SGM Evidenced-Based Mental Healthcare Implementation

NCT05890404 | Recruiting DMC

• 2 other identifiers: 20000352111R01MH133543-01
• Study Type: interventional
• Target: 1,410
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

CBT; LGBTQ

Outcome Measures

Primary Outcomes (2)

• 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.

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

• 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.

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

Secondary Outcomes (13)

• Change in Reach of LGBTQ-affirmative CBT.

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

• Change in Adoption of LGBTQ-affirmative CBT

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

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

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

• Change in Modification of LGBTQ-affirmative CBT

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

• Change in Adaptation to Local Contexts and Clients

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

Study Arms (3)

Materials Only

EXPERIMENTAL

The Materials Only arm will have access to a digital suite of online training materials for LGBTQ-Affirmative CBT prepared by the research team.

Behavioral: LGBTQ-Affirmative CBT Training: Materials Only

Direct Training

EXPERIMENTAL

In 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.

Behavioral: LGBTQ-Affirmative CBT Training: Direct Training

Local Supervision

EXPERIMENTAL

In 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.

Behavioral: LGBTQ-Affirmative CBT Training: Local Supervision

Interventions

LGBTQ-Affirmative CBT Training: Materials Only BEHAVIORAL

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.

Materials Only

LGBTQ-Affirmative CBT Training: Direct Training BEHAVIORAL

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.

Direct Training

LGBTQ-Affirmative CBT Training: Local Supervision BEHAVIORAL

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.

Local Supervision

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Eligible providers will meet the following criteria:
• 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

You may not qualify if:

• 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)
• Eligible clients will meet the following criteria:
• 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

Sponsors & Collaborators

• Yale University: lead
• Northwestern University: collaborator
• Arizona State University: collaborator
• Miami University: collaborator
• University of Miami: collaborator
• CenterLink: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Yale LGBTQ Mental Health Initiative with the Yale School of Public Office

New York, New York, 10001, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 40691571 DERIVED

Central Study Contacts

John E Pachankis, PhD

CONTACT

646-429-9407; John.Pachankis@yale.edu

Danielle M Chiaramonte, PhD

CONTACT

708-334-8331; Danielle.Chiaramonte@yale.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2023
• First Posted: June 6, 2023
• Study Start: February 8, 2024
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: August 5, 2025

Record last verified: 2025-08

Locations

US (1)