Clinical trial NCT05890404: SGM Evidenced-Based Mental Healthcare Implementation
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: CBT
LGBTQ
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Northwestern University
name: Arizona State University
name: Miami University
name: University of Miami
name: CenterLink
name: National Institute of Mental Health (NIMH)
First posted: 2023-06-06
Enrollment: 1410
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility 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

Primary outcomes:
measure: Change in Provider Implementation Fidelity
timeFrame: 4-month follow-up, 8-month follow-up, 12-month follow-up, and 24-month follow-up
measure: Change in Client Depression Symptoms
timeFrame: Baseline, 4-month follow-up, 8-month follow-up, 12-month follow-up, and 24-month follow-up
Secondary outcomes:
measure: Change in Reach of LGBTQ-affirmative CBT.
timeFrame: 4-month follow-up, 8-month follow-up, 12-month follow-up, and 24-month follow-up
measure: Change in Adoption of LGBTQ-affirmative CBT
timeFrame: Baseline, 4-month follow-up, 8-month follow-up, 12-month follow-up, and 24-month follow-up
measure: Change in Familiarity With and Use of LGBTQ-affirmative CBT skills
timeFrame: Baseline, 4-month follow-up, 8-month follow-up, 12-month follow-up, and 24-month follow-up
measure: Change in Modification of LGBTQ-affirmative CBT
timeFrame: Baseline, 4-month follow-up, 8-month follow-up, 12-month follow-up, and 24-month follow-up
measure: Change in Adaptation to Local Contexts and Clients
timeFrame: 4-month follow-up, 8-month follow-up, 12-month follow-up, and 24-month follow-up
measure: Change in Maintenance of LGBTQ-affirmative CBT
timeFrame: 4-mo follow-up, 8-mo follow-up, 12-mo follow-up, and 24-mo follow-up
measure: Change in Client Anxiety
timeFrame: Baseline, 4-month follow-up, 8-month follow-up, 12-month follow-up, and 24-month follow-up
measure: Change in Client PTSD Symptoms
timeFrame: Baseline, 4-month follow-up, 8-month follow-up, 12-month follow-up, and 24-month follow-up
measure: Change in Client Alcohol Use Behavior
timeFrame: Baseline, 4-month follow-up, 8-month follow-up, 12-month follow-up, and 24-month follow-up
measure: Change in Client Substance Use Behavior
timeFrame: Baseline, 4-month follow-up, 8-month follow-up, 12-month follow-up, and 24-month follow-up
measure: Change in Client internalized stigma
timeFrame: Baseline, 4-month follow-up, 8-month follow-up, 12-month follow-up, and 24-month follow-up
measure: Change in Client Social Isolation
timeFrame: Baseline, 4-month follow-up, 8-month follow-up, 12-month follow-up, and 24-month follow-up
measure: Change in Client Emotion Dysregulation
timeFrame: Baseline, 4-month follow-up, 8-month follow-up, 12-month follow-up, and 24-month follow-up
Other outcomes:
Locations:
city: New York
country: United States
facility: Yale LGBTQ Mental Health Initiative with the Yale School of Public Office
state: New York
Study officials:
References: