Reconsolidation-Based Intervention for Traumatic Memories

NCT ID: NCT06143800

Last Updated: 2023-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

390 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-31

Study Completion Date

2025-09-30

Brief Summary

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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:

* 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

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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.

Conditions

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Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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retrieval + self-focused cognitive reappraisal

Participants in this arm will first accept a memory reactivation to open the reconsolidation window, then accept the self-focused cognitive reappraisal intervention.

Group Type EXPERIMENTAL

reactivation

Intervention Type 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.

cognitive reappraisal intervention

Intervention Type 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.

retrieval + context-focused cognitive reappraisal

Participants in this arm will first accept a memory reactivation to open the reconsolidation window, then accept the context-focused cognitive reappraisal.

Group Type EXPERIMENTAL

reactivation

Intervention Type 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.

cognitive reappraisal intervention

Intervention Type 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.

non-retrieval + self-focused cognitive reappraisal

Participants in this arm will directly accept the self-focused cognitive reappraisal intervention without memory reactivation.

Group Type ACTIVE_COMPARATOR

cognitive reappraisal intervention

Intervention Type 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.

non-retrieval + context-focused cognitive reappraisal

Participants in this arm will directly accept the context-focused cognitive reappraisal intervention without memory reactivation.

Group Type ACTIVE_COMPARATOR

cognitive reappraisal intervention

Intervention Type 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.

Interventions

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reactivation

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.

Intervention Type BEHAVIORAL

cognitive reappraisal intervention

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.

Intervention Type BEHAVIORAL

Other Intervention Names

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memory retrieval

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Science and Technology Innovation Commission of Shenzhen Municipality

OTHER

Sponsor Role collaborator

Shenzhen Kangning Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jingchu Hu

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jingchu Hu, Dr.

Role: PRINCIPAL_INVESTIGATOR

Shenzhen Kangning Hospital

Central Contacts

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Jingchu Hu, Dr.

Role: CONTACT

(+86)15603072635

Other Identifiers

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JCYJ20220530165003007

Identifier Type: -

Identifier Source: org_study_id