ClinicalTrials.Veeva

Menu

SGM Evidenced-Based Mental Healthcare Implementation

Yale University logo

Yale University

Status

Enrolling

Conditions

LGBTQ
CBT

Treatments

Behavioral: LGBTQ-Affirmative CBT Training: Materials Only
Behavioral: LGBTQ-Affirmative CBT Training: Direct Training
Behavioral: LGBTQ-Affirmative CBT Training: Local Supervision

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT05890404
2000035211
1R01MH133543-01 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,410 estimated patients

Sex

All

Ages

15+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: Providers

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

Exclusion Criteria: Providers

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)

Inclusion Criteria: Clients

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

Exclusion Criteria: Clients

There are no exclusion criteria for clients

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

1,410 participants in 3 patient groups

Materials Only
Experimental group
Description:
The Materials Only arm will have access to a digital suite of online training materials for LGBTQ-Affirmative CBT prepared by the research team.
Treatment:
Behavioral: LGBTQ-Affirmative CBT Training: Materials Only
Direct Training
Experimental group
Description:
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.
Treatment:
Behavioral: LGBTQ-Affirmative CBT Training: Direct Training
Local Supervision
Experimental group
Description:
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.
Treatment:
Behavioral: LGBTQ-Affirmative CBT Training: Local Supervision

Trial contacts and locations

1

Loading...

Central trial contact

John E Pachankis, PhD; Danielle M Chiaramonte, PhD

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems