TLC Program for Substance Addiction
(TLC Trial)

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Illinois Institute of Technology

No Placebo Group

Trial Summary

What is the purpose of 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.

Research Team

Eligibility Criteria

The Trans-Led Care Study is for transgender adults who are currently using substances or in early recovery. Participants should be interested in a mutual-help group based on Acceptance and Commitment Therapy (ACT) to connect with their values and enhance mental health.

Inclusion Criteria

Live in the U.S.

My gender identity is different from the sex I was assigned at birth.

I am 18 years old or older.

See 3 more

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the TLC Program intervention, which includes Acceptance and Commitment Therapy (ACT) for stigma reduction, delivered via telehealth in a peer-led group format.

12 weeks

Weekly sessions (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments of psychological flexibility, health care empowerment, and HIV risk.

12 weeks

Follow-up assessments at 24 weeks

Treatment Details

Interventions

The TLC Program (Behavioral Intervention)

Trial OverviewThis trial tests the TLC Program, a new mutual-help approach designed by and for transgender individuals. It incorporates ACT techniques to help participants manage substance use through mindfulness and value-based actions.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: The TLC ProgramExperimental Treatment1 Intervention

Participants randomized to the TLC Program will receive TAU plus the telehealth, peer-delivered group intervention, "the TLC Program."

Group II: Treatment as Usual (TAU)Active Control1 Intervention

Participants randomized to the control condition will receive treatment-as-usual (TAU), following SAMHSA guidelines for risky alcohol and other drug use and CDC established standards of care for STD/HIV prevention counseling. Participants meeting criteria for risky alcohol, drug use, or sexual behavior will be provided 15-25 minutes of brief counseling including: 1) a discussion that the participants drinking or drug use is more than the recommended limits for safe consumption, and that staying below these limits is important for their health; 2) a discussion of HIV risk-reduction interventions (i.e., consistent condom use, PrEP, ART treatment as prevention); and 3) referral to treatment (i.e., regular screening for HIV/STDs, HIV care, and/or substance use treatment).