Trauma-Informed Intervention for Substance Use Disorders

(TRUST Trial)

Recruiting at 3 trial locations

Overseen By Erin Winston, MPA

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Michele Staton

Disqualifiers: Suicidal risk, others

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

Compensation: Varies

Number of Visits: 3

264 Participants Needed

Trial Summary

What is the purpose of this trial?

The overall aim of this study is to reduce overdose risk for criminal legal system (CLS) involved women during community re-entry through the adaptation and testing of an innovative, trauma-informed, relational intervention approach (Trust-Based Relational Intervention or TBRI).

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Trust-Based Relational Intervention (TBRI) for Substance Use Disorders?

Research shows that the quality of the relationship between a therapist and client, known as the therapeutic bond, can significantly aid recovery from substance use disorders. This suggests that treatments like TBRI, which focus on building trust and strong relationships, may be effective in helping individuals with substance use issues. ^{1 2 3 4 5}

Is trauma-informed intervention for substance use disorders safe for humans?

Research on trauma-informed care for substance use disorders, including integrated treatment programs, suggests that these interventions are generally safe, with minimal adverse outcomes reported in studies involving youth and adults with trauma histories. ^{1 3 5 6 7}

How is the Trust-Based Relational Intervention (TBRI) treatment different from other treatments for substance use disorders?

Trust-Based Relational Intervention (TBRI) is unique because it focuses on building trust and relationships as a core part of the treatment, which is particularly important for individuals with trauma histories. Unlike traditional treatments, TBRI integrates trauma-informed care principles, emphasizing safety, trust, and collaboration to address both substance use and trauma-related issues. ^{1 3 5 8 9}

Research Team

Kevin Knight, PhD

Principal Investigator

Texas Christian University

Michele Staton, MSW, PhD

Principal Investigator

University of Kentucky

Eligibility Criteria

This trial is for women with substance use disorders who are transitioning back into the community from the criminal legal system. It's designed to help them reduce their risk of overdose by using a new approach that considers their past trauma.

Inclusion Criteria

I will be released within the next 3 months.

Participating in prison-based SUD treatment program

Self-identified history of violent victimization

Exclusion Criteria

Release date greater than 3 months

No self-identified history of violent victimization

Indication of current suicidal risk

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

R61 Phase (Intervention adaptation)

Adaptation of the TBRI intervention for CLS-involved women, including prison group sessions and re-entry recovery support

Not specified

R33 Phase (Intervention testing)

Testing the effectiveness of the adapted TBRI-WRA to reduce overdose risk in the community following prison release

6 months

Baseline, 3 months, and 6 months post-release

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Treatment Details

Interventions

• Trust-Based Relational Intervention (TBRI)

Trial Overview The study tests an intervention called Trust-Based Relational Intervention (TBRI) combined with Treatment as Usual (TAU) and additional re-entry recovery support, against TBRI alone or just TAU. The goal is to see which method best reduces substance use and supports transition.

Participant Groups

Group I: TBRI alone Experimental Treatment 1 Intervention

Treatment as usual and the adapted version of TBRI for adult women

Group II: Re-entry Recovery Support Experimental Treatment 1 Intervention

Treatment as usual, the adapted TBRI, and on-going re-entry recovery support with the Safe Support Person (SPP).

Group III: Treatment As Usual (TAU) Active Control 1 Intervention

Traditional in-prison SUD treatment

Who Is Running the Clinical Trial?

Michele Staton

Lead Sponsor

Trials

5

Recruited

1,600+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Findings from Research

In a study involving 98 male veterans with substance use disorders and PTSD, the Seeking Safety therapy led to better drug use outcomes compared to standard treatment, indicating its effectiveness in this population.

Seeking Safety also resulted in higher treatment attendance and patient satisfaction, although the exact mechanism behind its effectiveness in reducing drug use remains unclear.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Seeking Safety treatment for male veterans with a substance use disorder and post-traumatic stress disorder symptomatology. Boden, MT., Kimerling, R., Jacobs-Lentz, J., et al.[2018]

This study will evaluate a new trauma-informed care model in a residential treatment service for youth aged 18-35 with substance use disorders and PTSD, focusing on staff training, service adaptations, and client support.

Outcomes will include adherence to the trauma-informed model and client treatment completion, with follow-up assessments on substance use and mental health at multiple time points over a year, aiming to improve treatment retention and outcomes for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Study protocol: implementing and evaluating a trauma-informed model of care in residential youth treatment for substance use disorders. Walter, ZC., Carlyle, M., Kerswell, N., et al.[2023]

Adolescents with a history of trauma are at a higher risk for developing substance use disorders (SUDs), and integrated treatment approaches are necessary to address both trauma and SUDs effectively.

A systematic review of 33 studies, including 13 randomized controlled trials, found that cognitive-behavioral therapy and other therapeutic approaches show promise in treating SUDs in traumatized youth, with exposure-based interventions yielding particularly strong results and minimal adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interventions for prevention and treatment of substance use in youth with traumatic childhood experiences: a systematic review and synthesis of the literature. Becker, TD., Castañeda Ramirez, S., Bruges Boude, A., et al.[2023]

Traumatic life experiences can create a neurobiological vulnerability that increases the risk of developing substance use disorders (SUDs), highlighting the importance of understanding trauma in treatment.

Implementing trauma-informed care in SUD treatment improves patient experiences and retention, suggesting that addressing trauma and stigma can lead to better outcomes for individuals with SUDs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Necessity of a Trauma-Informed Paradigm in Substance Use Disorder Services. Bartholow, LAM., Huffman, RT.[2023]

Women who use drugs often face high rates of trauma, which can hinder their access to substance use and harm reduction services, highlighting the need for trauma-informed practices in research and clinical care.

Applying the four principles of trauma-informed practice—awareness of trauma, safety and trust, collaborative choice, and strengths-based approaches—can enhance the inclusion and safety of women who use drugs in substance use research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Research With Women Who Use Drugs: Applying a Trauma-informed Framework. Robinson, K., Ickowicz, S.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

Seeking Safety treatment for male veterans with a substance use disorder and post-traumatic stress disorder symptomatology. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

The effects of therapeutic bond within a brief intervention for alcohol moderation for problem drinkers. [2018]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Study protocol: implementing and evaluating a trauma-informed model of care in residential youth treatment for substance use disorders. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

The therapeutic alliance in adolescent substance abuse treatment: a one-with-many analysis. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Integrated treatment programs for individuals with concurrent substance use disorders and trauma experiences: a systematic review and meta-analysis. [2022]

6. Germany pubmed.ncbi.nlm.nih.gov

Interventions for prevention and treatment of substance use in youth with traumatic childhood experiences: a systematic review and synthesis of the literature. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Reliability and construct validity of 3 psychometric trust scales for women seeking substance abuse treatment in a community setting. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

The Necessity of a Trauma-Informed Paradigm in Substance Use Disorder Services. [2023]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Research With Women Who Use Drugs: Applying a Trauma-informed Framework. [2023]