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Anxiety DisordersLGBTNCT05514964

Interned-delivered Intervention Based on Acceptance Principles

A study testing Feasibility study in people with Anxiety Disorders and Depression, run by West University of Timisoara at 1 site in Romania.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Anxiety Disorders, Depression, Mental Health Issue
What is being tested?
Feasibility study
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteRomania
Study dates
1 May 2022to 30 Sep 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.)

Trial locations and contacts

1 site in 1 country.

Romania1 site

  • West University of Timisoara

    Timișoara, 320104

Other trials in Romania

About this study

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

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.

Read the 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.

Being tested
Feasibility study
Keywords
LGBT, online psychological intervention, emotional difficulties, risk factors for anxiety and depression
Medical subject headings
Anxiety Disorders, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Feasibility studyBehavioural

    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.

Study groups in NCT05514964
Study groupRoleWhat they receive
Intervention ArmExperimentalThe 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.
Receives: Behavioral: Feasibility study

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

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

  3. 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.

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

  4. 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).

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

Secondary outcomes (6)

  1. 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.

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

  2. 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.

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

  3. 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.

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

  4. 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.

    Measured: Pre-Intervention

  5. 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.

    Measured: Pre-Intervention

  6. 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:

    1. 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.
    2. 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.

    Measured: Pre-Intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Aug 2022
  2. Study start1 May 2022
  3. Primary completion31 Aug 2022
  4. Study completion30 Sep 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Model description
Feasibility study: * An online psychological intervention program (six weeks); * Measurement points: Pre-Intervention and Post-Intervention;
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05514964
Sponsor's protocol ID
RO-NO-2019-0412
Acronym
LGBT
Status last verified
Nov 2022
First submitted
22 Aug 2022
Last updated
14 Sep 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Isbasoiu AB, Sava FA, Larsen TMB, Anderssen N, Rotaru TS, Rusu A, Salagean N, Tulbure BT. An Internet-Based Intervention to Increase the Ability of Lesbian, Gay, and Bisexual People to Cope With Adverse Events: Single-Group Feasibility Study. JMIR Form Res. 2024 May 15;8:e56198. doi: 10.2196/56198.

    PubMed 38749024

Questions about this trial

What is this clinical trial studying?

A study testing Feasibility study in people with Anxiety Disorders and Depression, run by West University of Timisoara at 1 site in Romania.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Generalized Anxiety Disorder-7 (GAD-7) (time frame: Change from Pre- to Post-Intervention (6 weeks)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05514964, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2023.

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