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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new support group, the TLC Program, designed for transgender adults who use substances or are newly in recovery. The program is based on Acceptance and Commitment Therapy (ACT), which uses mindfulness to help people connect with their values and improve mental health. Participants will either receive standard care or join the TLC Program, delivered via telehealth and led by peers. Transgender individuals who have faced substance-related challenges in the past year might be a good fit for this trial. As an unphased trial, this study offers a unique opportunity to contribute to innovative support strategies tailored for the transgender community.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that the TLC Program is safe for transgender adults?

Research has shown that Acceptance and Commitment Therapy (ACT) is generally safe and well-tolerated. Many studies have examined its use in mental health care and found that it improves well-being by teaching mindfulness skills. Although specific data on the safety of the TLC Program is not available, the known safety of ACT suggests that the TLC Program is likely safe as well. It aims to help individuals connect with their values and improve mental health, a key component of ACT.

As the TLC Program is a form of mental health counseling rather than a drug or medical procedure, the risk of physical side effects is low. The program was developed with input from transgender and gender-diverse community members, mental health providers, and researchers, enhancing its relevance and acceptance among those it is designed to help. This collaboration also supports the program's safety and effectiveness. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the TLC Program for substance addiction because it combines traditional treatment with a novel, telehealth, peer-delivered group intervention. Unlike standard treatments that primarily rely on in-person counseling and medication, the TLC Program offers greater accessibility and support through digital means, allowing participants to receive help from the comfort of their homes. This approach not only enhances convenience but also leverages peer support, which can be crucial for motivation and accountability in recovery. By integrating telehealth, the TLC Program aims to reach a broader audience and provide a continuous, supportive environment that could improve long-term outcomes for those struggling with addiction.

What evidence suggests that the TLC Program is effective for substance addiction?

Research has shown that therapeutic community (TC) programs effectively help people with substance use problems. In several studies, participants in TC programs reduced substance use and improved their social lives. They also experienced better legal outcomes and higher employment rates. One study found that alcohol cravings significantly decreased after just two weeks in a treatment center. This trial will compare the TLC Program, which includes telehealth and peer-delivered group intervention, with Treatment as Usual (TAU). These programs focus on building resilience and making positive lifestyle changes, which can greatly aid recovery. ^{3 6 7 8 9}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3562581/

Therapeutic Communities for Addictions: A Review of Their ... Two out of three studies showed significantly better substance use and legal outcomes among TC participants, and five studies found superior employment and ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0376871619301875

The effectiveness of residential treatment services for ... Of 23 studies, 10 were rated as methodologically strong, 5 as moderate and 8 as weak. Results provide moderate evidence for the effectiveness ...

3. tandfonline.com tandfonline.com/doi/full/10.1080/13284207.2025.2533128

Effectiveness of a therapeutic community for substance use Research has shown that TCs can effectively reduce substance dependence and improve social functioning, employment, and prosocial behaviours (De Leon, Citation ...

4. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK541232/

Residential Treatment for Substance Use Disorder - NCBI - NIH Among patients in a residential alcohol detoxification program, alcohol craving scores were significantly lower at two-week follow-up (p=0.04) ...

5. journals.lww.com journals.lww.com/jan/fulltext/2022/10000/effectiveness_of_therapeutic_community_program_on.5.aspx

Effectiveness of Therapeutic Community Program on... The purpose of this study was to examine the effectiveness of a therapeutic community program on resilience and positive change of lifestyle in people with ...

6. cdc.gov cdc.gov/youth-behavior/risk-behaviors/teens-linked-to-care.html

Teens Linked to Care (TLC) Of the students screened for risky substance use through TLC, the program's effects showed that: 27% received brief intervention by a health ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12180564/

Substance Use Disorder Treatment Outcomes This review aims to parse such heterogeneity by analysing the operational definitions of variables used to derive metrics and outcome criteria.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4007701/

The Continuing Care Model of Substance Use Treatment Results revealed that patients receiving residential treatment for an average of 90 days demonstrated significantly less improvement with respect to ASI alcohol ...

9. rti.org rti.org/rti-press-publication/tracking-quality-addiction-treatment-time-across-states-using-federal-government-signs-higher-qualit

Tracking the Quality of Addiction Treatment The goal of this study was to determine what percentage of specialty addiction treatment facilities have the attributes or signs that indicate higher quality.