Clinical trial NCT03602222: An LGBT-Competency Program for Mental Health Professionals in Romania
Official title: Increasing Provider Competence for Treating Stress-related Mental Health Conditions in Low Resource Settings
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stigma, Social
Gays
Lesbians
Bisexuals
Gender Dysphoria
Keywords: LGBT mental health
provider training in LGBT-affirmative clinical practice
Lead sponsor: Rutgers University
Sponsor class: OTHER
Collaborators: name: Yale University
First posted: 2018-07-26
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 120 MHPs will be randomized to receive the training either in-person or mobile on the web, concomitantly.
Primary purpose: OTHER

Brief summary: Lesbian, gay, bisexual and transgender individuals (LGBTI) present increased morbidity compared to the general population, which is attributed to healthcare discrimination and lack of LGBT-specific expertise, especially in high-stigma countries. Motivated by fear, Romanian LGBTI conceal their identities and report significantly more barriers to healthcare access than heterosexuals. Poor mental health, specifically anxiety and depression, is elevated for Romanian LGBTI, and associated with poor physical health (e.g., HIV risk, alcohol abuse.) However, LGBT-competent mental health professionals (MHPs) are nearly non-existent in Romania, and thus the negative impact of homophobia on mental health cannot be ameliorated. Given that a pilot of an in-person LGBT-affirmative MHP training recently tested in Romania showed significant receptivity and increased competence among MHPs, this training is ripe for testing its feasibility and efficacy in creating significant change via mobile delivery, in a randomized controlled trial (RCT). Proving the efficacy of this first mobile training and supervision model has high potential for cost-effective and expeditious boundless dissemination. Aim 1 will test the relative feasibility and efficacy of the mHealth MHP training by conducting an RCT comparing a mobile training (MT) of MHP LGBT-competency program (n=60) to the equivalent in-person training (IPT) (n=60) recently piloted. Both programs' content and structure will be identical (2-day trainings and two boosters 6 months apart). At baseline, 4, 8, and 12 months, all MHPs' LGBT-related attitudes, knowledge of LGBT health needs and clinical practice, and LGBT caseload will be assessed in a mobile fashion. In Aim 2 will test the efficacy of a companion mHealth supervision and consultation program in maintaining LGBT competency and enhancing LGBT-friendly practice. Half of the MHPs in each group will receive mHealth supervision and expert consultation program, consisting of monthly 2-hour virtual group meetings to discuss case studies, in order to determine the added benefit of mobile supervision. At the end of the study, 10 MHPs will provide interview-based program feedback. In Aim 3, the investigators will build mHealth research capacity among MHPs by demonstrating how to integrate mobile data collection tools in clinical practice to monitor client progress for personalized treatment plans.

Detailed description: Participants and Procedures. Partner Consortium. The PI has strategically chosen four types of partners in order to maximize the sustainability of our training. The study team's multidisciplinarity will increase the potential for reach across domains that are pivotal in changing the landscape of mental health for LGBTI in Romania. First, the team partnered with a multi-service provider, the Romanian Association against AIDS (ARAS), a non-governmental not-for-profit organization founded in 1992 to support the health of hidden and vulnerable groups including LGBTI. ARAS intends to expand the depth and breadth of its LGBT-competency in mental health. Second, the team has received the essential support of academics (Hyperion University and Professors Călugaru and Dumitriu), which are forefront agents for social change. Third, individual MHPs in private practice who are connected with key associations have signed on as liaisons to their affiliated organizations (e.g., Bellanima Center for Psychotherapy and Psychiatry) to facilitate training participation. Fourth, the team continues its fruitful collaboration with their technical developer, Data Center Solutions (DCS), who built the mobile platform on which the team delivered live therapy for DMDN, collected real-time mental health and behavioral data, and disseminated sexual health materials. DCS is an expert in health systems information technology (medical e-learning; patient health-promotion), and will build our mHealth training platform.

Inclusion Criteria. 120 Romanian practicing MHPs (psychologists or psychiatrists) or MHPs in training will be eligible to participate.

Recruitment. The Partner Consortium will advertise the project via web-postings, listservs and eblasts to their national circles. Facebook ads were the most successful source of recruitment for DMDN. The team will thus be able to canvas all regions of Romania. Further, due to the pilot work, the team is maintaining contact with close to 100 MHPs from Bucharest (the capital), and other cities (e.g., Sibiu, Iasi, Cluj Napoca, Timisoara). While they will not be eligible to participate because they had exposure to the program, they will circulate, as indicated by their Letters of Support, future trainings among their circles of individual practice and professional affiliations (e.g., Romanian Collegiate of Psychologists, the Cognitive Behavioral Therapy Association of Romania).

Screening and Consent. Study ads will link to the Qualtrics electronic screener easily accessed from any mobile device. MHPs will take the 5-minute survey (Appendix 2) to determine eligibility, and be randomized to either the MT group or IPT group (based on age and geographical region). The study budgeted travel stipends for one-third of the MHPs, whom the team anticipate live outside Bucharest, such that travel costs will not impede their participation in IPT and to ensure that each group will include samples that are unbiased geographically. Notably, the pilot included non-Bucharest residents. Alternate training dates will be offered for those unable to attend the trainings. Group assignment, training dates, locations, and link to a Qualtrics baseline (BL) survey will be sent prior to the training. The BL contains the consent form with our contacts for questions. The team tested these procedures in the pilot, during which the PI answered study questions from MHPs via email.

Sixty MHPs will be randomized to receive a 2-day IPT in Bucharest, and 60 MHPs will be randomized to the equivalent 3-day MT, on a DCS-designed platform compatible with any mobile device, and with document-sharing and voice-conferencing capabilities. The didactic trainings will be interspersed with answering MHP's questions (voice or text).

Supervision and Consultation. After the first follow-up (4 months post training), half of the IPT MHPs and half of the MT MHPs (n=30 per group, total n=60) will receive 2-hour monthly mobile supervision using a forum format on our mobile platform for 8 months. DCS will design a group chat feature, similar to the one they devised for a previous pilot study. The live monthly supervision will occur on this platform after the 4-month and before the 12-month assessments. This system will provide MHPs with a fully automated and interactive mobile platform through which they will participate in supervision, as well as submit questions and receive answers for case consultation from the experts (Dr. Pachankis and DMDN intervention psychologists) within 48 hours. Further, MHPs will receive case studies through our mobile website, monthly, with response options asking them their best approach to helping the client (e.g., common LGBT stressor situations such as coming out, negotiating sexual safety, reducing isolation, or replacing health-depleting behaviors such as excessive drinking with healthy alternatives). Cases are fully discussed during supervision. At the end of the study, those who did not receive supervision will be given access to all the case studies and the mobile consultation site to achieve equity.

Boosters. We will hold two 2-hour IPT and MT boosters, respectively, 6 and 12 months post training, and provide an overview of LGBT-affirmative therapy principles, their incorporation into clinical practice, clarifications, and troubleshooting. Case studies will be included covering common issues raised by LGBTI.

Measures of MHP Attitudes, Knowledge, and Clinical Practice. The mixed-methods design involves qualitative interviews (n=10) and 30-min. self-administered internet-based quantitative surveys (n=120) by MHPs, the latter being administered at BL, and at 4, 8, and 12-month follow-ups. Surveys will be identical and assess, in a mobile fashion, changes in MHPs' LGBT attitudes, knowledge of LGBT health needs, clinical practice skills, and LGBT caseload.

Feasibility and Acceptability. Feasibility measures include data on session attendance. Acceptability measures include 5-min. session rating surveys (on mobile devices), and the 10 qualitative interviews.

Efficacy. MHPs will report their age, gender, specialization, years of clinical practice, and LGBT caseload. We will measure attitudes, knowledge and clinical skills; and the presence of explicit and implicit stigma and homophobia.

Eligibility criteria: Inclusion Criteria:

* Romanian practicing MHPs (psychologists or psychiatrists) or MHPs in training

Exclusion Criteria:

* All those who do not meet the inclusion criteria

Primary outcomes:
measure: Changes in attitudes towards LGBT patients as assessed by the Attitudes Subscale of the Sexual Orientation Provider Competency Scale
timeFrame: Change in negative attitudes (mean scores) from baseline to each follow-up assessment point (4, 8, and 12 months post-training )
measure: Changes in knowledge for LGBT competent practice as assessed by the Knowledge Subscale of the Sexual Orientation Provider Competency Scale
timeFrame: Change in Knowledge (mean scores) from baseline to each follow-up assessment point (4, 8, and 12 months post-training )
measure: Changes in clinical skills as assessed by the Clinical Skills subscale of the Sexual Orientation Provider Competency Scale
timeFrame: Change in Clinical Skills (mean scores) from baseline to each follow-up assessment point (4, 8, and 12 months post-training )
measure: Changes in homophobic attitudes towards LGBT patients as assessed by the Modern Homonegativity Scale
timeFrame: Change in homophobic attitudes (mean scores) from baseline to each follow-up assessment point (4, 8, and 12 months post-training )
measure: Changes in implicit bias attitudes towards homosexual (gay or lesbian) individuals as assessed by the Sexual Orientation Implicit Association Test (Sexual Orientation IAT)
timeFrame: Change in implicit bias (mean scores) from baseline to each follow-up assessment point (4, 8, and 12 months post-training )
Secondary outcomes:
measure: LGBT client case load
timeFrame: Change (increase) in LGBT client case load (total number reported) from baseline to each follow-up assessment point (4, 8, and 12 months post-training )
measure: Intervention Feasibility measured by session attendance
timeFrame: Feasibility (session attendance) will be measured at baseline, and the two boosters at 6 months and 12 months post-baseline. An indicator of high feasibility includes 120 attendees for the training and two boosters.
measure: Intervention Acceptability measured by session rating surveys
timeFrame: The session ratings will take place at the end of the training. The training consisted of 2 days and it was held approximately two weeks after baseline.
measure: Intervention Acceptability measured by qualitative interviews
timeFrame: The 10 qualitative interviews will take place at the end of the study (12 months post training).
Other outcomes:
Locations:
city: Bucharest
country: Romania
facility: ARAS
Study officials:
affiliation: Rutgers University
name: Corina Lelutiu-Weinberger, PhD
role: STUDY_DIRECTOR
References: