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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04559698
Other study ID # 2000028914
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 1, 2020
Est. completion date June 26, 2021

Study information

Verified date March 2022
Source Yale University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of the proposed study is to train mental health providers (MHPs) at lesbian, gay, bisexual, transgender, and queer (LGBTQ) community centers across the United States in evidence-based, LGBTQ-affirmative cognitive-behavioral therapy (CBT).


Description:

The purpose of the proposed study is to train mental health providers (MHPs) at LGBTQ community centers across the United States in evidence-based, LGBTQ-affirmative cognitive-behavioral therapy (CBT). The primary objective of this study is to determine whether the LGBTQ-affirmative CBT training increases LGBTQ and CBT knowledge, clinical skills, and cultural humility among a sample of MHPs from LGBTQ community centers in the U.S. The proposed prospective study will follow a 2-arm waitlist randomized-controlled trial design where one group of MHPs will be randomized to receive the intervention training (i.e., the immediate training group) in LGBTQ-affirmative CBT, and the second group of MHPs will be randomized to a waitlist control group. The proposed mixed-methods study will consist of predominantly quantitative self-report measures, as well as a qualitative self-assessment of participants' LGBTQ-affirmative CBT clinical skills. All study measures will be administered online at three time points-- baseline, 4-months post-baseline, and 8-months post-baseline (changed prior to randomization from 3-months and 6-months, respectively)-- via the secure Yale Qualtrics survey software.


Recruitment information / eligibility

Status Completed
Enrollment 121
Est. completion date June 26, 2021
Est. primary completion date June 26, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 18+ years old - Fluent in English - Mental health provider (including, but not limited to licensed practicing counselors, licensed clinical social workers, licensed marital and family therapists, clinical/counseling psychologists, pre-doctoral psychology interns, third-year or greater graduate practicum students/externs) - Currently practicing in an LGBTQ community center that is coordinated by CenterLink, the coordinating hub for LGBTQ community centers in the U.S. Exclusion Criteria: - • Individuals unwilling or unable to give informed consent at the time of participation and/or not fitting the eligibility criteria outlined above

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
LGBTQ-affirmative CBT training
Participants will take part in 11-week LGBTQ-affirmative CBT training via Zoom for 1-hour per week.

Locations

Country Name City State
United States Yale LGBTQ+ Mental Health Initiative - Research Lab New York New York

Sponsors (3)

Lead Sponsor Collaborator
Yale University David R. Kessler, M.D. '55 Fund for LGBTQ Mental Health Research at Yale, The Fund for Lesbian and Gay Studies at Yale

Country where clinical trial is conducted

United States, 

References & Publications (8)

Bidell, M. P. (2005). The Sexual Orientation Counselor Competency Scale: Assessing attitudes, skills, and knowledge of counselors working with lesbian, gay, and bisexual clients. Counselor Education and Supervision, 44(4), 267-279.

Gonzalez, E., Sperandio, K. R., Mullen, P. R., & Tuazon, V. E. (2021). Development and initial testing of the Multidimensional Cultural Humility Scale. Measurement and Evaluation in Counseling and Development, 54(1), 56-70.

Lelutiu-Weinberger C, Pachankis JE. Acceptability and Preliminary Efficacy of a Lesbian, Gay, Bisexual, and Transgender-Affirmative Mental Health Practice Training in a Highly Stigmatizing National Context. LGBT Health. 2017 Oct;4(5):360-370. doi: 10.1089/lgbt.2016.0194. Epub 2017 Sep 11. — View Citation

Meyer IH. Prejudice, social stress, and mental health in lesbian, gay, and bisexual populations: conceptual issues and research evidence. Psychol Bull. 2003 Sep;129(5):674-697. doi: 10.1037/0033-2909.129.5.674. Review. — View Citation

Myles, P. J., & Milne, D. L. (2004). Outcome evaluation of a brief shared learning programme in cognitive behavioural therapy. Behavioural and Cognitive Psychotherapy, 32(2), 177-188.

Pachankis JE, McConocha EM, Clark KA, Wang K, Behari K, Fetzner BK, Brisbin CD, Scheer JR, Lehavot K. A transdiagnostic minority stress intervention for gender diverse sexual minority women's depression, anxiety, and unhealthy alcohol use: A randomized controlled trial. J Consult Clin Psychol. 2020 Jul;88(7):613-630. doi: 10.1037/ccp0000508. Epub 2020 May 21. — View Citation

Rousmaniere, T. (2017). Deliberate practice for psychotherapists: A guide to improving clinical effectiveness. Routledge/Taylor & Francis Group.

White Hughto JM, Clark KA, Altice FL, Reisner SL, Kershaw TS, Pachankis JE. Improving correctional healthcare providers' ability to care for transgender patients: Development and evaluation of a theory-driven cultural and clinical competence intervention. Soc Sci Med. 2017 Dec;195:159-169. doi: 10.1016/j.socscimed.2017.10.004. Epub 2017 Oct 30. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Familiarity With LGBTQ-Affirmative CBT Skills Familiarity with LGBTQ-affirmative CBT skills will be measured using a self-developed questionnaire by the researchers for the purpose of this study. This questionnaire consists of 7 items rated on a 5-point Likert scale for each item. An overall score of 35 (sum of all items) would be the highest possible score on the questionnaire and would indicate a high level of familiarity with LGBTQ-affirmative CBT skills. Four-month Pre-intervention, Immediate Pre-intervention, Immediate Post-intervention, Four-month Post-intervention
Primary Use of LGBTQ-Affirmative CBT Skills Use LGBTQ-affirmative CBT skills will be measured using a self-developed questionnaire by the researchers for the purpose of this study. This questionnaire consists of 7 items rated on a 5-point Likert scale for each item. An overall score of 35 (sum of all items) would be the highest possible score on the questionnaire and would indicate a high level of use of LGBTQ-affirmative CBT skills. Four-month Pre-intervention, Immediate Pre-intervention, Immediate Post-intervention, Four-month Post-intervention
Secondary Self-Reported LGBTQ Clinical Skills Competency Competency in LGBTQ clinical skills will be measured using the Sexual Orientation Counselor Competency Scale (SOCCS) - Clinical Skills subscale. This subscale consists of 11-items from a psychometrically validated measure, based on a 7-point Likert scale assessing the extent to which respondents endorse clinical competence as related to their skills in working with clients of diverse sexual identities. For the present study, items have been adapted to specifically assess competence in clinical skills based on an LGBTQ-affirmative CBT framework. An overall score of 7 (arithmetic mean of all 11 items) would be the highest possible score and would indicate a high level of competence in LGBTQ clinical skills. Four-month Pre-intervention, Immediate Pre-intervention, Immediate Post-intervention, Four-month Post-intervention
Secondary Applied LGBTQ Clinical Skills Competency Competency in LGBTQ clinical skills will be measured by asking participants to provide responses to videos of fictional LGBTQ clients. Participants will watch 2 brief video clips (90 seconds each) of fictional clients presenting concerns they would like to address in psychotherapy. Participants will then be asked to write a brief paragraph describing what clinical approaches they would use in clinical treatment in order to address the challenges discussed by the fictional client. These written responses will be rated based on 22 items on a 2-point scale of 0 (did not mention at all), 1 (briefly discussed), and 2 (discussed in detail) to determine participants' LGBTQ-affirmative and general CBT skills. Items coded related to LGBTQ-affirmative CBT skills will not be double coded in the comparable items related to general CBT skills. Average scores will be taken such that 2 would be the highest possible score and would indicate a high level of competence in LGBTQ clinical skills. Four-month Pre-intervention, Immediate Pre-intervention, Immediate Post-intervention, Four-month Post-intervention
Secondary Applied CBT Clinical Skills Competency Competency in general CBT clinical skills will be measured by asking participants to provide responses to videos of fictional LGBTQ clients. Participants will watch 2 brief video clips (90 seconds each) of fictional clients presenting concerns they would like to address in psychotherapy. Participants will then be asked to write a brief paragraph describing what clinical approaches they would use in clinical treatment in order to address the challenges discussed by the fictional client. These written responses will be rated based on 22 items on a 2-point scale of 0 (did not mention at all), 1 (briefly discussed), and 2 (discussed in detail) to determine participants' LGBTQ-affirmative and general CBT skills. Items coded related to LGBTQ-affirmative CBT skills will not be double coded in the comparable items related to general CBT skills. Average scores will be taken such that 2 would be the highest possible score and would indicate a high level of competence in CBT clinical skills. Four-month Pre-intervention, Immediate Pre-intervention, Immediate Post-intervention, Four-month Post-intervention
Secondary LGBTQ Cultural Humility LGBTQ cultural humility will be measured using the Multidimensional Cultural Humility Scale (MCHS). This questionnaire is a 15-item self-report psychometrically validated measure assessing the extent to which respondents endorse an ability to maintain an other-oriented, interpersonal stance in relation to cultural identities most salient to clients. For the present study, items were adapted to specifically assess cultural humility as related to working with LGBTQ clients. An overall score of 90 (sum of all items) would be the highest possible score on the questionnaire and would indicate a high level of LGBTQ cultural humility. Four-month Pre-intervention, Immediate Pre-intervention, Immediate Post-intervention, Four-month Post-intervention
Secondary Content Knowledge of Minority Stress Content knowledge of minority stress will be measured using a self-developed, 10-item multiple-choice measure by the researchers for the purpose of this study and based on past minority stress research. An overall score of 10 (i.e., answering all 10-items correctly) would be the highest possible score on the measure and would indicate a high level of content knowledge of minority stress. Four-month Pre-intervention, Immediate Pre-intervention, Immediate Post-intervention, Four-month Post-Intervention
Secondary Content Knowledge of CBT/LGBTQ-Affirmative CBT Content knowledge of CBT/LGBTQ-affirmative CBT will be measured using a self-developed, 10-item multiple-choice measure by the researchers for the purpose of this study based on past interventional studies of LGBTQ-affirmative CBT. An overall score of 10 (i.e., answering all 10-items correctly) would be the highest possible score on the measure and would indicate a high level of content knowledge of CBT/LGBTQ-affirmative CBT. Four-month Pre-intervention, Immediate Pre-intervention, Immediate Post-intervention, Four-month Post-intervention
Secondary Acceptability of LGBTQ-affirmative CBT Training Acceptability of LGBTQ-affirmative CBT will measured using a self-developed questionnaire by the researchers based on past research on training acceptability. Participants will be asked to report how many of the 11 training sessions they attended. Participants will then be asked 2 qualitative questions in regard to which of the 11 training sessions they found most and least helpful. Participants will also be asked 7 questions based on a 5-point Likert scale regarding their interest and perceived benefit from the training. An overall score of 35 (sum of all items) on the Likert scale items would be the highest possible score on the measure and would indicate a high level of perceived acceptability of the LGBTQ-affirmative CBT training. Immediate Post-intervention
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