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Depression - Major Depressive DisorderNCT07908628

Effectiveness of Internet-based Unified Protocol (iUP) for Emotional Problems: A Randomized Controlled Trial

A study testing Internet-based Unified Protocol (iUP) in people with Depression - Major Depressive Disorder and Generalised Anxiety Disorder, run by New Life Psychiatric Rehabilitation Association at 1 site in Hong Kong.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 29 years
What is being tested?
Internet-based Unified Protocol (iUP)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
78 participants
Where
1 siteHong Kong
Study dates
1 Nov 2026to 31 Oct 2037
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 29 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Able to speak, read and write Chinese
  • Present caseness according to NHS Talking Therapies (formerly IAPT) criteria, defined as a PHQ-9 total score ≥ 10 and/or a GAD-7 total score ≥ 8 at the start of treatment

Who cannot join

  • Present with a history of psychosis in the recent 2 years
  • Present with severe risk for self-harm or suicide (i.e., indicated as being at higher risk on the P4 Screener)
  • Present with active homicidal ideations
  • Demonstrate sub-average intelligence (e.g., based on a history of intellectual disability)
  • Concurrently receive other psychological services
  • Present with current substance abuse
  • Present with a known, formal diagnosis of autism spectrum disorder (ASD)
  • Present with unstable psychiatric medication states in recent 3 months (i.e., had recent initiation of psychiatric medication or dosage change)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Ms. Sut Leng Sherry IM contact

+852 2778 4503

sherryim@nlpra.org.hk

Mr. Wing Leong Lewis NG contact

+852 2778 4503

lewisng@nlpra.org.hk

Hong Kong1 site
  • New Life Psychiatric Rehabilitation Association

    Hong Kong, Kowloon

    Ms. Sut Leng Sherry IM, +852 2778 4503, jceclinic@nlpra.org.hk

Other trials in Hong Kong

About this study

Official title: Effectiveness of an Adapted, Internet-based Version of a Transdiagnostic Intervention (Unified Protocol) for Emotional Problems: A Randomized Controlled Trial

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:

  • Is the iUP intervention effective in treating depression and anxiety disorders?
  • How long is the treatment effect sustained after the intervention ends?
  • Does the intervention also improve real-world functioning, such as occupational and academic performance?
Read more

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:

  • Receive a 14-week iUP intervention either immediately or after a 14-week waiting period according to randomisation
  • Complete weekly and follow-up questionnaires throughout the study period
Being tested
Internet-based Unified Protocol (iUP), Waitlist Control Group
Medical subject headings
Generalized Anxiety Disorder, Anxiety Disorders, Panic Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Internet-based Unified Protocol (iUP)Behavioural

    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.

  • Waitlist Control GroupOther

    No intervention will be delivered.

Study groups in NCT07908628
Study groupRoleWhat they receive
Internet-based Unified Protocol (iUP) Intervention groupExperimentalParticipants 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.
Receives: Behavioral: Internet-based Unified Protocol (iUP)
Waitlist control groupPlacebo comparatorParticipants 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.
Receives: Other: Waitlist Control Group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: 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.

  2. 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).

    Measured: 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.

Secondary outcomes (15)
  1. 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).

    Measured: 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.

  2. 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).

    Measured: 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.

  3. 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).

    Measured: 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.

  4. 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).

    Measured: 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.

  5. 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).

    Measured: 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.

  6. 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).

    Measured: 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.

  7. 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).

    Measured: 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.

  8. 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).

    Measured: 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.

  9. 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).

    Measured: 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.

  10. 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).

    Measured: 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.

  11. 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).

    Measured: 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.

  12. 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).

    Measured: 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.

  13. 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).

    Measured: 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.

  14. 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.

    Measured: 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.

  15. 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).

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Nov 2026
  2. Study start1 Nov 2026 (estimated)
  3. Primary completion31 Oct 2036 (estimated)
  4. Study completion31 Oct 2037 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
78 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07908628
Sponsor's protocol ID
CREC Ref. No.: 2026.451
Status last verified
Oct 2026
First submitted
26 Oct 2026
Last updated
2 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Powell CLYM, Farchione TJ, Barlow DH, Leung PWL. A pilot trial of a transdiagnostic treatment for emotional disorders-a locally adapted variant of group Unified Protocol (UP) for Chinese adults. Transl Behav Med. 2021 May 25;11(5):1142-1150. doi: 10.1093/tbm/ibaa104.

    PubMed 33159447

Questions about this trial

What is this clinical trial studying?

A study testing Internet-based Unified Protocol (iUP) in people with Depression - Major Depressive Disorder and Generalised Anxiety Disorder, run by New Life Psychiatric Rehabilitation Association at 1 site in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ms. Sut Leng Sherry IM (+852 2778 4503, sherryim@nlpra.org.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient Health Questionnaire-9 (PHQ-9) (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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07908628, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.

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