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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Active control group: Support therapy (ST) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Web-based single-session growth mindset intervention for adolescent anxiety | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 8-week post-intervention |
| Depression, and suicidal/self-hurting thoughts |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Hong Kong Polytechnic University | Hong Kong | Hong Kong |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40249649 | Derived | 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. | |
| 36930199 | Derived | Zhu 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. |
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| ID | Term |
|---|---|
| D000098647 | Generalized Anxiety Disorder |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
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| 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. |
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| 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. |
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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". |
| 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". | 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". | 8-week post-intervention |
| 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. | 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. | 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. | 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. | 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. | 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). | 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). | 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). | 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. | 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. | 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. | 8-week post-intervention |