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

PTSD Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05536908
• Other study ID #: D4083-P
• Secondary ID: I21RX004083-01A1
• Status: Recruiting
• Phase: N/A
• Start date: June 22, 2023
• Est. completion date: December 1, 2024

Study information

• Verified date: June 2024
• Source: VA Office of Research and Development
• Contact: Dana Holohan
• Phone: (540) 982-2463
• Email: Dana.Holohan[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 1, 2024
• Est. primary completion date: September 2, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• PTSD
• Substance Use Disorders
• Substance-Related Disorders

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Salem VA Medical Center, Salem, VA	Salem	Virginia

Sponsors (3)

Lead Sponsor	Collaborator
VA Office of Research and Development	Center for Biostatistics and Health Data Science, VA Boston Healthcare System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	Suicide Attempts	Count of suicide attempt(s) denoted by Suicide Behavior Reports from study enrollment through 3 month follow-up.	Week 16
Secondary	Homelessness Status	Record review to determine housing status based on CPRS notes and diagnosis special category.	Week 16
Secondary	Drug Screen status	Drug screen results through 3 month follow-up period will be captured via record review in CPRS.	Week 16