NCT07607834

Brief Summary

This pilot randomized active-comparison study examined two formats of emotional awareness and cognitive reappraisal training for adults with co-occurring anxiety and depressive symptoms. Participants were assigned to either a real-time awareness group or a retrospective awareness group. The real-time awareness group used a smartwatch-based heart-rate prompting system to identify emotions in daily life and later complete cognitive reappraisal exercises. The retrospective awareness group completed daily evening reflection and cognitive reappraisal exercises based on emotional events from that day. The study lasted six weeks and included assessments at baseline, mid-intervention, and post-intervention. Outcomes included anxiety symptoms, depressive symptoms, emotional clarity, mood repair, cognitive reappraisal, expressive suppression, and psychological well-being. The purpose of the study was to examine preliminary patterns of change and compare how the two formats may support emotion regulation processes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 25, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2024

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

May 21, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 26, 2026

Completed
Last Updated

May 26, 2026

Status Verified

May 1, 2026

Enrollment Period

5 months

First QC Date

May 21, 2026

Last Update Submit

May 21, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Change in Anxiety Symptoms

    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.

    Baseline, mid-intervention approximately 2 weeks after baseline, and post-intervention approximately 6 weeks after baseline.

  • Change in Depressive Symptoms

    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.

    Baseline, mid-intervention approximately 2 weeks after baseline, and post-intervention approximately 6 weeks after baseline.

Secondary Outcomes (5)

  • Change in Emotional Clarity

    Baseline, mid-intervention approximately 2 weeks after baseline, and post-intervention approximately 6 weeks after baseline.

  • Change in Mood Repair

    Baseline, mid-intervention approximately 2 weeks after baseline, and post-intervention approximately 6 weeks after baseline.

  • Change in Cognitive Reappraisal

    Baseline, mid-intervention approximately 2 weeks after baseline, and post-intervention approximately 6 weeks after baseline.

  • Change in Expressive Suppression

    Baseline, mid-intervention approximately 2 weeks after baseline, and post-intervention approximately 6 weeks after baseline.

  • Change in Psychological Well-Being

    Baseline, mid-intervention approximately 2 weeks after baseline, and post-intervention approximately 6 weeks after baseline.

Study Arms (2)

Real-Time Awareness With Cognitive Reappraisal

EXPERIMENTAL

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.

Behavioral: Wearable-Based Real-Time Emotional Awareness and Cognitive Reappraisal Training

Retrospective Awareness With Cognitive Reappraisal

ACTIVE COMPARATOR

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.

Behavioral: Retrospective Emotion Journaling and Cognitive Reappraisal Training

Interventions

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.

Real-Time Awareness With Cognitive Reappraisal

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.

Retrospective Awareness With Cognitive Reappraisal

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

亞洲大學

Taichung, 41354, Taiwan

Location

MeSH Terms

Conditions

Anxiety DisordersDepressionEmotional Regulation

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehaviorSelf-ControlSocial Behavior

Study Officials

  • Han-Yun Chang, Ph.D.

    Asia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 21, 2026

First Posted

May 26, 2026

Study Start

January 25, 2024

Primary Completion

June 20, 2024

Study Completion

June 20, 2024

Last Updated

May 26, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will share

De-identified individual participant data and analytic code may be available from the authors upon reasonable request, subject to ethical approval and participant confidentiality restrictions.

Shared Documents
ANALYTIC CODE
Time Frame
De-identified individual participant data and analytic code will be available after publication and for five years.
Access Criteria
De-identified individual participant data and analytic code may be shared with qualified researchers for research purposes upon reasonable request. Requests will be reviewed by the study team and will require appropriate ethical approval, a data-sharing agreement when applicable, and compliance with participant confidentiality restrictions.

Locations