Reconsolidation-Based Intervention for Traumatic Memories

NCT06143800 | Unknown

• 1 other identifier: JCYJ20220530165003007
• Study Type: interventional
• Target: 390
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Depression

Keywords

Psychological Trauma; Memory

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (3)

• The changes in the Baker Depression Scale (BDI).

  baseline, 8 weeks, and one year after treatment

• The changes in the State-Trait Anxiety Scale (STAI)

  baseline, 8 weeks, and one year after treatment

• The changes in the GROSS Self-Rating Emotional Regulation Style Questionnaire

  baseline, 8 weeks, and one year after treatment

Study Arms (4)

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.

Behavioral: reactivation; Behavioral: cognitive reappraisal intervention

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.

Behavioral: reactivation; Behavioral: cognitive reappraisal intervention

non-retrieval + self-focused cognitive reappraisal

ACTIVE COMPARATOR

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

Behavioral: cognitive reappraisal intervention

non-retrieval + context-focused cognitive reappraisal

ACTIVE COMPARATOR

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

Behavioral: cognitive reappraisal intervention

Interventions

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.

Also known as: memory retrieval

retrieval + context-focused cognitive reappraisal; retrieval + self-focused cognitive reappraisal

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.

non-retrieval + context-focused cognitive reappraisal; non-retrieval + self-focused cognitive reappraisal; retrieval + context-focused cognitive reappraisal; retrieval + self-focused cognitive reappraisal

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shenzhen Kangning Hospital: lead
• Science and Technology Innovation Commission of Shenzhen Municipality: collaborator

MeSH Terms

Conditions

Depression; Psychological Trauma

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Jingchu Hu, Dr.

  Shenzhen Kangning Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jingchu Hu, Dr.

CONTACT

(+86)15603072635; hujingchu@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 31, 2023
• First Posted: November 22, 2023
• Study Start: December 1, 2023
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: November 22, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: These information will be shared after the related paper is published and will be available for at least one year
• Access Criteria: The information will be shared on the Open Science Framework for the public