Interned-delivered Intervention Based on Acceptance Principles

Depression Clinical Trial

— LGBT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05514964
• Other study ID #: RO-NO-2019-0412
• Status: Completed
• Phase: N/A
• Start date: May 1, 2022
• Est. completion date: September 30, 2022

Study information

• Verified date: November 2022
• Source: West University of Timisoara
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: September 30, 2022
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.)

Related Conditions & MeSH terms

• Anxiety Disorders
• Depression
• Mental Health Issue
• Well-Being

Intervention

Behavioral:
• Feasibility study
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.

Locations

Country	Name	City	State
Romania	West University of Timisoara	Timisoara

Sponsors (2)

Lead Sponsor	Collaborator
West University of Timisoara	University of Bergen

Country where clinical trial is conducted

Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Change from Pre- to Post-Intervention (6 weeks)
Primary	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.	Change from Pre- to Post-Intervention (6 weeks)
Primary	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.	Change from Pre- to Post-Intervention (6 weeks)
Primary	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).	Change from Pre- to Post-Intervention (6 weeks)
Secondary	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.	Change from Pre- to Post-Intervention (6 weeks)
Secondary	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.	Change from Pre- to Post-Intervention (6 weeks)
Secondary	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.	Change from Pre- to Post-Intervention (6 weeks)
Secondary	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.	Pre-Intervention
Secondary	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.	Pre-Intervention
Secondary	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.	Pre-Intervention

External Links

•   The Romanian website where the program was implemented.