AzTrials
AzTrials

CBTNCT05890404

SGM Evidenced-Based Mental Healthcare Implementation

A study testing LGBTQ-Affirmative CBT Training: Materials Only, LGBTQ-Affirmative CBT Training: Direct Training and LGBTQ-Affirmative CBT Training: Local Supervision in people with CBT and 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
Search all trials

Trial summary

The purpose of the proposed study is to identify effective strategies for implementing lesbian, gay, bisexual, transgender, and queer (LGBTQ)- affirmative Cognitive-Behavioral Therapy (CBT) at LGBTQ community centers across the United States. Read more about this study

Who is it for?
Ages 15 years and olderHealthy volunteers can take part
Conditions the study is for
CBT, LGBTQ
What is being tested?
LGBTQ-Affirmative CBT Training: Materials Only, LGBTQ-Affirmative CBT Training: Direct Training and LGBTQ-Affirmative CBT Training: Local Supervision
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,379 participants
Where
1 siteUnited States
Study dates
8 Feb 2024to 25 May 2026
Phase
Interventional
Are there results?
None posted in the registry

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 15 years and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • Eligible providers will meet the following criteria:
  • 18 years of age or older
  • working as a psychologist, psychiatrist, social worker, mental health counselor, nurse practitioner, or peer support provider
  • affiliated with a US LGBTQ community center
  • providing mental health services to at least one sexual or gender minority (SGM) client
  • Eligible clients will meet the following criteria:
Show all 9Show fewer
  • of age to consent to mental health treatment in the state in which they live
  • receiving ongoing mental health services at one of the 15 LGBTQ centers selected for the client evaluation aim of the present study
  • self-identifying as LGBTQ

Who cannot join

  • Providers will be deemed ineligible due to:
  • possessing substantive experience with LGBTQ-affirmative CBT (e.g., having read most the LGBTQ-affirmative CBT treatment manual, attended LGBTQ-affirmative CBT training, or been supervised by someone who has previously attended the LGBTQ-affirmative CBT training)
  • There are no exclusion criteria for clients

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Yale LGBTQ Mental Health Initiative with the Yale School of Public Office

    New York, New York, 10001

Other trials in United States

About this study

Official title: Implementing Sustainable Evidence-based Mental Healthcare in Low-resource Community Settings Nationwide to Advance Mental Health Equity for Sexual and Gender Minority Individuals

The purpose of the proposed study is to identify effective strategies for implementing lesbian, gay, bisexual, transgender, and queer (LGBTQ)- affirmative Cognitive-Behavioral Therapy (CBT) at LGBTQ community centers across the United States.

Read the detailed description

The purpose of the proposed study is to identify effective strategies for implementing lesbian, gay, bisexual, transgender, and queer (LGBTQ)-affirmative CBT (cognitive-behavioral therapy) at LGBTQ community centers across the United States. This study will specifically compare the effectiveness of three implementation strategies: (1) training materials only, (2), training materials and direct training from our expert trainers, and (3) training materials, direct training, and local supervision from a clinical supervisor. The proposed prospective study will utilize a type 3 hybrid implementation-effectiveness trial. This design is used to compare the impact of two or more implementation strategies while also gathering effectiveness data and is recommended when there is already strong evidence for the intervention's effectiveness, strong basis that the implementation strategies are feasible, and strong implementation momentum. Randomization will occur on the center-level, so that MHPs working in the same center will receive one of the three types of training.

Outcomes include mental health providers' changes in demonstrated skills in providing LGBTQ-affirmative CBT from baseline to 4-, 8-, 12-, and 24-months post-baseline. This study will also investigate determinants of successful implementation of LGBTQ-affirmative CBT and examine the impact of the implementation strategies on client mental health.

Conditions
CBT, LGBTQ
Being tested
LGBTQ-Affirmative CBT Training: Materials Only, LGBTQ-Affirmative CBT Training: Direct Training, LGBTQ-Affirmative CBT Training: Local Supervision

What participants receive

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

  • LGBTQ-Affirmative CBT Training: Materials OnlyBehavioural

    Participants will be provided a digital suite of online self-guided learning materials, including step-by-step treatment materials, client handouts, and "how to" instructions for delivering the treatment.

  • LGBTQ-Affirmative CBT Training: Direct TrainingBehavioural

    Participants will be provided a digital suite of online self-guided learning materials, including step-by-step treatment materials, client handouts, and "how to" instructions for delivering the treatment. In addition, participants will receive 12 weekly 1-hour live training webinars on delivering LGBTQ-affirmative CBT led by expert trainers.

  • LGBTQ-Affirmative CBT Training: Local SupervisionBehavioural

    Participants will be provided a digital suite of online self-guided learning materials, including step-by-step treatment materials, client handouts, and "how to" instructions for delivering the treatment. In addition, participants will receive 12 weekly 1-hour live training webinars on delivering LGBTQ-affirmative CBT led by expert trainers. This arm will also receive one year of ongoing (at least monthly) supervision in LGBTQ-affirmative CBT from an expert supervisor at your center.

Study groups in NCT05890404
Study groupRoleWhat they receive
Materials OnlyExperimentalThe Materials Only arm will have access to a digital suite of online training materials for LGBTQ-Affirmative CBT prepared by the research team.
Receives: Behavioral: LGBTQ-Affirmative CBT Training: Materials Only
Direct TrainingExperimentalIn addition to receiving access to the online training materials, the Direct Training arm will receive 12 weekly 1-hour live webinars on delivering LGBTQ-affirmative CBT led by our four expert trainers.
Receives: Behavioral: LGBTQ-Affirmative CBT Training: Direct Training
Local SupervisionExperimentalIn addition to receiving the online training materials and live webinars, the Local Supervision arm will receive guidance from an on-site clinical supervisor, who will be nominated by the center director as someone with substantial CBT experience.
Receives: Behavioral: LGBTQ-Affirmative CBT Training: Local Supervision

What is being measured

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

  1. Change in Provider Implementation Fidelity

    Provider implementation fidelity of LGBTQ-Affirmative Therapy will serve as the primary implementation outcome and will be measured using a simulated practice assessment. Providers will watch two brief (three-minute) video clips of an SGM actor roleplaying a presenting concern and briefly describe in writing the clinical approaches they would use to address the concern. Research assistants will code the videos for important themes using a a scale created by expert LGBTQ-affirmative trainers for this study. This 2-item Likert scale ranges from 0 (did not mention [theme]) to 2 (discussed [theme] in-depth), and has a score range of 0-4. A higher score is indicative of a higher fidelity to the the treatment protocol. Administration time is 20 minutes.

    Measured: 4-month follow-up, 8-month follow-up, 12-month follow-up, and 24-month follow-up

  2. Change in Client Depression Symptoms

    Client depression symptoms will serve as the primary effectiveness outcome and will be Client depression symptoms will be measured on the client survey using the 9-item version of the Patient Health Questionnaire (PHQ-9). Participants respond to each item on a scale of 0 ("not at all") to 3 ("nearly every day"). Total scores range from 0-27, and are calculated as the sum of the 9 items. A higher score of indicative of higher depression symptomatology. Administration time is 6 minutes.

    Measured: Baseline, 4-month follow-up, 8-month follow-up, 12-month follow-up, and 24-month follow-up

Secondary outcomes (13)
  1. Change in Reach of LGBTQ-affirmative CBT.

    Reach of LGBTQ-affirmative CBT will be assessed on the provider survey as the percent of clients who receive LBGTQ-affirmative CBT out of total center clients. Total scores range from 0-100%; a higher percent indicates a stronger reach of LGBTQ-affirmative CBT. Additionally, opened-ended questions in provider interviews will highlight reasons for stronger or weaker reach.

    Measured: 4-month follow-up, 8-month follow-up, 12-month follow-up, and 24-month follow-up

  2. Change in Adoption of LGBTQ-affirmative CBT

    Adoption of LGBTQ-affirmative CBT will be assessed on the provider survey as percent of providers who practice LGBTQ-affirmative CBT out of number trained. The range for this measure is 0-100%. Semi-structured qualitative interviews with providers will highlight why and in what cases providers chose not to implement. We will also use secondary data from CenterLink to describe factors of centers choosing not to receive training.

    Measured: Baseline, 4-month follow-up, 8-month follow-up, 12-month follow-up, and 24-month follow-up

  3. Change in Familiarity With and Use of LGBTQ-affirmative CBT skills

    Familiarity with and use of LGBTQ-affirmative CBT skills will be assessed on the provider survey using Familiarity and Use Scale. This instrument contains 14 items, to which participants respond to each item on a Likert scale from 1 ("not at all"/"not at all familiar" ) to 5 ("very often"/"extremely familiar").* The total score is calculated by summing the items, and can range from 1-70. A higher score indicates higher familiarity with and use of LGBTQ-affirmative CBT skills. Administration time is 7 minutes.

    *Dependent on the phrasing/context of the item

    Measured: Baseline, 4-month follow-up, 8-month follow-up, 12-month follow-up, and 24-month follow-up

  4. Change in Modification of LGBTQ-affirmative CBT

    Modification of LGBTQ-affirmative CBT will be assessed on the provider survey using the Modification and Adaptation Checklist. This instrument contains 14 items as well as corresponding codes (0 -12) that denote different types of modifications. As these codes do not have corresponding values, this measure is not scored. Administration time is

    Measured: Baseline, 4-month follow-up, 8-month follow-up, 12-month follow-up, and 24-month follow-up

  5. Change in Adaptation to Local Contexts and Clients

    Adaptation to local contexts and clients will be assessed on the provider interview following our published guidance on intentional adaptation to local contexts/clients, as covered in the training.

    Measured: 4-month follow-up, 8-month follow-up, 12-month follow-up, and 24-month follow-up

  6. Change in Maintenance of LGBTQ-affirmative CBT

    Maintenance of LGBTQ-affirmative CBT will be assessed on the director survey and provider survey using the Program Sustainability Assessment Tool. This instrument contains 8 subscales and 40 total items, to which participants respond to each item on a Likert scale from 1 ("little or no extent" ) to 7 ("a very great extent"). The total score is calculated by first computing the mean for each subscale, and then computing the means of those scores. The total score can range from 1-7. A higher score indicates stronger maintenance of LGBTQ-affirmative CBT. Administration time is 15 minutes.

    operationalized as ongoing program support, funding stability, center capacity, and fit with strategic planning of LGBTQ-affirmative CBT. Assessed via the director survey and the provider survey and interview.

    Measured: 4-mo follow-up, 8-mo follow-up, 12-mo follow-up, and 24-mo follow-up

  7. Change in Client Anxiety

    Client anxiety will be assessed on the client survey using Generalized Anxiety Disorder Scale, 7 item Version. Participants respond on a Likert scale from 0 ("not at all") and 3 ("nearly every day"). The total score is calculated by summing the scores for each item, resulting in a range of 0-15. A higher score indicates higher anxiety symptomatology. Administration time is 5 minutes.

    Measured: Baseline, 4-month follow-up, 8-month follow-up, 12-month follow-up, and 24-month follow-up

  8. Change in Client PTSD Symptoms

    Client PTSD symptoms will be measured on the client survey using the PTSD Checklist for Diagnostic and Statistical Manual-5. This instrument contains 20 items, to which participants respond on a Likert scale from 0 ("not at all") to 4 ("extremely") The total score is calculated by summing the scores for each item, resulting in a range of 0-80. A higher score indicates higher PTSD symptomatology. Administration time is 10 minutes.

    Measured: Baseline, 4-month follow-up, 8-month follow-up, 12-month follow-up, and 24-month follow-up

  9. Change in Client Alcohol Use Behavior

    Client alcohol use behavior will be assessed on the client survey using the Alcohol Use Disorders Identification Test - Consumption. This instrument contains 3 items, to which participants respond on a Likert scale from 0 to 4 (the value of each point changes for each question). The total score is calculated by summing the scores for each item, resulting in a range of 0-12. A higher score indicates greater alcohol consumption. Administration time is 2 minutes.

    Measured: Baseline, 4-month follow-up, 8-month follow-up, 12-month follow-up, and 24-month follow-up

  10. Change in Client Substance Use Behavior

    Client substance use* behavior will be assessed on the client survey using the Drug Use Disorders Identification Test - Consumption. This instrument 4 items, to which participants respond on a Likert scale from 0 to 4 (the value of each point changes for each question). The total score is calculated by summing the scores for each item, resulting in a range of 0-16. A higher score indicates greater substance consumption. Administration time is 2 minutes.

    *excluding alcohol

    Measured: Baseline, 4-month follow-up, 8-month follow-up, 12-month follow-up, and 24-month follow-up

  11. Change in Client internalized stigma

    Client internalized stigma will be assessed on the client survey using the 3-item Internalized Stigma subscale of the Lesbian, Gay, Bisexual Identity Scale (LGBIS). Participants respond on a Likert scale from 1 ("disagree strongly" to 6 ("agree strongly"). The total score is calculated by first computing the mean for each subscale, and then computing the means of those scores. The range for possible total scores is 1-18. A higher score indicates greater internalized stigma. Administration time is 2 minutes.

    Measured: Baseline, 4-month follow-up, 8-month follow-up, 12-month follow-up, and 24-month follow-up

  12. Change in Client Social Isolation

    Client social isolation will be assessed on the client survey using the UCLA Loneliness Scale. This instrument contains 3 items, to which participants respond on a Likert scale from 1 ("hardly ever") to 3 ("often"). The total score is calculated by summing the scores for each item, resulting in a range of 1-9. A higher score indicates greater social isolation. Administration time is 2 minutes.

    Measured: Baseline, 4-month follow-up, 8-month follow-up, 12-month follow-up, and 24-month follow-up

  13. Change in Client Emotion Dysregulation

    Client emotion dysregulation will be assessed on the client survey using the Difficulties in Emotion Regulation Scale - Short Form. This instrument contains 6 subscales and 18 total items, to which participants respond on a Likert scale from 1 ("almost never") to 5 ("almost always"). The total score is calculated by summing the scores for each item, resulting in a range of 1-18. A higher score indicates greater difficulties emotional regulation. Administration time is 10 minutes.

    Measured: Baseline, 4-month follow-up, 8-month follow-up, 12-month follow-up, and 24-month follow-up

Timeline

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

  1. First posted6 Jun 2023
  2. Study start8 Feb 2024
  3. Primary completion25 May 2026
  4. Study completion25 May 2026

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
Single blind
Who is masked
Outcomes assessor
Enrolment
1,379 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05890404
Sponsor's protocol ID
2000035211
Other IDs
1R01MH133543-01
Status last verified
Jul 2026
First submitted
25 May 2023
Last updated
3 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Pachankis JE, Chiaramonte D, Baldwin HT, Prachniak C, Levine DS, Van S, Hobbs RJ, Ankrum H, Wilkins LJ, Harvey TD, Harkness A, Jackson SD, Matsuno E, Soulliard ZA, Last BS, Burger J, Delehant M, Zhou X, Hagaman AK, Li DH, Mustanski B. Implementing LGBTQ-affirmative CBT: study protocol for an effectiveness-implementation trial at 90 LGBTQ community centers. BMC Health Serv Res. 2025 Jul 21;25(1):962. doi: 10.1186/s12913-025-13136-3.

    PubMed 40691571

Questions about this trial

What is this clinical trial studying?

A study testing LGBTQ-Affirmative CBT Training: Materials Only, LGBTQ-Affirmative CBT Training: Direct Training and LGBTQ-Affirmative CBT Training: Local Supervision in people with CBT and 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 9 inclusion and 3 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 3 Aug 2026. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Change in Provider Implementation Fidelity (time frame: 4-month follow-up, 8-month follow-up, 12-month follow-up, and 24-month follow-up). 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 NCT05890404, which also lists 1 linked publication.

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 3 Aug 2026.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in