An interventional study of Internet-based Unified Protocol (iUP) and Waitlist Control Group in Depression - Major Depressive Disorder, Generalised Anxiety Disorder and Anxiety Disorder (Panic Disorder or GAD), sponsored by New Life Psychiatric Rehabilitation Association. Not yet recruiting at 1 site in Hong Kong. Open to participants aged 18 Years to 29 Years. Per ClinicalTrials.gov, last updated 2026-11-02.
Sponsored by New Life Psychiatric Rehabilitation Association · Not applicable, Interventional, and Treatment
The goal of this clinical trial is to learn if an internet-based Unified Protocol (iUP) intervention is effective for treating depression and anxiety disorders in Hong Kong young adults aged 18-29 years. This study is conducted within the eClinic, a public mental health support service provided by a Hong Kong non-government organisation (NGO). The main questions it aims to answer are:
Researchers will compare participants who receive the iUP intervention immediately with those in a wait-list control group (who receive no intervention during the waiting period) to evaluate the effectiveness of iUP.
Participants will:
151 studies on the registry are indexed under Generalized Anxiety Disorder; 89 are open to participants now.
This study's planned enrollment of 78 is below the median of 98 across 124 interventional studies indexed under Generalized Anxiety Disorder.
Browse Generalized Anxiety Disorder studies →New Life Psychiatric Rehabilitation Association is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
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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 group will receive a 14-week internet-based Unified Protocol (iUP) intervention and complete weekly and follow-up questionnaires throughout the study period.
Behavioral: Internet-based Unified Protocol (iUP)
Participants in this group will not receive any intervention during the first 14 weeks. They will also need to complete weekly questionnaires during the 14-week waiting period. After completing the questionnaires at week 14, they will begin the same 14-week internet-based Unified Protocol (iUP) intervention.
Other: Waitlist Control Group
Internet-based Unified Protocol (iUP) programme comprises 8 modules: 1) motivation enhancement, 2) functional nature of emotion, 3) mindful emotion awareness, 4) cognitive flexibility, 5) distress tolerance of unpleasant physical sensations, 6) psychoeducation on emotional behaviors that aim to avoid or decrease emotions, 7) emotion exposures, and 8) relapse prevention. Core modules will be delivered more intensively during the first 4 weeks, after which clinicians will choose and assign elective modules according to each participant's clinical needs for the remaining 10 weeks. Corresponding home practice will be assigned weekly throughout the intervention. Clinicians will provide individual sessions (20-30 minutes) through video call or telephone twice weekly during the first 4 weeks and once weekly thereafter. In each session, participants will receive feedback on completed online modules and home practice, and will be coached in applying UP skills to current emotional difficulties.
No intervention will be delivered.
Patient Health Questionnaire-9 (PHQ-9)
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).
Time frame: 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)
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).
Time frame: 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.
Taiwan version of Penn State Worry Questionnaire (T-PSWQ)
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).
Time frame: 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)
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).
Time frame: 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)
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).
Time frame: 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.
Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)
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).
Time frame: 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)
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).
Time frame: 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)
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).
Time frame: 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)
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).
Time frame: 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)
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).
Time frame: 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)
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).
Time frame: 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)
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).
Time frame: 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)
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).
Time frame: 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)
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).
Time frame: 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)
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).
Time frame: 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.
Work and Social Adjustment Scale (WSAS)
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.
Time frame: 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)
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).
Time frame: 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.
Plan to share: No
Start is estimated for Nov 2026; primary completion for Oct 2036, 119 months later.
Of 67 non-industry interventional studies with no phase under Generalized Anxiety Disorder, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 67. This study's planned 119 months is above that.
Counting every sponsor, half of 70 studies reached it within 33 months; a quarter within 17 and three quarters within 64.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Generalized Anxiety Disorder →
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