Web-based Single-session Growth Mindset Intervention for Adolescent Anxiety

Study Overview
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Brief Summary
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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, the vast majority (65%) of them do not access services. Long waitlists in public services, the high cost of private services, or the fear of being stigmatized in school can hinder access to services. The high prevalence of anxiety and low intervention uptake indicates that there is a need to develop timely, scalable, and potent interventions suitable for adolescents. Growth mindset single-session interventions (SSIs) have the potential to be scalable interventions for diagnosable or subclinical psychopathology in adolescents. The key mechanism of effective SSIs is to provide precise intervention on the key aspect to trigger sudden gains and symptom reduction. The principal investigator's previous project (2019-2020) found a fixed mindset of negative emotion more closely related to anxiety than was a fixed mindset of personality. The findings provide strong support that intervention targeted on the fixed mindset of negative emotion can be a more precise intervention for adolescent anxiety than the existing SSI on growth mindset of personality (SSI-GP). The proposed study is to develop The Single-session Intervention of Growth Mindset for Anxiety (SIGMA) to teach adolescents that negative emotions can change and to compare its effectiveness in reducing anxiety to SSI-GP and an active control group with a three-arm randomized control trial. Adolescents (N=549, ages 12-16) from secondary schools will be randomised to one of three intervention conditions: the SIGMA, SSI-GP, or active control. All programs are approximately 40 minutes in length and self-administered by youth. Adolescents will be assessed for their anxiety symptoms (primary outcome), perceived control, hopelessness, and attitude towards help-seeking at pre-intervention, and 2-week and 8-week follow-up. A pilot test has confirmed the feasibility and acceptability of SIGMA among adolescents. The investigators hypothesised that SIGMA and SSI-GP will result in a larger reduction in anxiety symptoms than the control intervention at the end of treatment and follow-up period. The investigators also predict SIGMA will have a greater effect than SSI-GP. Intention-to-treat principle and linear regression-based maximum likelihood multi-level models will be used for data analysis. The project brings together experts in mindset research, local social work, web-based intervention, statistics, youth mental health studies, and psychiatry. This study will provide evidence on what matters in growth mindset interventions for adolescent anxiety and serve as a scalable and accessible intervention to improve the well-being of young people.

Official Title
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Web-based Single-session Growth Mindset Intervention for Adolescent Anxiety: A Three-arm Cluster Randomised Control Trial

Conditions
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Anxiety Generalized

Intervention / Treatment
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* Other: Web-based single-session growth mindset intervention for adolescent anxiety


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age between 12-16; 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. Exclusion Criteria: no parental consent; inability to stay focused to complete the intervention and survey 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.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single-session Intervention of Growth Mindset for Anxiety (SIGMA)<br>The SIGMA intervention group will adapt the SSI-GP protocol in two ways: (a) by introducing the growth mindset of emotions rather than personality and (b) providing an experiential process of negative emotion change. SIGMA also 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 emotion. | Other: Web-based single-session growth mindset intervention for adolescent anxiety<br>* This proposed study will use a three-arm, parallel group, randomized control trial design to evaluate the efficacy of SIGMA compared to both 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.<br>|
| Experimental: Single session on growth mindset of personality (SSI-GP)<br>The SSI-GP intervention group will use the intervention protocol of Project Personality (https://osf.io/a9uv2/). The investigators will translate it into Chinese using bilingual native English and Chinese speakers. The key potent elements of SSI-GP consist of five components [17, 40, 41]: (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 personality traits. | Other: Web-based single-session growth mindset intervention for adolescent anxiety<br>* This proposed study will use a three-arm, parallel group, randomized control trial design to evaluate the efficacy of SIGMA compared to both 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.<br>|
| Active Comparator: Active control group: Support therapy (ST)<br>The control condition will be 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. ST group does not teach or emphasize specific skills or beliefs. The active control group includes the same number of reading and writing activities as do the SIGMA and SSI-GP interventions. Also, to mirror the intervention groups as closely as possible, supportive therapy will include vignettes written by older, high-school-aged youths, who describe times when they benefited from sharing their feelings with friends or family members. | Other: Web-based single-session growth mindset intervention for adolescent anxiety<br>* This proposed study will use a three-arm, parallel group, randomized control trial design to evaluate the efficacy of SIGMA compared to both 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety Symptoms | Generalized Anxiety Disorder-7 (GAD-7) | baseline | 
| Anxiety Symptoms | Generalized Anxiety Disorder-7 (GAD-7) | 2-week post-intervention | 
| Anxiety Symptoms | Generalized Anxiety Disorder-7 (GAD-7) | 8-week post-intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perceived control | 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 4 items (e.g., I am able to control my level of anxiety) rated from 0 to 5. 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. | 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 4 items (e.g., I am able to control my level of anxiety) rated from 0 to 5. 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 4 items (e.g., I am able to control my level of anxiety) rated from 0 to 5. 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 Hopelessness Scale will be used to measure the participants' faith in the future. Each item scores on a 7-point Likert scale, 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 My future seems dark to me. Cronbach's alpha in the PI's ECS study was .74. | baseline | 
| Hopelessness | The four-item Hopelessness Scale will be used to measure the participants' faith in the future. Each item scores on a 7-point Likert scale, 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 My future seems dark to me. Cronbach's alpha in the PI's ECS study was .74. | 2-week post-intervention | 
| Hopelessness | The four-item Hopelessness Scale will be used to measure the participants' faith in the future. Each item scores on a 7-point Likert scale, 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 My future seems dark to me. Cronbach's alpha in the PI's ECS study was .74. | 8-week post-intervention | 
| Attitude towards seeking help | The Attitude toward Seeking Counselling Help Assessment (ATSCHA) will be used to measure participants' understanding of counselling and attitudes toward seeking counselling help. The ATSCHA includes 7 items, scoring on a 5-point Likert scale, the average of the 7 items is scored as an indicator of one's counselling attitude. 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. | baseline | 
| Attitude towards seeking help | The Attitude toward Seeking Counselling Help Assessment (ATSCHA) will be used to measure participants' understanding of counselling and attitudes toward seeking counselling help. The ATSCHA includes 7 items, scoring on a 5-point Likert scale, the average of the 7 items is scored as an indicator of one's counselling attitude. 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. | 2-week post-intervention | 
| Attitude towards seeking help | The Attitude toward Seeking Counselling Help Assessment (ATSCHA) will be used to measure participants' understanding of counselling and attitudes toward seeking counselling help. The ATSCHA includes 7 items, scoring on a 5-point Likert scale, the average of the 7 items is scored as an indicator of one's counselling attitude. 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. | 8-week post-intervention | 
| Psychological wellbeing | The Warwick-Edinburgh Mental Well-being Scale (WEMWBS-14) will be used to measure the extent to which participants generally experience wellbeing states. The WEMWBS includes 14 items, scoring on 5-pont Likert scale, the average of all 14 items indicates the wellbeing of the participants. Sample item is I have been feeling optimistic about the future. Cronbach's alpha was .93. | baseline | 
| Psychological wellbeing | The Warwick-Edinburgh Mental Well-being Scale (WEMWBS-14) will be used to measure the extent to which participants generally experience wellbeing states. The WEMWBS includes 14 items, scoring on 5-pont Likert scale, the average of all 14 items indicates the wellbeing 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 Warwick-Edinburgh Mental Well-being Scale (WEMWBS-14) will be used to measure the extent to which participants generally experience wellbeing states. The WEMWBS includes 14 items, scoring on 5-pont Likert scale, the average of all 14 items indicates the wellbeing of the participants. Sample item is I have been feeling optimistic about the future. Cronbach's alpha was .93. | 8-week post-intervention |