Anxiety GeneralizedNCT05027880
Web-based Single-session Growth Mindset Intervention for Adolescent Anxiety
A study testing Web-based single-session growth mindset intervention for adolescent anxiety in people with Anxiety Generalized, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
Anxiety disorders are the most common mental disorders worldwide. In Hong Kong, 7% of adolescents are diagnosed with anxiety disorders, and one in every four secondary school students reports clinical-level anxiety symptoms. However, 65% of them do not access services. Read more about this study
- Who is it for?
- Ages 12 to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety Generalized
- What is being tested?
- Web-based single-session growth mindset intervention for adolescent anxiety
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 731 participants
- Where
- 1 siteHong Kong
- Study dates
- 5 Dec 2022to 30 Jun 2023
- 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 12 to 20 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- secondary school students in grades 7-11;
- Chinese youth who can read and write Chinese;
- enough visual and auditory abilities to complete the intervention and assessment;
- ability to give assent to participate in the study.
Who cannot join
- no parental consent;
- inability to stay focused to complete the intervention which is approximately 45 minutes;
- intellectual disability or severe illness or pain that would lead to significant bias in students' health and mental health situation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Examination of Web-based Single-session Growth Mindset Interventions for Reducing Adolescent Anxiety: A Four-arm Cluster Randomized Controlled Trial
Anxiety disorders are the most common mental disorders worldwide. In Hong Kong, 7% of adolescents are diagnosed with anxiety disorders, and one in every four secondary school students reports clinical-level anxiety symptoms. However, 65% of them do not access services. Long waitlists in public services, the high cost of private services, or the fear of being stigmatized can hinder service access. The high prevalence of anxiety and low intervention uptake indicate a pressing need to develop timely, scalable, and potent interventions suitable for adolescents. Single-session interventions (SSIs) have the potential to be scalable interventions for diagnosable or subclinical psychopathology in adolescents. Providing precise and context-adapted intervention is the key to achieving intervention efficacy. This study aims to compare the effectiveness of four SSIs: Single-session Intervention of Growth Mindset for Anxiety (SIGMA), SIGMA with booster messages, SSI of Growth mindset of Personality (SSI-GP), and active control using support therapy (ST), in reducing adolescent anxiety. Adolescents (N=731, aged 12-20) from secondary schools have been randomized to one of the four intervention conditions: the SIGMA, SIGMA-BOOSTER, SSI-GP, or active control. The implementation of each intervention is approximately 45 minutes in length. Adolescent participants reported anxiety symptoms, depression symptoms, and suicidal/self-hurting thoughts (primary outcomes); perceived control, hopelessness, attitude toward help-seeking and psychological well-being (secondary outcomes) at pre-intervention, the 2-week and 8-week follow-up. A pilot test has confirmed the feasibility and acceptability of SIGMA among adolescents. We hypothesized that SIGMA (including SIGMA and SIGMA-BOOSTER) and SSI-GP will result in a larger reduction in anxiety symptoms than the control intervention. We also predict SIGMA (including SIGMA and SIGMA-BOOSTER) will be more effective than SSI-GP. We will use the intention-to-treat principle and generalised estimating equation models for data analysis. This study was conducted from December 2022 to June 2023, with results expected to be available by March 2024. This protocol introduces the implementation content and strategies of growth mindset SSIs among school students. The study will provide evidence on the efficacy of different growth mindset SSIs for adolescent anxiety. It will also establish implementation strategies for self-administrative SSIs among school students, which can serve as a pioneer implementation of a scalable and self-accessible brief intervention to improve the well-being of young people.
- Conditions
- Anxiety Generalized
- Being tested
- Web-based single-session growth mindset intervention for adolescent anxiety
- Medical subject headings
- Generalized Anxiety Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web-based single-session growth mindset intervention for adolescent anxietyBehavioural
This proposed study uses a four-arm, parallel group, cluster randomized controlled trial design to evaluate the efficacy of SIGMA compared to a web-based growth mindset SSI (SSI-GP) and an active web-based control programme. The concurrent parallel group structure assures that the different groups take part in their respective intervention at the same time.
| Study group | Role | What they receive |
|---|---|---|
| Single-session Intervention of Growth Mindset for Anxiety (SIGMA) | Experimental | The SIGMA intervention group adapts the SSI-GP protocol in two ways: (a) by introducing the growth mindset of negative emotions rather than personality and (b) providing experiential process of negative emotion change. SIGMA consists of five components: (a) an introduction to emotions and the brain for conveying a scientific understanding of emotion and growth mindset of negative emotions; (b) stories and testimonials from high-school-aged youths who described their beliefs that people's negative emotion states (e.g., anxiety, depression, and stress) are malleable, and how these mindsets influence their coping with anxiety; (c) emotion changing experience induced by short videos; (d) common questions and misconceptions about growth mindset; and (e) self-persuasion writing exercises in which the participants write notes to younger students about the growth mindset of negative emotion. Receives: Behavioral: Web-based single-session growth mindset intervention for adolescent anxiety |
| Single-session Intervention on growth mindset of personality (SSI-GP) | Experimental | The SSI-GP intervention group uses the intervention protocol of Project Personality. Two bilingual native English and Chinese speakers translated it into Chinese and made adaptations to better fit the local context. The SSI-GP consist of five components: (a) an introduction to the brain about the potential of neuroplasticity and behavioural change; (b) written testimonials from older, high-school-aged youths of their belief in change of personality; (c) additional vignettes written by older youths about how growth mindset of personality helped them succeed following setbacks; (d) overview of common questions and misconceptions about growth mindset; and (e) an exercise of writing notes to younger students about the malleability of people's personal traits. Receives: Behavioral: Web-based single-session growth mindset intervention for adolescent anxiety |
| Active control group: Support therapy (ST) | Active comparator | The control condition is a structurally similar web-based session of supportive therapy. The goals of supportive therapy are to encourage the client to identify and express feelings and to share their emotions-both positive and negative-with close others. The ST group does not teach or emphasize specific skills or beliefs. The active control group includes the same number of activities as do the SIGMA and SSI-GP interventions. Also, to mirror the intervention groups as closely as possible, supportive therapy includes vignettes written by similar school-aged youths, who describe times when they benefited from sharing their feelings with friends or family members. Receives: Behavioral: Web-based single-session growth mindset intervention for adolescent anxiety |
| SIGMA-BOOSTER | Experimental | The SIGMA-BOOSTER group receives the same intervention as the SIGMA group, the only difference is that the SIGMA-BOOSTER group receives booster messages with core intervention content every 2 weeks between the 2-week post-test and the 2-month follow-up survey, that is, a total of 5 weekly booster messages are sent to the SIGMA-BOOSTER group, which will help us determine the most effective way of implementing the intervention. Receives: Behavioral: Web-based single-session growth mindset intervention for adolescent anxiety |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety Symptoms
Anxiety symptoms measured by the Generalised Anxiety Disorder-7 (GAD-7) are the primary outcome. The GAD-7 scale includes seven items that assess whether anxiety symptoms have bothered the individual in the previous two weeks, ranging the frequency from 0 (not at all) to 3 (nearly every day). Example items were "Feeling nervous, anxious, or on edge", and "Not being able to stop or control worrying". GAD-7 is the self-rating scale and effectively reflects symptom severity in adolescents; it is highly correlated with clinician-administered ratings of anxiety symptoms. It is brief and suitable for self-report study. Cronbach's alpha was .93.
Measured: baseline
Anxiety Symptoms
Anxiety symptoms measured by the Generalised Anxiety Disorder-7 (GAD-7) are the primary outcome. The GAD-7 scale includes seven items that assess whether anxiety symptoms have bothered the individual in the previous two weeks, ranging the frequency from 0 (not at all) to 3 (nearly every day). Example items were "Feeling nervous, anxious, or on edge", and "Not being able to stop or control worrying". GAD-7 is the self-rating scale and effectively reflects symptom severity in adolescents; it is highly correlated with clinician-administered ratings of anxiety symptoms. It is brief and suitable for self-report study. Cronbach's alpha was .93.
Measured: 2-week post-intervention
Anxiety Symptoms
Anxiety symptoms measured by the Generalised Anxiety Disorder-7 (GAD-7) are the primary outcome. The GAD-7 scale includes seven items that assess whether anxiety symptoms have bothered the individual in the previous two weeks, ranging the frequency from 0 (not at all) to 3 (nearly every day). Example items were "Feeling nervous, anxious, or on edge", and "Not being able to stop or control worrying". GAD-7 is the self-rating scale and effectively reflects symptom severity in adolescents; it is highly correlated with clinician-administered ratings of anxiety symptoms. It is brief and suitable for self-report study. Cronbach's alpha was .93.
Measured: 8-week post-intervention
Depression, and suicidal/self-hurting thoughts
The Patient Health Questionnaire-9 (PHQ-9) is used to measure participants' depression level and suicidal/self-hurting thoughts. The PHQ-9 scale includes nine items that assessed whether the depression symptoms and suicidal/self-hurting thoughts have bothered the individual in the previous two weeks, ranging the frequency from 0 (not at all) to 3 (nearly every day). Depression level is indexed by the sum of the first 8 items, while the last item indicates the suicidal/self-hurting thoughts. Example items of the PHQ-9 were "Little interest or pleasure in doing things", "Feeling down, depressed or hopeless", and "Thoughts that you would be better off dead or of hurting yourself in some way".
Measured: baseline
Depression, and suicidal/self-hurting thoughts
The Patient Health Questionnaire-9 (PHQ-9) is used to measure participants' depression level and suicidal/self-hurting thoughts. The PHQ-9 scale includes nine items that assessed whether the depression symptoms and suicidal/self-hurting thoughts have bothered the individual in the previous two weeks, ranging the frequency from 0 (not at all) to 3 (nearly every day). Depression level is indexed by the sum of the first 8 items, while the last item indicates the suicidal/self-hurting thoughts. Example items of the PHQ-9 were "Little interest or pleasure in doing things", "Feeling down, depressed or hopeless", and "Thoughts that you would be better off dead or of hurting yourself in some way".
Measured: 2-week post-intervention
Depression, and suicidal/self-hurting thoughts
The Patient Health Questionnaire-9 (PHQ-9) is used to measure participants' depression level and suicidal/self-hurting thoughts. The PHQ-9 scale includes nine items that assessed whether the depression symptoms and suicidal/self-hurting thoughts have bothered the individual in the previous two weeks, ranging the frequency from 0 (not at all) to 3 (nearly every day). Depression level is indexed by the sum of the first 8 items, while the last item indicates the suicidal/self-hurting thoughts. Example items of the PHQ-9 were "Little interest or pleasure in doing things", "Feeling down, depressed or hopeless", and "Thoughts that you would be better off dead or of hurting yourself in some way".
Measured: 8-week post-intervention
Secondary outcomes (12)
Perceived control
The Anxiety Control Questionnaire-Emotion Control (ACQ-EC) is a 15-item questionnaire that measures how much perceived control participants have over their anxiety. It is one of the 3 validated subscales of the Anxiety Control questionnaire, and contains 5 items (e.g., I am able to control my level of anxiety), including one reversed item (i.e., When I am anxious, I find it hard to focus on anything other than my anxiety), rated from 0 (strongly disagree) to 5 (strongly agree). The scale has a well-validated factor structure in a non-clinically selected sample, is strongly associated with anxiety and depression symptoms, and has demonstrated good internal consistency in previous investigations. Cronbach's alpha was .73.
Measured: baseline
Perceived control
The Anxiety Control Questionnaire-Emotion Control (ACQ-EC) is a 15-item questionnaire that measures how much perceived control participants have over their anxiety. It is one of the 3 validated subscales of the Anxiety Control questionnaire, and contains 5 items (e.g., I am able to control my level of anxiety), including one reversed item (i.e., When I am anxious, I find it hard to focus on anything other than my anxiety), rated from 0 (strongly disagree) to 5 (strongly agree). The scale has a well-validated factor structure in a non-clinically selected sample, is strongly associated with anxiety and depression symptoms, and has demonstrated good internal consistency in previous investigations. Cronbach's alpha was .73.
Measured: 2-week post-intervention
Perceived control
The Anxiety Control Questionnaire-Emotion Control (ACQ-EC) is a 15-item questionnaire that measures how much perceived control participants have over their anxiety. It is one of the 3 validated subscales of the Anxiety Control questionnaire, and contains 5 items (e.g., I am able to control my level of anxiety), including one reversed item (i.e., When I am anxious, I find it hard to focus on anything other than my anxiety), rated from 0 (strongly disagree) to 5 (strongly agree). The scale has a well-validated factor structure in a non-clinically selected sample, is strongly associated with anxiety and depression symptoms, and has demonstrated good internal consistency in previous investigations. Cronbach's alpha was .73.
Measured: 8-week post-intervention
Hopelessness
The four-item helplessness subscale of the Demoralization Scale will be used to measure the participants' faith in the future. Each item scores on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree), and the mean of all 4 items is taken to measure the hopelessness, with a higher score meaning correspondingly higher level of hopelessness. An example item is "I feel hopeless". The Cronbach's alpha of the Chinese version of this helplessness subscale was .72.
Measured: baseline
Hopelessness
The four-item helplessness subscale of the Demoralization Scale will be used to measure the participants' faith in the future. Each item scores on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree), and the mean of all 4 items is taken to measure the hopelessness, with a higher score meaning correspondingly higher level of hopelessness. An example item is "I feel hopeless". The Cronbach's alpha of the Chinese version of this helplessness subscale was .72.
Measured: 2-week post-intervention
Hopelessness
The four-item helplessness subscale of the Demoralization Scale will be used to measure the participants' faith in the future. Each item scores on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree), and the mean of all 4 items is taken to measure the hopelessness, with a higher score meaning correspondingly higher level of hopelessness. An example item is "I feel hopeless". The Cronbach's alpha of the Chinese version of this helplessness subscale was .72.
Measured: 8-week post-intervention
Attitude towards seeking help
We use two items from the Attitude toward Seeking Counselling Help Assessment (ATSCHA) to measure participants' understanding of counselling and attitudes toward seeking counselling help. An example item is "If I believed I was having a mental breakdown, my first inclination would be to get professional attention". Cronbach's alpha was .72. We develop a brief scale including three items to assess participants' help-seeking behaviour. The three items are "when I encounter difficulties, I will not ask help from teachers", "when I encounter difficulties, I will not ask help from social workers/counsellors", and "Professional counseling and treatments can help people improve mental health". This scale will be rated on a 7-point Likert scale, from 1 (strongly disagree) to 7 (strongly agree).
Measured: baseline
Attitude towards seeking help
We use two items from the Attitude toward Seeking Counselling Help Assessment (ATSCHA) to measure participants' understanding of counselling and attitudes toward seeking counselling help. An example item is "If I believed I was having a mental breakdown, my first inclination would be to get professional attention". Cronbach's alpha was .72. We develop a brief scale including three items to assess participants' help-seeking behaviour. The three items are "when I encounter difficulties, I will not ask help from teachers", "when I encounter difficulties, I will not ask help from social workers/counsellors", and "Professional counseling and treatments can help people improve mental health". This scale will be rated on a 7-point Likert scale, from 1 (strongly disagree) to 7 (strongly agree).
Measured: 2-week post-intervention
Attitude towards seeking help
We use two items from the Attitude toward Seeking Counselling Help Assessment (ATSCHA) to measure participants' understanding of counselling and attitudes toward seeking counselling help. An example item is "If I believed I was having a mental breakdown, my first inclination would be to get professional attention". Cronbach's alpha was .72. We develop a brief scale including three items to assess participants' help-seeking behaviour. The three items are "when I encounter difficulties, I will not ask help from teachers", "when I encounter difficulties, I will not ask help from social workers/counsellors", and "Professional counseling and treatments can help people improve mental health". This scale will be rated on a 7-point Likert scale, from 1 (strongly disagree) to 7 (strongly agree).
Measured: 8-week post-intervention
Psychological wellbeing
The short version Warwick-Edinburgh Mental Well-being Scale (WEMWBS-14) will be used to measure the extent to which participants generally experience well-being states. The WEMWBS includes 14 items, scoring on a 5-pont Likert scale ranging from 1 (none of the time) to 5 (all of the time), the average of all 14 items indicates the well-being of the participants. Sample item is "I have been feeling optimistic about the future". Cronbach's alpha was .93.
Measured: baseline
Psychological wellbeing
The short version Warwick-Edinburgh Mental Well-being Scale (WEMWBS-14) will be used to measure the extent to which participants generally experience well-being states. The WEMWBS includes 14 items, scoring on a 5-pont Likert scale ranging from 1 (none of the time) to 5 (all of the time), the average of all 14 items indicates the well-being of the participants. Sample item is "I have been feeling optimistic about the future". Cronbach's alpha was .93.
Measured: 2-week post-intervention
Psychological wellbeing
The short version Warwick-Edinburgh Mental Well-being Scale (WEMWBS-14) will be used to measure the extent to which participants generally experience well-being states. The WEMWBS includes 14 items, scoring on a 5-pont Likert scale ranging from 1 (none of the time) to 5 (all of the time), the average of all 14 items indicates the well-being of the participants. Sample item is "I have been feeling optimistic about the future". Cronbach's alpha was .93.
Measured: 8-week post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2021
- Study start5 Dec 2022
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Anxiety GeneralizedStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 731 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05027880
- Sponsor's protocol ID
- HSEARS20201004001-01
- Status last verified
- Jan 2024
- First submitted
- 20 Aug 2021
- Last updated
- 5 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhu S, Hu Y, Qi D, Tse S, Chan KL, Sun J, Lee P. Effects of Web-Based Single-Session Growth Mindset Interventions for Reducing Adolescent Anxiety: Four-Armed Randomized Controlled Trial. JMIR Pediatr Parent. 2025 Apr 18;8:e63500. doi: 10.2196/63500.
PubMed 40249649Zhu S, Tse S, Chan KL, Lee P, Cheng Q, Sun J. Examination of Web-Based Single-Session Growth Mindset Interventions for Reducing Adolescent Anxiety: Study Protocol of a 3-Arm Cluster Randomized Controlled Trial. JMIR Res Protoc. 2023 Mar 17;12:e41758. doi: 10.2196/41758.
PubMed 36930199
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examination of Web-based Single-session Growth Mindset Interventions for Reducing Adolescent Anxiety: A Four-arm Cluster Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05027880
- Acronym / sponsor ID
- HSEARS20201004001-01
- Conditions
- Anxiety Generalized
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 731 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 5 Dec 2022 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 30 Aug 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.
Anxiety disorders are the most common mental disorders worldwide. In Hong Kong, 7% of adolescents are diagnosed with anxiety disorders, and one in every four secondary school students reports clinical-level anxiety symptoms. However, 65% of them do not access services. Long waitlists in public services, the high cost of private services, or the fear of being stigmatized can hinder service access. The high prevalence of anxiety and low intervention uptake indicate a pressing need to develop timely, scalable, and potent interventions suitable for adolescents. Single-session interventions (SSIs) have the potential to be scalable interventions for diagnosable or subclinical psychopathology in adolescents. Providing precise and context-adapted intervention is the key to achieving intervention efficacy. This study aims to compare the effectiveness of four SSIs: Single-session Intervention of Growth Mindset for Anxiety (SIGMA), SIGMA with booster messages, SSI of Growth mindset of Personality (SSI-GP), and active control using support therapy (ST), in reducing adolescent anxiety. Adolescents (N=731, aged 12-20) from secondary schools have been randomized to one of the four intervention conditions: the SIGMA, SIGMA-BOOSTER, SSI-GP, or active control. The implementation of each intervention is approximately 45 minutes in length. Adolescent participants reported anxiety symptoms, depression symptoms, and suicidal/self-hurting thoughts (primary outcomes); perceived control, hopelessness, attitude toward help-seeking and psychological well-being (secondary outcomes) at pre-intervention, the 2-week and 8-week follow-up. A pilot test has confirmed the feasibility and acceptability of SIGMA among adolescents. We hypothesized that SIGMA (including SIGMA and SIGMA-BOOSTER) and SSI-GP will result in a larger reduction in anxiety symptoms than the control intervention. We also predict SIGMA (including SIGMA and SIGMA-BOOSTER) will be more effective than SSI-GP. We will use the intention-to-treat principle and generalised estimating equation models for data analysis. This study was conducted from December 2022 to June 2023, with results expected to be available by March 2024. This protocol introduces the implementation content and strategies of growth mindset SSIs among school students. The study will provide evidence on the efficacy of different growth mindset SSIs for adolescent anxiety. It will also establish implementation strategies for self-administrative SSIs among school students, which can serve as a pioneer implementation of a scalable and self-accessible brief intervention to improve the well-being of young people.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Single-session Intervention of Growth Mindset for Anxiety (SIGMA) | Experimental | Behavioral: Web-based single-session growth mindset intervention for adolescent anxietyThe SIGMA intervention group adapts the SSI-GP protocol in two ways: (a) by introducing the growth mindset of negative emotions rather than personality and (b) providing experiential process of negative emotion change. SIGMA consists of five components: (a) an introduction to emotions and the brain for conveying a scientific understanding of emotion and growth mindset of negative emotions; (b) stories and testimonials from high-school-aged youths who described their beliefs that people's negative emotion states (e.g., anxiety, depression, and stress) are malleable, and how these mindsets influence their coping with anxiety; (c) emotion changing experience induced by short videos; (d) common questions and misconceptions about growth mindset; and (e) self-persuasion writing exercises in which the participants write notes to younger students about the growth mindset of negative emotion. |
| Single-session Intervention on growth mindset of personality (SSI-GP) | Experimental | Behavioral: Web-based single-session growth mindset intervention for adolescent anxietyThe SSI-GP intervention group uses the intervention protocol of Project Personality. Two bilingual native English and Chinese speakers translated it into Chinese and made adaptations to better fit the local context. The SSI-GP consist of five components: (a) an introduction to the brain about the potential of neuroplasticity and behavioural change; (b) written testimonials from older, high-school-aged youths of their belief in change of personality; (c) additional vignettes written by older youths about how growth mindset of personality helped them succeed following setbacks; (d) overview of common questions and misconceptions about growth mindset; and (e) an exercise of writing notes to younger students about the malleability of people's personal traits. |
| Active control group: Support therapy (ST) | Active comparator | Behavioral: Web-based single-session growth mindset intervention for adolescent anxietyThe control condition is a structurally similar web-based session of supportive therapy. The goals of supportive therapy are to encourage the client to identify and express feelings and to share their emotions-both positive and negative-with close others. The ST group does not teach or emphasize specific skills or beliefs. The active control group includes the same number of activities as do the SIGMA and SSI-GP interventions. Also, to mirror the intervention groups as closely as possible, supportive therapy includes vignettes written by similar school-aged youths, who describe times when they benefited from sharing their feelings with friends or family members. |
| SIGMA-BOOSTER | Experimental | Behavioral: Web-based single-session growth mindset intervention for adolescent anxietyThe SIGMA-BOOSTER group receives the same intervention as the SIGMA group, the only difference is that the SIGMA-BOOSTER group receives booster messages with core intervention content every 2 weeks between the 2-week post-test and the 2-month follow-up survey, that is, a total of 5 weekly booster messages are sent to the SIGMA-BOOSTER group, which will help us determine the most effective way of implementing the intervention. |
Who may qualify
- Ages
- 12 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- secondary school students in grades 7-11;
- Chinese youth who can read and write Chinese;
- enough visual and auditory abilities to complete the intervention and assessment;
- ability to give assent to participate in the study.
Key exclusion criteria (3 listed)
- no parental consent;
- inability to stay focused to complete the intervention which is approximately 45 minutes;
- intellectual disability or severe illness or pain that would lead to significant bias in students' health and mental health situation.
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 |
|---|---|---|
| Web-based single-session growth mindset intervention for adolescent anxietyThis proposed study uses a four-arm, parallel group, cluster randomized controlled trial design to evaluate the efficacy of SIGMA compared to a web-based growth mindset SSI (SSI-GP) and an active web-based control programme. The concurrent parallel group structure assures that the different groups take part in their respective intervention at the same time. | Behavioural | Active control group: Support therapy (ST), SIGMA-BOOSTER, Single-session Intervention of Growth Mindset for Anxiety (SIGMA), Single-session Intervention on growth mindset of personality (SSI-GP) |
Primary outcome
Anxiety Symptoms
Time frame: baseline
Anxiety symptoms measured by the Generalised Anxiety Disorder-7 (GAD-7) are the primary outcome. The GAD-7 scale includes seven items that assess whether anxiety symptoms have bothered the individual in the previous two weeks, ranging the frequency from 0 (not at all) to 3 (nearly every day). Example items were "Feeling nervous, anxious, or on edge", and "Not being able to stop or control worrying". GAD-7 is the self-rating scale and effectively reflects symptom severity in adolescents; it is highly correlated with clinician-administered ratings of anxiety symptoms. It is brief and suitable for self-report study. Cronbach's alpha was .93.
Anxiety Symptoms
Time frame: 2-week post-intervention
Anxiety symptoms measured by the Generalised Anxiety Disorder-7 (GAD-7) are the primary outcome. The GAD-7 scale includes seven items that assess whether anxiety symptoms have bothered the individual in the previous two weeks, ranging the frequency from 0 (not at all) to 3 (nearly every day). Example items were "Feeling nervous, anxious, or on edge", and "Not being able to stop or control worrying". GAD-7 is the self-rating scale and effectively reflects symptom severity in adolescents; it is highly correlated with clinician-administered ratings of anxiety symptoms. It is brief and suitable for self-report study. Cronbach's alpha was .93.
Anxiety Symptoms
Time frame: 8-week post-intervention
Anxiety symptoms measured by the Generalised Anxiety Disorder-7 (GAD-7) are the primary outcome. The GAD-7 scale includes seven items that assess whether anxiety symptoms have bothered the individual in the previous two weeks, ranging the frequency from 0 (not at all) to 3 (nearly every day). Example items were "Feeling nervous, anxious, or on edge", and "Not being able to stop or control worrying". GAD-7 is the self-rating scale and effectively reflects symptom severity in adolescents; it is highly correlated with clinician-administered ratings of anxiety symptoms. It is brief and suitable for self-report study. Cronbach's alpha was .93.
Depression, and suicidal/self-hurting thoughts
Time frame: baseline
The Patient Health Questionnaire-9 (PHQ-9) is used to measure participants' depression level and suicidal/self-hurting thoughts. The PHQ-9 scale includes nine items that assessed whether the depression symptoms and suicidal/self-hurting thoughts have bothered the individual in the previous two weeks, ranging the frequency from 0 (not at all) to 3 (nearly every day). Depression level is indexed by the sum of the first 8 items, while the last item indicates the suicidal/self-hurting thoughts. Example items of the PHQ-9 were "Little interest or pleasure in doing things", "Feeling down, depressed or hopeless", and "Thoughts that you would be better off dead or of hurting yourself in some way".
Depression, and suicidal/self-hurting thoughts
Time frame: 2-week post-intervention
The Patient Health Questionnaire-9 (PHQ-9) is used to measure participants' depression level and suicidal/self-hurting thoughts. The PHQ-9 scale includes nine items that assessed whether the depression symptoms and suicidal/self-hurting thoughts have bothered the individual in the previous two weeks, ranging the frequency from 0 (not at all) to 3 (nearly every day). Depression level is indexed by the sum of the first 8 items, while the last item indicates the suicidal/self-hurting thoughts. Example items of the PHQ-9 were "Little interest or pleasure in doing things", "Feeling down, depressed or hopeless", and "Thoughts that you would be better off dead or of hurting yourself in some way".
Depression, and suicidal/self-hurting thoughts
Time frame: 8-week post-intervention
The Patient Health Questionnaire-9 (PHQ-9) is used to measure participants' depression level and suicidal/self-hurting thoughts. The PHQ-9 scale includes nine items that assessed whether the depression symptoms and suicidal/self-hurting thoughts have bothered the individual in the previous two weeks, ranging the frequency from 0 (not at all) to 3 (nearly every day). Depression level is indexed by the sum of the first 8 items, while the last item indicates the suicidal/self-hurting thoughts. Example items of the PHQ-9 were "Little interest or pleasure in doing things", "Feeling down, depressed or hopeless", and "Thoughts that you would be better off dead or of hurting yourself in some way".
12 secondary outcomes
Perceived control
Time frame: baseline
Perceived control
Time frame: 2-week post-intervention
Perceived control
Time frame: 8-week post-intervention
Hopelessness
Time frame: baseline
Hopelessness
Time frame: 2-week post-intervention
Hopelessness
Time frame: 8-week post-intervention
Attitude towards seeking help
Time frame: baseline
Attitude towards seeking help
Time frame: 2-week post-intervention
Attitude towards seeking help
Time frame: 8-week post-intervention
Psychological wellbeing
Time frame: baseline
Psychological wellbeing
Time frame: 2-week post-intervention
Psychological wellbeing
Time frame: 8-week post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
- Derived from this study: PubMed 40249649Zhu S, Hu Y, Qi D, Tse S, Chan KL, Sun J, Lee P. Effects of Web-Based Single-Session Growth Mindset Interventions for Reducing Adolescent Anxiety: Four-Armed Randomized Controlled Trial. JMIR Pediatr Parent. 2025 Apr 18;8:e63500. doi: 10.2196/63500.
- Derived from this study: PubMed 36930199Zhu S, Tse S, Chan KL, Lee P, Cheng Q, Sun J. Examination of Web-Based Single-Session Growth Mindset Interventions for Reducing Adolescent Anxiety: Study Protocol of a 3-Arm Cluster Randomized Controlled Trial. JMIR Res Protoc. 2023 Mar 17;12:e41758. doi: 10.2196/41758.
- Individual participant dataSharing planned: No
Related trials for Anxiety Generalized
Not yet recruitingPhase 1
Microbiota Modulation for Psychiatry Patients
Depression - Major Depressive Disorder, Generalized Anxiety Disorder (GAD)
RecruitingPhase 3
A Trial of the Efficacy and Safety of Fixed Doses of SEP-363856 in Adults With Generalized Anxiety Disorder
Generalized Anxiety Disorder
Recruiting
Electroacupuncture for Generalized Anxiety Disorder: Clinical Efficacy and Neuroimaging Mechanisms
Generalized Anxiety Disorder
Recruiting
Neural Mechanisms of Real-world Emotions and Internalizing
Major Depression, Generalized Anxiety
Not yet recruiting
Miles for Mental Health
Generalized Anxiety Disorder (GAD), Depressive and Anxiety Disorders
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 Web-based single-session growth mindset intervention for adolescent anxiety in people with Anxiety Generalized, run by The Hong Kong Polytechnic University 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 4 inclusion and 3 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: finished, as of the sponsor's last update on 5 Jan 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Anxiety Symptoms (time frame: baseline). The study lists 6 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 NCT05027880, which also lists 2 linked publications.
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 Jan 2024.