Deaf-Accessible Therapy Toolkit for Alcoholism and PTSD
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Massachusetts, Worcester
Disqualifiers: Concurrent psychotherapy, Prisoners, Pregnant, others
No Placebo Group
Trial Summary
What is the purpose of this trial?The U.S. Deaf community - a group of more than one million Americans who communicate using American Sign Language (ASL) - experiences nearly triple the rate of lifetime problem drinking and twice the rate of trauma exposure compared to the general population. Although there are several treatments for alcohol use disorder (AUD) and posttraumatic stress disorder (PTSD) in hearing populations, none have been developed for or tested with Deaf clients. To address these barriers, the study team developed Signs of Safety, a Deaf-accessible therapy toolkit for treating AUD and PTSD. Their aims are to conduct a nationwide, virtual clinical trial to compare (1) Signs of Safety with (2) treatment as usual and (3) a no treatment control, to collect data on clinical outcomes, and to explore potential mediators and moderators of outcome.
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.
What data supports the effectiveness of the treatment Deaf-Accessible Therapy Toolkit for Alcoholism and PTSD?
Research on the Seeking Safety treatment, which is similar to the Deaf-Accessible Therapy Toolkit, shows it can help reduce PTSD symptoms and improve coping skills in people with PTSD and substance use disorders. Studies have found Seeking Safety to be effective in various settings, including military and civilian populations, and it has shown improvements in PTSD symptoms, substance use, and emotional regulation.
12345Is the Deaf-Accessible Therapy Toolkit for Alcoholism and PTSD safe for humans?
In studies of psychosocial therapies, including those for substance abuse, serious adverse events (major negative effects) were rare and not linked to the therapy itself. This suggests that such therapies are generally safe for humans.
678910How is the Signs of Safety treatment different from other treatments for alcoholism and PTSD?
The Signs of Safety treatment is unique because it is specifically designed to be accessible for Deaf individuals, using American Sign Language (ASL) to address both trauma and addiction. It combines a Deaf-accessible toolkit with the existing Seeking Safety protocol, making it the first evidence-based treatment evaluated for use with the Deaf community.
111121314Eligibility Criteria
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.
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Trial Timeline
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
Participant Groups
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.
3Treatment groups
Experimental Treatment
Active Control
Group I: Seeking Safety + Signs of Safety toolkitExperimental Treatment1 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 usualActive Control1 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 treatmentActive Control1 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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Massachusetts Medical SchoolWorcester, MA
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Who Is Running the Clinical Trial?
University of Massachusetts, WorcesterLead Sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)Collaborator
References
Efficacy of "seeking safety" in a Dutch population of traumatized substance-use disorder outpatients: study protocol of a randomized controlled trial. [2021]Traumatic experiences and, more specifically, posttraumatic stress disorder (PTSD) are highly prevalent among substance use disorder (SUD) patients. This comorbidity is associated with worse treatment outcomes in substance use treatment programs and more crisis interventions. International guidelines advise an integrated approach to the treatment of trauma related problems and SUD. Seeking Safety is an integrated treatment program that was developed in the United States. The aim of the current study is to test the efficacy of this program in the Netherlands in an outpatient SUD population.
A multisite randomized controlled trial of Seeking Safety vs. Relapse Prevention Training for women with co-occurring posttraumatic stress disorder and substance use disorders. [2020]Background: Co-occurring posttraumatic stress disorder (PTSD) and substance use disorders (SUD) are associated with a more severe course and worse outcome than either disorder alone. In Europe, few treatments have been evaluated for PTSD and SUD. Seeking Safety, a manualized, integrated, cognitive-behavioural treatment, has been shown to be effective in studies in the USA. Objective: To test the efficacy of Seeking Safety plus treatment as usual (TAU) in female outpatients with PTSD and SUD compared to Relapse Prevention Training (RPT) plus TAU and TAU alone. Method: In five German study centres a total of N = 343 women were randomized into one of the three study conditions. PTSD severity (primary outcome), substance use, depression and emotion dysregulation (secondary outcomes) were assessed at baseline, post-treatment, as well as at three months and six months post-treatment. Results: Treatment participants attended M = 6.6 sessions (Seeking Safety) and M = 6.1 sessions (RPT). In an intent-to-treat analysis, Seeking Safety plus TAU, RPT plus TAU and TAU alone showed comparable decreases in PTSD severity over the course of the study. Seeking Safety plus TAU showed superior efficacy to TAU alone on depression and emotion regulation and RPT plus TAU was more effective than TAU alone on number of substance-free days and alcohol severity. Minimum-dose analyses suggest additional effects of both programmes among participants who attended at least eight group sessions. Conclusions: With respect to PTSD symptoms, a brief dose of Seeking Safety and RPT in addition to TAU was not superior to TAU alone in women with PTSD and SUD. However, Seeking Safety and RPT showed greater reductions than TAU alone in other domains of psychopathology and substance use outcomes respectively. Future studies should investigate further variables, such as what aspects of each treatment appeal to particular patients and how best to disseminate them.
Moving toward trauma-informed practice in addiction treatment: a collaborative model of agency assessment. [2014]Clients in substance abuse treatment need, in addition to evidence-based and sensitive treatment services in general, a system of care that takes into account the impact of trauma and violence in so many of their lives. In addition, services need to be delivered in a way that avoids triggering trauma memories or causing unintentional re-traumatization. To that end, this article describes an agency self-assessment process that combines a trauma-informed assessment, a NIATx process of "walking-through" and use of the Institute of Healthcare Improvement's Plan-Do-Study-Act (PDSA) cycles, and a user-friendly format. The trauma-informed assessment is designed to address issues of safety of clients and staff members, reduction of re-traumatization, consistency in practice, and client empowerment. It brings a non-judgmental, collaborative approach to process and practice improvement. The article describes how the assessment process can be--and has been--used to develop an Action Plan, including trainings and the identification of "trauma champions"; i.e., staff who will continue to spread trauma-informed changes and new evidence-based practices throughout the agency. As we enter a period of healthcare reform, addressing trauma as an integral part of addiction treatment also allows us to better deal with the totality of our clients' health problems.
Seeking Safety Pilot Outcome Study at Walter Reed National Military Medical Center. [2018]Post-traumatic stress disorder (PTSD) and substance use disorder are two of the most prominent psychiatric disorders among military service members. Seeking Safety (SS) is an evidence-based behavioral therapy model for this comorbidity. This article reports results of a study of SS conducted in a military setting. Our pilot trial addressed outcomes, feasibility, and satisfaction. SS was conducted as is to evaluate its impact without adaptation for military culture. The sample was 24 outpatient service members (from the Army, Navy, Air Force, and Marines) with 33% minority representation. Inclusion criteria were current PTSD and/or SUD. Ten clinicians participated in this study after receiving SS training. Results showed significant improvements on most outcomes, including substance use on the Brief Addiction Monitor; PTSD symptoms on the PTSD Checklist-Military Version (total and criterion D); and the Trauma Symptom Checklist-40 (sexual abuse trauma index and anxiety subscale); functioning on the Sheehan Disability Scale (total and family subscale); psychopathology on the Zung Depression Scale total; the Behavior and Symptom Identification Scale (BASIS)-24 (total and subscales depression functioning, emotional liability, and psychosis); and the Brief Symptom Inventory-18 (total and anxiety subscale); and coping on the Coping Self-Efficacy Scale (total). Satisfaction was strong. Discussion includes methodology limitations and next steps.
Does seeking safety reduce PTSD symptoms in women receiving physical disability compensation? [2014]This secondary analysis investigated the impact of 12 sessions of Seeking Safety (SS) on reducing posttraumatic stress disorder (PTSD) symptoms in a sample of dually diagnosed women with physical disabilities versus nondisabled (ND) women. SS is an evidence-based and widely implemented manualized therapy for PTSD and/or substance use disorder. It is a present-focused model that promotes coping skills and psychoeducation.
Review: Adverse event monitoring and reporting in studies of pediatric psychosocial interventions: a systematic review. [2023]Adverse event monitoring in studies of psychotherapy is crucial to clinical decision-making, particularly for weighing of benefits and harms of treatment approaches. In this systematic review, we identified how adverse events are defined, measured, and reported in studies of psychosocial interventions for children with mental disorders.
Defining and assessing adverse events and harmful effects in psychotherapy study protocols: A systematic review. [2023]The assessment of safety data has become a standard across many clinical interventions. The aim of this systematic review is to investigate the extent to which harm is addressed within psychotherapy study protocols. The review includes study protocols of randomized controlled trials published between 2004 and 2017 investigating the effects of psychotherapy in adult patients with affective disorders, phobia, anxiety, obsessive-compulsive disorder, posttraumatic stress disorder, and/or personality disorders. We conducted a systematic search in the CENTRAL, Medline, PsycINFO, and Web of Science databases as well as in relevant journals. In total, 115 study protocols were included, examining 168 psychotherapy and 85 control conditions. These protocols differed considerably in the way they conceptualized harm: 77 explicitly addressed harm, 62 considered serious adverse events, and 39 considered adverse events. Although serious adverse events were defined somewhat consistently, adverse events were not. Our results imply that clinical researchers do not apply standardized approaches with regard to harm concepts, assessment, and management. To gather data on frequencies of harmful effects, we argue a higher degree of standardization would be useful. Feasible recommendations are provided based on examples of good practice from the reviewed study protocols. (PsycInfo Database Record (c) 2023 APA, all rights reserved).
Developing a research tool to detect iatrogenic adverse events in psychiatric health care by involving service users and health professionals. [2023]Most health professionals working in psychiatric care will experience adverse events (AE) such as service user suicide or violence, during their career Norway lacks measures to capture potential iatrogenic injuries, such as risk assessment measures, to evaluate patient records for AEs in both inpatient and outpatient psychiatric clinics in hospitals WHAT THE PAPER ADDS TO EXISTING KNOWLEDGE: We have described an approach to the validation of a research tool between different national contexts; a process that went beyond language translation We have incorporated the understanding of health professionals and service users; to bring together the lifeworld of the patient with the professional definition of AEs, triggers and risk areas of AEs in a psychiatric context. The service users' experiences resulted in modifications to the tool.
Serious adverse events in randomized psychosocial treatment studies: safety or arbitrary edicts? [2021]Human subjects protection policies developed for pharmaceutical trials are now being widely applied to psychosocial intervention studies. This study examined occurrences of serious adverse events (SAEs) reported in multicenter psychosocial trials of the National Institute on Drug Abuse Clinical Trials Network. Substance-abusing participants (N = 1,687) were randomized to standard care or standard care plus either contingency management or motivational enhancement. Twelve percent of participants experienced 1 or more SAEs during the 27,198 person-weeks of follow-up. Of the 260 SAEs recorded, none were judged by the data safety monitoring board to be study related, and there were no significant differences between experimental and control conditions in SAE incidence rates. These data underscore the need to reconsider the rationale behind, and appropriate methods for, monitoring safety during psychosocial therapy trials.
Strategies for safety reporting in substance abuse trials. [2013]Reporting all adverse events (AEs) and serious adverse events (SAEs) in substance use disorder (SUD) clinical trials has yielded limited relevant safety information and has been burdensome to research sites.
Developing Signs of Safety: A Deaf-accessible counselling toolkit for trauma and addiction. [2022]The U.S. Deaf community-more than half a million Americans who communicate using American Sign Language (ASL)-experiences higher rates of trauma exposure and substance use disorder (SUD) than the general population. Yet there are no evidence-based treatments for any behavioural health condition that have been evaluated for use with Deaf people. The driving aim of our work, therefore, has been to develop and formally evaluate a Deaf-accessible trauma/SUD counselling approach. Here we describe our initial intervention development work and a single-arm pilot that evaluated the feasibility, acceptability, and preliminary clinical efficacy of Signs of Safety-a Deaf-accessible toolkit to be used with an existing, widely adopted protocol for trauma and addiction (Seeking Safety). Preliminary efficacy results indicated clinically significant reductions in PTSD symptoms and frequency of alcohol use for the Seeking Safety/Signs of Safety model. Frequency of drug use did not change significantly-likely attributable to the mid-study legalization of recreational marijuana in our state. Next steps include the redesign and refilming of Signs of Safety based on pilot participant feedback, again using a Deaf-engaged development and production process. This new toolkit will be tested via a pilot randomized controlled trial designed based on present methodological lessons learned.
Working therapeutically with deaf people recovering from trauma and addiction. [2018]This article reviews what is known about behavioral health treatment of deaf persons with comorbid trauma and addiction.
Within-treatment clinical markers of dropout risk in integrated treatments for comorbid PTSD and alcohol use disorder. [2023]Integrated interventions for comorbid posttraumatic stress disorder (PTSD) and alcohol use disorder (AUD) are effective, but many patients prematurely drop out from treatment. Little is known about within-treatment risk factors for dropout, limiting the ability during therapy to identify patients at risk for attrition.
Unique issues faced by deaf individuals entering substance abuse treatment and following discharge. [2019]Several barriers can frustrate a deaf individual's intention to enter a substance abuse treatment program. Because few specialized programs work with the Deaf, it is difficult to determine the factors that influence a deaf individual's desire to maintain sobriety following completion of a residential treatment program. A sample of 100 individuals was drawn from the Minnesota Chemical Dependency Program for Deaf and Hard of Hearing Individuals, a model hospital-based inpatient treatment program. The study participants were asked to complete pretreatment and posttreatment surveys upon admission and discharge, respectively, in addition to a follow-up survey, to help determine which background factors might be associated with different treatment outcomes for deaf and hard of hearing persons who completed treatment in the program. Results are presented for the pretreatment and posttreatment assessments, and for the follow-up survey. Study limitations are discussed and recommendations are given for future treatment programs serving deaf and hard of hearing individuals.