- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07607834
Real-Time and Retrospective Emotion Awareness With Cognitive Reappraisal Training
Real-Time and Retrospective Emotion Awareness With Cognitive Reappraisal: Effects on Anxious-Depressive Symptoms and Well-Being
Study Overview
Status
Detailed Description
The study used a pilot randomized active-comparison design. Participants were adults aged 18 to 45 years with co-occurring anxiety and depressive symptoms. Eligible participants were randomly assigned to one of two intervention conditions: a real-time awareness condition or a retrospective awareness condition. The intervention lasted six weeks and included three assessment points: baseline/pretest, mid-intervention assessment, and post-intervention assessment.
The intervention consisted of two sequential phases. The first phase lasted approximately two weeks and focused on heart-rate baseline collection and emotional awareness training. Participants in the real-time awareness condition wore a smartwatch for three consecutive days to establish an individualized heart-rate baseline, followed by eleven days of real-time emotion identification training triggered by physiological prompts. When heart rate exceeded the individualized threshold, participants received a vibration prompt and selected the emotion category that best represented their current state. Participants in the retrospective awareness condition received no active intervention during this initial phase.
The second phase consisted of four weeks of cognitive reappraisal training for both groups. The reappraisal training was based on psychological distancing, particularly self-distancing and third-person perspective taking. During this phase, participants in the real-time awareness condition continued to receive physiological prompts and completed cognitive reappraisal exercises immediately after these prompts. Participants in the retrospective awareness condition completed daily evening reappraisal exercises based on emotionally salient events recalled from that day. Both groups attended weekly meetings with the researcher to review strategy use and discuss difficulties encountered during implementation.
Self-report outcomes were assessed at baseline, mid-intervention, and post-intervention. The study examined changes in anxiety symptoms, depressive symptoms, emotional clarity, mood repair, cognitive reappraisal, expressive suppression, and psychological well-being. The primary purpose was to characterize feasibility, preliminary effects, and temporal patterns of change associated with the two intervention formats rather than to establish definitive treatment efficacy.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Taichung, Taiwan, 41354
- 亞洲大學
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adults aged 18 to 45 years.
- Self-reported co-occurring anxiety and depressive symptoms.
- Score of 8 or above on the Chinese version of the Beck Anxiety Inventory.
- Score between 14 and 28 on the Chinese version of the Beck Depression Inventory-II.
- Ability to provide written informed consent and complete the study procedures.
Exclusion Criteria:
- Illegal substance use.
- Excessive alcohol or caffeine consumption, defined as more than four caffeinated beverages or four cans of beer per day.
- Major psychiatric disorders or cognitive impairment, such as schizophrenia or neurocognitive disorders.
- Current psychiatric medication use.
- Ongoing psychological or psychiatric treatment.
- Pregnancy or current responsibility for caring for an infant.
- Severe depressive symptoms, defined as a Beck Depression Inventory-II score of 29 or above.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Real-Time Awareness With Cognitive Reappraisal
Participants in this arm wore a smartwatch to establish an individualized heart-rate baseline and subsequently received vibration prompts when heart rate exceeded the individualized threshold.
During the emotional awareness phase, participants identified their current emotional state following physiological prompts.
During the cognitive reappraisal phase, participants completed a third-person perspective-taking reappraisal exercise immediately after physiological prompts.
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This behavioral intervention combined wearable-based physiological prompting, real-time emotion identification, and third-person cognitive reappraisal.
Participants wore a smartwatch that monitored heart rate continuously.
When heart rate exceeded 20% above the individualized baseline, the device delivered a vibration prompt.
Participants identified their current emotion from six basic emotion categories.
During the reappraisal phase, they recorded the triggering event, emotion category, emotional intensity, and thoughts, and then completed a third-person perspective-taking reappraisal exercise.
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|
Active Comparator: Retrospective Awareness With Cognitive Reappraisal
Participants in this arm received no active intervention during the initial awareness phase.
During the cognitive reappraisal phase, participants completed a daily evening reappraisal exercise based on an emotionally salient event from that day.
They recorded the emotion category, emotional intensity, and thoughts experienced at the time of the event, then completed the same third-person perspective-taking reappraisal exercise as the real-time awareness group.
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This behavioral intervention combined daily end-of-day emotional reflection with third-person cognitive reappraisal.
Participants recalled an emotionally salient event from that day, recorded the emotion category, emotional intensity, and thoughts experienced at the time of the event, and then reinterpreted the event from the perspective of a personally significant or neutral third-person figure.
They subsequently reported their post-reappraisal emotion category, emotional intensity, and new thoughts.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in Anxiety Symptoms
Time Frame: Baseline, mid-intervention approximately 2 weeks after baseline, and post-intervention approximately 6 weeks after baseline.
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Anxiety symptoms were assessed using the Chinese version of the Beck Anxiety Inventory (BAI).
The BAI consists of 21 items rated on a 4-point scale from 0 to 3, with total scores ranging from 0 to 63.
Higher scores indicate greater anxiety symptom severity.
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Baseline, mid-intervention approximately 2 weeks after baseline, and post-intervention approximately 6 weeks after baseline.
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Change in Depressive Symptoms
Time Frame: Baseline, mid-intervention approximately 2 weeks after baseline, and post-intervention approximately 6 weeks after baseline.
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Depressive symptoms were assessed using the Chinese version of the Beck Depression Inventory-II (BDI-II).
The BDI-II consists of 21 items rated on a 4-point scale from 0 to 3, with total scores ranging from 0 to 63.
Higher scores indicate greater depressive symptom severity.
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Baseline, mid-intervention approximately 2 weeks after baseline, and post-intervention approximately 6 weeks after baseline.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in Emotional Clarity
Time Frame: Baseline, mid-intervention approximately 2 weeks after baseline, and post-intervention approximately 6 weeks after baseline.
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Emotional clarity was assessed using the emotional clarity subscale of the Chinese version of the Trait Meta-Mood Scale (TMMS).
Higher scores indicate greater perceived ability to identify and understand one's emotions.
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Baseline, mid-intervention approximately 2 weeks after baseline, and post-intervention approximately 6 weeks after baseline.
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Change in Mood Repair
Time Frame: Baseline, mid-intervention approximately 2 weeks after baseline, and post-intervention approximately 6 weeks after baseline.
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Mood repair was assessed using the mood repair subscale of the Chinese version of the Trait Meta-Mood Scale (TMMS).
Higher scores indicate stronger perceived ability to regulate, alleviate, or repair negative emotional states.
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Baseline, mid-intervention approximately 2 weeks after baseline, and post-intervention approximately 6 weeks after baseline.
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Change in Cognitive Reappraisal
Time Frame: Baseline, mid-intervention approximately 2 weeks after baseline, and post-intervention approximately 6 weeks after baseline.
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Cognitive reappraisal was assessed using the cognitive reappraisal subscale of the Chinese version of the Emotion Regulation Questionnaire (ERQ).
Higher scores indicate greater habitual use of cognitive reappraisal.
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Baseline, mid-intervention approximately 2 weeks after baseline, and post-intervention approximately 6 weeks after baseline.
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Change in Expressive Suppression
Time Frame: Baseline, mid-intervention approximately 2 weeks after baseline, and post-intervention approximately 6 weeks after baseline.
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Expressive suppression was assessed using the expressive suppression subscale of the Chinese version of the Emotion Regulation Questionnaire (ERQ).
Higher scores indicate greater habitual use of expressive suppression.
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Baseline, mid-intervention approximately 2 weeks after baseline, and post-intervention approximately 6 weeks after baseline.
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Change in Psychological Well-Being
Time Frame: Baseline, mid-intervention approximately 2 weeks after baseline, and post-intervention approximately 6 weeks after baseline.
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Psychological well-being was assessed using the psychological well-being subscale of the Taiwan Subjective Well-Being Scale Short-Form (TSWBS-SF).
The subscale consists of 4 items rated on a 4-point Likert scale, with total scores ranging from 4 to 16.
Higher scores indicate greater psychological well-being.
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Baseline, mid-intervention approximately 2 weeks after baseline, and post-intervention approximately 6 weeks after baseline.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Han-Yun Chang, Ph.D., Asia University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CRREC-112-036
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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