Clinical trial NCT05514964: Interned-delivered Intervention Based on Acceptance Principles
Official title: An Online Intervention to Increase the Ability of LGBT People to Cope With Adverse Events: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety Disorders
Depression
Mental Health Issue
Well-Being
Keywords: LGBT
online psychological intervention
emotional difficulties
risk factors for anxiety and depression
Lead sponsor: West University of Timisoara
Sponsor class: OTHER
Collaborators: name: University of Bergen
First posted: 2022-08-25
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Feasibility study:

* An online psychological intervention program (six weeks);
* Measurement points: Pre-Intervention and Post-Intervention;
Primary purpose: PREVENTION

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.

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.)

Primary outcomes:
measure: Generalized Anxiety Disorder-7 (GAD-7)
timeFrame: Change from Pre- to Post-Intervention (6 weeks)
measure: Social Phobia Inventory (SPIN)
timeFrame: Change from Pre- to Post-Intervention (6 weeks)
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Change from Pre- to Post-Intervention (6 weeks)
measure: The Alcohol Use Disorders Identification Test (AUDIT)
timeFrame: Change from Pre- to Post-Intervention (6 weeks)
Secondary outcomes:
measure: Acceptance and Action Questionnaire 2 (AAQ2)
timeFrame: Change from Pre- to Post-Intervention (6 weeks)
measure: Brief Multidimensional Experiential Avoidance Questionnaire (BMEAQ)
timeFrame: Change from Pre- to Post-Intervention (6 weeks)
measure: PTSD Checklist for DSM-5 (PCL-5)
timeFrame: Change from Pre- to Post-Intervention (6 weeks)
measure: Internalized Homophobia Scale (IHS)
timeFrame: Pre-Intervention
measure: Sexual Orientation Concealment Scale (SOCS6)
timeFrame: Pre-Intervention
measure: Daily Heterosexist Experiences Questionnaire (DHEQ)
timeFrame: Pre-Intervention
Other outcomes:
Locations:
city: Timisoara
country: Romania
facility: West University of Timisoara
Study officials:
References: