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

Evaluating the Impact of Supplementing Residential Substance Use Treatment With Written Exposure Therapy for Veterans With Co-Occurring PTSD and Substance Use Disorders

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.

Study Overview

• Status: Completed
• Conditions: PTSD; Substance Use Disorders
• Intervention / Treatment: Behavioral: Residential Written Exposure Therapy; Behavioral: Treatment as Usual

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.

Two small sub-studies were approved and added: 1) as a longer term follow-up, study staff reached out to prior participants to re-evaluate their symptoms using the same measures. Participants were reconsented for this additional time period as it was not a part of the original study. 2) A small group of Veterans enrolled in the residential substance use treatment program were recruited for a follow-up study to evaluate the impact of administering a clinician interview for PTSD on PTSD and depressive symptoms at four time points.

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Salem, Virginia, United States, 24153-6404
      • Salem VA Medical Center, Salem, VA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: resWET; 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.	Behavioral: Residential Written Exposure Therapy; 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.; Other Names: resWET
Active Comparator: Treatment as Usual (TAU); 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.	Behavioral: Treatment as Usual; 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.; Other Names: TAU

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Week 4
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.	Week 4
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.	Week 1, 4, 8, 16
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.	Weeks 1, 2, 3, 4, 8, 16
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.	Week 1, 4, 8, 16
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.	Weeks 1, 2, 3, 4, 8, 16
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.	Week 1, 4, 8, 16
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.	Weeks 1, 4, 8, 16
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.	Week 16
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.	Week 4
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.	Week 4
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.	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Cravings	5 point Likert scale developed for this study. Item ranges from 1 (no craving) to 5 (extreme craving).	Weeks 1, 2, 3, and 4
Suicide Attempts	Count of suicide attempt(s) denoted by Suicide Behavior Reports from study enrollment through 3 month follow-up.	Week 16
Homelessness Status	Record review to determine housing status based on CPRS notes and diagnosis special category.	Week 16
Drug Screen status	Drug screen results through 3 month follow-up period will be captured via record review in CPRS.	Week 16

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Columbia Suicide Severity Rating Scale	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.	Week 1, 4, 8, and 16

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Collaborators: VA Boston Healthcare System; Center for Biostatistics and Health Data Science
• Investigators: Principal Investigator: Dana Holohan, Salem VA Medical Center, Salem, VA

Publications and helpful links

General Publications

• Stoltz JF, Nicolas A. Study of amino groups of the human platelet membrane. Acta Haematol. 1978;60(5):304-9. doi: 10.1159/000207727.
• Okamoto M, Takeshima H, Komiyama K, Umezawa I. Mechanism of action of acetyl kidamycin. II. Inhibition of RNA synthesis in HeLa cells. J Antibiot (Tokyo). 1976 Dec;29(12):1334-8. doi: 10.7164/antibiotics.29.1334.
• Lagenstein I, Sternowsky HJ, Blaschke E, Rothe M, Fehr R. Treatment of childhood epilepsy with dipropylacetic acid (DPA). Arch Psychiatr Nervenkr (1970). 1978 Oct 9;226(1):43-55. doi: 10.1007/BF00344123.
• Timar M. The extrapolation of liver function data from the animal to the human in the treatment of the acute stage of liver damage with the hepatotropic factor. Farmaco Prat. 1976 Sep;31(9):473-8. No abstract available.
• Bartal A, Mekori T, Haasz R, Cohen Y, Robinson E. Multiple lymphocyte transformation tests by phytohemagglutinin in healthy individuals: transient episodes of decreased lymphocyte blastogenesis. Acta Haematol. 1978;60(3):148-60. doi: 10.1159/000207711.
• Siegel ME, Siemsen JK. A new noninvasive approach to peripheral vascular disease: thallium-201 leg scans. AJR Am J Roentgenol. 1978 Nov;131(5):827-30. doi: 10.2214/ajr.131.5.827.
• Oda S, Oda E, Tanaka KR. Relationship of density distribution and pyruvate kinase electrophoretic pattern of erythrocytes in sickle cell diseases and other disorders. Acta Haematol. 1978;60(4):201-9. doi: 10.1159/000207716.
• McAllister PE, Nagabayashi T, Wolf K. Viruses of eels with and without stomatopapillomas. Ann N Y Acad Sci. 1978 Sep 29;298:233-44. doi: 10.1111/j.1749-6632.1977.tb19268.x. No abstract available.
• Mani RL, Eisenberg RL. Complications of catheter cerebral arteriography: analysis of 5,000 procedures. II. Relation of complication rates to clinical and arteriographic diagnoses. AJR Am J Roentgenol. 1978 Nov;131(5):867-9. doi: 10.2214/ajr.131.5.867.
• Pokrovskii AV, Kazanchian PO, Spiridonov AA, Kiiashko VA. [Indications for restoration of patency of the inferior mesenteric artery in reconstructive operations on the terminal segment of the aorta]. Khirurgiia (Mosk). 1976 Nov;(11):93-9. No abstract available. Russian.
• Morell A, Skvaril F, Huser HJ, Spengler G, Barandun S. Cytoplasmic immunoglobulins in bone marrow cells of polyclonal and of monoclonal origin. Acta Haematol. 1978;60(3):137-47. doi: 10.1159/000207710.
• Scott RS, Espiner EA, Donald RA, Livesey JH. Hormonal responses during treatment of acute diabetic ketoacidosis with constant insulin infusions. Clin Endocrinol (Oxf). 1978 Nov;9(5):463-74. doi: 10.1111/j.1365-2265.1978.tb03586.x.

Study record dates

Study Major Dates

• Study Start (Actual): June 22, 2023
• Primary Completion (Actual): January 5, 2026
• Study Completion (Actual): January 15, 2026

Study Registration Dates

• First Submitted: September 8, 2022
• First Submitted That Met QC Criteria: September 8, 2022
• First Posted (Actual): September 13, 2022

Study Record Updates

• Last Update Posted (Actual): February 9, 2026
• Last Update Submitted That Met QC Criteria: February 4, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: PTSD; Treatment; Comorbidity; Substance Use Disorders
• Additional Relevant MeSH Terms: Trauma and Stressor Related Disorders; Mental Disorders; Chemically-Induced Disorders; Stress Disorders, Traumatic; Substance-Related Disorders; Stress Disorders, Post-Traumatic; Therapeutics
• Other Study ID Numbers: D4083-P; I21RX004083-01A1 (U.S. NIH Grant/Contract: VA Office of Research and Development)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• 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