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LGBTQNCT04559698

Assessing Mental Health Providers' Clinical Knowledge and Skills Via an Online Training on LGBTQ-affirmative Cognitive-behavioral Therapy

A study testing LGBTQ-affirmative CBT training in people with LGBTQ, run by Yale University at 1 site in United States.

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 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). Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
LGBTQ
What is being tested?
LGBTQ-affirmative CBT training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
121 participants
Where
1 siteUnited States
Study dates
1 Oct 2020to 26 Jun 2021
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • 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.

Who cannot join

  • • Individuals unwilling or unable to give informed consent at the time of participation and/or not fitting the eligibility criteria outlined above

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Yale LGBTQ+ Mental Health Initiative - Research Lab

    New York, New York, 10010

Other trials in United States

About this study

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).

Read the detailed 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.

Conditions
LGBTQ
Being tested
LGBTQ-affirmative CBT training

What participants receive

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

  • LGBTQ-affirmative CBT trainingBehavioural

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

Study groups in NCT04559698
Study groupRoleWhat they receive
immediate training groupExperimentalParticipants will take part in 11-week LGBTQ-affirmative CBT training via Zoom for 1-hour per week. The participants in the immediate training group will take part in the first 11-week course.
Receives: Behavioral: LGBTQ-affirmative CBT training
waitlist control groupExperimentalParticipants will take part in 11-week LGBTQ-affirmative CBT training via Zoom for 1-hour per week. The participants in the waitlist control group will take part in the second 11-week course.
Receives: Behavioral: LGBTQ-affirmative CBT training

What is being measured

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

  1. 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.

    Measured: Four-month Pre-intervention, Immediate Pre-intervention, Immediate Post-intervention, Four-month Post-intervention

  2. 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.

    Measured: Four-month Pre-intervention, Immediate Pre-intervention, Immediate Post-intervention, Four-month Post-intervention

Secondary outcomes (7)

  1. 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.

    Measured: Four-month Pre-intervention, Immediate Pre-intervention, Immediate Post-intervention, Four-month Post-intervention

  2. 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.

    Measured: Four-month Pre-intervention, Immediate Pre-intervention, Immediate Post-intervention, Four-month Post-intervention

  3. 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.

    Measured: Four-month Pre-intervention, Immediate Pre-intervention, Immediate Post-intervention, Four-month Post-intervention

  4. 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.

    Measured: Four-month Pre-intervention, Immediate Pre-intervention, Immediate Post-intervention, Four-month Post-intervention

  5. 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.

    Measured: Four-month Pre-intervention, Immediate Pre-intervention, Immediate Post-intervention, Four-month Post-Intervention

  6. 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.

    Measured: Four-month Pre-intervention, Immediate Pre-intervention, Immediate Post-intervention, Four-month Post-intervention

  7. 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.

    Measured: Immediate Post-intervention

Timeline

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

  1. First posted23 Sep 2020
  2. Study start1 Oct 2020
  3. Primary completion26 Jun 2021
  4. Study completion26 Jun 2021

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
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
121 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04559698
Sponsor's protocol ID
2000028914
Status last verified
Mar 2022
First submitted
16 Sep 2020
Last updated
14 Mar 2022
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

  • 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.

    PubMed 12956539

  • 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.

    PubMed 32437174

  • 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.

  • 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.

    PubMed 29096945

  • 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.

    PubMed 28891750

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

  • Pachankis JE, Soulliard ZA, Seager van Dyk I, Layland EK, Clark KA, Levine DS, Jackson SD. Training in LGBTQ-affirmative cognitive behavioral therapy: A randomized controlled trial across LGBTQ community centers. J Consult Clin Psychol. 2022 Jul;90(7):582-599. doi: 10.1037/ccp0000745.

    PubMed 35901370

Questions about this trial

What is this clinical trial studying?

A study testing LGBTQ-affirmative CBT training in people with LGBTQ, run by Yale University at 1 site in United States.

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 1 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 Mar 2022. 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 United States. 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?

Yes. Results are posted in the registry (first posted 14 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Familiarity With LGBTQ-Affirmative CBT Skills (time frame: Four-month Pre-intervention, Immediate Pre-intervention, Immediate Post-intervention, Four-month Post-intervention). The study lists 2 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 NCT04559698, which also lists 9 linked publications.

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 Mar 2022.

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