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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06222528
Other study ID # 8317
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 31, 2024
Est. completion date July 2024

Study information

Verified date May 2024
Source New York State Psychiatric Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Depression is a leading cause of illness and disability in teenagers. Longer duration of untreated depression (DUD) is associated with greater severity, poorer outcome, and cognitive impairment. Stigma toward people with depression has been identified as a barrier to seeking help; therefore, reducing stigma toward young people at depressive risk could enhance their receptivity to seeking treatment. Social contact is a form of interpersonal contact with members of the stigmatized group and the most effective type of intervention for improvement in stigma-related knowledge and attitudes. In a prior study, the investigators developed short video interventions to reduce stigma and increase treatment seeking among adolescents with depression. The videos feature adolescent protagonists varied by race/ethncitiy and gender (Black girl, Black boy, White girl, White boy, Hispanic girl, Hispanic boy, nonbinary or transgender adolescent) who will share their experiences with depression, challenges, and recovery process. The investigators would like to conduct a randomized controlled trial (RCT) to test the efficacy of these tailored videos as compared to a video control condition (which provides information about depression and how to seek help but does not include a personal story) on reducing self-stigma and increasing help-seeking intentions and behavior at baseline, post, 2 week follow-up, and 4 week follow-up among adolescents ages 14-18 recruited via Cloudresearch. The videos will be shown again at 2 week follow-up.


Description:

In a randomized control trial (RCT) with pre-, post-intervention, and 2 and 4 week follow-up assessments, the investigators aim to test the efficacy of brief social contact video interventions, varying protagonist race/ethnicity, as compared to video control in reducing depression related stigma and increasing treatment-seeking intentions and behavior among adolescents ages 14-18 recruited via Cloudresearch, a crowdsourcing platform. The control condition will include a video that will provide information about depression and how to seek help but does not include a personal story. The tailored video interventions will be assigned based on participant demographics and will include adolescent protagonists varied by race/ethnicity and gender (Black girl, Black boy, White girl, White boy, Hispanic girl, Hispanic boy, nonbinary or transgender adolescent). Videos will be shown at baseline and 2 week follow-up. The investigators hypothesize that 1) Brief social contact-based video interventions will reduce stigma towards depression and increase treatment-seeking intentions and behavior compared to video control which provides information about depression and help seeking but does not include a personal story.


Recruitment information / eligibility

Status Recruiting
Enrollment 1200
Est. completion date July 2024
Est. primary completion date July 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 14 Years to 18 Years
Eligibility Inclusion Criteria: - Ages 14-18 - English speaking - US Residents Exclusion Criteria: - Age less than 14 or greater than 18 - Non-English speaking - Non-US Resident

Study Design


Intervention

Behavioral:
Brief video intervention (Black Girl)
A brief social contact-based video. The video presented a young Black girl, a professional actor, sharing her scripted personal story of struggles with depression and raising themes of recovery and hope.
Brief video intervention (Black Boy)
A brief social contact-based video. The video presented a young Black boy, a professional actor, sharing his scripted personal story of struggles with depression and raising themes of recovery and hope.
Brief video intervention (Latinx Girl)
A brief social contact-based video. The video presented a young Latinx girl, a professional actor, sharing her scripted personal story of struggles with depression and raising themes of recovery and hope.
Brief video intervention (Latinx Boy)
A brief social contact-based video. The video presented a young Latinx boy, a professional actor, sharing his scripted personal story of struggles with depression and raising themes of recovery and hope.
Brief video intervention (White Girl)
A brief social contact-based video. The video presented a young White girl, a professional actor, sharing her scripted personal story of struggles with depression and raising themes of recovery and hope.
Brief video intervention (White Boy)
A brief social contact-based video. The video presented a young White boy, a professional actor, sharing his scripted personal story of struggles with depression and raising themes of recovery and hope.
Brief video intervention (Nonbinary or transgender)
A brief social contact-based video. The video presented a young nonbinary or transgender adolescent, a professional actor, sharing their scripted personal story of struggles with depression and raising themes of recovery and hope.
Control Condition
A video that will provide information about depression and how to seek help but does not include a personal story.

Locations

Country Name City State
United States New York State Psychiatric Institute New York New York

Sponsors (1)

Lead Sponsor Collaborator
New York State Psychiatric Institute

Country where clinical trial is conducted

United States, 

References & Publications (5)

Brenner RE, Colvin KF, Hammer JH, Vogel DL. Using Item Response Theory to Develop Revised (SSOSH-7) and Ultra-Brief (SSOSH-3) Self-Stigma of Seeking Help Scales. Assessment. 2021 Jul;28(5):1488-1499. doi: 10.1177/1073191120958496. Epub 2020 Sep 25. — View Citation

Clement S, Brohan E, Jeffery D, Henderson C, Hatch SL, Thornicroft G. Development and psychometric properties the Barriers to Access to Care Evaluation scale (BACE) related to people with mental ill health. BMC Psychiatry. 2012 Jun 20;12:36. doi: 10.1186/1471-244X-12-36. — View Citation

de Vreede T, Andel SA, de Vreede GJ, Spector P, Singh V, Padmanabhan B. What is engagement and how do we measure it? Toward a domain independent definition and scale. Proceedings of the 52nd Hawaii International Conference on System Sciences. 2019, Hawaii. p. 749-758.

Elhai JD, Schweinle W, Anderson SM. Reliability and validity of the Attitudes Toward Seeking Professional Psychological Help Scale-Short Form. Psychiatry Res. 2008 Jun 30;159(3):320-9. doi: 10.1016/j.psychres.2007.04.020. Epub 2008 Apr 22. — View Citation

Griffiths KM, Christensen H, Jorm AF, Evans K, Groves C. Effect of web-based depression literacy and cognitive-behavioural therapy interventions on stigmatising attitudes to depression: randomised controlled trial. Br J Psychiatry. 2004 Oct;185:342-9. doi: 10.1192/bjp.185.4.342. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Depression Stigma The Depression Stigma Scale (DSS) is a self-report scale comprised of two 9-item subscales measuring participants' personal beliefs about depression and participants' beliefs about others' attitudes (Griffiths et al., 2004). The current study will only utilize the personal beliefs subscale. Each item is rated on a 5-point Likert scale ranging from strongly disagree (1) to strongly agree (5). Scores range from 9 to 45. Higher scores indicate more stigma. Baseline
Primary Depression Stigma The Depression Stigma Scale (DSS) is a self-report scale comprised of two 9-item subscales measuring participants' personal beliefs about depression and participants' beliefs about others' attitudes (Griffiths et al., 2004). The current study will only utilize the personal beliefs subscale. Each item is rated on a 5-point Likert scale ranging from strongly disagree (1) to strongly agree (5). Scores range from 9 to 45. Higher scores indicate more stigma. Post (immediately after the videos are shown)
Primary Depression Stigma The Depression Stigma Scale (DSS) is a self-report scale comprised of two 9-item subscales measuring participants' personal beliefs about depression and participants' beliefs about others' attitudes (Griffiths et al., 2004). The current study will only utilize the personal beliefs subscale. Each item is rated on a 5-point Likert scale ranging from strongly disagree (1) to strongly agree (5). Scores range from 9 to 45. Higher scores indicate more stigma. 2 week follow-up
Primary Depression Stigma The Depression Stigma Scale (DSS) is a self-report scale comprised of two 9-item subscales measuring participants' personal beliefs about depression and participants' beliefs about others' attitudes (Griffiths et al., 2004). The current study will only utilize the personal beliefs subscale. Each item is rated on a 5-point Likert scale ranging from strongly disagree (1) to strongly agree (5). Scores range from 9 to 45. Higher scores indicate more stigma. 4 week follow-up
Primary Attitude Towards Seeking Professional Psychological Help Treatment seeking intentions will be measured using three items from the Attitudes Towards Seeking Professional Psychological Help Scale (ATSPPHS) Scale (Elhai et al., 2008). Items include: 'I might want to have psychological counselling in the future', 'I would want to get psychological help if I were worried or upset for a long period of time' and 'A person with an emotional problem is not likely to solve it alone; he or she is more likely to solve it with professional help'. Responses range from 1 (disagree) to 4 (agree). Total scores range from 3 to 12 with higher scores indicating higher treatment seeking intentions. Baseline
Primary Attitude Towards Seeking Professional Psychological Help Treatment seeking intentions will be measured using three items from the Attitudes Towards Seeking Professional Psychological Help Scale (ATSPPHS) Scale (Elhai et al., 2008). Items include: 'I might want to have psychological counselling in the future', 'I would want to get psychological help if I were worried or upset for a long period of time' and 'A person with an emotional problem is not likely to solve it alone; he or she is more likely to solve it with professional help'. Responses range from 1 (disagree) to 4 (agree). Total scores range from 3 to 12 with higher scores indicating higher treatment seeking intentions. Post (immediately after the videos are shown)
Primary Attitude Towards Seeking Professional Psychological Help Treatment seeking intentions will be measured using three items from the Attitudes Towards Seeking Professional Psychological Help Scale (ATSPPHS) Scale (Elhai et al., 2008). Items include: 'I might want to have psychological counselling in the future', 'I would want to get psychological help if I were worried or upset for a long period of time' and 'A person with an emotional problem is not likely to solve it alone; he or she is more likely to solve it with professional help'. Responses range from 1 (disagree) to 4 (agree). Total scores range from 3 to 12 with higher scores indicating higher treatment seeking intentions. 2 week follow-up
Primary Attitude Towards Seeking Professional Psychological Help Treatment seeking intentions will be measured using three items from the Attitudes Towards Seeking Professional Psychological Help Scale (ATSPPHS) Scale (Elhai et al., 2008). Items include: 'I might want to have psychological counselling in the future', 'I would want to get psychological help if I were worried or upset for a long period of time' and 'A person with an emotional problem is not likely to solve it alone; he or she is more likely to solve it with professional help'. Responses range from 1 (disagree) to 4 (agree). Total scores range from 3 to 12 with higher scores indicating higher treatment seeking intentions. 4 week follow-up
Secondary Emotional engagement Emotional engagement will be measured using the Emotional Engagement Scale (de Vreede et al., 2019). The scale includes three items asking about emotional engagement (e.g., "I care about the contents of this video"), and response choices range from 1 (strongly disagree) to 4 (strongly agree). Total scores range from 3 to 12, with higher scores indicating greater emotional engagement. Post (immediately after the videos are shown
Secondary Emotional engagement Emotional engagement will be measured using the Emotional Engagement Scale (de Vreede et al., 2019). The scale includes three items asking about emotional engagement (e.g., "I care about the contents of this video"), and response choices range from 1 (strongly disagree) to 4 (strongly agree). Total scores range from 3 to 12, with higher scores indicating greater emotional engagement. 2 week follow-up
Secondary Treatment related stigma Treatment-related stigma will be measured with the Self-Stigma of Seeking Help scale (SSOSH-3) (Brenner et al., 2021). Items include "I would feel inadequate if I went to a therapist for psychological help," "It would make me feel inferior to ask a therapist for help," and "If I went to a therapist, I would be less satisfied with myself." Response range from 1 (strongly disagree) to 5 (strongly agree). Total scores range from 3 to 15, with higher scores indicating greater stigma. Baseline
Secondary Treatment related stigma Treatment-related stigma will be measured with the Self-Stigma of Seeking Help scale (SSOSH-3) (Brenner et al., 2021). Items include "I would feel inadequate if I went to a therapist for psychological help," "It would make me feel inferior to ask a therapist for help," and "If I went to a therapist, I would be less satisfied with myself." Response range from 1 (strongly disagree) to 5 (strongly agree). Total scores range from 3 to 15, with higher scores indicating greater stigma. Post (immediately after the videos are shown)
Secondary Treatment related stigma Treatment-related stigma will be measured with the Self-Stigma of Seeking Help scale (SSOSH-3) (Brenner et al., 2021). Items include "I would feel inadequate if I went to a therapist for psychological help," "It would make me feel inferior to ask a therapist for help," and "If I went to a therapist, I would be less satisfied with myself." Response range from 1 (strongly disagree) to 5 (strongly agree). Total scores range from 3 to 15, with higher scores indicating greater stigma. 2 week follow-up
Secondary Treatment related stigma Treatment-related stigma will be measured with the Self-Stigma of Seeking Help scale (SSOSH-3) (Brenner et al., 2021). Items include "I would feel inadequate if I went to a therapist for psychological help," "It would make me feel inferior to ask a therapist for help," and "If I went to a therapist, I would be less satisfied with myself." Response range from 1 (strongly disagree) to 5 (strongly agree). Total scores range from 3 to 15, with higher scores indicating greater stigma. 4 week follow-up
Secondary Barriers to Access to Care Evaluation (BACE V3) Barriers to care will be measured with items selected from the Barriers to Access to Care Evaluation (BACE v3) (Clement et al., 2012). Response range from 0 (not at all) to 3 (a lot). Total scores range from 0 to 24, with higher scores indicating greater barriers. Baseline
Secondary Barriers to Access to Care Evaluation (BACE V3) Barriers to care will be measured with items selected from the Barriers to Access to Care Evaluation (BACE v3) (Clement et al., 2012). Response range from 0 (not at all) to 3 (a lot). Total scores range from 0 to 24, with higher scores indicating greater barriers. Post (immediately after the videos are shown)
Secondary Barriers to Access to Care Evaluation (BACE V3) Barriers to care will be measured with items selected from the Barriers to Access to Care Evaluation (BACE v3) (Clement et al., 2012). Response range from 0 (not at all) to 3 (a lot). Total scores range from 0 to 24, with higher scores indicating greater barriers. 2 week follow-up
Secondary Barriers to Access to Care Evaluation (BACE V3) Barriers to care will be measured with items selected from the Barriers to Access to Care Evaluation (BACE v3) (Clement et al., 2012). Response range from 0 (not at all) to 3 (a lot). Total scores range from 0 to 24, with higher scores indicating greater barriers. 4 week follow-up
Secondary Mental Health Treatment One item will be utilized to measure prior mental health treatment: Have you ever received mental health treatment? Baseline
Secondary Actual help seeking Two items will be utilized to measure help seeking: Over the past 2 weeks, have you sought out mental health treatment? and Over the past 2 weeks, did you feel more able/willing to open up to others about how you are feeling? 2 week follow-up
Secondary Actual help seeking Two items will be utilized to measure help seeking: Over the past 4 weeks, have you sought out mental health treatment? and Over the past 4 weeks, did you feel more able/willing to open up to others about how you are feeling? 4 week follow-up
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