Online Self-help Transdiagnostic Psychological InterventionNCT05160376
Efficacy of Guided and Unguided Online Self-help Psychological Intervention
A study testing Self-help CBT with email reminder and text message and Feedback calls on participants' progress in people with Online Self-help Transdiagnostic Psychological Intervention and Anxiety, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
This study will examine the efficacy of guided and unguided online transdiagnostic self-help cognitive behavioral therapy (CBT) for reducing anxiety and/or depression symptoms in Hong-kong residents. Numerous literature demonstrates online self-help interventions' efficacy on depression and anxiety. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Online Self-help Transdiagnostic Psychological Intervention, Anxiety, Depression
- What is being tested?
- Self-help CBT with email reminder and text message and Feedback calls on participants' progress
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteHong Kong
- Study dates
- 24 Jan 2022to 31 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have anxiety and/or depression symptoms, scoring 10 or above, in accordance with Patient Health Questionnaire (PHQ-9) or General Anxiety Disorder-7 (GAD-7);
- Hong Kong residents aged 18-65;
- Have access to the internet and have a valid email address for communication;
- Able to read Chinese and type in Chinese or English; and
- Willing to provide informed consent.
Who cannot join
- Had received psychotherapy for depression and/or anxiety in the past 6 months;
- Have reported the diagnosis of major psychiatric, bipolar disorder, medical or neurocognitive disorders, or have experienced dissociative symptoms that make participation infeasible or interfere with the adherence to the digital self-help intervention;
- Will participate in another similar study/ other similar studies concurrently;
- Any suicidal ideation (scoring above 2 in item 9 in PHQ-9)
- Have reported substance abuse or dependence history;
- Had changes in psychotropic drugs within 2 weeks before baseline assessment; and
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Guided and Unguided Online Self-help Psychological Intervention for Improving Depressive and Anxiety Symptoms: A Pilot Randomized Controlled Trial
This study will examine the efficacy of guided and unguided online transdiagnostic self-help cognitive behavioral therapy (CBT) for reducing anxiety and/or depression symptoms in Hong-kong residents. Numerous literature demonstrates online self-help interventions' efficacy on depression and anxiety. Nonetheless, existing research overlooks the mechanism of change, the online treatment outcome's potential predictors, and the effect of therapist's guidance on participants' treatment expectancy and its mediating effect on treatment outcome, which are essential to optimize intervention's efficacy.
96 Hong-kong residents, aged 18-65, with mild to moderate anxiety and/or depression will be recruited. Eligible participants will be randomly assigned to either guided group (Group-1) or unguided group (Group-2) or waitlist control group (Group-3) in a 1:1:1 ratio. Group-1 will receive weekly manualized progress feedback from trained researchers under supervision, after each weekly treatment. Group-2 will not receive the aforementioned feedback. Group-1 and Group-2 will receive reminders on the 5th, 6th and 7th day if weekly treatment is not completed. All participants will complete baseline assessments before treatment, six weekly treatments (except Group-3), a post-treatment assessment immediately and four-week after treatment. Randomly selected participants will complete an individual interview after treatment. Feedback will be gathered through a phone call to improve the intervention in the future.
Read the detailed description
This study will be a pilot randomized control trial that examines the efficacy of guided and unguided transdiagnostic online self-help cognitive behavioral therapy for reducing symptoms of anxiety and depression in the Hong Kong adult resident population. Despite online self-help intervention has been widely recognized by its efficacy in improving depression and anxiety symptoms, the existing literature overlooks the mechanism of change and the potential predictors of online treatment outcome, as well as the effect of therapist's guidance on participants' treatment expectancy and its mediating effect on treatment outcome. However, the aforementioned research gaps are essential for optimizing the efficacy of online self-help interventions.
Prior to all study procedures, online informed consent with phone support will be obtained from potential participants. Around 96 eligible participants will be randomly assigned to either guided intervention group or unguided intervention group or waitlist control group in a ratio of 1:1:1. The randomization will be performed by an independent assessor using a computer-generated list of numbers. No deception is necessary.
The participants in the guided intervention group will receive feedback calls (approximately 15 minutes) on participants' progress after each online self-help intervention session. The check-in includes treatment concepts clarification, homework checking, and technical issues solving. The check-ins will be delivered by a clinical psychology trainee or an undergraduate trained psychology student under the supervision of a clinical psychology professor. The participants in the unguided intervention group will not receive the aforementioned check-ins. The participants in both guided and unguided intervention groups will receive an email reminder and text message if the participants have not completed the required session of that week on the 5th, 6th, and 7th of the same week. Both technical supports are available for both groups. The waitlist unguided control group will not receive any online self-help intervention. All participants will complete a set of baseline assessments before the first session, a post-treatment assessment immediately after treatment, and a post-treatment assessment four-week after the treatment. Apart from the waitlist control group, both guided and unguided intervention groups will receive a total of six weekly online treatments. Randomly selected participants will complete an individual interview after treatment. Feedback will be gathered through a phone call or online feedback form to improve the intervention in the future.
- Being tested
- Self-help CBT with email reminder and text message, Feedback calls on participants' progress
- Keywords
- Online Self-help, Online Psychological Intervention, Unguided Online Self-help, Guided Online Self-help, Transdiagnostic intervention
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-help CBT with email reminder and text messageOther
An online transdiagnostic self-help intervention that is delivered through an online mental health platform.
Email reminder and text message will be sent to remind participant to complete the module
Feedback calls on participants' progressOther
Feedback calls (approximately 15 minutes) on participants' progress from a clinical psychology trainee or an undergraduate trained psychology student under the supervision of a clinical psychology professor
| Study group | Role | What they receive |
|---|---|---|
| Guided Intervention Group | Experimental | The participants in the guided intervention group will receive feedback calls (approximately 15 minutes) on participants' progress from a clinical psychology trainee or an undergraduate trained psychology student under the supervision of a clinical psychology professor, after each online self-help intervention session. The participants in the guided intervention group will also receive an email reminder and text message if the participants have not completed the required session of that week on the 5th, 6th, and 7th of the same week. Technical supports are available. Receives: Other: Self-help CBT with email reminder and text message; Other: Feedback calls on participants' progress |
| Unguided Intervention Group | Experimental | The participants in the unguided intervention group will not receive the aforementioned feedback calls. The participants in the unguided intervention group will only receive an email reminder and text message if the participants have not completed the required session of that week on the 5th, 6th, and 7th of the same week. Technical supports are available. Receives: Other: Self-help CBT with email reminder and text message |
| Wait-list Control Group | No intervention | The waitlist control group will not receive any online self-help intervention. Unguided intervention will be provided to the waitlist control group after both the Post-treatment Assessment Phrase are finished. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Depressive Symptoms - The Patient Health Questionnaire-9 (PHQ-9)
The Patient Health Questionnaire-9 (PHQ-9) is a self-report measure that consists of 4-point Likert-scale questions that assess the severity of depressive symptoms. This measure reflects the DSM-IV diagnostic criteria of depression. Higher score means that the respondent has more depressive symptoms. Total score categories: 0-4 is no clinically significant depressive symptoms, 5-9 indicates mild depressive symptom,10-14 indicates moderate depressive symptoms, 15-19 indicates moderately severe depressive symptoms, 20-27 indicates extremely severe depressive symptom. This measure also shows good convergent validity with other measures and are widely used in mental health research (Beard et al., 2016; Kroenke et al., 2010)
Measured: Baseline Assessment Phrase, Post-treatment Assessment Phrase (Immediately after Treatment), Post-treatment Assessment Phrase (Four-week after Treatment)
Change in Anxiety Symptoms - The General Anxiety Disorder-7 (GAD-7)
The General Anxiety Disorder-7 (GAD-7) is a self-report measure to evaluate the severity of anxiety symptoms. This measure reflects the DSM-IV diagnostic criteria of anxiety. Total score categories: 0-4 is no clinically significant depressive symptoms, 5-9 indicates mild depressive symptom,10-14 indicates moderate depressive symptoms, 15-19 indicates moderately severe depressive symptoms, 20-27 indicates extremely severe depressive symptom. This measure also shows good convergent validity with other measures and are widely used in mental health research (Beard et al., 2016; Kroenke et al., 2010)
Measured: Baseline Assessment Phrase, Post-treatment Assessment Phrase (Immediately after Treatment), Post-treatment Assessment Phrase (Four-week after Treatment)
Secondary outcomes (6)
Change in Quality-adjusted Life Years - The Short Form Six-Dimension (SF-6D)
The Short Form Six-Dimension (SF-6D) is a self-report measure that assesses health-related quality of life to estimate participant's quality-adjusted life years (QALYs). This instrument was validated in the Chinese population and widely applied in previous mental health research.
Measured: Baseline Assessment Phrase, Post-treatment Assessment Phrase (Immediately after Treatment), Post-treatment Assessment Phrase (Four-week after Treatment)
Change in Insomnia Severity Index (ISI)
A 7-item scale designed to evaluate perceived insomnia severity. Ratings on the 5-point Likert scale are obtained on the perceived severity of sleep-onset, sleep-maintenance, early morning awakening problems, satisfaction with current sleep pattern, interference with daily functioning, noticeably of impairment attributed to the sleep problem, and level of distress caused by the sleep problem. Total score categories: 0-7 is no clinically significant insomnia, 8-14 is subthreshold insomnia,15-21 is clinical insomnia (moderate severity), and 22-28 is clinical insomnia (severe)
Measured: Baseline Assessment Phrase, Post-treatment Assessment Phrase (Immediately after Treatment), Post-treatment Assessment Phrase (Four-week after Treatment)
Change in the Perceived Stress Scale (PSS)
The PSS measures the perceived amount of stress experienced over the past month. The total score ranged from 0-40. Higher score means that the respondent has higher perceived stress level.
Measured: Baseline Assessment Phrase, Post-treatment Assessment Phrase (Immediately after Treatment), Post-treatment Assessment Phrase (Four-week after Treatment)
Change in emotional regulation strategies - Emotion Regulation Questionnaire (ERQ)
The Emotion Regulation Questionnaire (ERQ) is a self-report questionnaire that consists of 10 questions to assess how often the participants use cognitive reappraisal and expressive suppression as emotional regulation strategies. The total score ranged from 10-70. Higher score indicates that the respondent use cognitive reappraisal and expressive suppression as emotional regulation strategies more frequently.
Measured: Baseline Assessment Phrase, Post-treatment Assessment Phrase (Immediately after Treatment), Post-treatment Assessment Phrase (Four-week after Treatment)
Change in frequency of applying CBT-based skills - Frequency of Actions and Thoughts Scale (FATS)
The Frequency of Actions and Thoughts Scale (FATS) is a self-report scale that assesses how frequent the participants apply the CBT-based skills they learned. The total score ranged from 0-48. Higher score means that the respondent has higher frequency of applying the CBT-based skills they learned.
Measured: Baseline Assessment Phrase, Post-treatment Assessment Phrase (Immediately after Treatment), Post-treatment Assessment Phrase (Four-week after Treatment)
Change in Positive Beliefs about Rumination Scale - Adapted Version (PBRS-A)
Positive Beliefs about Rumination Scale (PBRS-A) is a 9-item instrument that measures positive belief on their rumination. The total score ranged from 9-36. Higher score means that the respondent has more positive beliefs about rumination.
Measured: Baseline Assessment Phrase, Post-treatment Assessment Phrase (Immediately after Treatment), Post-treatment Assessment Phrase (Four-week after Treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2021
- Study start24 Jan 2022
- Primary completion26 Mar 2022
- Study completion31 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Online Self-help Transdiagnostic Psychological InterventionStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fiona YY Ho, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05160376
- Sponsor's protocol ID
- PSY018
- Status last verified
- Mar 2022
- First submitted
- 3 Dec 2021
- Last updated
- 5 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Guided and Unguided Online Self-help Psychological Intervention for Improving Depressive and Anxiety Symptoms: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05160376
- Acronym / sponsor ID
- PSY018
- Keywords
- Online Self-help, Online Psychological Intervention, Unguided Online Self-help, Guided Online Self-help, Transdiagnostic intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 24 Jan 2022 (actual)
- Primary completion
- 26 Mar 2022 (actual)
- Study completion
- 31 Jul 2022 (estimated)
- First posted
- 16 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will examine the efficacy of guided and unguided online transdiagnostic self-help cognitive behavioral therapy (CBT) for reducing anxiety and/or depression symptoms in Hong-kong residents. Numerous literature demonstrates online self-help interventions' efficacy on depression and anxiety. Nonetheless, existing research overlooks the mechanism of change, the online treatment outcome's potential predictors, and the effect of therapist's guidance on participants' treatment expectancy and its mediating effect on treatment outcome, which are essential to optimize intervention's efficacy.
96 Hong-kong residents, aged 18-65, with mild to moderate anxiety and/or depression will be recruited. Eligible participants will be randomly assigned to either guided group (Group-1) or unguided group (Group-2) or waitlist control group (Group-3) in a 1:1:1 ratio. Group-1 will receive weekly manualized progress feedback from trained researchers under supervision, after each weekly treatment. Group-2 will not receive the aforementioned feedback. Group-1 and Group-2 will receive reminders on the 5th, 6th and 7th day if weekly treatment is not completed. All participants will complete baseline assessments before treatment, six weekly treatments (except Group-3), a post-treatment assessment immediately and four-week after treatment. Randomly selected participants will complete an individual interview after treatment. Feedback will be gathered through a phone call to improve the intervention in the future.
Detailed description
This study will be a pilot randomized control trial that examines the efficacy of guided and unguided transdiagnostic online self-help cognitive behavioral therapy for reducing symptoms of anxiety and depression in the Hong Kong adult resident population. Despite online self-help intervention has been widely recognized by its efficacy in improving depression and anxiety symptoms, the existing literature overlooks the mechanism of change and the potential predictors of online treatment outcome, as well as the effect of therapist's guidance on participants' treatment expectancy and its mediating effect on treatment outcome. However, the aforementioned research gaps are essential for optimizing the efficacy of online self-help interventions.
Prior to all study procedures, online informed consent with phone support will be obtained from potential participants. Around 96 eligible participants will be randomly assigned to either guided intervention group or unguided intervention group or waitlist control group in a ratio of 1:1:1. The randomization will be performed by an independent assessor using a computer-generated list of numbers. No deception is necessary.
The participants in the guided intervention group will receive feedback calls (approximately 15 minutes) on participants' progress after each online self-help intervention session. The check-in includes treatment concepts clarification, homework checking, and technical issues solving. The check-ins will be delivered by a clinical psychology trainee or an undergraduate trained psychology student under the supervision of a clinical psychology professor. The participants in the unguided intervention group will not receive the aforementioned check-ins. The participants in both guided and unguided intervention groups will receive an email reminder and text message if the participants have not completed the required session of that week on the 5th, 6th, and 7th of the same week. Both technical supports are available for both groups. The waitlist unguided control group will not receive any online self-help intervention. All participants will complete a set of baseline assessments before the first session, a post-treatment assessment immediately after treatment, and a post-treatment assessment four-week after the treatment. Apart from the waitlist control group, both guided and unguided intervention groups will receive a total of six weekly online treatments. Randomly selected participants will complete an individual interview after treatment. Feedback will be gathered through a phone call or online feedback form to improve the intervention in the future.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Guided Intervention Group | Experimental | Other: Self-help CBT with email reminder and text message, Other: Feedback calls on participants' progressThe participants in the guided intervention group will receive feedback calls (approximately 15 minutes) on participants' progress from a clinical psychology trainee or an undergraduate trained psychology student under the supervision of a clinical psychology professor, after each online self-help intervention session. The participants in the guided intervention group will also receive an email reminder and text message if the participants have not completed the required session of that week on the 5th, 6th, and 7th of the same week. Technical supports are available. |
| Unguided Intervention Group | Experimental | Other: Self-help CBT with email reminder and text messageThe participants in the unguided intervention group will not receive the aforementioned feedback calls. The participants in the unguided intervention group will only receive an email reminder and text message if the participants have not completed the required session of that week on the 5th, 6th, and 7th of the same week. Technical supports are available. |
| Wait-list Control Group | No intervention | –The waitlist control group will not receive any online self-help intervention. Unguided intervention will be provided to the waitlist control group after both the Post-treatment Assessment Phrase are finished. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Have anxiety and/or depression symptoms, scoring 10 or above, in accordance with Patient Health Questionnaire (PHQ-9) or General Anxiety Disorder-7 (GAD-7);
- Hong Kong residents aged 18-65;
- Have access to the internet and have a valid email address for communication;
- Able to read Chinese and type in Chinese or English; and
- Willing to provide informed consent.
Key exclusion criteria (7 listed)
- Had received psychotherapy for depression and/or anxiety in the past 6 months;
- Have reported the diagnosis of major psychiatric, bipolar disorder, medical or neurocognitive disorders, or have experienced dissociative symptoms that make participation infeasible or interfere with the adherence to the digital self-help intervention;
- Will participate in another similar study/ other similar studies concurrently;
- Any suicidal ideation (scoring above 2 in item 9 in PHQ-9)
- Have reported substance abuse or dependence history;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-help CBT with email reminder and text messageAn online transdiagnostic self-help intervention that is delivered through an online mental health platform. Email reminder and text message will be sent to remind participant to complete the module | Other | Guided Intervention Group, Unguided Intervention Group |
| Feedback calls on participants' progressFeedback calls (approximately 15 minutes) on participants' progress from a clinical psychology trainee or an undergraduate trained psychology student under the supervision of a clinical psychology professor | Other | Guided Intervention Group |
Primary outcome
Change in Depressive Symptoms - The Patient Health Questionnaire-9 (PHQ-9)
Time frame: Baseline Assessment Phrase, Post-treatment Assessment Phrase (Immediately after Treatment), Post-treatment Assessment Phrase (Four-week after Treatment)
The Patient Health Questionnaire-9 (PHQ-9) is a self-report measure that consists of 4-point Likert-scale questions that assess the severity of depressive symptoms. This measure reflects the DSM-IV diagnostic criteria of depression. Higher score means that the respondent has more depressive symptoms. Total score categories: 0-4 is no clinically significant depressive symptoms, 5-9 indicates mild depressive symptom,10-14 indicates moderate depressive symptoms, 15-19 indicates moderately severe depressive symptoms, 20-27 indicates extremely severe depressive symptom. This measure also shows good convergent validity with other measures and are widely used in mental health research (Beard et al., 2016; Kroenke et al., 2010)
Change in Anxiety Symptoms - The General Anxiety Disorder-7 (GAD-7)
Time frame: Baseline Assessment Phrase, Post-treatment Assessment Phrase (Immediately after Treatment), Post-treatment Assessment Phrase (Four-week after Treatment)
The General Anxiety Disorder-7 (GAD-7) is a self-report measure to evaluate the severity of anxiety symptoms. This measure reflects the DSM-IV diagnostic criteria of anxiety. Total score categories: 0-4 is no clinically significant depressive symptoms, 5-9 indicates mild depressive symptom,10-14 indicates moderate depressive symptoms, 15-19 indicates moderately severe depressive symptoms, 20-27 indicates extremely severe depressive symptom. This measure also shows good convergent validity with other measures and are widely used in mental health research (Beard et al., 2016; Kroenke et al., 2010)
6 secondary outcomes
Change in Quality-adjusted Life Years - The Short Form Six-Dimension (SF-6D)
Time frame: Baseline Assessment Phrase, Post-treatment Assessment Phrase (Immediately after Treatment), Post-treatment Assessment Phrase (Four-week after Treatment)
Change in Insomnia Severity Index (ISI)
Time frame: Baseline Assessment Phrase, Post-treatment Assessment Phrase (Immediately after Treatment), Post-treatment Assessment Phrase (Four-week after Treatment)
Change in the Perceived Stress Scale (PSS)
Time frame: Baseline Assessment Phrase, Post-treatment Assessment Phrase (Immediately after Treatment), Post-treatment Assessment Phrase (Four-week after Treatment)
Change in emotional regulation strategies - Emotion Regulation Questionnaire (ERQ)
Time frame: Baseline Assessment Phrase, Post-treatment Assessment Phrase (Immediately after Treatment), Post-treatment Assessment Phrase (Four-week after Treatment)
Change in frequency of applying CBT-based skills - Frequency of Actions and Thoughts Scale (FATS)
Time frame: Baseline Assessment Phrase, Post-treatment Assessment Phrase (Immediately after Treatment), Post-treatment Assessment Phrase (Four-week after Treatment)
Change in Positive Beliefs about Rumination Scale - Adapted Version (PBRS-A)
Time frame: Baseline Assessment Phrase, Post-treatment Assessment Phrase (Immediately after Treatment), Post-treatment Assessment Phrase (Four-week after Treatment)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2022.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-help CBT with email reminder and text message and Feedback calls on participants' progress in people with Online Self-help Transdiagnostic Psychological Intervention and Anxiety, run by Chinese University of Hong Kong 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 5 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 5 Apr 2022. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Depressive Symptoms - The Patient Health Questionnaire-9 (PHQ-9) (time frame: Baseline Assessment Phrase, Post-treatment Assessment Phrase (Immediately after Treatment), Post-treatment Assessment Phrase (Four-week after Treatment)). 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?
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 5 Apr 2022.