- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
-
Taichung, Taïwan, 41354
- 亞洲大學
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
La 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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
|
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.
|
|
Comparateur actif: 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.
|
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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in Anxiety Symptoms
Délai: Baseline, mid-intervention approximately 2 weeks after baseline, and post-intervention approximately 6 weeks after baseline.
|
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
Délai: Baseline, mid-intervention approximately 2 weeks after baseline, and post-intervention approximately 6 weeks after baseline.
|
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.
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in Emotional Clarity
Délai: Baseline, mid-intervention approximately 2 weeks after baseline, and post-intervention approximately 6 weeks after baseline.
|
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.
|
Baseline, mid-intervention approximately 2 weeks after baseline, and post-intervention approximately 6 weeks after baseline.
|
|
Change in Mood Repair
Délai: Baseline, mid-intervention approximately 2 weeks after baseline, and post-intervention approximately 6 weeks after baseline.
|
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.
|
Baseline, mid-intervention approximately 2 weeks after baseline, and post-intervention approximately 6 weeks after baseline.
|
|
Change in Cognitive Reappraisal
Délai: Baseline, mid-intervention approximately 2 weeks after baseline, and post-intervention approximately 6 weeks after baseline.
|
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.
|
Baseline, mid-intervention approximately 2 weeks after baseline, and post-intervention approximately 6 weeks after baseline.
|
|
Change in Expressive Suppression
Délai: Baseline, mid-intervention approximately 2 weeks after baseline, and post-intervention approximately 6 weeks after baseline.
|
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.
|
Baseline, mid-intervention approximately 2 weeks after baseline, and post-intervention approximately 6 weeks after baseline.
|
|
Change in Psychological Well-Being
Délai: Baseline, mid-intervention approximately 2 weeks after baseline, and post-intervention approximately 6 weeks after baseline.
|
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.
|
Baseline, mid-intervention approximately 2 weeks after baseline, and post-intervention approximately 6 weeks after baseline.
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Han-Yun Chang, Ph.D., Asia University
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- CRREC-112-036
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Délai de partage IPD
Critères d'accès au partage IPD
Type d'informations de prise en charge du partage d'IPD
- ANALYTIC_CODE
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .