LGBT: Interned-delivered Intervention Based on Acceptance Principles

Sponsor

West University of Timisoara (Other)

Overall Status

Recruiting

CT.gov ID

NCT05514964

Collaborator

University of Bergen (Other)

Enrollment

Location

Arm

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Our main objectives for the online intervention were the following:

Designing and implementing an internet-delivered prevention program based on acceptance principles, to support LGBT people who confront with emotional difficulties in becoming more resilient;

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

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

Condition or Disease	Intervention/Treatment	Phase
Anxiety Disorders Depression Mental Health Issue Well-Being	Behavioral: Feasibility study	N/A

Detailed Description

Our study is part of a project which addresses a topic under the thematic area of "social sciences and humanities, including gender studies and social inclusion studies." It targets a particularly disadvantaged group known as the LGBT (lesbian, gay, bisexual, and transgender) community.

The psychosocial and socioeconomic status, in a broader sense, encompasses more than just financial, educational, and occupational aspects. It 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. They also suffer from marginalization, poorer mental and physical health, and even legal discrimination (e.g., no recognition of same-sex unions).

Our study aims at implementing evidence-based interventions meant to improve the quality of life within the LGBT community. We will also provide mental health support for young LGBT people to cope with potential adverse events.

The implementation of our study will contribute in achieving our three objectives presented above. For instance, by developing and validating an online intervention meant to increase the identity self-acceptance among LGBT participants, we will provide an easily accessible tool to apply the research results with expected positive mental health outcomes for this target group.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Feasibility study: A psychological intervention program for six weeks; Delivered online on: called PACT program; Measurement points: Pretest and Post-test; Without Follow-up.Feasibility study:A psychological intervention program for six weeks; Delivered online on: called PACT program; Measurement points: Pretest and Post-test; Without Follow-up.

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

May 1, 2022

Anticipated Primary Completion Date :

Aug 31, 2022

Anticipated Study Completion Date :

Sep 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention Arm The experimental arm will benefit from the Acceptance and Commitment Therapy Manual of John Forsyth & Georg Eifert (2016). The Mindfulness & Acceptance Workbook for Anxiety: A Guide to Breaking Free from Anxiety, Phobias & Worry Using Acceptance & Commitment Therapy, New Harbinger Publications and also taking into consideration the APA Guidelines for Psychological Practice With Lesbian, Gay and Bisexual Clients.	Behavioral: Feasibility study Individuals wishing to participate in this study will be informed about the intervention via the project website and Facebook page of the project. Prior to the start of the study, participants will be instructed to read the Informed Consent and express their agreement to participate. Only then they will be able to complete the screening questionnaires online. The ACT therapeutic program (based on Acceptance and Commitment Therapy protocol) consists of six treatment modules adapted to the online environment. Each module is structured like a therapy session and contains at least two or three homework assignments. Each participant will be assigned to an online psychotherapist. At the end of the six modules, participants will complete the post-test measurements.

Arm

Intervention/Treatment

Experimental: Intervention Arm

The experimental arm will benefit from the Acceptance and Commitment Therapy Manual of John Forsyth & Georg Eifert (2016). The Mindfulness & Acceptance Workbook for Anxiety: A Guide to Breaking Free from Anxiety, Phobias & Worry Using Acceptance & Commitment Therapy, New Harbinger Publications and also taking into consideration the APA Guidelines for Psychological Practice With Lesbian, Gay and Bisexual Clients.

Behavioral: Feasibility study

Individuals wishing to participate in this study will be informed about the intervention via the project website and Facebook page of the project. Prior to the start of the study, participants will be instructed to read the Informed Consent and express their agreement to participate. Only then they will be able to complete the screening questionnaires online. The ACT therapeutic program (based on Acceptance and Commitment Therapy protocol) consists of six treatment modules adapted to the online environment. Each module is structured like a therapy session and contains at least two or three homework assignments. Each participant will be assigned to an online psychotherapist. At the end of the six modules, participants will complete the post-test measurements.

Outcome Measures

Primary Outcome Measures

Generalized Anxiety Disorder-7 (GAD-7) [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) [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.
Patient Health Questionnaire-9 (PHQ-9) [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) [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).

Secondary Outcome Measures

Acceptance and Action Questionnaire 2 (AAQ2) [Change from Pre- to Post-Intervention (6 weeks)]
The AAQ2 scale has 10 items and was designed to measure the ACT's model of mental health and behavioral effectiveness. Scores range from 7 to 49 points, with high scores indicating greater experiential avoidance and immobility.
Brief Multidimensional Experiential Avoidance Questionnaire (BMEAQ) [Change from Pre- to Post-Intervention (6 weeks)]
The 15 items BMEAQ scale was developed to measure the tendency to avoid negative internal experiences. Scores range from 15 to 90 points, with high scores indicating greater tendency in experiential avoidance of the negative feelings.
PTSD Checklist for DSM-5 (PCL-5) [Change from Pre- to Post-Intervention (6 weeks)]
The PCL-5 scale was designed to measure participant's level of post-traumatic stress. The scale is unidimensional and the total score rages from 0 to 80. Low scores are associated with low levels of post-traumatic stress, while high scores are associated with high levels of post-traumatic stress.
Internalized Homophobia Scale (IHS) [Change from Pre- to Post-Intervention (6 weeks)]
The Internalized Homophobia Scale has 26 items and was designed to measure the internalized homonegativity. The items are scored on a Likert-type scale from 0 "strongly disagree" to 6 "strongly agree". The total score rages from 0 to 156, where high scores are associated with high levels of internalized homophobia.
Sexual Orientation Concealment Scale (SOCS6) [Change from Pre- to Post-Intervention (6 weeks)]
The Sexual Orientation Concealment Scale is a 6 items measure designed to assess lesbian, gay and bisexual (LGB) individual's active concealment of their sexual minority status. Averaging the six items produces the overall SOCS score, which ranges from 0 to 24, where high scores are associated with high levels of concealment.
Daily Heterosexist Experiences Questionnaire (DHEQ) [Change from Pre- to Post-Intervention (6 weeks)]
The Daily Heterosexist Experiences Questionnaire has 50 items and they are scored on a Likert-type scale from 0 "It didn't happen to me/It doesn't apply to me" to 5 "It happened to me and it bothered me a lot". The measure can be scored in two ways: Occurrence: Responses are recoded 0 = 0 (did not occur) and 1 through 5 = 1 (did occur). Items are then summed for a total score indicating how many of these experiences participants have had. Distress: Responses are recoded so that 0 and 1 = 1 (did not bother) and the rest of the responses remain the same. A mean is then computed for responses to all items, indicating the mean level of distress participant feels related to these experiences. The scale has nine subscales: Vigilance, Harassment and discrimination, Gender expression, Parenting, Victimization, Family of origin, Vicarious trauma, Isolation and HIV/AIDS.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

fluency in Romanian language;
age - at least 18 years old;
sexual orientation: gay or bisexual;
gender identity: male, female or transgender;
an unchanged dosage of medication during the last month (in case of taking medication);
unemployed, lack of parental support or other critical personal situations.

Exclusion Criteria:

suicidal ideation (i.e., if exceed a score of 1 on suicide item 9 from PHQ9);
alcohol dependence (i.e., if AUDIT score > 15);
obstacles in participation (i.e., not having Internet access, long travel plans during the treatment, etc.);
psychosis, according to the medication status.