COMBO ConditionNCT05333848
Effects of Internet-based Storytelling Programs in Reducing Mental Illness Stigma With Mediation by Interactivity and Stigma Content
A study testing Internet-based storytelling programs with interactivity and stigma content, Internet-based storytelling programs with stigma content only and Internet-based storytelling programs with interactivity only in people with COMBO Condition and STIGMA Condition, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
Mental illness stigma has been a concerning issue globally due to its adverse effects on the recovery of people with mental illness and may delay help-seeking for mental health out of the concern of being stigmatized. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COMBO Condition, STIGMA Condition, INTERACT Condition
- What is being tested?
- Internet-based storytelling programs with interactivity and stigma content, Internet-based storytelling programs with stigma content only and Internet-based storytelling programs with interactivity only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 263 participants
- Where
- 1 siteHong Kong
- Study dates
- 27 Dec 2020to 4 Mar 2021
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- aged 18 years or above
- able to read and understand Chinese
Who cannot join
- less than 18 years of age
- unable to read or understand Chinese
Trial locations and contacts
1 site in 1 country.
About this study
Mental illness stigma has been a concerning issue globally due to its adverse effects on the recovery of people with mental illness and may delay help-seeking for mental health out of the concern of being stigmatized. With technological advancement, Internet-based mental health stigma reduction interventions have been developed to combat mental illness stigma and the effects have been promising.
The present study aimed to examine the differential effects of Internet-based storytelling programs varied on level of interactivity and stigma content in reducing mental illness stigma.
In the present study, the investigator hypothesized that an Internet-based storytelling program with a combination of interactivity and stigma content would lead to the most significant reduction in public stigma, microaggression, and social distance from people with mental illnesses, followed by Internet-based storytelling program with stigma content-only and interactivity-only, compared with control. Secondly, the investigator hypothesized that the effects observed in stigma reduction would be mediated by perceived autonomy and immersiveness due to the presence of interactivity.
- Being tested
- Internet-based storytelling programs with interactivity and stigma content, Internet-based storytelling programs with stigma content only, Internet-based storytelling programs with interactivity only, Internet-based storytelling programs with no interactivity and no stigma content
- Keywords
- mental illness stigma, Internet-based, interactivity, storytelling, social distance, microaggression
- Medical subject headings
- Microaggression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-based storytelling programs with interactivity and stigma contentBehavioural
Participants viewed an interactive stigma content website. Within 10 minutes post-experiment, participants completed the post-experiment questionnaire. One week after the experiment, participants completed the follow-up questionnaire.
Internet-based storytelling programs with stigma content onlyBehavioural
Participants viewed a non-interactive stigma content website. Within 10 minutes post-experiment, participants completed the post-experiment questionnaire. One week after the experiment, participants completed the follow-up questionnaire.
Internet-based storytelling programs with interactivity onlyBehavioural
Participants viewed an interactive non-stigma content website. Within 10 minutes post-experiment, participants completed the post-experiment questionnaire. One week after the experiment, participants completed the follow-up questionnaire.
Internet-based storytelling programs with no interactivity and no stigma contentBehavioural
Participants viewed a non-interactive non-stigma content website. Within 10 minutes post-experiment, participants completed the post-experiment questionnaire. One week after the experiment, participants completed the follow-up questionnaire.
| Study group | Role | What they receive |
|---|---|---|
| COMBO condition | Experimental | An interactive stigma content website. Receives: Behavioral: Internet-based storytelling programs with interactivity and stigma content |
| STIGMA condition | Experimental | A non-interactive stigma content website. Receives: Behavioral: Internet-based storytelling programs with stigma content only |
| INTERACT condition | Experimental | An interactive non-stigma content website. Receives: Behavioral: Internet-based storytelling programs with interactivity only |
| CONTROL condition | Placebo comparator | A non-interactive non-stigma content website. Receives: Behavioral: Internet-based storytelling programs with no interactivity and no stigma content |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Public Stigma towards People with Mental Illness within 10 minutes post-experiment, and at 1-week follow-up
The 21-item Public Stigma Scale-Mental Illness-Short Version was used to assess mental illness public stigma and personal advocacy. Each item was rated on a 6-point Likert scale from 1 (strongly disagree) to 6 (strongly agree). Reverse scoring was done for personal advocacy items. Higher scores indicated a higher level of public stigma towards people with mental illness.
Measured: baseline, within 10 minutes post-experiment, and 1-week follow-up
Change from Baseline Microaggression within 10 minutes post-experiment, and at 1-week follow-up
Microaggression was measured by the 17-item Mental Illness Microaggressions Scale, which covers assumption of inferiority, patronization, and fear of mental illness. Each item was rated on a 4-point Likert scale from 1 (strongly disagree) to 4 (strongly agree). Higher scores indicated a higher level of mircroaggression.
Measured: baseline, within 10 minutes post-experiment, and 1-week follow-up
Change from Baseline Social Distance from People with Mental Illness within 10 minutes post-experiment, and at 1-week follow-up
The 8-item Social Distancing Scale was used to measure the social distance from people with mental illnesses. Each item was rated on a 6-point Likert scale from 1 (very willing) to 6 (very unwilling). Higher scores indicated a higher level of social distance from people with mental illness.
Measured: baseline, within 10 minutes post-experiment, and 1-week follow-up
Perceived autonomy
To assess perceived autonomy of the Web page experience, the 10-item Self Determination Scale (SDS) was used in the post-experiment questionnaire. Each item was a pair of opposite statements, where participants rated their level of perceived choice and self-awareness with a slider from 1 (only A feels true) to 5 (only B feels true). Higher scores indicated a higher level of perceived autonomy.
Measured: within 10 minutes post-experiment
Immersiveness
The 15-item Transportation Scale was used to assess participants' immersiveness in the Web experience. It had a 4-point Likert scale from 1 (very much) to 4 (not at all). Items 2, 5 and 9 were framed negatively. All the items are scored in the direction that higher scores indicated a higher level of immersivenss.
Measured: within 10 minutes post-experiment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2022
- Study start27 Dec 2020
- Primary completion4 Mar 2021
- Study completion4 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COMBO ConditionStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- A 2x2 factorial design randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 263 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hiu Ching Tiffany Fong, Chinese University of Hong Kong
- Investigators
- Winnie Wing-Sze Mak, PhD, Study chair, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05333848
- Sponsor's protocol ID
- dre20024
- Status last verified
- Apr 2022
- First submitted
- 31 Mar 2022
- Last updated
- 19 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The identifiable personal information collected will be de-linked from the research data and stored separately. The research data will receive a unique number that cannot be traced back to the individuals. All information obtained in the course of this experiment will be used for research purposes only; it will be protected and kept confidential by the researchers of this project and not be shared with a third party unless forced by law. The identifiable information will be destroyed after data analysis and reporting.
Publications
Fong THC, Mak WWS. The Effects of Internet-Based Storytelling Programs (Amazing Adventure Against Stigma) in Reducing Mental Illness Stigma With Mediation by Interactivity and Stigma Content: Randomized Controlled Trial. J Med Internet Res. 2022 Aug 12;24(8):e37973. doi: 10.2196/37973.
PubMed 35969460
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Internet-based Storytelling Programs in Reducing Mental Illness Stigma With Mediation by Interactivity and Stigma Content
- ClinicalTrials.gov ID
- NCT05333848
- Acronym / sponsor ID
- dre20024
- Keywords
- mental illness stigma, Internet-based, interactivity, storytelling, social distance, microaggression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 263 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 27 Dec 2020 (actual)
- Primary completion
- 4 Mar 2021 (actual)
- Study completion
- 4 Mar 2021 (actual)
- First posted
- 19 Apr 2022 (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.
Mental illness stigma has been a concerning issue globally due to its adverse effects on the recovery of people with mental illness and may delay help-seeking for mental health out of the concern of being stigmatized. With technological advancement, Internet-based mental health stigma reduction interventions have been developed to combat mental illness stigma and the effects have been promising.
The present study aimed to examine the differential effects of Internet-based storytelling programs varied on level of interactivity and stigma content in reducing mental illness stigma.
In the present study, the investigator hypothesized that an Internet-based storytelling program with a combination of interactivity and stigma content would lead to the most significant reduction in public stigma, microaggression, and social distance from people with mental illnesses, followed by Internet-based storytelling program with stigma content-only and interactivity-only, compared with control. Secondly, the investigator hypothesized that the effects observed in stigma reduction would be mediated by perceived autonomy and immersiveness due to the presence of interactivity.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- A 2x2 factorial design randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| COMBO condition | Experimental | Behavioral: Internet-based storytelling programs with interactivity and stigma contentAn interactive stigma content website. |
| STIGMA condition | Experimental | Behavioral: Internet-based storytelling programs with stigma content onlyA non-interactive stigma content website. |
| INTERACT condition | Experimental | Behavioral: Internet-based storytelling programs with interactivity onlyAn interactive non-stigma content website. |
| CONTROL condition | Placebo comparator | Behavioral: Internet-based storytelling programs with no interactivity and no stigma contentA non-interactive non-stigma content website. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- aged 18 years or above
- able to read and understand Chinese
Key exclusion criteria (2 listed)
- less than 18 years of age
- unable to read or understand Chinese
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 |
|---|---|---|
| Internet-based storytelling programs with interactivity and stigma contentParticipants viewed an interactive stigma content website. Within 10 minutes post-experiment, participants completed the post-experiment questionnaire. One week after the experiment, participants completed the follow-up questionnaire. | Behavioural | COMBO condition |
| Internet-based storytelling programs with stigma content onlyParticipants viewed a non-interactive stigma content website. Within 10 minutes post-experiment, participants completed the post-experiment questionnaire. One week after the experiment, participants completed the follow-up questionnaire. | Behavioural | STIGMA condition |
| Internet-based storytelling programs with interactivity onlyParticipants viewed an interactive non-stigma content website. Within 10 minutes post-experiment, participants completed the post-experiment questionnaire. One week after the experiment, participants completed the follow-up questionnaire. | Behavioural | INTERACT condition |
| Internet-based storytelling programs with no interactivity and no stigma contentParticipants viewed a non-interactive non-stigma content website. Within 10 minutes post-experiment, participants completed the post-experiment questionnaire. One week after the experiment, participants completed the follow-up questionnaire. | Behavioural | CONTROL condition |
Primary outcome
Change from Baseline Public Stigma towards People with Mental Illness within 10 minutes post-experiment, and at 1-week follow-up
Time frame: baseline, within 10 minutes post-experiment, and 1-week follow-up
The 21-item Public Stigma Scale-Mental Illness-Short Version was used to assess mental illness public stigma and personal advocacy. Each item was rated on a 6-point Likert scale from 1 (strongly disagree) to 6 (strongly agree). Reverse scoring was done for personal advocacy items. Higher scores indicated a higher level of public stigma towards people with mental illness.
Change from Baseline Microaggression within 10 minutes post-experiment, and at 1-week follow-up
Time frame: baseline, within 10 minutes post-experiment, and 1-week follow-up
Microaggression was measured by the 17-item Mental Illness Microaggressions Scale, which covers assumption of inferiority, patronization, and fear of mental illness. Each item was rated on a 4-point Likert scale from 1 (strongly disagree) to 4 (strongly agree). Higher scores indicated a higher level of mircroaggression.
Change from Baseline Social Distance from People with Mental Illness within 10 minutes post-experiment, and at 1-week follow-up
Time frame: baseline, within 10 minutes post-experiment, and 1-week follow-up
The 8-item Social Distancing Scale was used to measure the social distance from people with mental illnesses. Each item was rated on a 6-point Likert scale from 1 (very willing) to 6 (very unwilling). Higher scores indicated a higher level of social distance from people with mental illness.
Perceived autonomy
Time frame: within 10 minutes post-experiment
To assess perceived autonomy of the Web page experience, the 10-item Self Determination Scale (SDS) was used in the post-experiment questionnaire. Each item was a pair of opposite statements, where participants rated their level of perceived choice and self-awareness with a slider from 1 (only A feels true) to 5 (only B feels true). Higher scores indicated a higher level of perceived autonomy.
Immersiveness
Time frame: within 10 minutes post-experiment
The 15-item Transportation Scale was used to assess participants' immersiveness in the Web experience. It had a 4-point Likert scale from 1 (very much) to 4 (not at all). Items 2, 5 and 9 were framed negatively. All the items are scored in the direction that higher scores indicated a higher level of immersivenss.
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 19 Apr 2022.
- Derived from this study: PubMed 35969460Fong THC, Mak WWS. The Effects of Internet-Based Storytelling Programs (Amazing Adventure Against Stigma) in Reducing Mental Illness Stigma With Mediation by Interactivity and Stigma Content: Randomized Controlled Trial. J Med Internet Res. 2022 Aug 12;24(8):e37973. doi: 10.2196/37973.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. The identifiable personal information collected will be de-linked from the research data and stored separately. The research data will receive a unique number that cannot be traced back to the individuals. All information obtained in the course of this experiment will be used for research purposes only; it will be protected and kept confidential by the researchers of this project and not be shared with a third party unless forced by law. The identifiable information will be destroyed after data analysis and reporting.
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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.
Winnie Wing-Sze Mak, PhD study chair
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet-based storytelling programs with interactivity and stigma content, Internet-based storytelling programs with stigma content only and Internet-based storytelling programs with interactivity only in people with COMBO Condition and STIGMA Condition, run by Chinese University of Hong Kong 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 2 inclusion and 2 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 19 Apr 2022. 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. Some participants in this study may receive a placebo. 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?
Change from Baseline Public Stigma towards People with Mental Illness within 10 minutes post-experiment, and at 1-week follow-up (time frame: baseline, within 10 minutes post-experiment, and 1-week follow-up). The study lists 5 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 NCT05333848, which also lists 1 linked publication.
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 19 Apr 2022.