An interventional study of reactivation and cognitive reappraisal intervention in Depression, sponsored by Shenzhen Kangning Hospital. Not yet recruiting. Open to participants aged 18 Years to 25 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-22.
Sponsored by Shenzhen Kangning Hospital · Not applicable, Interventional, and Treatment
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.
8,577 studies on the registry are indexed under Depression; 1,720 are open to participants now.
This study's planned enrollment of 390 is above the median of 81 across 7,063 interventional studies indexed under Depression.
Browse Depression studies →Shenzhen Kangning Hospital is the lead sponsor of 8 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
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
Participants in this arm will directly accept the self-focused cognitive reappraisal intervention without memory reactivation.
Behavioral: cognitive reappraisal intervention
Participants in this arm will directly accept the context-focused cognitive reappraisal intervention without memory reactivation.
Behavioral: cognitive reappraisal intervention
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
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: baseline, 8 weeks, and one year after treatment
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.
Time frame: 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.
Time frame: 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.
Time frame: baseline, 8 weeks, and one year after treatment
No study locations are listed for this record.
Plan to share: Yes — We wiil share our data on the Open Science Framework after data collection
Supporting information: Study protocol, Statistical analysis plan
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
No publications or documents are linked to this record.
Start is estimated for Dec 2023; primary completion for Sep 2025, 21 months later.
Of 3,468 non-industry interventional studies with no phase under Depression, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's planned 21 months is close to that.
Counting every sponsor, half of 3,566 studies reached it within 21 months; a quarter within 9 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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Shenzhen Kangning Hospital