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Clinical Trials/NCT05514964
NCT05514964
Completed
N/A

An Online Intervention to Increase the Ability of LGBT People to Cope With Adverse Events: A Feasibility Study

West University of Timisoara1 site in 1 country15 target enrollmentMay 1, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Anxiety Disorders
Sponsor
West University of Timisoara
Enrollment
15
Locations
1
Primary Endpoint
Patient Health Questionnaire-9 (PHQ-9)
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

The main objectives for the online intervention were the following:

Designing and implementing an internet-delivered prevention program based on acceptance principles, to support LGBT participants to tackle emotional difficulties more effectively and to become more resilient;

Helping LGBT individuals to remain out of the clinical level of depression and anxiety;

Creating this primary prevention program as a suitable strategy for LGBT individuals to confront emotional difficulties by targeting key risk factors before they evolve further.

Detailed Description

This study is part of a research project which addresses a topic under the thematic area of "social sciences and humanities, including gender studies and social inclusion studies." The study targets a particularly disadvantaged group known as the LGBT (lesbian, gay, bisexual, and transgender) community. The psycho-social and socioeconomic status, in a broader sense, encompasses more than just financial, educational, and occupational aspects. This status also includes the quality of life, an attribute that is consistently dependent on physical and psychological health. Evidence suggests that people who identify as LGBT are susceptible to various inequalities, including differences in incomes, workplace, and social discrimination. The participants also may suffer from marginalization, poorer mental and physical health, and even legal discrimination (e.g., no recognition of same-sex unions). This study aims at implementing evidence-based interventions meant to improve the quality of life within the LGBT community. The investigators will also provide mental health support for young LGBT people to cope with potential adverse events. The implementation of the study will contribute in achieving the three objectives presented above. For instance, by developing and validating an online intervention meant to increase the identity self-acceptance among LGBT participants, the investigators will provide an easily accessible tool to apply the research results with expected positive mental health outcomes for this target group.

Registry
clinicaltrials.gov
Start Date
May 1, 2022
End Date
September 30, 2022
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • be fluent in Romanian,
  • be at least 18 years of age,
  • sexual orientation: gay or bisexual,
  • having low or moderate symptoms for at least one of the following self-report scales: generalized anxiety - GAD7 between 5 - 14; social anxiety - SPIN between 21 - 40; depression - PHQ9 between 5 and 14; alcohol - AUDIT between 8 and 14

Exclusion Criteria

  • suicidal ideation (i.e., if exceed a score of 1 on suicide item 9 from PHQ9);
  • changes in the dosage if psychotropic medication during the last month (if present),
  • have bipolar disorder or psychosis (according to medication status),
  • have an alcohol/substance abuse and/or dependence (i.e., AUDIT score \> 15),
  • have high/clinical levels of anxiety, social anxiety or depression (above the cut-off range - see above)
  • currently take part in other psychological treatment,
  • obvious obstacle to participation (i.e., no current Internet access, long travel plans during the treatment period etc.)

Outcomes

Primary Outcomes

Patient Health Questionnaire-9 (PHQ-9)

Time Frame: Change from Pre- to Post-Intervention (6 weeks)

The Patient Health Questionnaire 9 (PHQ9) was designed to measure participant's level of depression. The scale is unidimensional and the total score ranges from 0 to 27. Low scores are associated with low levels of depression, while high scores are associated with high levels of depression.

The Alcohol Use Disorders Identification Test (AUDIT)

Time Frame: Change from Pre- to Post-Intervention (6 weeks)

The AUDIT scale has 10 questions. Possible responses to each question are scored 0, 1, 2, 3 or 4, with the exception of questions 9 and 10 which have responses of 0, 2 and 4. The range of possible scores is from 0 to 40 where 0 indicates an abstainer who has never had any problems from alcohol. A score of 1 to 7 suggests low risk consumption according to World Health Organization (WHO) guidelines. Scores from 8 to 14 suggest hazardous or harmful alcohol consumption and a score of 15 or more indicates the likelihood of alcohol dependence (moderate-severe alcohol use disorder).

Generalized Anxiety Disorder-7 (GAD-7)

Time Frame: Change from Pre- to Post-Intervention (6 weeks)

Generalized Anxiety Disorder 7 (GAD7) was designed to measure participant's level of generalized anxiety or worry. The scale is unidimensional and the total score ranges from 0 to 21. Low scores are associated with low levels of worry, while high scores are associated with high levels of worry.

Social Phobia Inventory (SPIN)

Time Frame: Change from Pre- to Post-Intervention (6 weeks)

The SPIN scale was designed to measure participant's level of social phobia. The scale is unidimensional and the total score ranges from 0 to 68. Low scores are associated with low levels of social phobia, while high scores are associated with high levels of social phobia.

Secondary Outcomes

  • Acceptance and Action Questionnaire 2 (AAQ2)(Change from Pre- to Post-Intervention (6 weeks))
  • Sexual Orientation Concealment Scale (SOCS6)(Pre-Intervention)
  • Daily Heterosexist Experiences Questionnaire (DHEQ)(Pre-Intervention)
  • Brief Multidimensional Experiential Avoidance Questionnaire (BMEAQ)(Change from Pre- to Post-Intervention (6 weeks))
  • PTSD Checklist for DSM-5 (PCL-5)(Change from Pre- to Post-Intervention (6 weeks))
  • Internalized Homophobia Scale (IHS)(Pre-Intervention)

Study Sites (1)

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