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

Anxiety Generalized Clinical Trial

Official title:

Examination of Web-based Single-session Growth Mindset Interventions for Reducing Adolescent Anxiety: A Four-arm Cluster Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05027880
• Other study ID #: HSEARS20201004001-01
• Status: Completed
• Phase: N/A
• Start date: December 5, 2022
• Est. completion date: June 30, 2023

Study information

• Verified date: January 2024
• Source: The Hong Kong Polytechnic University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 731
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 20 Years

Eligibility

Inclusion Criteria:

1. secondary school students in grades 7-11;

2. Chinese youth who can read and write Chinese;

3. enough visual and auditory abilities to complete the intervention and assessment;

4. ability to give assent to participate in the study.

Exclusion Criteria:

1. no parental consent;

2. inability to stay focused to complete the intervention which is approximately 45 minutes;

3. intellectual disability or severe illness or pain that would lead to significant bias in students' health and mental health situation.

Related Conditions & MeSH terms

• Anxiety Disorders
• Anxiety Generalized

Intervention

Behavioral:
• Web-based single-session growth mindset intervention for adolescent anxiety
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.

Locations

Country	Name	City	State
Hong Kong	The Hong Kong Polytechnic University	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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".	baseline
Primary	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
Primary	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
Secondary	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.	baseline
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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