Alcohol Use DisorderNCT03845985
Piloting "Signs of Safety": A Deaf-Accessible Therapy Toolkit for Alcohol Use Disorder and Trauma
A study testing Seeking Safety + Signs of Safety toolkit in people with Alcohol Use Disorder and Post Traumatic Stress Disorder, run by University of Massachusetts, Worcester at 1 site in United States.
Trial summary
The U.S. Deaf community - more than 500,000 Americans who communicate using American Sign Language (ASL) - experiences nearly triple the rate of lifetime problem drinking and twice the rate of trauma exposure as compared to the general population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Use Disorder, Post Traumatic Stress Disorder
- What is being tested?
- Seeking Safety + Signs of Safety toolkit
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jun 2019to 31 Jul 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Self-identification as a Deaf ASL user
- Age 18 or older
- Past-month alcohol consumption, as measured by the Alcohol Use Disorder Identification Test
- Subthreshold or full PTSD on the PTSD Checklist for DSM-5 (past-month referent time period; "subthreshold" = endorsement of at least two B-E criteria at a severity of "moderate" or higher)
- Ability to attend weekly study sessions at one of three study locations (Eastern, Central, or Western MA)
- Ability to access a videophone (the standard telecommunication device for the Deaf community)
Who cannot join
- Participation in concurrent therapies (Note: Participants in both study conditions will be asked to refrain from concurrent formal psychotherapy; however, aligning with the Seeking Safety model, AA/NA/DRA attendance will be encouraged and attendance will be tracked as a potential outcome mediator).
- Members of the following special populations: Adults unable to consent; Individuals younger than 18; Prisoners; Pregnant women (Note: We will not knowingly include pregnant women as participants; however, we will not assess participants' pregnancy status.)
- Exclusion criteria are intentionally minimal to recruit a diverse sample. Other behavioral health comorbidities (e.g., mood/anxiety disorders, substance use disorders other than AUD) will not be excluded, given high rates of comorbidity.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Massachusetts Medical School
Worcester, Massachusetts, 01655
About this study
The U.S. Deaf community - more than 500,000 Americans who communicate using American Sign Language (ASL) - experiences nearly triple the rate of lifetime problem drinking and twice the rate of trauma exposure as compared to the general population. Although there are validated treatments for alcohol use disorder (AUD) and post-traumatic stress disorder (PTSD) in hearing populations, there are no evidence-based treatments for any behavioral health condition that have been validated for use with Deaf clients. To address these barriers, the study team has developed "Signs of Safety", a Deaf-accessible therapy toolkit for treating AUD and PTSD. The study team's ongoing aims are to conduct a two-arm pilot RCT of "Signs of Safety" and to collect data on feasibility, preliminary clinical outcomes, and potential mediators and moderators of outcome.
Read the detailed description
The U.S. Deaf community - 500,000+ Americans who communicate using American Sign Language (ASL) - experiences nearly triple the rate of lifetime problem drinking compared to the general population and twice the rate of trauma exposure. Although there are validated treatments for comorbid alcohol use disorder (AUD) and posttraumatic stress disorder (PTSD) in hearing populations, there are no evidence-based treatments to treat any behavioral health condition with Deaf clients. Current treatments fail to meet Deaf clients' unique linguistic and cultural needs. Deaf people's median English reading level falls at the fourth grade, and many have low health literacy due to reduced incidental learning (e.g., inability to communicate with hearing parents, overhear family conversations, or understand spoken health information on TV/radio/public service announcements). Written treatment materials, therefore, require plain text revisions, ASL translations, or ASL narrative storytelling. Equally important are materials that incorporate Deaf values and social norms, increasing clinicians' cultural competence and enhancing client engagement.
To address these barriers, the Principal Investigator conducted a pilot study to develop a prototype of "Signs of Safety": a Deaf-accessible toolkit to be used alongside a widely-disseminated protocol for addiction/PTSD - Seeking Safety. Seeking Safety has demonstrated efficacy for reduction of AUD and PTSD symptoms in hearing populations. Among available evidence-based protocols, "Seeking Safety" is the optimal choice to adapt for Deaf clients - its focus on simple coping skills that simultaneously target AUD and PTSD (or either alone) is an ideal match for Deaf people's language and learning deficits, which prohibit use of verbal problem-solving and cognitive processing strategies that other psychotherapies require. Yet, Seeking Safety's client materials rely on written English and are not well understood by Deaf clients. As such, the "Signs of Safety" toolkit includes a therapist guide and population-specific client materials (e.g., visual handouts; ASL teaching stories on digital video). It is designed for Deaf/signing clinicians, as well as non-signing clinicians working with ASL interpreters.
Data from the Principal Investigator's "Signs of Safety" single-arm pilot study (n = 13) show significant reductions in alcohol use frequency and PTSD severity from baseline to immediate post-treatment follow-up. Participants also reported high levels of satisfaction with the model, and provided detailed feedback about how to further improve "Signs of Safety" for a professional-quality, second iteration. The proposed study builds upon the Principal Investigator's pilot work by generating a final, professional iteration of Signs of Safety to be used in future efficacy work. Based on pilot results, the study team created a second iteration of the "Signs of Safety" toolkit, including re-filming ASL teaching stories, re-designing visual handouts, and revising the therapist companion guide. The study team will then develop a training program for "Signs of Safety" and certify four study clinicians.
The study team proposes to conduct a two-arm pilot RCT of "Signs of Safety". The study team aims to enroll 60 Deaf adults with past-month PTSD and past-month alcohol consumption to participate in 12 weekly individual treatment sessions. The pilot RCT will compare the 12-session protocol of Seeking Safety + "Signs of Safety" toolkit with an assessment-only waitlist control. Across conditions, assessment will occur at baseline, week 4, week 8, immediate post-treatment/week 12, and one-month follow-up/week 16. The study team will analyze key aspects of feasibility for both study arms (e.g., recruitment, retention, assessment process). Primary clinical outcomes at immediate post-treatment and one-month follow-up are past 30-day alcohol use frequency/quantity and past 30-day PTSD severity. Exploratory analyses will be conducted to examine potential moderators and mediators of change (e.g., motivation for treatment, provider cultural competency, coping skills, self-compassion, understanding of health information) leading to positive outcome. Results from this study will produce feasibility and preliminary efficacy data to support for a full-scale RCT to evaluate "Signs of Safety", and a community-engaged model for conducting RCTs with Deaf participants.
- Being tested
- Seeking Safety + Signs of Safety toolkit
- Keywords
- psychotherapy, trauma, addiction, Deaf
- Medical subject headings
- Alcoholism, Stress Disorders, Post-Traumatic, Wounds and Injuries, Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Seeking Safety + Signs of Safety toolkitBehavioural
Seeking Safety is an existing, present-focused, first-stage manualized treatment for trauma and addiction. Session content engages clients in themes relevant to addiction and trauma, and to help them learn a specific skill to target symptoms of both AUD and PTSD (e.g., "Coping with Triggers," "Asking for Help").
"Signs of Safety" is a culturally and linguistically Deaf-accessible toolkit to be used alongside Seeking Safety. The toolkit includes a therapist guide and population-specific client materials (e.g., visual handouts; ASL teaching stories on digital video). It is designed for Deaf/signing clinicians, as well as non-signing clinicians working with ASL interpreters.
| Study group | Role | What they receive |
|---|---|---|
| Seeking Safety + Signs of Safety toolkit | Experimental | Participants randomized to receive the intervention will be provided 12 one-hour weekly individual treatment sessions with one of four ASL-fluent study clinicians in Massachusetts. Assessments will occur at baseline, week 4, week 8, immediate post-treatment/week 12, and one-month follow-up/week 16. Receives: Behavioral: Seeking Safety + Signs of Safety toolkit |
| Assessment-only Waitlist Control | No intervention | Participants randomized to the waitlist control condition will be offered the opportunity to receive the 12-session Seeking Safety + Signs of Safety toolkit intervention after an approximate 16 week waiting period. This 16 week waiting period is equivalent to the current waitlist to receive psychotherapy services through the PI's outpatient clinic. Assessments will occur at baseline, week 4, week 8, immediate post-treatment/week 12, and one-month follow-up/week 16. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline Percent Drinking Days Per Month at Immediate Post-Treatment
Change from baseline percent drinking days per month (i.e., days with 1+ drink) at immediate post-intervention or 12 weeks as assessed by Alcohol Timeline Followback
Measured: Change from baseline to immediate post-intervention at 12 weeks
Change From Baseline Percent Drinking Days Per Month at One-month Follow-up
Change from baseline percent drinking days per month (i.e., days with 1+ drink) at one-month follow-up or 16 weeks as assessed by Alcohol Timeline Followback
Measured: Change from baseline to one-month follow-up at 16 weeks
Change From Baseline Percent Binge Drinking Days Per Month at Immediate Post-Treatment
Change from baseline percent binge drinking days per month (i.e., days with 5+ drinks for men, 4+ for women) at immediate post-intervention or 12 weeks as assessed by Alcohol Timeline Followback
Measured: Change from baseline to immediate post-intervention at 12 weeks
Change From Baseline Percent Binge Drinking Days Per Month at One-month Follow-up
Change from baseline percent binge drinking days per month (i.e., days with 5+ drinks for men, 4+ for women) at one-month follow-up or 16 weeks as assessed by Alcohol Timeline Followback
Measured: Change from baseline to one-month follow-up at 16 weeks
Change From Baseline Number of Drinks Per Month at Immediate Post-Treatment
Change from baseline number of drinks per month at immediate post-treatment or 12 weeks as assessed by Alcohol Timeline Followback
Measured: Change from baseline to immediate post-intervention at 12 weeks
Change From Baseline Number of Drinks Per Month at One-month Follow-up
Change from baseline number of drinks per month at one-month follow-up or 16 weeks as assessed by Alcohol Timeline Followback
Measured: Change from baseline to one-month follow-up at 16 weeks
Change From Baseline Past 30-day PTSD Severity to Immediate Post-Treatment as Assessed by PCL-5
Total Score on the PCL-5 divided by 20 items. Minimum score = 0; Maximum score = 4. Higher values represent more severe symptoms of PTSD.
Measured: Change from baseline to immediate post-intervention at 12 weeks
Change From Baseline Past 30-day PTSD Severity at One-month Follow-up as Assessed by PCL-5
Total Score on the PCL-5 divided by 20 items. Minimum score = 0; Maximum score = 4. Higher values represent more severe symptoms of PTSD.
Measured: Change from baseline to one-month follow-up at 16 weeks
Secondary outcomes (4)
The Brief Comprehensive Effects of Alcohol Questionnaire (B-CEOA)
All four subscales: Min. = 1, Max. = 4.
Risk and Aggression/Liquid Courage/Sociability Subscale: Higher values indicate greater outcome expectancies of drinking alcohol on risk-taking, aggression, courage, and sociability.
Self-Perception/Cognitive and Behavioral Impairment Subscale: Higher values indicate greater outcome expectancies on distorted self-perception and impaired behavior.
Sexuality Subscale: Higher values indicate greater outcome expectancies on sexual behavior.
Tension Reduction Subscale: Higher values indicate greater outcome expectancies on tension reduction.
Measured: Baseline/Pre-intervention, Week 4, Week 8, Week 12/Post-intervention, and Week 16/One-month Follow-up
Penn Alcohol Craving Scale (PACS)
Total score = sum of all 5 items.
Minimum = 0; Maximum = 30.
Higher values indicate higher severity of alcohol craving.
Measured: Baseline/Pre-intervention, Week 4, Week 8, Week 12/Post-intervention, and Week 16/One-month Follow-up
Trauma Symptom Checklist - 40 (TSC-40)
Sum of all items divided by 40 items.
Minimum = 0; Maximum = 3.
Higher values indicate more severe trauma symptoms.
Measured: Baseline/Pre-Intervention, Week 12/Post-Intervention, Week 16/One-month Follow-up
Behavior and Symptom Identification Scale - 24 (BASIS-24)
Sum of all items divided by 24 items. Minimum = 0; Maximum = 4. Higher values indicate worsening behavior or more severe behavioral health symptoms.
Measured: Baseline/Pre-Intervention, Week 12/Post-Intervention, Week 16/One-month Follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2019
- Study start3 Jun 2019
- Primary completion31 Jul 2022
- Study completion31 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- More trials run by University of Massachusetts, WorcesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Melissa L. Anderson, University of Massachusetts, Worcester
- Investigators
- Melissa L Anderson, PhD, Principal investigator, University of Massachusetts, Worcester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03845985
- Sponsor's protocol ID
- H00016364
- Other IDs
- R34AA026929
- Status last verified
- Feb 2024
- First submitted
- 1 Feb 2019
- Last updated
- 12 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data after deidentification that underlie the reported results (text, tables, figures, and appendices) will be available beginning 9 months and ending 36 months following article publication. Investigators whose proposed use of the data has been approved by an independent review committee may use the data for individual participant data meta-analysis. Proposals may be submitted up to 36 months follow article publication. Please contact the Principal Investigator for information regarding submitting proposals and accessing data.
Publications
Heffernan K. Seeking Safety: A Treatment Manual for PTSD and Substance Abuse. Psychother Res. 2003 Mar;13(1):125-6. doi: 10.1080/713869629. No abstract available.
PubMed 22475169
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Piloting "Signs of Safety": A Deaf-Accessible Therapy Toolkit for Alcohol Use Disorder and Trauma
- ClinicalTrials.gov ID
- NCT03845985
- Acronym / sponsor ID
- H00016364
- Keywords
- psychotherapy, trauma, addiction, Deaf
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 3 Jun 2019 (actual)
- Primary completion
- 31 Jul 2022 (actual)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 19 Feb 2019 (actual)
- Results
- Posted 29 Sep 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The U.S. Deaf community - more than 500,000 Americans who communicate using American Sign Language (ASL) - experiences nearly triple the rate of lifetime problem drinking and twice the rate of trauma exposure as compared to the general population. Although there are validated treatments for alcohol use disorder (AUD) and post-traumatic stress disorder (PTSD) in hearing populations, there are no evidence-based treatments for any behavioral health condition that have been validated for use with Deaf clients. To address these barriers, the study team has developed "Signs of Safety", a Deaf-accessible therapy toolkit for treating AUD and PTSD. The study team's ongoing aims are to conduct a two-arm pilot RCT of "Signs of Safety" and to collect data on feasibility, preliminary clinical outcomes, and potential mediators and moderators of outcome.
Detailed description
The U.S. Deaf community - 500,000+ Americans who communicate using American Sign Language (ASL) - experiences nearly triple the rate of lifetime problem drinking compared to the general population and twice the rate of trauma exposure. Although there are validated treatments for comorbid alcohol use disorder (AUD) and posttraumatic stress disorder (PTSD) in hearing populations, there are no evidence-based treatments to treat any behavioral health condition with Deaf clients. Current treatments fail to meet Deaf clients' unique linguistic and cultural needs. Deaf people's median English reading level falls at the fourth grade, and many have low health literacy due to reduced incidental learning (e.g., inability to communicate with hearing parents, overhear family conversations, or understand spoken health information on TV/radio/public service announcements). Written treatment materials, therefore, require plain text revisions, ASL translations, or ASL narrative storytelling. Equally important are materials that incorporate Deaf values and social norms, increasing clinicians' cultural competence and enhancing client engagement.
To address these barriers, the Principal Investigator conducted a pilot study to develop a prototype of "Signs of Safety": a Deaf-accessible toolkit to be used alongside a widely-disseminated protocol for addiction/PTSD - Seeking Safety. Seeking Safety has demonstrated efficacy for reduction of AUD and PTSD symptoms in hearing populations. Among available evidence-based protocols, "Seeking Safety" is the optimal choice to adapt for Deaf clients - its focus on simple coping skills that simultaneously target AUD and PTSD (or either alone) is an ideal match for Deaf people's language and learning deficits, which prohibit use of verbal problem-solving and cognitive processing strategies that other psychotherapies require. Yet, Seeking Safety's client materials rely on written English and are not well understood by Deaf clients. As such, the "Signs of Safety" toolkit includes a therapist guide and population-specific client materials (e.g., visual handouts; ASL teaching stories on digital video). It is designed for Deaf/signing clinicians, as well as non-signing clinicians working with ASL interpreters.
Data from the Principal Investigator's "Signs of Safety" single-arm pilot study (n = 13) show significant reductions in alcohol use frequency and PTSD severity from baseline to immediate post-treatment follow-up. Participants also reported high levels of satisfaction with the model, and provided detailed feedback about how to further improve "Signs of Safety" for a professional-quality, second iteration. The proposed study builds upon the Principal Investigator's pilot work by generating a final, professional iteration of Signs of Safety to be used in future efficacy work. Based on pilot results, the study team created a second iteration of the "Signs of Safety" toolkit, including re-filming ASL teaching stories, re-designing visual handouts, and revising the therapist companion guide. The study team will then develop a training program for "Signs of Safety" and certify four study clinicians.
The study team proposes to conduct a two-arm pilot RCT of "Signs of Safety". The study team aims to enroll 60 Deaf adults with past-month PTSD and past-month alcohol consumption to participate in 12 weekly individual treatment sessions. The pilot RCT will compare the 12-session protocol of Seeking Safety + "Signs of Safety" toolkit with an assessment-only waitlist control. Across conditions, assessment will occur at baseline, week 4, week 8, immediate post-treatment/week 12, and one-month follow-up/week 16. The study team will analyze key aspects of feasibility for both study arms (e.g., recruitment, retention, assessment process). Primary clinical outcomes at immediate post-treatment and one-month follow-up are past 30-day alcohol use frequency/quantity and past 30-day PTSD severity. Exploratory analyses will be conducted to examine potential moderators and mediators of change (e.g., motivation for treatment, provider cultural competency, coping skills, self-compassion, understanding of health information) leading to positive outcome. Results from this study will produce feasibility and preliminary efficacy data to support for a full-scale RCT to evaluate "Signs of Safety", and a community-engaged model for conducting RCTs with Deaf participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Seeking Safety + Signs of Safety toolkit | Experimental | Behavioral: Seeking Safety + Signs of Safety toolkitParticipants randomized to receive the intervention will be provided 12 one-hour weekly individual treatment sessions with one of four ASL-fluent study clinicians in Massachusetts. Assessments will occur at baseline, week 4, week 8, immediate post-treatment/week 12, and one-month follow-up/week 16. |
| Assessment-only Waitlist Control | No intervention | –Participants randomized to the waitlist control condition will be offered the opportunity to receive the 12-session Seeking Safety + Signs of Safety toolkit intervention after an approximate 16 week waiting period. This 16 week waiting period is equivalent to the current waitlist to receive psychotherapy services through the PI's outpatient clinic. Assessments will occur at baseline, week 4, week 8, immediate post-treatment/week 12, and one-month follow-up/week 16. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Self-identification as a Deaf ASL user
- Age 18 or older
- Past-month alcohol consumption, as measured by the Alcohol Use Disorder Identification Test
- Subthreshold or full PTSD on the PTSD Checklist for DSM-5 (past-month referent time period; "subthreshold" = endorsement of at least two B-E criteria at a severity of "moderate" or higher)
- Ability to attend weekly study sessions at one of three study locations (Eastern, Central, or Western MA)
Key exclusion criteria (3 listed)
- Participation in concurrent therapies (Note: Participants in both study conditions will be asked to refrain from concurrent formal psychotherapy; however, aligning with the Seeking Safety model, AA/NA/DRA attendance will be encouraged and attendance will be tracked as a potential outcome mediator).
- Members of the following special populations: Adults unable to consent; Individuals younger than 18; Prisoners; Pregnant women (Note: We will not knowingly include pregnant women as participants; however, we will not assess participants' pregnancy status.)
- Exclusion criteria are intentionally minimal to recruit a diverse sample. Other behavioral health comorbidities (e.g., mood/anxiety disorders, substance use disorders other than AUD) will not be excluded, given high rates of comorbidity.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Seeking Safety + Signs of Safety toolkitSeeking Safety is an existing, present-focused, first-stage manualized treatment for trauma and addiction. Session content engages clients in themes relevant to addiction and trauma, and to help them learn a specific skill to target symptoms of both AUD and PTSD (e.g., "Coping with Triggers," "Asking for Help"). "Signs of Safety" is a culturally and linguistically Deaf-accessible toolkit to be used alongside Seeking Safety. The toolkit includes a therapist guide and population-specific client materials (e.g., visual handouts; ASL teaching stories on digital video). It is designed for Deaf/signing clinicians, as well as non-signing clinicians working with ASL interpreters. | Behavioural | Seeking Safety + Signs of Safety toolkit |
Primary outcome
Change From Baseline Percent Drinking Days Per Month at Immediate Post-Treatment
Time frame: Change from baseline to immediate post-intervention at 12 weeks
Change from baseline percent drinking days per month (i.e., days with 1+ drink) at immediate post-intervention or 12 weeks as assessed by Alcohol Timeline Followback
Change From Baseline Percent Drinking Days Per Month at One-month Follow-up
Time frame: Change from baseline to one-month follow-up at 16 weeks
Change from baseline percent drinking days per month (i.e., days with 1+ drink) at one-month follow-up or 16 weeks as assessed by Alcohol Timeline Followback
Change From Baseline Percent Binge Drinking Days Per Month at Immediate Post-Treatment
Time frame: Change from baseline to immediate post-intervention at 12 weeks
Change from baseline percent binge drinking days per month (i.e., days with 5+ drinks for men, 4+ for women) at immediate post-intervention or 12 weeks as assessed by Alcohol Timeline Followback
Change From Baseline Percent Binge Drinking Days Per Month at One-month Follow-up
Time frame: Change from baseline to one-month follow-up at 16 weeks
Change from baseline percent binge drinking days per month (i.e., days with 5+ drinks for men, 4+ for women) at one-month follow-up or 16 weeks as assessed by Alcohol Timeline Followback
Change From Baseline Number of Drinks Per Month at Immediate Post-Treatment
Time frame: Change from baseline to immediate post-intervention at 12 weeks
Change from baseline number of drinks per month at immediate post-treatment or 12 weeks as assessed by Alcohol Timeline Followback
Change From Baseline Number of Drinks Per Month at One-month Follow-up
Time frame: Change from baseline to one-month follow-up at 16 weeks
Change from baseline number of drinks per month at one-month follow-up or 16 weeks as assessed by Alcohol Timeline Followback
Change From Baseline Past 30-day PTSD Severity to Immediate Post-Treatment as Assessed by PCL-5
Time frame: Change from baseline to immediate post-intervention at 12 weeks
Total Score on the PCL-5 divided by 20 items. Minimum score = 0; Maximum score = 4. Higher values represent more severe symptoms of PTSD.
Change From Baseline Past 30-day PTSD Severity at One-month Follow-up as Assessed by PCL-5
Time frame: Change from baseline to one-month follow-up at 16 weeks
Total Score on the PCL-5 divided by 20 items. Minimum score = 0; Maximum score = 4. Higher values represent more severe symptoms of PTSD.
4 secondary outcomes
The Brief Comprehensive Effects of Alcohol Questionnaire (B-CEOA)
Time frame: Baseline/Pre-intervention, Week 4, Week 8, Week 12/Post-intervention, and Week 16/One-month Follow-up
Penn Alcohol Craving Scale (PACS)
Time frame: Baseline/Pre-intervention, Week 4, Week 8, Week 12/Post-intervention, and Week 16/One-month Follow-up
Trauma Symptom Checklist - 40 (TSC-40)
Time frame: Baseline/Pre-Intervention, Week 12/Post-Intervention, Week 16/One-month Follow-up
Behavior and Symptom Identification Scale - 24 (BASIS-24)
Time frame: Baseline/Pre-Intervention, Week 12/Post-Intervention, Week 16/One-month Follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 22475169Heffernan K. Seeking Safety: A Treatment Manual for PTSD and Substance Abuse. Psychother Res. 2003 Mar;13(1):125-6. doi: 10.1080/713869629. No abstract available.
- Individual participant dataSharing planned: Yes. Individual participant data after deidentification that underlie the reported results (text, tables, figures, and appendices) will be available beginning 9 months and ending 36 months following article publication. Investigators whose proposed use of the data has been approved by an independent review committee may use the data for individual participant data meta-analysis. Proposals may be submitted up to 36 months follow article publication. Please contact the Principal Investigator for information regarding submitting proposals and accessing data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melissa L Anderson, PhD principal investigator
University of Massachusetts, Worcester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Seeking Safety + Signs of Safety toolkit in people with Alcohol Use Disorder and Post Traumatic Stress Disorder, run by University of Massachusetts, Worcester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline Percent Drinking Days Per Month at Immediate Post-Treatment (time frame: Change from baseline to immediate post-intervention at 12 weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03845985, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2024.