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Evaluating Supplementing Residential Substance Use Treatment With Written Exposure Therapy for Veterans With Post Traumatic Stress Disorder (PTSD) and Substance Use Disorders (SUD)

Primary Purpose

PTSD, Substance Use Disorders

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Residential Written Exposure Therapy
Treatment as Usual
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for PTSD focused on measuring PTSD, Substance Use Disorders, Treatment, Comorbidity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnoses of a substance use disorder (SUD) and PTSD
  • Enrolled in the residential substance use disorder treatment program (DOM SUD) at the Salem VAMC

Exclusion Criteria:

  • Current Manic Episode
  • Current Suicidal Intent
  • Previous Written Exposure treatment
  • Unable to write

Sites / Locations

  • Salem VA Medical Center, Salem, VARecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

resWET

Treatment as Usual (TAU)

Arm Description

Residential Written Exposure Therapy (resWET): Treatment as Usual (TAU) plus 5-individual Written Exposure Therapy (WET) sessions (40-60 min each; Marx & Sloan, 2019) twice a week for two weeks and once a week for the final session, administered by WET trained psychologists, social workers, or postdoctoral residents. Treatment instructions are read, patients write for 30 minutes, and the writing is briefly processed. No formal written homework is required.

Treatment as Usual (DOM SUD): The DOM SUD (TAU) is a 24-bed intensive substance use disorder (SUD) residential program with a typical 28-day length of stay. The program focuses on evidence-based treatments for SUD such as Cognitive-Behavioral Therapy, Motivational Enhancement Therapy, Medication Assisted Treatment, and Contingency Management therapy. Patients diagnosed with Post-traumatic Stress Disorder (PTSD) are typically referred to outpatient PTSD treatment following DOM SUD and often attend Seeking Safety during the program. Most of the programming is group-based though Veterans also have weekly individual case management appointments.

Outcomes

Primary Outcome Measures

Client Satisfaction Questionnaire (CSQ-8)
Standardized patient treatment satisfaction measure, used in substance use treatment settings (Kelly et al, 2018). 8 items measuring satisfaction with treatment, Likert scales from 1 (low satisfaction) to 4 (high satisfaction). Total scores range from 8 to 32, with higher scores indicating greater satisfaction. High concurrent validity and internal consistency. Average item scores of 3 or higher indicate satisfaction with treatment. Completed by participants at the conclusion of 28 day program.
Acceptability of Intervention Measure (AIM)
Four item Likert scale, ranging from 1-5, with higher scores indicating greater acceptability of intervention. Completed by program staff and WET providers at the conclusion of treatment. Average scores of 4 or higher on each measure will be used as our criterion for acceptability.
Change in World Health Organization-Disability Assessment Schedule (WHO-DAS 2.0)
A 36-item self-report measure of functioning in several areas: Understanding and Communicating, Getting Around, Self-Care, Getting Along with People, Life Activities, and Participation in Society. This measure has high internal consistency, high test-retest reliability, and good concurrent validity. Items are rated on a 5-point Likert scale ranging from 0-4. Higher scores are indicative of greater functional disability. 0 score indicates no disability and 100 means full disability. Subscales include: Cognition, Mobility, Self-care, Getting Along, Life Activities (household), Life Activities (work/school), and Participation. Each subscale has a range from 0 to 100 as above.
Change in PTSD Checklist-5 (PCL-5)
20-item self-report measure that assesses for DSM-5 symptoms of PTSD. Items are responded to on a 5-point Likert scale ranging from 0-4. Total scores range from 0-80 with higher scores indicative of greater symptom severity. A cut-off score of 33 is often used to determine clinical significance of symptoms . The scale has strong internal consistency, good convergent validity, and acceptable discriminant validity. It is also sensitive to change and can be used to track treatment related changes over time.
Change in Clinician Administered PTSD Scale for DSM-5 (CAPS-5)
A gold-standard 30-item clinician administered structured interview used to make diagnoses of PTSD. Severity score based on 20 items, ranging from 0-4, with higher scores indicating greater severity. Range from 0-80.
Change in Patient Health Questionnaire-9 (PHQ-9)
A 9 item self-report measure of depressive symptoms, with a 10th item assessing symptom associated distress. Items are rated on a 4-point Likert scale ranging from 0-3. Scores range from 0-30 with higher scores indicative of greater symptom severity. This measure is shown to have high internal validity and strong predictive validity. Cut off scores greater or equal to 10 are used to determine clinical significance of symptoms.
Change in Brief Addition Monitor (BAM)
A 17-item self-report measure that provides scores on three factors: Recovery Protection, Physical and Psychological Problems, and Substance Use and Risk. Each shown to be responsive to treatment related change. The measure shows acceptable psychometric properties. Items are scored from 0 to 4, with a range from 0 to 68. Higher scores are indicative of more difficulties.
Change in Timeline Follow Back for Substance Use (TLFB)
A calendar-based follow-back method to provide continuous measure of substance use. This detailed procedure elicits daily information on substance use and has been found reliable. The main outcome measures will be percentage of participants abstinent for each follow-up period and mean number of days abstinent. A tally of days using alcohol, drugs, and polysubstance use are computed, with a range of 0 for no days used over 30 day period, to 30 with daily use.
Treatment Attendance
Treatment attendance (number of WET sessions attended out of those scheduled vs. case management sessions attended vs. scheduled). Converted to percentage (sessions attended/ scheduled). Higher numbers indicate better attendance, range from 0-100.
Intervention Appropriateness Measure (IAM)
4 item Likert scale, ranging from 1-5, with higher scores indicating greater appropriateness. Completed by program staff and WET providers at the conclusion of treatment. Average scores of 4 or higher on each measure will be used as our criterion for appropriateness.
Feasibility of Intervention Measure (FIM)
4 item Likert scales, ranging from 1-5, with higher scores indicating greater intervention feasibility. Completed by program staff and WET providers at the conclusion of treatment. Average scores of 4 or higher on each measure will be used as our criterion for feasibility.
Treatment Completion rates
Participants will be categorized into Treatment Completer for WET if all 5 sessions are completed and DOM SUD Treatment Completer if the 28-day program is completed.

Secondary Outcome Measures

Change in Cravings
5 point Likert scale developed for this study. Item ranges from 1 (no craving) to 5 (extreme craving).
Suicide Attempts
Count of suicide attempt(s) denoted by Suicide Behavior Reports from study enrollment through 3 month follow-up.
Homelessness Status
Record review to determine housing status based on CPRS notes and diagnosis special category.
Drug Screen status
Drug screen results through 3 month follow-up period will be captured via record review in CPRS.

Full Information

First Posted
September 8, 2022
Last Updated
June 23, 2023
Sponsor
VA Office of Research and Development
Collaborators
VA Boston Healthcare System, Center for Biostatistics and Health Data Science
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1. Study Identification

Unique Protocol Identification Number
NCT05536908
Brief Title
Evaluating Supplementing Residential Substance Use Treatment With Written Exposure Therapy for Veterans With Post Traumatic Stress Disorder (PTSD) and Substance Use Disorders (SUD)
Official Title
Evaluating the Impact of Supplementing Residential Substance Use Treatment With Written Exposure Therapy for Veterans With Co-Occurring PTSD and Substance Use Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 22, 2023 (Actual)
Primary Completion Date
September 2, 2024 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
Collaborators
VA Boston Healthcare System, Center for Biostatistics and Health Data Science

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Posttraumatic Stress Disorder (PTSD) and Substance Use Disorder (SUD) are highly comorbid, and comorbidity increases risk for poor functional outcomes. Risks for poor quality of life and suicide increase further for those with co-occurring PTSD and SUD diagnoses as compared to either condition alone, with suicide attempt rates three times higher for Veterans with alcohol use disorder and PTSD (Norman, Haller, Hamblen, Southwick & Pietrzak, 2018). For patients with PTSD-SUD, there is evidence of greater PTSD symptom severity and poorer SUD treatment outcomes (e.g., Back et al., 2000), as well as higher rates of homelessness and disability (Bowe & Rosenheck, 2015). PTSD-SUD treatments have shown promising reductions in PTSD and SUD symptoms (Flanagan, Korte, Killeen & Back,2016). Yet, there are still major challenges in widely implementing concurrent or single-target gold-standard treatments for this population, especially with rural veterans where care access may be limited (e.g., Flanagan et al., 2016). Written Exposure Therapy (WET) is a front-line, brief and effective treatment for PTSD that addresses some of the challenges posed by other gold-standard treatments. This project is designed to examine the feasibility and acceptability of Written Exposure Therapy (WET) delivered to Veterans with comorbid PTSD-SUD while they are completing a 28 day-residential SUD program (DOM SUD). The preliminary effects of the treatment during the program, and at one month and 3-month follow-up periods will also be examined, with particular attention to rates of substance use, homelessness, treatment attendance, treatment completion, quality of life, suicidality, and PTSD and depression symptoms. Veterans enrolled in the residential substance use disorder clinic will be recruited for screening into the study. Those that meet criteria for PTSD will be randomized into one of two treatment arms: Treatment as Usual (TAU: DOM SUD) and Written Exposure Therapy in a residential SUD program (resWET). Those in the TAU control group will participate in the DOM SUD treatment program, while those in the resWET group will also have five individual treatment sessions of WET. Participants will complete weekly measures of symptoms, in addition to rating cravings for substance use. Treatment completion rates will also be compiled for both DOM SUD and resWET. Participants will complete pre-treatment, post-treatment, 1 month, and 3 month follow-up measures to look for important trends regarding symptom responses to treatment (e.g., PTSD, depression), as well as suicide attempts, homelessness, treatment attendance, treatment completion, substance use, and quality of life. This preliminary data will be used to inform future studies. Additionally, providers will provide feedback to provide essential information about implementation barriers that need to be addressed for the broader uptake of the treatment approach and to enhance accessibility of the treatment. All Veterans will also provide feedback about their treatment. Findings will be used to improve the treatment and assessment approach and to prepare for a larger study to evaluate resWET.
Detailed Description
Posttraumatic Stress Disorder (PTSD) and Substance Use Disorder (SUD) are highly comorbid, and comorbidity increases risk for poor functional outcomes. SUDs are associated with poor functional outcomes, such as quality of life, community engagement, and suicide (Teeters, Lancaster, Brown & Back, 2017). Risks for poor quality of life and suicide increase further for those with co-occurring PTSD and SUD diagnoses as compared to either condition alone, with suicide attempt rates three times higher for Veterans with alcohol use disorder and PTSD (Norman, Haller, Hamblen, Southwick & Pietrzak, 2018). For patients with PTSD-SUD, there is evidence of greater PTSD symptom severity and poorer SUD treatment outcomes (e.g., Back et al., 2000), as well as higher rates of homelessness and disability (Bowe & Rosenheck, 2015). PTSD-SUD treatments have shown promising reductions in PTSD and SUD symptoms (Flanagan, Korte, Killeen & Back, 2016). Yet, there are still major challenges in widely implementing concurrent or single-target gold-standard treatments for this population, especially with rural veterans where care access may be limited (e.g., Flanagan et al., 2016). Written Exposure Therapy (WET) is a front-line, brief and effective treatment for PTSD that addresses some of the challenges posed by other gold-standard treatments. This project is designed to examine the feasibility and acceptability of Written Exposure Therapy (WET) delivered to Veterans with comorbid PTSD-SUD while they are completing a 28 day-residential SUD program (DOM SUD). The preliminary effects of the treatment during the program, and at one month and 3-month follow-up periods will also be examined, with particular attention to rates of substance use, homelessness, treatment attendance, treatment completion, quality of life, suicidality, and PTSD and depression symptoms. Veterans enrolled in the DOM SUD with PTSD Checklist-5 (PCL-5) scores over 33 will be recruited for further screening into the study. Those that meet criteria for PTSD through confirmation using the Clinician Administered PTSD Scale for DSM-5 (CAPS-5) will be randomized into one of two treatment arms: Treatment as Usual (TAU: DOM SUD) and Written Exposure Therapy in a residential SUD program (resWET). Randomization will be stratified by gender and oversampling for women and minority participants will be used. Those in the TAU control group will participate in the DOM SUD treatment program, while those in the resWET group will also have five individual treatment sessions of WET. Participants will complete weekly measures of symptoms, in addition to rating cravings for substance use. Treatment completion rates will also be compiled for both DOM SUD and resWET. Participants will complete pre-treatment, post-treatment, 1 month, and 3 month follow-up measures in person, over video, or by phone, and these measures, along with data available from the treatment record, will be examined using descriptive analyses to look for important trends regarding both symptom responses (e.g., PTSD, depression) to treatment, as well as behavioral and functional outcomes (such as suicide attempts, homelessness, treatment attendance, treatment completion, substance use, quality of life). This preliminary data will be used to inform future studies using this treatment approach. Additionally, providers in the DOM SUD will complete treatment feasibility and satisfaction surveys and focus groups to provide essential information about implementation barriers that need to be addressed for the uptake of the treatment approach and to enhance the accessibility of the treatment. All Veterans will also provide feedback about their treatment, through survey when the treatment is complete, and focus group participation. Findings from both qualitative and quantitative data will be used to improve the treatment and assessment approach and to determine effect sizes of key measures (World Health Organization- Disability Assessment Schedule (WHO-DAS), PTSD Checklist (PCL), Patient Health Questionnaire (PHQ-9)) to prepare for a fully powered randomized control trial (RCT) to systematically evaluate resWET.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PTSD, Substance Use Disorders
Keywords
PTSD, Substance Use Disorders, Treatment, Comorbidity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Veterans are assigned to the combined PTSD/ residential substance use treatment (resWET) or Treatment as Usual (TAU: residential substance use treatment program).
Masking
Outcomes Assessor
Masking Description
Provider conducting CAPS-5 will not have access to treatment condition
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
resWET
Arm Type
Experimental
Arm Description
Residential Written Exposure Therapy (resWET): Treatment as Usual (TAU) plus 5-individual Written Exposure Therapy (WET) sessions (40-60 min each; Marx & Sloan, 2019) twice a week for two weeks and once a week for the final session, administered by WET trained psychologists, social workers, or postdoctoral residents. Treatment instructions are read, patients write for 30 minutes, and the writing is briefly processed. No formal written homework is required.
Arm Title
Treatment as Usual (TAU)
Arm Type
Active Comparator
Arm Description
Treatment as Usual (DOM SUD): The DOM SUD (TAU) is a 24-bed intensive substance use disorder (SUD) residential program with a typical 28-day length of stay. The program focuses on evidence-based treatments for SUD such as Cognitive-Behavioral Therapy, Motivational Enhancement Therapy, Medication Assisted Treatment, and Contingency Management therapy. Patients diagnosed with Post-traumatic Stress Disorder (PTSD) are typically referred to outpatient PTSD treatment following DOM SUD and often attend Seeking Safety during the program. Most of the programming is group-based though Veterans also have weekly individual case management appointments.
Intervention Type
Behavioral
Intervention Name(s)
Residential Written Exposure Therapy
Other Intervention Name(s)
resWET
Intervention Description
Residential Written Exposure Therapy (resWET): TAU plus 5-individual WET sessions (40-60 min each; Marx & Sloan, 2019) twice a week for two weeks and once a week for the final session, administered by WET trained psychologists, social workers, or postdoctoral residents. Treatment instructions are read, patients write for 30 minutes, and the writing is briefly processed. No formal written homework is required.
Intervention Type
Behavioral
Intervention Name(s)
Treatment as Usual
Other Intervention Name(s)
TAU
Intervention Description
Treatment as Usual (DOM SUD): The DOM SUD (TAU) is a 24-bed intensive SUD residential program with a typical 28-day length of stay. The program focuses on evidence-based treatments for SUD such as Cognitive-Behavioral Therapy, Motivational Enhancement Therapy, Medication Assisted Treatment, and Contingency Management therapy. Patients diagnosed with PTSD are typically referred to outpatient PTSD treatment following DOM SUD and often attend Seeking Safety during the program. Most of the programming is group-based though Veterans also have weekly individual case management appointments.
Primary Outcome Measure Information:
Title
Client Satisfaction Questionnaire (CSQ-8)
Description
Standardized patient treatment satisfaction measure, used in substance use treatment settings (Kelly et al, 2018). 8 items measuring satisfaction with treatment, Likert scales from 1 (low satisfaction) to 4 (high satisfaction). Total scores range from 8 to 32, with higher scores indicating greater satisfaction. High concurrent validity and internal consistency. Average item scores of 3 or higher indicate satisfaction with treatment. Completed by participants at the conclusion of 28 day program.
Time Frame
Week 4
Title
Acceptability of Intervention Measure (AIM)
Description
Four item Likert scale, ranging from 1-5, with higher scores indicating greater acceptability of intervention. Completed by program staff and WET providers at the conclusion of treatment. Average scores of 4 or higher on each measure will be used as our criterion for acceptability.
Time Frame
Week 4
Title
Change in World Health Organization-Disability Assessment Schedule (WHO-DAS 2.0)
Description
A 36-item self-report measure of functioning in several areas: Understanding and Communicating, Getting Around, Self-Care, Getting Along with People, Life Activities, and Participation in Society. This measure has high internal consistency, high test-retest reliability, and good concurrent validity. Items are rated on a 5-point Likert scale ranging from 0-4. Higher scores are indicative of greater functional disability. 0 score indicates no disability and 100 means full disability. Subscales include: Cognition, Mobility, Self-care, Getting Along, Life Activities (household), Life Activities (work/school), and Participation. Each subscale has a range from 0 to 100 as above.
Time Frame
Week 1, 4, 8, 16
Title
Change in PTSD Checklist-5 (PCL-5)
Description
20-item self-report measure that assesses for DSM-5 symptoms of PTSD. Items are responded to on a 5-point Likert scale ranging from 0-4. Total scores range from 0-80 with higher scores indicative of greater symptom severity. A cut-off score of 33 is often used to determine clinical significance of symptoms . The scale has strong internal consistency, good convergent validity, and acceptable discriminant validity. It is also sensitive to change and can be used to track treatment related changes over time.
Time Frame
Weeks 1, 2, 3, 4, 8, 16
Title
Change in Clinician Administered PTSD Scale for DSM-5 (CAPS-5)
Description
A gold-standard 30-item clinician administered structured interview used to make diagnoses of PTSD. Severity score based on 20 items, ranging from 0-4, with higher scores indicating greater severity. Range from 0-80.
Time Frame
Week 1, 4, 8, 16
Title
Change in Patient Health Questionnaire-9 (PHQ-9)
Description
A 9 item self-report measure of depressive symptoms, with a 10th item assessing symptom associated distress. Items are rated on a 4-point Likert scale ranging from 0-3. Scores range from 0-30 with higher scores indicative of greater symptom severity. This measure is shown to have high internal validity and strong predictive validity. Cut off scores greater or equal to 10 are used to determine clinical significance of symptoms.
Time Frame
Weeks 1, 2, 3, 4, 8, 16
Title
Change in Brief Addition Monitor (BAM)
Description
A 17-item self-report measure that provides scores on three factors: Recovery Protection, Physical and Psychological Problems, and Substance Use and Risk. Each shown to be responsive to treatment related change. The measure shows acceptable psychometric properties. Items are scored from 0 to 4, with a range from 0 to 68. Higher scores are indicative of more difficulties.
Time Frame
Week 1, 4, 8, 16
Title
Change in Timeline Follow Back for Substance Use (TLFB)
Description
A calendar-based follow-back method to provide continuous measure of substance use. This detailed procedure elicits daily information on substance use and has been found reliable. The main outcome measures will be percentage of participants abstinent for each follow-up period and mean number of days abstinent. A tally of days using alcohol, drugs, and polysubstance use are computed, with a range of 0 for no days used over 30 day period, to 30 with daily use.
Time Frame
Weeks 1, 4, 8, 16
Title
Treatment Attendance
Description
Treatment attendance (number of WET sessions attended out of those scheduled vs. case management sessions attended vs. scheduled). Converted to percentage (sessions attended/ scheduled). Higher numbers indicate better attendance, range from 0-100.
Time Frame
Week 16
Title
Intervention Appropriateness Measure (IAM)
Description
4 item Likert scale, ranging from 1-5, with higher scores indicating greater appropriateness. Completed by program staff and WET providers at the conclusion of treatment. Average scores of 4 or higher on each measure will be used as our criterion for appropriateness.
Time Frame
Week 4
Title
Feasibility of Intervention Measure (FIM)
Description
4 item Likert scales, ranging from 1-5, with higher scores indicating greater intervention feasibility. Completed by program staff and WET providers at the conclusion of treatment. Average scores of 4 or higher on each measure will be used as our criterion for feasibility.
Time Frame
Week 4
Title
Treatment Completion rates
Description
Participants will be categorized into Treatment Completer for WET if all 5 sessions are completed and DOM SUD Treatment Completer if the 28-day program is completed.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Change in Cravings
Description
5 point Likert scale developed for this study. Item ranges from 1 (no craving) to 5 (extreme craving).
Time Frame
Weeks 1, 2, 3, and 4
Title
Suicide Attempts
Description
Count of suicide attempt(s) denoted by Suicide Behavior Reports from study enrollment through 3 month follow-up.
Time Frame
Week 16
Title
Homelessness Status
Description
Record review to determine housing status based on CPRS notes and diagnosis special category.
Time Frame
Week 16
Title
Drug Screen status
Description
Drug screen results through 3 month follow-up period will be captured via record review in CPRS.
Time Frame
Week 16
Other Pre-specified Outcome Measures:
Title
Columbia Suicide Severity Rating Scale
Description
Used for suicide risk assessment. Includes questions on suicidal ideation, intensity of ideation, and suicidal behavior. The C-SSRS showed strong concurrent validity with documented suicide attempts and showed good predictive validity in predicting future attempts. Used for study eligibility and safety monitoring, no total score or range of score is utilized.
Time Frame
Week 1, 4, 8, and 16

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnoses of a substance use disorder (SUD) and PTSD Enrolled in the residential substance use disorder treatment program (DOM SUD) at the Salem VAMC Exclusion Criteria: Current Manic Episode Current Suicidal Intent Previous Written Exposure treatment Unable to write
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dana Holohan
Phone
(540) 982-2463
Ext
2934
Email
Dana.Holohan@va.gov
First Name & Middle Initial & Last Name or Official Title & Degree
Tracy A Hicks
Phone
(540) 982-2463
Ext
1568
Email
Tracy.Hicks2@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dana Holohan
Organizational Affiliation
Salem VA Medical Center, Salem, VA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Salem VA Medical Center, Salem, VA
City
Salem
State/Province
Virginia
ZIP/Postal Code
24153-6404
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tracy A Hicks
Phone
540-982-2463
Ext
1568
Email
Tracy.Hicks2@va.gov
First Name & Middle Initial & Last Name & Degree
Donna J Arsura
Phone
(540) 982-2463
Ext
1225
Email
donna.arsura@va.gov
First Name & Middle Initial & Last Name & Degree
Dana Holohan

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified participant data that underlie the results reported in the article.
IPD Sharing Time Frame
Beginning 9 months and ending after 3 years of article publication.
IPD Sharing Access Criteria
Proposals should be directed to: dana.holohan@va,gov. To gain access, data requestors will need to sign a data access agreement and Salem IRB needs to approve the request.
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Evaluating Supplementing Residential Substance Use Treatment With Written Exposure Therapy for Veterans With Post Traumatic Stress Disorder (PTSD) and Substance Use Disorders (SUD)

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