About this trial
This study is testing a new mutual-help group called "the TLC program" for transgender adults who use substances or are recently in recovery. The TLC Program is based on Acceptance and Commitment Therapy or "ACT" which is a type of mental health counseling that focuses on using mindfulness skills to connect a person to their values and improve their mental health. The TLC Program was developed by transgender and gender diverse community members, mental health providers, and researchers.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
be 18 years of age or older;
speak primarily English;
live in the U.S.;
have a gender identity different from their assumed gender, or sex assigned, at birth;
Disqualifiers
None
Trial design
Parallel
Treatments tested in this trial
The TLC Program
BehavioralParticipants randomized to the TLC Program will receive TAU plus the telehealth, peer-delivered group intervention. The TLC Program was adapted from Acceptance and Commitment Therapy (ACT) - an acceptance and mindfulness-based third wave cognitive behavioral therapy. The intervention will be delivered in a group format with peer facilitators via telehealth using videoconferencing. The protocol covers all six ACT core concepts (i.e., contact with the present, acceptance, defusion, self-as-context, values, and committed action) with tailored examples and exercises focused on gender affirmation, internalized stigma, and substance use. Additional sessions are included defining stigma, how stigma affects physical and sexual health and engagement with healthcare, and values-driven self-care goals of substance use reduction and healthcare engagement. Sessions are approximately 1.5 hours each and are delivered over 12 weeks.
Treatment groups
Trial outcomes
Primary outcomes
Gender Minority Stress and Resilience Scale Internalized Transphobia
Minimum value = 0, Maximum value = 1, Higher score = worse outcome
Health Care Empowerment Inventory
Minimum value = 1, Maximum value = 5, Higher score = better outcome
Patient-Reported Outcomes Measurement Information System (PROMIS)
Measuring psychological distress (depression and anxiety), Minimum value = 1 (per subscale), Maximum value = 5 (per subscale), Higher score = worse outcome
Psychological Flexibility, Multidimensional Psychological Flexibility Inventory (MPFI)
Minimum value = 1 (per subscale), Maximum value = 6 (per subscale), Higher score = worse outcome
Secondary outcomes
Substance Use Timeline Followback Interview
HIV Risk Questionnaire
Participants will be reporting number of sexual partners, types of sexual activities, and various HIV risk factors including condom use, PrEP use, and treatment as prevention
Other outcomes
PTSD Life Events Checklist for DSM-5
Participants will indicate whether certain difficult or stressful life events they have experienced
Intersectional Discrimination Index (InDI)
Minimum value = 0, Maximum value = 13, Higher score = worse outcome
Access to Gender Affirmation in Healthcare Questionnaire
Minimum value = 1, Maximum value = 5 Higher score = Better outcome
Need for Gender Affirmation Questionnaire
Minimum value = 1, Maximum value = 5
Sponsors and contacts
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Illinois Institute of Technology
Lead sponsor
National Institute on Drug Abuse (NIDA)
Collaborator