Clinical trial NCT05349877: Efficacy of a Brief Intervention to Improve Sexual and Gender Minorities' Mental Health: Randomized Controlled Trial.
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
Overall status: UNKNOWN
Phase: NA
Conditions: Depression
Anxiety
Psychological Distress
Social Phobia
Post Traumatic Stress Disorder
Suicidal Ideation
Sex, Unsafe
Discrimination, Social
Behavior, Risk
Self Esteem
Lead sponsor: Pontificia Universidade Católica do Rio Grande do Sul
Sponsor class: OTHER
First posted: 2022-04-27
Enrollment: 306
Sex: ALL
Minimum age (years): 16
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change from baseline depression at 3 and 6 moths after the intervention.
timeFrame: Baseline (T0), one week after the intervention (T1), three months after the intervention (T2), and six the intervention (T3).
measure: Change from baseline anxiety at 1 week, and 3 and 6 moths after the intervention.
timeFrame: Baseline (T0), one week after the intervention (T1), three months after the intervention (T2), and six the intervention (T3).
measure: Change from baseline social phobia at 1 week, and 3 and 6 moths after the intervention.
timeFrame: Baseline (T0), one week after the intervention (T1), three months after the intervention (T2), and six the intervention (T3).
measure: Change from baseline post-traumatic stress at 1 week, and 3 and 6 moths after the intervention.
timeFrame: Baseline (T0), one week after the intervention (T1), three months after the intervention (T2), and six the intervention (T3).
measure: Change from baseline on suicide ideation at 3 and 6 moths after the intervention.
timeFrame: Baseline (T0), three months after the intervention (T2), and six the intervention (T3).
measure: Change from baseline on substance use at 3 and 6 moths after the intervention.
timeFrame: Baseline (T0), three months after the intervention (T2), and six the intervention (T3).
measure: Change from baseline on sex risk behaviors at 3 and 6 moths after the intervention.
timeFrame: Baseline (T0), three months after the intervention (T2), and six the intervention (T3).
Secondary outcomes:
measure: Change from baseline on resilience at 1 week, and 3 and 6 moths after the intervention.
timeFrame: Baseline (T0), one week after the intervention (T1), three months after the intervention (T2), and six the intervention (T3).
measure: Change from baseline on self-esteem at 1 week, and 3 and 6 moths after the intervention.
timeFrame: Baseline (T0), one week after the intervention (T1), three months after the intervention (T2), and six the intervention (T3).
Other outcomes:
Locations:
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