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Trial · NCT07908628

Registered outcomes17

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryPatient Health Questionnaire-9 (PHQ-9)Intake, weekly during the 14-week intervention period (Weeks 1 - 14), and at 1-, 2-, 3-, 6-, and 12-month follow-ups after the end of the intervention.
Patient Health Questionnaire-9 (PHQ-9) is a 9-item self-report questionnaire designed to screen for depression and assess its severity in both clinical and research settings. Participants rate the frequency of depressive symptoms over the past two weeks on a 4-point Likert scale ranging from 0 (not at all) to 3 (nearly every day). Total scores range from 0 to 27, with higher scores indicating greater depression severity. In a Hong Kong community sample, the PHQ-9 demonstrated good internal consistency (α = .82) and test-retest reliability (r = .76) (Yu et al., 2012).
PrimaryGeneralized Anxiety Disorder-7 (GAD-7)Intake, weekly during the 14-week intervention period (Weeks 1 - 14), and at 1-, 2-, 3-, 6-, and 12-month follow-ups after the end of the intervention.
Generalized Anxiety Disorder-7 (GAD-7) is a 7-item self-report questionnaire designed to screen for anxiety and assess its severity in both clinical and research settings. Participants rate the frequency of anxiety symptoms over the past two weeks on a 4-point Likert scale ranging from 0 (not at all) to 3 (nearly every day). Total scores range from 0 to 21, with higher scores indicating greater anxiety severity. In a sample of Chinese medical university students, the GAD-7 demonstrated high internal consistency (α = .93; Zhang et al., 2021).
SecondaryTaiwan version of Penn State Worry Questionnaire (T-PSWQ)Weeks 1, 5 and 14 during the 14-week intervention period, as well as at 3- and 12-month follow-ups after the end of the intervention.
Taiwan version of Penn State Worry Questionnaire (T-PSWQ) The Penn State Worry Questionnaire (PSWQ) is a 16-item self-report measure designed to assess pathological or trait-based worry (Meyer et al., 1990). In the current study, the Taiwan version of the PSWQ will be used. Participants rate how typical or characteristic each item is of them on a 5-point Likert scale ranging from 1 (not at all) to 5 (very typical of me). Total scores range from 16 to 80, with higher scores indicating greater levels of worry. In a sample of university students, the Taiwan version of the PSWQ demonstrated high internal consistency (α = .88; Teng et al., 2015).
SecondaryLiebowitz Social Anxiety Scale (LSAS)Weeks 1, 5 and 14 during the 14-week intervention period, as well as at 3- and 12-month follow-ups after the end of the intervention.
Liebowitz Social Anxiety Scale (LSAS) is a 24-item self-report tool designed to assess fear and avoidance associated with Social Anxiety Disorder (SAD). In the current study, the Chinese version of the LSAS will be used. Participants rate each item on a 4-point Likert scale ranging from 0 (none) to 3 (severe) for fear and from 0 (never) to 3 (usually) for avoidance. Total scores range from 0 to 144, with higher scores indicating greater social anxiety. The Chinese version of the LSAS has demonstrated robust internal consistency (α \> .90) and high test-retest reliability (r \> .75) (He \& Zhang, 2004).
SecondaryChinese version of Obsessive-Compulsive Inventory-Revised (C-OCI-R)Weeks 1, 5 and 14 during the 14-week intervention period, as well as at 3- and 12-month follow-ups after the end of the intervention.
Chinese version of Obsessive-Compulsive Inventory-Revised (C-OCI-R) Obsessive-Compulsive Inventory-Revised (OCI-R) is an 18-item self-report questionnaire designed to measure the severity of obsessive-compulsive symptoms (Foa et al., 2022). In the current study, the Chinese version of the scale (C-OCI-R) will be used. Participants rate each item on a 5-point Likert scale ranging from 0 (not at all) to 4 (extremely). Total scores range from 0 to 72, with higher scores indicating greater severity of obsessive-compulsive symptoms. The C-OCI-R has demonstrated excellent internal consistency (α = .92) and excellent test-retest reliability (ρ = .96; Hon et al., 2019).
SecondaryPosttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)Weeks 1, 5 and 14 during the 14-week intervention period, as well as at 3- and 12-month follow-ups after the end of the intervention.
The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) is a 20-item self-report questionnaire designed to assess the severity of posttraumatic stress disorder (PTSD) symptoms according to DSM-5 criteria (Blevins et al., 2015). In the current study, the Chinese version of the PCL-5 will be used. Participants rate each item on a 5-point Likert scale ranging from 0 (not at all) to 4 (extremely). Total scores range from 0 to 80, with higher scores indicating greater PTSD symptom severity. The Chinese version of the PCL-5 has demonstrated excellent internal consistency (α = .95; Fung et al., 2019).
SecondaryInsomnia Severity Index (ISI)Weeks 1, 5 and 14 during the 14-week intervention period, as well as at 3- and 12-month follow-ups after the end of the intervention.
Insomnia Severity Index (ISI) is a 7-item self-report questionnaire developed to evaluate the nature, severity, and impact of insomnia. In the current study, the Chinese version of the scale (ISI-C) will be used. Participants rate each item on a 5-point Likert scale ranging from 0 (no problem) to 4 (very severe problem). Total scores range from 0 to 28, with higher scores indicating greater insomnia severity. The ISI-C has demonstrated excellent internal consistency (α = .94; Yang et al., 2009).
SecondaryShort Health Anxiety Inventory (SHAI)Weeks 1, 5 and 14 during the 14-week intervention period, as well as at 3- and 12-month follow-ups after the end of the intervention.
Short Health Anxiety Inventory (SHAI) is an 18-item self-report questionnaire designed to measure health anxiety. In the current study, the Chinese version of the scale (CSHAI) will be used. Participants rate each item on a 4-point scale ranging from 0 to 3. Total scores range from 0 to 54, with higher scores indicating greater health anxiety. The CSHAI has demonstrated good internal consistency (α = .74; Zhang et al., 2015).
SecondaryBrief Experiential Avoidance Questionnaire (BEAQ)Weeks 1, 5 and 14 during the 14-week intervention period, as well as at 3- and 12-month follow-ups after the end of the intervention.
Brief Experiential Avoidance Questionnaire (BEAQ) is a 15-item self-report questionnaire designed to assess individuals' experiential avoidance (Gámez et al., 2014). In the current study, the Chinese version of the BEAQ will be used. Participants rate each item on a 6-point Likert scale ranging from 1 (strongly disagree) to 6 (strongly agree). Total scores range from 15 to 90, with higher scores indicating greater experiential avoidance. The BEAQ has demonstrated good internal consistency (α \> .80) across clinical, student, and community samples (Gámez et al., 2014). The Chinese version of the BEAQ has demonstrated good internal consistency (α = .85; Lo et al., 2023).
SecondaryDifficulties in Emotion Regulation Scale-16 (DERS-16)Weeks 1, 5 and 14 during the 14-week intervention period, as well as at 3- and 12-month follow-ups after the end of the intervention.
Difficulties in Emotion Regulation Scale-16 (DERS-16) is a 16-item self-report questionnaire designed to assess difficulties with emotion regulation. In the current study, the Chinese version of the DERS-16 will be used. Participants rate each item on a 5-point Likert scale ranging from 1 (almost never) to 5 (almost always). Total scores range from 16 to 80, with higher scores indicating greater difficulties in emotion regulation. The DERS-16 has demonstrated excellent internal consistency (α \> .90) and good test-retest reliability (r = .85; Bjureberg et al., 2015). The Chinese version of DERS-16, which has shown excellent internal consistency (α = .90) and good test-retest reliability (r = .84; Li et al., 2018).
SecondaryGratitude Questionnaire-5 (GQ-5)Weeks 1, 5 and 14 during the 14-week intervention period, as well as at 3- and 12-month follow-ups after the end of the intervention.
Gratitude Questionnaire-5 (GQ-5) is a 5-item self-report questionnaire designed to assess individuals' tendency to experience gratitude. In the current study, the Chinese version of the GQ-5 will be used. Participants rate each item on a 7-point Likert scale ranging from 1 (strongly disagree) to 7 (strongly agree). Total scores range from 5 to 35, with higher scores indicating greater levels of gratitude. The Chinese version of the GQ-5 has demonstrated good internal consistency across Chinese samples (α = .79-80; Chen et al., 2009; Zeng et al., 2017).
SecondaryCognitive Distortions Questionnaire (CD-Quest)Weeks 1, 5 and 14 during the 14-week intervention period, as well as at 3- and 12-month follow-ups after the end of the intervention.
Cognitive Distortions Questionnaire (CD-Quest) is a 15-item self-report questionnaire designed to assess the frequency and severity of common cognitive errors or distortions. In the current study, the Chinese version of the CD-Quest will be used. For each item, participants indicate whether the distortion occurred and rate its frequency and intensity on a combined 0-5 scale (0 = did not occur; 5 = almost all the time with high intensity). Total scores range from 0 to 75, with higher scores indicating greater levels of cognitive distortions. The Chinese version of the CD-Quest has demonstrated excellent internal consistency (α \> .92) and good test-retest reliability (r = .93; Qian et al., 2020).
SecondaryCognitive Flexibility Inventory (CFI)Weeks 1, 5 and 14 during the 14-week intervention period, as well as at 3- and 12-month follow-ups after the end of the intervention.
Cognitive Flexibility Inventory (CFI) is a 20-item self-report questionnaire designed to assess cognitive flexibility. In the current study, the Chinese version of the CFI will be used. Participants rate each item on a 7-point Likert scale ranging from 1 (strongly disagree) to 7 (strongly agree). Total scores range from 20 to 140, with higher scores indicating greater cognitive flexibility. The CFI has demonstrated excellent internal consistency (α = .90-.91) and good test-retest reliability (r = .81; Dennis \& Vander Wal, 2010). The Chinese version of the CFI has shown good internal reliability in Chinese samples (α \> .80; Wang et al., 2016; Yu et al., 2020).
SecondaryRosenberg Self-Esteem Scale (RSE)Weeks 1, 5 and 14 during the 14-week intervention period, as well as at 3- and 12-month follow-ups after the end of the intervention.
Rosenberg Self-Esteem Scale (RSE) is a 10-item self-report questionnaire designed to assess self-esteem. In the current study, the Chinese version of the RSE will be used. Participants rate each item on a 4-point Likert scale ranging from 1 (strongly agree) to 4 (strongly disagree). Total scores range from 10 to 40, with higher scores indicating greater self-esteem. The original RSE has demonstrated high internal consistency (α = .92) and good test-retest reliability (r = .85-.88; Rosenberg, 1979). The Chinese version has shown good internal consistency (α = .76; Tsang, 1997). A revised positive-worded version has also demonstrated good internal consistency (α ≥ .83) and good test-retest reliability (r = .76) in Chinese samples (Chen et al., 2015).
SecondaryEuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L)Weeks 1, 5 and 14 during the 14-week intervention period, as well as at 3- and 12-month follow-ups after the end of the intervention.
EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) is a 5-item self-report questionnaire designed to measure health-related quality of life across five dimensions. In the current study, the Chinese version of the EQ-5D-5L will be used. Participants rate each dimension on a 5-point scale with response options specific to that dimension. Higher levels on each dimension indicate greater problems in that area of health. The Chinese version of the EQ-5D-5L has demonstrated good internal consistency (α = .78) and good test-retest reliability (r = .78; Cheung et al., 2016).
SecondaryWork and Social Adjustment Scale (WSAS)Weeks 1, 5 and 14 during the 14-week intervention period, as well as at 3-, 6- and 12-month follow-ups after the end of the intervention.
Work and Social Adjustment Scale (WSAS) is a 5-item self-report questionnaire designed to measure the severity of functional impairment across key life domains. In the current study, the Chinese version of the WSAS will be used. Participants rate each item on a 9-point Likert scale ranging from 0 (not at all) to 8 (very severely). Total scores range from 0 to 40, with higher scores indicating greater functional impairment. The WSAS has demonstrated good internal consistency (α ≥ .79) and good test-retest reliability (r = .73; Mundt et al., 2002). A Chinese version previously translated for a related project will be used in the current study.
SecondaryGeneral Self-Efficacy Scale (GSE)Weeks 1, 5 and 14 during the 14-week intervention period, as well as at 3-, 6- and 12-month follow-ups after the end of the intervention.
General Self-Efficacy Scale (GSE) is a 10-item self-report questionnaire designed to assess generalized beliefs in one's ability to cope with challenging situations. In the current study, the Chinese version of the GSE will be used. Participants rate each item on a 4-point Likert scale ranging from 1 (not at all true) to 4 (exactly true). Total scores range from 10 to 40, with higher scores indicating greater perceived self-efficacy. The Chinese version of the GSE has demonstrated good internal consistency (α = .91-.92; Cheung \& Sun, 1999; Chiu \& Tsang, 2004).

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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