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Reducing Self-stigma Using Brief Video Intervention

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05878470
Recruitment Status : Completed
First Posted : May 26, 2023
Last Update Posted : May 26, 2023
Sponsor:
Information provided by (Responsible Party):
Doron Amsalem, New York State Psychiatric Institute

Tracking Information
First Submitted Date  ICMJE May 9, 2023
First Posted Date  ICMJE May 26, 2023
Last Update Posted Date May 26, 2023
Actual Study Start Date  ICMJE January 25, 2023
Actual Primary Completion Date March 7, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 18, 2023)
  • Self-stigma [ Time Frame: Baseline ]
    The investigators assessed self-stigma using 23 items across six domains: Stereotype Endorsement, Alienation, Stigma Resistance, Perceived Devaluation Discrimination, Secrecy, and Recovery Assessment Scale.
  • Self-stigma [ Time Frame: Post (immediately after the intervention and for the control immediately after doing the baseline survey) ]
    The investigators assessed self-stigma using 23 items across six domains: Stereotype Endorsement, Alienation, Stigma Resistance, Perceived Devaluation Discrimination, Secrecy, and Recovery Assessment Scale.
  • Self-stigma [ Time Frame: 30 day follow up ]
    The investigators assessed self-stigma using 23 items across six domains: Stereotype Endorsement, Alienation, Stigma Resistance, Perceived Devaluation Discrimination, Secrecy, and Recovery Assessment Scale.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Reducing Self-stigma Using Brief Video Intervention
Official Title  ICMJE Reducing Self-stigma Using Brief Video Intervention
Brief Summary

Stigma is a profound obstacle to care. Self-stigma decreases sense of self-competency, as well as healthcare seeking and treatment adherence and creates barriers to pursuing employment, independent living, and fulfilling social life. For example, people with mental disorders avoid, delay, or drop out of treatment due to a fear of labeling and discrimination or experience treatments as ineffective or disrespectful. Therefore, reducing self stigma can reduce self-blame, improve self-confidence and provide support for people living with mental illness.

In a prior study, the investigators developed a short video intervention to reduce self-stigma among people with schizophrenia. The investigators would like to test the efficacy of this video using Prolific (a crowdsourcing platform). Specifically, the investigators are interested in recruiting 1,200 Prolific participants, ages 18-35, who mentioned in their profile while enrolling to Prolific that they have a mental health condition, and randomized them into watching the newly developed video to reduce self-stigma or participate in the non-intervention control arm. Participants will be invited to participate in a follow-up survey 30 days after completing the first survey.

Detailed Description The primary objective of this study is to test the video efficacy in reducing self stigma among 1,200 Prolific users who mentioned in their profile while enrolling to Prolific that they have a mental health condition (600 in an intervention group, and 600 in a non-intervention control group). The study participants will be invited to participate in a 30-day follow up questionnaire. The investigators hypothesize finding a reduced level of self-stigma among those who watch the intervention video.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • Stigma, Social
  • Mental Health Disorder
Intervention  ICMJE Behavioral: video
A brief (119 seconds) social contact-based video. The video presented a young Black man in his early twenties, a professional actor, sharing his scripted personal story of struggles with psychotic illness and raising themes of recovery and hope.
Study Arms  ICMJE
  • Experimental: Brief video intervention
    Brief (119 seconds) social contact-based video
    Intervention: Behavioral: video
  • No Intervention: Non-intervention control
    Non-intervention control
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 18, 2023)
1214
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 7, 2023
Actual Primary Completion Date March 7, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • English-speaking
  • 18-35-year-old
  • US residents
  • Those who answered yes to "Do you have or have you had a diagnosed, ongoing mental health/illness/condition?"

Exclusion Criteria:

  • Non English-speaking
  • Non US residents
  • Age younger than 18 or older than 35
  • People who replied no to the question on ongoing mental health
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05878470
Other Study ID Numbers  ICMJE 8432
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Doron Amsalem, New York State Psychiatric Institute
Original Responsible Party Same as current
Current Study Sponsor  ICMJE New York State Psychiatric Institute
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account New York State Psychiatric Institute
Verification Date May 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP