- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03602222
An LGBT-Competency Program for Mental Health Professionals in Romania
Increasing Provider Competence for Treating Stress-related Mental Health Conditions in Low Resource Settings
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Bucharest, Romania
- ARAS
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Romanian practicing MHPs (psychologists or psychiatrists) or MHPs in training
Exclusion Criteria:
- All those who do not meet the inclusion criteria
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: In-person training LGBT mental health
In-person training LGBT mental health: Participants randomized to the in-person condition will receive training in LGBT-affirmative mental health counseling face-to-face.
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In-person training LGBT mental health: Half of the participants were randomly assigned to receive the training in LGBT mental health in-person.
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Experimental: Mobile training LGBT mental health
Mobile training LGBT mental health: Participants randomized to the mobile training condition will receive training in LGBT-affirmative mental health counseling while on the web.
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Mobile web training LGBT mental health: Half of the participants were randomly assigned to receive the training in LGBT mental health in a the mobile fashion (on the web).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in attitudes towards LGBT patients as assessed by the Attitudes Subscale of the Sexual Orientation Provider Competency Scale
Time Frame: Change in negative attitudes (mean scores) from baseline to each follow-up assessment point (4, 8, and 12 months post-training )
|
The Attitudes Subscale of the Sexual Orientation Provider Competency Scale measures providers' negative attitudes towards LGBT clients.
It consists of 10 items rated on a 5-point Likert scale ranging from 1, ''strongly disagree,'' to 5, ''strongly agree.''
A higher score indicates more negative attitudes.
|
Change in negative attitudes (mean scores) from baseline to each follow-up assessment point (4, 8, and 12 months post-training )
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Changes in knowledge for LGBT competent practice as assessed by the Knowledge Subscale of the Sexual Orientation Provider Competency Scale
Time Frame: Change in Knowledge (mean scores) from baseline to each follow-up assessment point (4, 8, and 12 months post-training )
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The Knowledge Subscale of the Sexual Orientation Provider Competency Scale measures providers' LGBT knowledge of issues that are specific to LGBT clients.
It consists of 8 items rated on a 5-point Likert scale ranging from 1, ''strongly disagree,'' to 5, ''strongly agree.''
A higher score indicates more knowledge.
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Change in Knowledge (mean scores) from baseline to each follow-up assessment point (4, 8, and 12 months post-training )
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Changes in clinical skills as assessed by the Clinical Skills subscale of the Sexual Orientation Provider Competency Scale
Time Frame: Change in Clinical Skills (mean scores) from baseline to each follow-up assessment point (4, 8, and 12 months post-training )
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The Clinical Skills Subscale of the Sexual Orientation Provider Competency Scale measures providers' clinical skills in addressing LGBT mental health issues.
It consists of 8 items rated on a 5-point Likert scale ranging from 1, ''strongly disagree,'' to 5, ''strongly agree.''
Item 7 was reverse-coded.
A higher score indicates more clinical skills.
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Change in Clinical Skills (mean scores) from baseline to each follow-up assessment point (4, 8, and 12 months post-training )
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Changes in homophobic attitudes towards LGBT patients as assessed by the Modern Homonegativity Scale
Time Frame: Change in homophobic attitudes (mean scores) from baseline to each follow-up assessment point (4, 8, and 12 months post-training )
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The Modern Homonegativity Scale measures providers' homophobic attitudes towards LGBT individuals.
It consists of 11 items rated on a 5-point Likert scale ranging from 1, ''strongly disagree,'' to 5, ''strongly agree.''
Items 5 and 8 were reverse-coded.
A higher score indicates higher homophobic attitudes.
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Change in homophobic attitudes (mean scores) from baseline to each follow-up assessment point (4, 8, and 12 months post-training )
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Changes in implicit bias attitudes towards homosexual (gay or lesbian) individuals as assessed by the Sexual Orientation Implicit Association Test (Sexual Orientation IAT)
Time Frame: Change in implicit bias (mean scores) from baseline to each follow-up assessment point (4, 8, and 12 months post-training )
|
The Sexual Orientation IAT measures providers' implicit bias against homosexual (gay or lesbian) individuals.
It consists of a reaction-time double categorization task in which participants are asked to categorize positive (e.g., "joyful") or negative (e.g., "disgusting") concepts and images of homosexual or heterosexual couples.
Scores range between -1 and +1, with scores closed to 0 indicating impartial attitudes towards either group, scores closer to -1 indicating lower implicit bias towards homosexual individuals.
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Change in implicit bias (mean scores) from baseline to each follow-up assessment point (4, 8, and 12 months post-training )
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
LGBT client case load
Time Frame: 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 )
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The number of LGBT clients a mental health professional has.
Higher intervention impact is indicated by increases in LGBT client load at each follow-up assessment point post-training.
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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 )
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Intervention Feasibility measured by session attendance
Time Frame: 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.
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Feasibility measures include data on session attendance.
These numbers should ideally be as close to 120 for the training sessions and booster sessions (6 and 12 months post training) as possible to indicate high intervention feasibility.
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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.
|
Intervention Acceptability measured by session rating surveys
Time Frame: 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.
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Acceptability measures include 5-minute session rating surveys of the quality of the training.
It consists of 9 items rated on a 5-point Likert scale ranging from 1, ''strongly disagree,'' to 5, ''strongly agree.''
The higher the score is, the higher the acceptability.
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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.
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Intervention Acceptability measured by qualitative interviews
Time Frame: The 10 qualitative interviews will take place at the end of the study (12 months post training).
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Acceptability measures include 10 phone qualitative interviews with randomly selected trainees.
These cannot be quantified, but themes will be identified (e.g., concept clarity, content appropriateness, missing information) indicative of positive and negative aspects identified by interviewees, informing how acceptable the training was and what changes need to be made for future iterations of it.
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The 10 qualitative interviews will take place at the end of the study (12 months post training).
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Corina Lelutiu-Weinberger, PhD, Rutgers University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RutgersU
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
- Informed Consent Form (ICF)
- Clinical Study Report (CSR)
- Analytic Code
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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