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

Primary Purpose

Anxiety Generalized

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Web-based single-session growth mindset intervention for adolescent anxiety
Sponsored by
The Hong Kong Polytechnic University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Anxiety Generalized

Eligibility Criteria

12 Years - 16 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. age between 12-16;
  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 and survey 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Active Comparator

    Arm Label

    Single-session Intervention of Growth Mindset for Anxiety (SIGMA)

    Single session on growth mindset of personality (SSI-GP)

    Active control group: Support therapy (ST)

    Arm Description

    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.

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Anxiety Symptoms
    Generalized Anxiety Disorder-7 (GAD-7)
    Anxiety Symptoms
    Generalized Anxiety Disorder-7 (GAD-7)
    Anxiety Symptoms
    Generalized Anxiety Disorder-7 (GAD-7)

    Secondary Outcome Measures

    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.

    Full Information

    First Posted
    August 20, 2021
    Last Updated
    August 7, 2022
    Sponsor
    The Hong Kong Polytechnic University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05027880
    Brief Title
    Web-based Single-session Growth Mindset Intervention for Adolescent Anxiety
    Official Title
    Web-based Single-session Growth Mindset Intervention for Adolescent Anxiety: A Three-arm Cluster Randomised Control Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 1, 2022 (Anticipated)
    Primary Completion Date
    December 31, 2023 (Anticipated)
    Study Completion Date
    December 31, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    The Hong Kong Polytechnic University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Anxiety Generalized

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    549 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Single-session Intervention of Growth Mindset for Anxiety (SIGMA)
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Single session on growth mindset of personality (SSI-GP)
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Active control group: Support therapy (ST)
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Web-based single-session growth mindset intervention for adolescent anxiety
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Anxiety Symptoms
    Description
    Generalized Anxiety Disorder-7 (GAD-7)
    Time Frame
    baseline
    Title
    Anxiety Symptoms
    Description
    Generalized Anxiety Disorder-7 (GAD-7)
    Time Frame
    2-week post-intervention
    Title
    Anxiety Symptoms
    Description
    Generalized Anxiety Disorder-7 (GAD-7)
    Time Frame
    8-week post-intervention
    Secondary Outcome Measure Information:
    Title
    Perceived control
    Description
    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.
    Time Frame
    baseline
    Title
    Perceived control
    Description
    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.
    Time Frame
    2-week post-intervention
    Title
    Perceived control
    Description
    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.
    Time Frame
    8-week post-intervention
    Title
    Hopelessness
    Description
    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.
    Time Frame
    baseline
    Title
    Hopelessness
    Description
    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.
    Time Frame
    2-week post-intervention
    Title
    Hopelessness
    Description
    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.
    Time Frame
    8-week post-intervention
    Title
    Attitude towards seeking help
    Description
    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.
    Time Frame
    baseline
    Title
    Attitude towards seeking help
    Description
    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.
    Time Frame
    2-week post-intervention
    Title
    Attitude towards seeking help
    Description
    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.
    Time Frame
    8-week post-intervention
    Title
    Psychological wellbeing
    Description
    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.
    Time Frame
    baseline
    Title
    Psychological wellbeing
    Description
    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.
    Time Frame
    2-week post-intervention
    Title
    Psychological wellbeing
    Description
    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.
    Time Frame
    8-week post-intervention

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    12 Years
    Maximum Age & Unit of Time
    16 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Shimin Zhu, PHD
    Phone
    +85251187809
    Email
    jasmine.zhu@polyu.edu.hk

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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