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Efficacy of a Brief Intervention to Improve Sexual and Gender Minorities' Mental Health: Randomized Controlled Trial. (ESCREVA-SE)

Primary Purpose

Depression, Anxiety, Psychological Distress

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Expressive writing
Self-affirmation
Placebo
Sponsored by
Pontificia Universidade Católica do Rio Grande do Sul
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression

Eligibility Criteria

16 Years - 100 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Self-identity as sexual and gender minority.
  • Being older than 16 years old.
  • Have a stable on-line connection for, at least, 20 minutes in a place where won't be disturbed.
  • Reports, in the baseline survey, previous experiences of discrimination, having depression or anxiety symptoms.
  • Currently living in Rio Grande do Sul.

Exclusion Criteria:

  • Disagrees with the consent form.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Placebo Comparator

    Arm Label

    Expressive writing

    Self-affirmation

    Placebo

    Arm Description

    Participants will be invited to join three writing activities, lasting 20 minutes daily in D1, D3, and D5 of the same week. For example, to write about a difficult or painful experience related discrimination and their feelings about it.

    Aiming to build self-efficacy, participants will be invite to writing, during 20 minutes daily in D1, D3, and D5 of the same week, a letter to a sexual and gender minority peer suffering from stigma and discrimination.

    Participants will be instruct to write about their daily routine, during 20 minutes daily in D1, D3, and D5 of the same week.

    Outcomes

    Primary Outcome Measures

    Change from baseline depression at 3 and 6 moths after the intervention.
    Assessed using the Center for Epidemiologic Studies - Depression (CES-D). CES-D is composed of 20 items. The final score ranges from 0 to 60 points. Originally, the cutoff point of the CES-D scale to identify the presence of depressive symptoms is equal or higher 16 points. However, when considering Brazilian samples, the cutoff point of equal or higher 12 points was proposed.
    Change from baseline anxiety at 1 week, and 3 and 6 moths after the intervention.
    Evaluated using the Generalized Anxiety Disorder 7-item (GAD-7). The GAD-7 consists of 7 questions based in part on the DSM-IV criteria for GAD and reflects the frequency of symptoms during the preceding 2-week period. The GAD-7 requires approximately 1-2 minutes to administer and for each symptom queried provides the following response options: "not at all," "several days," "over half the days" and "nearly every day" and these are scored, respectively, as 0, 1, 2 or 3. A score of 10 or greater on the GAD-7 represents a reasonable cut point for identifying cases of GAD.
    Change from baseline social phobia at 1 week, and 3 and 6 moths after the intervention.
    Evaluated using the Social Avoidance and Distress Scale (SADS). SADS is a 28 item true/false scale that measures measures aspects of social anxiety including distress, discomfort, fear and avoidance. A total score on the SADS is obtained based on the answers to the true/false questions. Higher scores indicate greater social anxiety.
    Change from baseline post-traumatic stress at 1 week, and 3 and 6 moths after the intervention.
    Post-Traumatic Stress Disorder Checklist - Civilian Version (PCL-C). The PCL-C is a 17-item self-report checklist of PTSD symptoms based closely on the DSM-IV criteria. The score consists in adding up all items from each of the 17 items for a total severity score (range = 17-85). The cut off 17-29 shows little to no severity, 28-29 suggests some PTSD symptom, 30-44 moderate to moderately high severity of PTSD symptoms, and 45-85 high severity of PTSD symptoms.
    Change from baseline on suicide ideation at 3 and 6 moths after the intervention.
    Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 is a clinically-validated screening tool that healthcare providers use to screen for depression, and also to diagnose and monitor the severity of the condition. A PHQ-9 score total of 0-4 points equals "normal" or minimal depression. Scoring between 5-9 points indicates mild depression, 10-14 points indicates moderate depression, 15-19 points indicates moderately severe depression, and 20 or more points indicates severe depression.
    Change from baseline on substance use at 3 and 6 moths after the intervention.
    Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) is an 8 questions tool that detects substance use and related problems. A 'global continuum of risk score' (or total substance involvement) is calculated by the addition of all items for all substances on the ASSIST and has a maximum score of 208.
    Change from baseline on sex risk behaviors at 3 and 6 moths after the intervention.
    Inquired using yes-no questions concerning unprotected intercourse and multiple sex partners, as well as the Perceived Risk of HIV Scale. Perceived Risk of HIV Scale is a self-report 8-item measure developed to assess how people think and feel about their risk of HIV infection based on their previous sexual behavior and covering several dimensions of perceived HIV risk. Higher scores are associated with a greater number of sex partners, episodes of unprotected sex and having sex while high.

    Secondary Outcome Measures

    Change from baseline on resilience at 1 week, and 3 and 6 moths after the intervention.
    Wagnild and Youngs's Resilience Scale that has presented the following scoring for the total score: 25-100 = Very low, 101-115 = Low, 116-130 = On the low end, 131-145 = Moderate, 146-160 = Moderately high, and 161-175 = High.
    Change from baseline on self-esteem at 1 week, and 3 and 6 moths after the intervention.
    Rosenberg Self-Esteem Scale. The scale ranges from 0-30. Scores between 15 and 25 are within normal range; scores below 15 suggest low self-esteem.

    Full Information

    First Posted
    March 11, 2022
    Last Updated
    April 22, 2022
    Sponsor
    Pontificia Universidade Católica do Rio Grande do Sul
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05349877
    Brief Title
    Efficacy of a Brief Intervention to Improve Sexual and Gender Minorities' Mental Health: Randomized Controlled Trial.
    Acronym
    ESCREVA-SE
    Official Title
    Efficacy of a Brief, Self-guided, On-line, Writing Intervention to Improve Mental Health Outcomes Among Sexual and Gender Minorities: a Randomized Controlled Trial.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 10, 2022 (Anticipated)
    Primary Completion Date
    June 30, 2022 (Anticipated)
    Study Completion Date
    December 15, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Pontificia Universidade Católica do Rio Grande do Sul

    4. Oversight

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

    5. Study Description

    Brief Summary
    Experiences of violence, from micro to physical aggressions, have a deleterious impact on mental health. According to the Minority Stress Theory, unfavorable social conditions (such as anticipated and experienced discrimination and internalized homophobia), mediated by resilience strategies, can lead to mental health or illness. Sexual and gender minorities (SGM) face stigma and discrimination aggravating multiple aspects of their lives: from school drop-out to halting health care access. SGM reveal avoiding medical assistance for fear of discrimination while health professionals disclose feeling unprepared to handle SGM health needs. There are two main challenges: 1) developing specific psychological interventions to reduce the impact of stigma and discrimination on SGM' mental health; and 2) training public health professionals to properly address SGM needs. Therefore, the present trial aims to assess the efficacy of a brief, self-guided, on-line, asynchronous and unsupervised psychological intervention in improving SGM' mental health.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Depression, Anxiety, Psychological Distress, Social Phobia, Post Traumatic Stress Disorder, Suicidal Ideation, Sex, Unsafe, Discrimination, Social, Behavior, Risk, Self Esteem

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Randomized, double-blind, clinical trial assessing the efficacy of a brief, unsupervised, self-guided psychological intervention targeting sexual and gender minorities' mental health.
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    306 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Expressive writing
    Arm Type
    Experimental
    Arm Description
    Participants will be invited to join three writing activities, lasting 20 minutes daily in D1, D3, and D5 of the same week. For example, to write about a difficult or painful experience related discrimination and their feelings about it.
    Arm Title
    Self-affirmation
    Arm Type
    Experimental
    Arm Description
    Aiming to build self-efficacy, participants will be invite to writing, during 20 minutes daily in D1, D3, and D5 of the same week, a letter to a sexual and gender minority peer suffering from stigma and discrimination.
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Participants will be instruct to write about their daily routine, during 20 minutes daily in D1, D3, and D5 of the same week.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Expressive writing
    Intervention Description
    Write, continuously for 20 minutes, about deepest emotions and thoughts concerning experiences of minority stress, exploring a particular event and how it has affected the participant.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Self-affirmation
    Intervention Description
    Write, continuously for 20 minutes, about values the participant think is important to overcome experiences of minority stress.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Placebo
    Intervention Description
    Write, continuously for 20 minutes, about their daily routine, without expressing feelings and deep thoughts about it.
    Primary Outcome Measure Information:
    Title
    Change from baseline depression at 3 and 6 moths after the intervention.
    Description
    Assessed using the Center for Epidemiologic Studies - Depression (CES-D). CES-D is composed of 20 items. The final score ranges from 0 to 60 points. Originally, the cutoff point of the CES-D scale to identify the presence of depressive symptoms is equal or higher 16 points. However, when considering Brazilian samples, the cutoff point of equal or higher 12 points was proposed.
    Time Frame
    Baseline (T0), one week after the intervention (T1), three months after the intervention (T2), and six the intervention (T3).
    Title
    Change from baseline anxiety at 1 week, and 3 and 6 moths after the intervention.
    Description
    Evaluated using the Generalized Anxiety Disorder 7-item (GAD-7). The GAD-7 consists of 7 questions based in part on the DSM-IV criteria for GAD and reflects the frequency of symptoms during the preceding 2-week period. The GAD-7 requires approximately 1-2 minutes to administer and for each symptom queried provides the following response options: "not at all," "several days," "over half the days" and "nearly every day" and these are scored, respectively, as 0, 1, 2 or 3. A score of 10 or greater on the GAD-7 represents a reasonable cut point for identifying cases of GAD.
    Time Frame
    Baseline (T0), one week after the intervention (T1), three months after the intervention (T2), and six the intervention (T3).
    Title
    Change from baseline social phobia at 1 week, and 3 and 6 moths after the intervention.
    Description
    Evaluated using the Social Avoidance and Distress Scale (SADS). SADS is a 28 item true/false scale that measures measures aspects of social anxiety including distress, discomfort, fear and avoidance. A total score on the SADS is obtained based on the answers to the true/false questions. Higher scores indicate greater social anxiety.
    Time Frame
    Baseline (T0), one week after the intervention (T1), three months after the intervention (T2), and six the intervention (T3).
    Title
    Change from baseline post-traumatic stress at 1 week, and 3 and 6 moths after the intervention.
    Description
    Post-Traumatic Stress Disorder Checklist - Civilian Version (PCL-C). The PCL-C is a 17-item self-report checklist of PTSD symptoms based closely on the DSM-IV criteria. The score consists in adding up all items from each of the 17 items for a total severity score (range = 17-85). The cut off 17-29 shows little to no severity, 28-29 suggests some PTSD symptom, 30-44 moderate to moderately high severity of PTSD symptoms, and 45-85 high severity of PTSD symptoms.
    Time Frame
    Baseline (T0), one week after the intervention (T1), three months after the intervention (T2), and six the intervention (T3).
    Title
    Change from baseline on suicide ideation at 3 and 6 moths after the intervention.
    Description
    Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 is a clinically-validated screening tool that healthcare providers use to screen for depression, and also to diagnose and monitor the severity of the condition. A PHQ-9 score total of 0-4 points equals "normal" or minimal depression. Scoring between 5-9 points indicates mild depression, 10-14 points indicates moderate depression, 15-19 points indicates moderately severe depression, and 20 or more points indicates severe depression.
    Time Frame
    Baseline (T0), three months after the intervention (T2), and six the intervention (T3).
    Title
    Change from baseline on substance use at 3 and 6 moths after the intervention.
    Description
    Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) is an 8 questions tool that detects substance use and related problems. A 'global continuum of risk score' (or total substance involvement) is calculated by the addition of all items for all substances on the ASSIST and has a maximum score of 208.
    Time Frame
    Baseline (T0), three months after the intervention (T2), and six the intervention (T3).
    Title
    Change from baseline on sex risk behaviors at 3 and 6 moths after the intervention.
    Description
    Inquired using yes-no questions concerning unprotected intercourse and multiple sex partners, as well as the Perceived Risk of HIV Scale. Perceived Risk of HIV Scale is a self-report 8-item measure developed to assess how people think and feel about their risk of HIV infection based on their previous sexual behavior and covering several dimensions of perceived HIV risk. Higher scores are associated with a greater number of sex partners, episodes of unprotected sex and having sex while high.
    Time Frame
    Baseline (T0), three months after the intervention (T2), and six the intervention (T3).
    Secondary Outcome Measure Information:
    Title
    Change from baseline on resilience at 1 week, and 3 and 6 moths after the intervention.
    Description
    Wagnild and Youngs's Resilience Scale that has presented the following scoring for the total score: 25-100 = Very low, 101-115 = Low, 116-130 = On the low end, 131-145 = Moderate, 146-160 = Moderately high, and 161-175 = High.
    Time Frame
    Baseline (T0), one week after the intervention (T1), three months after the intervention (T2), and six the intervention (T3).
    Title
    Change from baseline on self-esteem at 1 week, and 3 and 6 moths after the intervention.
    Description
    Rosenberg Self-Esteem Scale. The scale ranges from 0-30. Scores between 15 and 25 are within normal range; scores below 15 suggest low self-esteem.
    Time Frame
    Baseline (T0), one week after the intervention (T1), three months after the intervention (T2), and six the intervention (T3).

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    16 Years
    Maximum Age & Unit of Time
    100 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Self-identity as sexual and gender minority. Being older than 16 years old. Have a stable on-line connection for, at least, 20 minutes in a place where won't be disturbed. Reports, in the baseline survey, previous experiences of discrimination, having depression or anxiety symptoms. Currently living in Rio Grande do Sul. Exclusion Criteria: Disagrees with the consent form.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Angelo B Costa, PhD
    Phone
    +55 51 98405-4408
    Email
    angelobrandellicosta@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Anna Martha Fontanari
    Phone
    +55 51 99111-1771
    Email
    annamarthavf@gmail.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Efficacy of a Brief Intervention to Improve Sexual and Gender Minorities' Mental Health: Randomized Controlled Trial.

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