TLC Program for Substance Addiction

(TLC Trial)

Overseen By Arryn Guy, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Illinois Institute of Technology

Disqualifiers: Non-English speakers, Under 18, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 24

Duration: 12 weeks

124 Participants Needed

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.

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 identify as transgender.

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

Trial Overview This 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

Group I: The TLC Program Experimental Treatment 1 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 Control 1 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).

Who Is Running the Clinical Trial?

Illinois Institute of Technology

Lead Sponsor

Trials

26

Recruited

15,300+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+