cognitive reappraisal, and non-retrieval + cognitive reappraisal) for an eight-week intervention. Finally, the researchers will compare the improvement in depressive symptoms between the two groups and retest physiological arousal and subjective assessments of traumatic memories one year later to see the long-term effects of the memory-based reconsolidation intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| retrieval + self-focused cognitive reappraisal | Experimental | Participants in this arm will first accept a memory reactivation to open the reconsolidation window, then accept the self-focused cognitive reappraisal intervention. |
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| retrieval + context-focused cognitive reappraisal | Experimental | Participants in this arm will first accept a memory reactivation to open the reconsolidation window, then accept the context-focused cognitive reappraisal. |
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| non-retrieval + self-focused cognitive reappraisal | Active Comparator | Participants in this arm will directly accept the self-focused cognitive reappraisal intervention without memory reactivation. |
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| non-retrieval + context-focused cognitive reappraisal | Active Comparator | Participants in this arm will directly accept the context-focused cognitive reappraisal intervention without memory reactivation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| reactivation | Behavioral | During the retrieval phase, cues are presented to participants to reactivate their memories; participants in the non-retrieval group go directly to cognitive reappraisal phase. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Participants' Skin Conductance Response (SCR) | The level of SCR was assessed for each trial as the base-to-peak amplitudedifference in skin conductance of the largest deflection (in microsiemens; pS) in the 0.5-4.5-slatency window after stimulus onset. | baseline, 8 weeks, and one year after treatment |
| Change in the amygdala measured with fMRI | Changes in the difference in BOLD (Blood Oxygenation Level Dependent) signal in the amygdala between treated cue and untreated cue measured with fMRI. | baseline, 8 weeks, and one year after treatment |
| Change in the hippocampus measured with fMRI | Changes in the difference in BOLD (Blood Oxygenation Level Dependent) signal in the hippocampus between treated cue and untreated cue measured with fMRI. | baseline, 8 weeks, and one year after treatment |
| Change in the prefrontal cortex measured with fMRI | Changes in the difference in BOLD (Blood Oxygenation Level Dependent) signal in the prefrontal cortex between treated cue and untreated cue measured with fMRI | baseline, 8 weeks, and one year after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| The changes in the Baker Depression Scale (BDI). | To assess depressive symptom changes after the treatment using the Baker Depression Scale (BDI). The BDI consists of 21 items coded on a 4-point scale (0-3). The total scores ranged from 0 to 63. The higher the total scores, the higher the depressive symptom severity. | baseline, 8 weeks, and one year after treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jingchu Hu, Dr. | Contact | (+86)15603072635 | hujingchu@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Jingchu Hu, Dr. | Shenzhen Kangning Hospital | Principal Investigator |
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We wiil share our data on the Open Science Framework after data collection
These information will be shared after the related paper is published and will be available for at least one year
The information will be shared on the Open Science Framework for the public
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| ID | Term |
|---|---|
| D003863 | Depression |
| D000067073 | Psychological Trauma |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
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| cognitive reappraisal intervention | Behavioral | Subsequently, in the self-focused cognitive reappraisal group, participants will be instructed to use "disengagement" reappraisal to separate themselves from the picture situation and draw a subjective distance so as not to strongly feel the negative emotions brought by the picture. In the context-focused reappraisal group, participants will focus on the picture situation, reappraise the meaning of the picture situation, and assign positive meanings to it. |
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| The changes in the State-Trait Anxiety Scale (STAI) | To assess anxious symptom changes after the treatment using the State-Trait Anxiety Scale (STAI). The STAI consists of 40 items. All items are rated on a 4-point scale (e.g., from "Almost Never" to "Almost Always"). Higher scores indicate greater anxiety. | baseline, 8 weeks, and one year after treatment |
| The changes in the GROSS Self-Rating Emotional Regulation Style Questionnaire | To assess emotional regulation style changes after the treatment using the GROSS Self-Rating Emotional Regulation Style Questionnaire. It is a 10-item scale designed to measure respondents' tendency to regulate their emotions in two ways: (1) Cognitive Reappraisal and (2) Expressive Suppression. Respondents answer each item on a 7-point Likert-type scale (1 to 7). Items 1, 3, 5, 7, 8, 10 make up the Cognitive Reappraisal facet. Items 2, 4, 6, 9 make up the Expressive Suppression facet. Scoring is kept continuous. Each facet's scoring is kept separate. | baseline, 8 weeks, and one year after treatment |
| D001523 | Mental Disorders |