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Interned-delivered Intervention Based on Acceptance Principles (LGBT)

Primary Purpose

Anxiety Disorders, Depression, Mental Health Issue

Status
Completed
Phase
Not Applicable
Locations
Romania
Study Type
Interventional
Intervention
Feasibility study
Sponsored by
West University of Timisoara
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Anxiety Disorders focused on measuring LGBT, online psychological intervention, emotional difficulties, risk factors for anxiety and depression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • West University of Timisoara

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention Arm

Arm Description

The experimental arm were provided an intervention program based on 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. However, the initial treatment was adapted for the LGBT community using the suggestions from APA Guidelines for Psychological Practice With Lesbian, Gay and Bisexual Clients (2012) and Pachankis, J. E. (2014). Uncovering Clinical Principles and Techniques to Address Minority Stress, Mental Health, and Related Health Risks Among Gay and Bisexual Men. Clinical Psychology: Science and Practice, 21(4), 313-330. doi:10.1111/cpsp.12078.

Outcomes

Primary Outcome Measures

Generalized Anxiety Disorder-7 (GAD-7)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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.

Full Information

First Posted
August 22, 2022
Last Updated
September 12, 2023
Sponsor
West University of Timisoara
Collaborators
University of Bergen
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1. Study Identification

Unique Protocol Identification Number
NCT05514964
Brief Title
Interned-delivered Intervention Based on Acceptance Principles
Acronym
LGBT
Official Title
An Online Intervention to Increase the Ability of LGBT People to Cope With Adverse Events: A Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
May 1, 2022 (Actual)
Primary Completion Date
August 31, 2022 (Actual)
Study Completion Date
September 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
West University of Timisoara
Collaborators
University of Bergen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Disorders, Depression, Mental Health Issue, Well-Being
Keywords
LGBT, online psychological intervention, emotional difficulties, risk factors for anxiety and depression

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Feasibility study: An online psychological intervention program (six weeks); Measurement points: Pre-Intervention and Post-Intervention;
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Arm
Arm Type
Experimental
Arm Description
The experimental arm were provided an intervention program based on 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. However, the initial treatment was adapted for the LGBT community using the suggestions from APA Guidelines for Psychological Practice With Lesbian, Gay and Bisexual Clients (2012) and Pachankis, J. E. (2014). Uncovering Clinical Principles and Techniques to Address Minority Stress, Mental Health, and Related Health Risks Among Gay and Bisexual Men. Clinical Psychology: Science and Practice, 21(4), 313-330. doi:10.1111/cpsp.12078.
Intervention Type
Behavioral
Intervention Name(s)
Feasibility study
Intervention Description
Individuals interested to participate in this study were informed about the intervention via the project website and Facebook page of the project. Prior to the start of the study, participants were invited to read the Informed Consent and express their agreement to participate. Only after the Informed Consent was electronically signed, participants were able to complete the screening questionnaires online. The intervention program (based on Acceptance and Commitment Therapy) consists of six treatment modules adapted to the online environment. Each module was structured like a therapy session and contained at least two or three homework assignments. Each participant was assigned to an online psychotherapist. At the end of the six modules, participants completed the post-intervention measures.
Primary Outcome Measure Information:
Title
Generalized Anxiety Disorder-7 (GAD-7)
Description
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.
Time Frame
Change from Pre- to Post-Intervention (6 weeks)
Title
Social Phobia Inventory (SPIN)
Description
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.
Time Frame
Change from Pre- to Post-Intervention (6 weeks)
Title
Patient Health Questionnaire-9 (PHQ-9)
Description
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.
Time Frame
Change from Pre- to Post-Intervention (6 weeks)
Title
The Alcohol Use Disorders Identification Test (AUDIT)
Description
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).
Time Frame
Change from Pre- to Post-Intervention (6 weeks)
Secondary Outcome Measure Information:
Title
Acceptance and Action Questionnaire 2 (AAQ2)
Description
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.
Time Frame
Change from Pre- to Post-Intervention (6 weeks)
Title
Brief Multidimensional Experiential Avoidance Questionnaire (BMEAQ)
Description
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.
Time Frame
Change from Pre- to Post-Intervention (6 weeks)
Title
PTSD Checklist for DSM-5 (PCL-5)
Description
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.
Time Frame
Change from Pre- to Post-Intervention (6 weeks)
Title
Internalized Homophobia Scale (IHS)
Description
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.
Time Frame
Pre-Intervention
Title
Sexual Orientation Concealment Scale (SOCS6)
Description
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.
Time Frame
Pre-Intervention
Title
Daily Heterosexist Experiences Questionnaire (DHEQ)
Description
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.
Time Frame
Pre-Intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.)
Facility Information:
Facility Name
West University of Timisoara
City
Timisoara
ZIP/Postal Code
320104
Country
Romania

12. IPD Sharing Statement

Links:
URL
https://www.e-cbt.ro/program/PACT/programul-pact
Description
The Romanian website where the program was implemented.

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Interned-delivered Intervention Based on Acceptance Principles

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