Clinical trial NCT06143800: Reconsolidation-Based Intervention for Traumatic Memories
Official title: The Effect and Underlying Mechanism of Reconsolidation-Based Cognitive Reappraisal for Traumatic Memories in Patients With Major Depression Disorder
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Depression
Keywords: Psychological Trauma; Memory
Lead sponsor: Shenzhen Kangning Hospital
Sponsor class: OTHER
Collaborators: name: Science and Technology Innovation Commission of Shenzhen Municipality
First posted: 2023-11-22
Enrollment: 390
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: 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:

* Is cognitive reappraisal based on memory reconsolidation effective for laboratory-created traumatic memories? Which of the two classical cognitive reassessment schemes is more effective?
* What is the neural mechanism by which the novel cognitive reappraisal based on memory reconsolidation alters traumatic memories?
* Can repeated use of the novel cognitive reappraisal based on memory reconsolidation alter the actual childhood traumatic memories of patients with major depression disorder? Can it reduce depressive symptoms? Are the effects long-lasting? Participants will be grouped to receive the intervention (retrieval + cognitive reappraisal, non-retrieval + cognitive reappraisal). The researchers will compare the differences in long-term memory tests and the improvement in depressive symptoms between the two groups to see the effects of the memory-based reconsolidation intervention.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of major depression disorder
* Must have normal vision or corrected vision

Exclusion Criteria:

* Have physical diseases or other mental disorders
* Be pregnant, breastfeeding or do not have menstruation
* Drink alcohol or smoke within 24 hours before the experiment
* Participated in similar experiments before.
* History of severe cardiovascular and cerebrovascular diseases, stroke and other neurological diseases, and history of digestive system diseases.
* Severe hearing and vision impairment.
* Have metal implants in the body, such as non-removable dentures, scaffolds, steel plates, joint metal replacements, etc.
* Have Claustrophobia
* Have acute or chronic disease or infection

Primary outcomes:
measure: Change in Participants' Skin Conductance Response (SCR)
timeFrame: baseline, 8 weeks, and one year after treatment
measure: Change in the amygdala measured with fMRI
timeFrame: baseline, 8 weeks, and one year after treatment
measure: Change in the hippocampus measured with fMRI
timeFrame: baseline, 8 weeks, and one year after treatment
measure: Change in the prefrontal cortex measured with fMRI
timeFrame: baseline, 8 weeks, and one year after treatment
Secondary outcomes:
measure: The changes in the Baker Depression Scale (BDI).
timeFrame: baseline, 8 weeks, and one year after treatment
measure: The changes in the State-Trait Anxiety Scale (STAI)
timeFrame: baseline, 8 weeks, and one year after treatment
measure: The changes in the GROSS Self-Rating Emotional Regulation Style Questionnaire
timeFrame: baseline, 8 weeks, and one year after treatment
Other outcomes:
Locations:
Study officials:
affiliation: Shenzhen Kangning Hospital
name: Jingchu Hu, Dr.
role: PRINCIPAL_INVESTIGATOR
References: