DepressionNCT06143800
Reconsolidation-Based Intervention for Traumatic Memories
A study testing reactivation and cognitive reappraisal intervention in people with Depression, run by Shenzhen Kangning Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression
- What is being tested?
- reactivation and cognitive reappraisal intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 390 participants
- Where
- No sites listed yet
- Study dates
- Dec 2023to Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Clinical diagnosis of major depression disorder
- Must have normal vision or corrected vision
Who cannot join
- 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.
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- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effect and Underlying Mechanism of Reconsolidation-Based Cognitive Reappraisal for Traumatic Memories in Patients With Major Depression Disorder
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.
Read the 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.
- Conditions
- Depression
- Being tested
- reactivation, cognitive reappraisal intervention
- Keywords
- Psychological Trauma; Memory
- Medical subject headings
- Depression, Psychological Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
reactivationBehavioural
Also called memory retrieval
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 interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Behavioral: cognitive reappraisal intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: baseline, 8 weeks, and one year after treatment
Secondary outcomes (3)
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.
Measured: baseline, 8 weeks, and one year after treatment
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.
Measured: 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.
Measured: baseline, 8 weeks, and one year after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2023
- Study startDec 2023 (estimated)
- Primary completionSep 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 390 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen Kangning Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Science and Technology Innovation Commission of Shenzhen Municipality
- Responsible party
- Principal investigator, Jingchu Hu, Shenzhen Kangning Hospital
- Investigators
- Jingchu Hu, Dr., Principal investigator, Shenzhen Kangning Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06143800
- Sponsor's protocol ID
- JCYJ20220530165003007
- Status last verified
- Nov 2023
- First submitted
- 31 Oct 2023
- Last updated
- 22 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We wiil share our data on the Open Science Framework after data collection
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect and Underlying Mechanism of Reconsolidation-Based Cognitive Reappraisal for Traumatic Memories in Patients With Major Depression Disorder
- ClinicalTrials.gov ID
- NCT06143800
- Acronym / sponsor ID
- JCYJ20220530165003007
- Conditions
- Depression
- Keywords
- Psychological Trauma; Memory
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 390 participants (estimated)
- Lead sponsor
- Shenzhen Kangning HospitalUniversity, hospital or other
- Collaborators
- Science and Technology Innovation Commission of Shenzhen Municipality
- Study start
- Dec 2023 (estimated)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 22 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| retrieval + self-focused cognitive reappraisal | Experimental | Behavioral: reactivation, Behavioral: cognitive reappraisal interventionParticipants in this arm will first accept a memory reactivation to open the reconsolidation window, then accept the self-focused cognitive reappraisal intervention. |
| retrieval + context-focused cognitive reappraisal | Experimental | Behavioral: reactivation, Behavioral: cognitive reappraisal interventionParticipants in this arm will first accept a memory reactivation to open the reconsolidation window, then accept the context-focused cognitive reappraisal. |
| non-retrieval + self-focused cognitive reappraisal | Active comparator | Behavioral: cognitive reappraisal interventionParticipants in this arm will directly accept the self-focused cognitive reappraisal intervention without memory reactivation. |
| non-retrieval + context-focused cognitive reappraisal | Active comparator | Behavioral: cognitive reappraisal interventionParticipants in this arm will directly accept the context-focused cognitive reappraisal intervention without memory reactivation. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of major depression disorder
- Must have normal vision or corrected vision
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| reactivationAlso: memory retrievalDuring the retrieval phase, cues are presented to participants to reactivate their memories; participants in the non-retrieval group go directly to cognitive reappraisal phase. | Behavioural | retrieval + context-focused cognitive reappraisal, retrieval + self-focused cognitive reappraisal |
| cognitive reappraisal interventionSubsequently, 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. | Behavioural | non-retrieval + context-focused cognitive reappraisal, non-retrieval + self-focused cognitive reappraisal, retrieval + context-focused cognitive reappraisal, retrieval + self-focused cognitive reappraisal |
Primary outcome
Change in Participants' Skin Conductance Response (SCR)
Time frame: baseline, 8 weeks, and one year after treatment
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.
Change in the amygdala measured with fMRI
Time frame: baseline, 8 weeks, and one year after treatment
Changes in the difference in BOLD (Blood Oxygenation Level Dependent) signal in the amygdala between treated cue and untreated cue measured with fMRI.
Change in the hippocampus measured with fMRI
Time frame: baseline, 8 weeks, and one year after treatment
Changes in the difference in BOLD (Blood Oxygenation Level Dependent) signal in the hippocampus between treated cue and untreated cue measured with fMRI.
Change in the prefrontal cortex measured with fMRI
Time frame: baseline, 8 weeks, and one year after treatment
Changes in the difference in BOLD (Blood Oxygenation Level Dependent) signal in the prefrontal cortex between treated cue and untreated cue measured with fMRI
3 secondary outcomes
The changes in the Baker Depression Scale (BDI).
Time frame: baseline, 8 weeks, and one year after treatment
The changes in the State-Trait Anxiety Scale (STAI)
Time frame: baseline, 8 weeks, and one year after treatment
The changes in the GROSS Self-Rating Emotional Regulation Style Questionnaire
Time frame: baseline, 8 weeks, and one year after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
- Individual participant dataSharing planned: Yes. We wiil share our data on the Open Science Framework after data collection
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jingchu Hu, Dr. principal investigator
Shenzhen Kangning Hospital
Questions about this trial
What is this clinical trial studying?
A study testing reactivation and cognitive reappraisal intervention in people with Depression, run by Shenzhen Kangning Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jingchu Hu, Dr. ((+86)15603072635, hujingchu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Participants' Skin Conductance Response (SCR) (time frame: baseline, 8 weeks, and one year after treatment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2023.