Implementing Sustainable Evidence-based Mental Healthcare in Low-resource Community Settings Nationwide to Advance Mental Health Equity for Sexual and Gender Minority Individuals
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 1,379
- Locations
- 1
- Primary Endpoint
- Change in Provider Implementation Fidelity
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 15 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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 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
Arms & Interventions
Materials Only
The Materials Only arm will have access to a digital suite of online training materials for LGBTQ-Affirmative CBT prepared by the research team.
Intervention: LGBTQ-Affirmative CBT Training: Materials Only (Behavioral)
Direct Training
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.
Intervention: LGBTQ-Affirmative CBT Training: Direct Training (Behavioral)
Local Supervision
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.
Intervention: LGBTQ-Affirmative CBT Training: Local Supervision (Behavioral)
Outcomes
Primary Outcomes
Change in Provider Implementation Fidelity
Time Frame: 4-month follow-up, 8-month follow-up, 12-month follow-up, and 24-month follow-up
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.
Change in Client Depression Symptoms
Time Frame: Baseline, 4-month follow-up, 8-month follow-up, 12-month follow-up, and 24-month follow-up
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.
Secondary Outcomes
- Change in Client Substance Use Behavior(Baseline, 4-month follow-up, 8-month follow-up, 12-month follow-up, and 24-month follow-up)
- Change in Maintenance of LGBTQ-affirmative CBT(4-mo follow-up, 8-mo follow-up, 12-mo follow-up, and 24-mo 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 Reach of LGBTQ-affirmative CBT.(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)
- Change in Client PTSD Symptoms(Baseline, 4-month follow-up, 8-month follow-up, 12-month follow-up, and 24-month follow-up)
- Change in Client Alcohol Use Behavior(Baseline, 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 Client Anxiety(Baseline, 4-month follow-up, 8-month follow-up, 12-month follow-up, and 24-month follow-up)
- Change in Client internalized stigma(Baseline, 4-month follow-up, 8-month follow-up, 12-month follow-up, and 24-month follow-up)
- Change in Client Social Isolation(Baseline, 4-month follow-up, 8-month follow-up, 12-month follow-up, and 24-month follow-up)
- Change in Client Emotion Dysregulation(Baseline, 4-month follow-up, 8-month follow-up, 12-month follow-up, and 24-month follow-up)