Deaf-Accessible Therapy Toolkit for Alcoholism and PTSD

Overseen By Melissa L Anderson

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Massachusetts, Worcester

Disqualifiers: Concurrent psychotherapy, Prisoners, Pregnant, others

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

Compensation: Varies

Number of Visits: 14

Duration: 12 weeks

144 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new therapy toolkit called Signs of Safety, specifically designed for Deaf individuals dealing with alcohol use disorder (AUD) and posttraumatic stress disorder (PTSD). The study compares this toolkit with typical therapy and no treatment to determine the most effective approach. It aims to assist the Deaf community, which experiences higher rates of drinking problems and trauma. Deaf individuals who use American Sign Language (ASL) and have issues with alcohol or PTSD might be suitable candidates for this trial. As an unphased study, this trial offers a unique opportunity to contribute to research tailored for the Deaf community, potentially improving therapeutic options for those facing similar challenges.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, you cannot participate in formal psychotherapy while in the study.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Researchers are developing the Signs of Safety therapy toolkit to assist Deaf individuals with alcohol use disorder (AUD) and posttraumatic stress disorder (PTSD). However, past studies have not yet provided solid data on its safety. The toolkit is currently in an early trial phase called "Not Applicable," indicating limited information on participant tolerance.

Without specific safety data, it is important to note that early trials typically focus on the treatment's effectiveness and initial safety. So far, no reports of negative effects have emerged from this therapy, but further research is needed to confirm its safety. Prospective participants should consult the study team or a healthcare provider for more personalized information. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Deaf-Accessible Therapy Toolkit for Alcoholism and PTSD because it introduces a unique approach combining the Seeking Safety therapy with the innovative Signs of Safety toolkit. Unlike traditional treatments, which often rely on general counseling methods that aren't specifically tailored for Deaf individuals, this new toolkit is designed to be accessible and relevant to the Deaf community. It ensures therapy is delivered in American Sign Language by Deaf therapists, making it more culturally and linguistically appropriate. This approach not only targets PTSD and alcoholism more effectively but also fills a crucial gap in mental health services for Deaf individuals, offering hope for better outcomes.

What evidence suggests that this trial's treatments could be effective for alcoholism and PTSD in the Deaf community?

Research has shown that the Signs of Safety therapy toolkit, part of the experimental treatment arm in this trial, yields promising results for Deaf individuals with alcohol use disorder (AUD) and posttraumatic stress disorder (PTSD). In a small study, participants using this toolkit experienced a noticeable decrease in PTSD symptoms. This therapy is designed to be accessible for Deaf individuals by using American Sign Language (ASL) for communication. It follows a well-known method called Seeking Safety, commonly used to treat trauma and addiction. Although data specifically for the Deaf community is limited, early findings suggest the toolkit helps those facing unique challenges in accessing treatment. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for Deaf or hard-of-hearing adults who use American Sign Language, have problematic drinking habits as measured by the AUDIT score (≥8 for men, ≥6 for women), and show signs of PTSD. Participants must be able to use videoconferencing and online survey technology.

Inclusion Criteria

I identify as Deaf or hard-of-hearing.

I have access to video calling for consultations and therapy sessions.

I am proficient in American Sign Language.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 12 one-hour, weekly individual therapy sessions of Seeking Safety delivered with the Signs of Safety toolkit or therapy as usual.

12 weeks

12 virtual visits

Immediate Post-Treatment Assessment

Assessment of primary clinical outcomes including change from baseline percent binge drinking days per month and PTSD severity.

1 week

Three-month Follow-up

Participants are monitored for changes in drinking days, PTSD severity, and other secondary outcomes.

3 months

1 virtual visit

Six-month Follow-up

Participants are monitored for long-term changes in drinking days, PTSD severity, and other secondary outcomes.

6 months

1 virtual visit

What Are the Treatments Tested in This Trial?

Interventions

• Signs of Safety

Trial Overview The study compares a new Deaf-accessible therapy toolkit called Signs of Safety with standard treatment and no treatment in managing alcohol use disorder (AUD) and post-traumatic stress disorder (PTSD). It's a virtual nationwide trial focusing on clinical outcomes.

How Is the Trial Designed?

Group I: Seeking Safety + Signs of Safety toolkit Experimental Treatment 1 Intervention

Experimental participants will be offered 12 one-hour, weekly individual therapy sessions of Seeking Safety delivered with the Signs of Safety toolkit. Sessions will occur virtually via National Deaf Therapy's (NDT) secure HIPAA-compliant video chat platform. Length of treatment is limited to six months; number of completed sessions will be tracked as a measure of participant adherence.

Group II: Treatment as usual Active Control 1 Intervention

Participants assigned to the active comparison condition will receive therapy as usual - i.e., general, open-ended, non-manualized supportive counseling provided by an NDT therapist. In the absence of any evidence-based therapies available for Deaf clients, this unstructured therapy approach is the current standard of care in the field of Deaf mental health. All NDT therapists are Deaf, fluent in ASL, and specialize in issues common to Deaf individuals seeking mental health care. Like the experimental condition, participants will receive 12 one-hour, weekly individual therapy sessions via NDT's secure virtual therapy platform. Length of treatment is limited to six months; number of completed sessions will be tracked as a measure of participant adherence.

Group III: No treatment Active Control 1 Intervention

Participants in states with no NDT therapists and who prefer to be placed on NDT's waitlist instead of being referred outside of NDT for therapy will be automatically assigned to the no-treatment control condition. At the time of this submission, there are approximately 200 individuals on the NDT waitlist; individuals remain on the waitlist until a licensed therapist from their state joins the NDT team. Participants in the control condition will be prompted to complete assessments at baseline, week 6, week 12 (to approximate immediate post-treatment), week 25 (to approximate three-month follow-up), and week 38 (to approximate six-month follow-up). Such repeated assessment in the control arm will allow us to quantify and control for participants' natural change over time and any potential assessment reactivity.

Who Is Running the Clinical Trial?

University of Massachusetts, Worcester

Lead Sponsor

Trials

372

Recruited

998,000+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials

865

Recruited

1,091,000+

Published Research Related to This Trial

The study aims to evaluate the efficacy of the Seeking Safety program, an integrated treatment for PTSD and substance use disorder (SUD), in a Dutch outpatient population through a randomized controlled trial involving 12 group sessions.

It is expected that participants receiving Seeking Safety will show greater improvements in substance use severity and lower drop-out rates compared to those receiving Cognitive Behavioral Therapy (CBT), with assessments conducted at the start, end, and six months after treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of "seeking safety" in a Dutch population of traumatized substance-use disorder outpatients: study protocol of a randomized controlled trial. Kok, T., de Haan, HA., van der Meer, M., et al.[2021]

The study successfully translated and validated the 'Global Trigger Tool-Psychiatry' (GTT-P) for identifying iatrogenic adverse events in psychiatric care in Norway, incorporating insights from both health professionals and service users to enhance its effectiveness.

Implementing the GTT-P can help mental health nurses in Norway and Sweden to better identify potential triggers for adverse events, ultimately improving patient safety and reducing the risk of harm in psychiatric settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing a research tool to detect iatrogenic adverse events in psychiatric health care by involving service users and health professionals. Okkenhaug, A., Tritter, JQ., Landstad, BJ.[2023]

Substance abuse treatment must incorporate trauma-informed care to address the significant impact of trauma and violence on clients' lives, ensuring services are delivered in a way that avoids triggering past trauma.

The article outlines a self-assessment process that combines trauma-informed assessments with improvement cycles, leading to the development of an Action Plan that includes training staff as 'trauma champions' to promote ongoing trauma-informed practices within treatment agencies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Moving toward trauma-informed practice in addiction treatment: a collaborative model of agency assessment. Brown, VB., Harris, M., Fallot, R.[2014]

In a study involving 343 women with co-occurring PTSD and substance use disorders, the integrated treatment Seeking Safety plus treatment as usual (TAU) did not show superior efficacy in reducing PTSD severity compared to TAU alone, but it did improve outcomes related to depression and emotion regulation.

Relapse Prevention Training (RPT) plus TAU was more effective than TAU alone in increasing the number of substance-free days and reducing alcohol severity, indicating that while neither integrated treatment was superior for PTSD, they both offered benefits in other areas of mental health and substance use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A multisite randomized controlled trial of Seeking Safety vs. Relapse Prevention Training for women with co-occurring posttraumatic stress disorder and substance use disorders. Schäfer, I., Lotzin, A., Hiller, P., et al.[2020]

A pilot trial of the Seeking Safety (SS) therapy involving 24 military service members showed significant improvements in PTSD symptoms and substance use, indicating its effectiveness for treating these comorbid conditions.

Participants reported high satisfaction with the SS therapy, suggesting it is a feasible intervention for military personnel dealing with PTSD and substance use disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Seeking Safety Pilot Outcome Study at Walter Reed National Military Medical Center. Najavits, LM., Lande, RG., Gragnani, C., et al.[2018]

In a study of 353 women with PTSD and substance use disorder, those with physical disabilities showed significant and sustained reductions in PTSD symptoms after 12 sessions of Seeking Safety therapy, unlike those in the Women's Health Education group who returned to baseline levels by 12 months.

The findings highlight the effectiveness of Seeking Safety as a targeted treatment for PTSD in women with physical disabilities, emphasizing the need for specialized approaches to address trauma in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does seeking safety reduce PTSD symptoms in women receiving physical disability compensation? Anderson, ML., Najavits, LM.[2014]

Deaf individuals experience higher rates of mental health issues, including posttraumatic stress disorder (PTSD) and substance use disorder (SUD), compared to the general population, but there is limited understanding of how to effectively treat these comorbid conditions.

There is a pressing need for increased awareness and development of treatment tools for addressing comorbid PTSD and SUD in deaf clients, emphasizing the importance of integrating trauma-informed care into existing services for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Working therapeutically with deaf people recovering from trauma and addiction. Anderson, ML., Glickman, NS., Mistler, LA., et al.[2018]

A study involving 100 deaf and hard of hearing individuals from a specialized inpatient treatment program revealed significant barriers that affect their willingness to enter and complete substance abuse treatment.

The research highlights the need for tailored treatment programs that address the unique challenges faced by deaf individuals, as well as the importance of understanding background factors that influence their recovery outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Unique issues faced by deaf individuals entering substance abuse treatment and following discharge. Guthmann, D., Blozis, SA.[2019]

In a study of 110 veterans undergoing treatment for comorbid PTSD and alcohol use disorder, increased alcohol consumption during therapy was linked to a significantly higher risk of dropping out, particularly in those receiving integrated exposure therapy.

Specifically, for each additional drink consumed per day, the risk of dropout increased fivefold, highlighting the importance of monitoring alcohol use as a potential marker for patient retention in treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Within-treatment clinical markers of dropout risk in integrated treatments for comorbid PTSD and alcohol use disorder. Kline, AC., Panza, KE., Harlé, KM., et al.[2023]

A systematic review of 115 psychotherapy study protocols revealed that while 77 protocols explicitly addressed harm, there was a lack of standardization in how harm was conceptualized and assessed, particularly regarding adverse events.

The review highlighted that although serious adverse events were defined consistently, the definitions and considerations for adverse events varied widely, suggesting a need for more standardized approaches in clinical research to effectively monitor and report harm.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Defining and assessing adverse events and harmful effects in psychotherapy study protocols: A systematic review. Klatte, R., Strauss, B., Flückiger, C., et al.[2023]

In a study involving 1,687 substance-abusing participants over 27,198 person-weeks, 12% experienced serious adverse events (SAEs), but none were deemed related to the psychosocial interventions being tested.

There were no significant differences in the incidence rates of SAEs between those receiving standard care and those receiving additional interventions like contingency management or motivational enhancement, suggesting that these psychosocial treatments are safe in terms of serious adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Serious adverse events in randomized psychosocial treatment studies: safety or arbitrary edicts? Petry, NM., Roll, JM., Rounsaville, BJ., et al.[2021]

The Deaf community in the U.S. faces higher rates of trauma and substance use disorders, yet there are no evidence-based treatments specifically evaluated for them.

The pilot study of the Signs of Safety toolkit, designed for Deaf individuals, showed promising results with significant reductions in PTSD symptoms and alcohol use, indicating its potential effectiveness in addressing these issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing Signs of Safety: A Deaf-accessible counselling toolkit for trauma and addiction. Anderson, ML., Glickman, NS., Wolf Craig, KS., et al.[2022]

In a systematic review of 117 studies on psychosocial interventions for childhood mental disorders, only 31% monitored adverse events, highlighting a significant gap in safety reporting.

Among the studies that did monitor adverse events, there was a lack of consistency in how these events were defined and assessed, with only 11% evaluating the causes of the events, which is crucial for understanding the risks associated with these treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review: Adverse event monitoring and reporting in studies of pediatric psychosocial interventions: a systematic review. Lodewyk, K., Bagnell, A., Courtney, DB., et al.[2023]

A new standardized strategy for reporting adverse events (AEs) and serious adverse events (SAEs) in substance use disorder (SUD) clinical trials was developed, which aims to reduce the reporting burden while maintaining safety monitoring.

In a review of 17 SUD trials involving 6737 participants, the new strategy showed a significant reduction in irrelevant safety event reporting, leading to a more consistent safety assessment system tailored to the risks associated with specific trial interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Strategies for safety reporting in substance abuse trials. Lindblad, R., Campanella, M., Styers, D., et al.[2013]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06278922

Evaluating Signs of Safety: A Deaf-Accessible Therapy ... Among Deaf people in treatment for alcohol use disorder (AUD), 74% report lifetime physical, emotional, or sexual abuse and 44% report past-year abuse. Comorbid ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03845985

Piloting "Signs of Safety": A Deaf-Accessible Therapy ... The study team has developed "Signs of Safety", a Deaf-accessible therapy toolkit for treating AUD and PTSD.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8511355/

Developing Signs of Safety: A Deaf-Accessible Counseling ... A Deaf-accessible toolkit to be used with an existing, widely adopted protocol for trauma and addiction (Seeking Safety).

4. deafyes.org deafyes.org/signs-of-safety/

Signs of Safety Our team developed Signs of Safety, a Deaf-accessible therapy toolkit for treating AUD and PTSD. We are conducting a nationwide, virtual clinical trial.

5. withpower.com withpower.com/trial/phase-alcohol-drinking-8-2024-f957a

Deaf-Accessible Therapy Toolkit for Alcoholism and PTSD The pilot study of the Signs of Safety toolkit, designed for Deaf individuals, showed promising results with significant reductions in PTSD symptoms and ...

6. reporter.nih.gov reporter.nih.gov/search/oX8iBOWh_0uwp3SohkWGFQ/project-details/10718928

A Deaf-Accessible Therapy Toolkit for AUD and Trauma The Signs of Safety toolkit provides a supplemental therapist guide and population-specific client materials (e.g., visual handouts, filmed ASL teaching stories) ...

7. centerwatch.com centerwatch.com/clinical-trials/listings/NCT03845985/piloting-signs-of-safety-a-deaf-accessible-therapy-toolkit-for-alcohol-use-disorder-and-trauma

Piloting "Signs of Safety": A Deaf-Accessible Therapy ... To address these barriers, the study team has developed "Signs of Safety", a Deaf-accessible therapy toolkit for treating AUD and PTSD. The ...