Interned-delivered Intervention Based on Acceptance Principles

NCT05514964 | Completed

• 1 other identifier: RO-NO-2019-0412
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

LGBT; online psychological intervention; emotional difficulties; risk factors for anxiety and depression

Outcome Measures

Primary Outcomes (4)

• 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)

• 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)

• 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)

• 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 Outcomes (6)

• Acceptance and Action Questionnaire 2 (AAQ2)

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

• Brief Multidimensional Experiential Avoidance Questionnaire (BMEAQ)

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

• PTSD Checklist for DSM-5 (PCL-5)

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

• Internalized Homophobia Scale (IHS)

  Pre-Intervention

• Sexual Orientation Concealment Scale (SOCS6)

  Pre-Intervention

Study Arms (1)

Intervention Arm

EXPERIMENTAL

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.

Behavioral: Feasibility study

Interventions

Feasibility study BEHAVIORAL

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.

Intervention Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• West University of Timisoara: lead
• University of Bergen: collaborator

Study Sites (1)

West University of Timisoara

Timișoara, 320104, Romania

Location

Related Publications (1)

• 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.

  PMID: 38749024 DERIVED

Related Links

• The Romanian website where the program was implemented.

MeSH Terms

Conditions

Anxiety Disorders; Depression

Interventions

Feasibility Studies

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Epidemiologic Study Characteristics; Epidemiologic Methods; Investigative Techniques; Evaluation Studies as Topic; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Feasibility study: * An online psychological intervention program (six weeks); * Measurement points: Pre-Intervention and Post-Intervention;

Study Record Dates

• First Submitted: August 22, 2022
• First Posted: August 25, 2022
• Study Start: May 1, 2022
• Primary Completion: August 31, 2022
• Study Completion: September 30, 2022
• Last Updated: September 14, 2023

Record last verified: 2022-11

Locations

RO (1)