An interventional study of Written Exposure Therapy and Cognitive Behavioral Therapy for Substance Use Disorders (skill components) in Stress Disorders, Post-Traumatic and Substance-Related Disorders, sponsored by VA Office of Research and Development. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-29.
Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Treatment
Among 263 studies in Stress Disorders, Post-Traumatic by VA Office of Research and Development — 56 open to participants now, 66 under way, 4 of them phase 3. Stress Disorders, Post-Traumatic · VA Office of Research and Development.
Among the 263 studies in Stress Disorders, Post-Traumatic by VA Office of Research and Development, this one is the 203rd largest by planned enrollment of the 246 interventional ones that give a count, is one of 3 that started in 2028, is one of 185 with no phase, reaches primary completion later than 49 of the 65 other live ones, and was the 263rd registered.
2,682 studies on the registry are indexed under Stress Disorders, Post-Traumatic; 601 are open to participants now.
This study's planned enrollment of 30 is below the median of 69 across 2,196 interventional studies indexed under Stress Disorders, Post-Traumatic.
Browse Stress Disorders, Post-Traumatic studies →56 of the 263 studies in Stress Disorders, Post-Traumatic by VA Office of Research and Development are open now, in 1 country. Each count lists the studies.
Of the 417 Stress Disorders, Post-Traumatic studies recruiting now, 186 (45%) set no upper age limit and 205 (49%) stop at 75 or younger; 63 take children under 18; 89 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →263 studies; the count open now beside each. This study's row is marked.
First in 2000; this study’s year is marked. 3 started in 2028.
Median enrollment 87 across the 246 interventional studies, 110 across the 17 observational. Of the 193 that completed or were terminated, 167 (87%) have results posted.
VA Office of Research and Development is the lead sponsor of 1,771 studies on the registry; 392 are open to participants now.
Of its 213 completed or terminated interventional studies of FDA-regulated products, 185 (87%) have results posted.
21 of the studies in Stress Disorders, Post-Traumatic by VA Office of Research and Development that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06000475VA Office of Research and DevelopmentEnhancing Memory in Cognitive Processing Therapy for PTSD | 2026-12-31 |
| NCT05812131VA Office of Research and DevelopmentCOPEWeb Training for Providers | 2027-01-01 |
| NCT05149534VA Office of Research and DevelopmentrTMS-augmented Written Exposure Therapy for PTSD | 2027-01-29 |
| NCT05776056VA Office of Research and DevelopmentMethylphenidate for the Treatment of PTSD With Associated Neurocognitive Complaints | 2027-03-31 |
| NCT05789329VA Office of Research and DevelopmentNon-Inferiority Trial of TrIGR for PTSD | 2027-03-31 |
Among the 263 studies in Stress Disorders, Post-Traumatic by VA Office of Research and Development, from their registry updates:
Veterans with co-occurring posttraumatic stress disorder (PTSD) and substance use disorder (SUD) experience significant impairment and worse treatment outcomes compared to those with either condition alone, including higher rates of psychiatric hospitalization, relapse, and suicide risk. Unfortunately, integrated treatment options for PTSD-SUD remain extremely limited despite strong Veteran preference for integrated care over sequential or concurrent models. The only current integrated, evidence-based treatment aligned with VA/DoD clinical guidelines, Concurrent Treatment of PTSD and Substance Use Disorders Using Prolonged Exposure (COPE), requires 12 weekly 90-minute sessions and is associated with a 43-46% dropout rate, with most dropout occurring after six or more sessions. The high treatment burden and dropout rate indicate a critical need to develop a brief, effective, integrated intervention for Veterans with PTSD-SUD.
Written Exposure Therapy (WET) is an evidence-based treatment for PTSD requiring only five 60-minute sessions, with substantially lower dropout than other trauma-focused therapies. The investigators have developed a treatment targeting PTSD and comorbid SUD called RISE (Rapid Recovery through Integrated Substance Use Treatment and Written Exposure for PTSD), that integrates WET with core components of Cognitive Behavioral Therapy for Substance Use Disorder (CBT-SUD), including functional analysis, urge and craving management, cognitive restructuring, refusal skills, and relapse prevention. By combining these two evidence-based treatments, RISE is designed to reduce treatment burden and dropout relative to existing integrated approaches while addressing both conditions concurrently.
The primary goal of this study is to evaluate the feasibility and acceptability of RISE relative to CBT-SUD alone among Veterans with PTSD-SUD. Proposed is a randomized, two-arm pilot clinical trial in which 30 Veterans with PTSD-SUD will be randomized 2:1 to either 1) RISE, an integrated six-session treatment combining WET and CBT-SUD, or 2) CBT-SUD alone, delivered in a matched six-session, 90-minute format. Specific aims include: AIM 1) To evaluate the feasibility of RISE, including recruitment, session attendance, and treatment completion rates; AIM 2) To evaluate the acceptability of RISE using the Client Satisfaction Questionnaire-8; and an EXPLORATORY AIM) To generate preliminary estimates of change in PTSD and substance use symptom severity to inform a future fully-powered non-inferiority trial. If found feasible and acceptable, RISE has the potential to significantly expand access to integrated, guideline-concordant care for Veterans with PTSD-SUD while reducing treatment burden and improving long-term PTSD and SUD outcomes.
Veterans with co-occurring posttraumatic stress disorder (PTSD) and substance use disorder (SUD) experience significant impairment and worse treatment outcomes compared to those with either condition alone, including higher rates of psychiatric hospitalization, relapse, and suicide risk. Unfortunately, integrated treatment options for PTSD-SUD remain extremely limited despite strong Veteran preference for integrated care over sequential or concurrent models. The only current integrated, evidence-based treatment aligned with VA/DoD clinical guidelines, Concurrent Treatment of PTSD and Substance Use Disorders Using Prolonged Exposure (COPE), requires 12 weekly 90-minute sessions and is associated with a 43-46% dropout rate, with most dropout occurring after six or more sessions. The high treatment burden and dropout rate indicate a critical need to develop a brief, effective, integrated intervention for Veterans with PTSD-SUD. Further, despite the chronic and relapsing nature of SUD, providers across SUD, PTSD, and general mental health clinics report a clear need for integrated treatments but continue to treat these conditions sequentially due to the siloed nature of specialty clinics.
Written Exposure Therapy (WET) is an evidence-based treatment for PTSD requiring only five 60-minute sessions, with substantially lower dropout than other trauma-focused therapies (6.4-12.5% versus 35.6-39.7% for Cognitive Processing Therapy and Prolonged Exposure) and demonstrated non-inferiority to both. The investigators have developed a treatment targeting PTSD and comorbid SUD called RISE (Rapid Recovery through Integrated Substance Use Treatment and Written Exposure for PTSD), that integrates WET with core components of Cognitive Behavioral Therapy for Substance Use Disorder (CBT-SUD), an evidence-based, VA-disseminated treatment that addresses the relationship between thoughts, emotions, behaviors, and environmental factors related to substance use. RISE incorporates functional analysis of substance use behaviors, skills for managing urges and cravings, cognitive restructuring, refusal skills, and relapse prevention and coping planning, delivered across six weekly, 90-minute individual sessions, half the treatment length of COPE.
The primary goal of the current study is to evaluate the feasibility and acceptability of RISE relative to CBT-SUD alone among Veterans with PTSD-SUD, using a randomized, two-arm pilot design. Thirty Veteran participants with PTSD-SUD will be randomized 2:1 to either 1) RISE, an integrated six-session treatment combining WET for PTSD with CBT-SUD skill components, or 2) CBT-SUD alone, delivered individually over a matched six-session, 90-minute format to equate total clinical contact time across arms. Both arms will be delivered in-person at the VA Mid-Atlantic MIRECC or via telehealth, per Veteran preference. Specific aims include: AIM 1) To evaluate the feasibility of RISE, including recruitment and enrollment rate, session attendance, and treatment completion rate, assessed continuously throughout the study's two-year enrollment period; AIM 2) To evaluate the acceptability of RISE using the Client Satisfaction Questionnaire-8, administered at post-treatment; and an EXPLORATORY AIM) To generate preliminary within-person estimates of change in PTSD symptom severity (PCL-5, CAPS-5) and substance use severity (BAM-R) at baseline, post-treatment, and 3-month follow-up, and to examine the proportion of Veterans no longer meeting diagnostic criteria for PTSD and/or a SUD (QuickSCID-5, CAPS-5) at post-treatment and follow-up, to inform effect size estimates for a future fully-powered non-inferiority trial. If RISE is found to be feasible and acceptable, it could be integrated into existing VA SUD, PTSD, and general mental health clinics without requiring the additional resources needed to implement COPE, meaningfully expanding Veterans' access to guideline-concordant, integrated PTSD-SUD care.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Is currently engaged in psychotherapy for posttraumatic stress disorder (PTSD) or a substance use disorder (SUD)
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An intervention that integrates Written Exposure Therapy (WET) for PTSD with core components of Cognitive Behavioral Therapy for Substance Use Disorder (CBT-SUD), delivered over six weekly, 90-minute individual sessions.
Behavioral: Written Exposure Therapy · Behavioral: Cognitive Behavioral Therapy for Substance Use Disorders (skill components)
An evidence-based, individually delivered Cognitive Behavioral Therapy for Substance Use Disorder, delivered over six weekly, 90-minute sessions matched to RISE for total clinical contact time.
Behavioral: Cognitive Behavioral Therapy for Substance Use Disorders
A brief, evidence-based PTSD treatment involving structured trauma account writing sessions, integrated across Sessions 2 through 6 of the RISE protocol.
Also known as: WET
Core cognitive-behavioral skill components for substance use disorder (SUD), including functional analysis (Session 2), urge and craving management (Session 3), cognitive restructuring (Session 4), refusal skills (Session 5), and coping planning (Session 6).
Also known as: CBT-SUD
Individually delivered cognitive-behavioral therapy targeting substance use, including functional analysis, managing urges and cravings, cognitive restructuring, refusal skills, and relapse prevention and coping planning, tailored in format and pacing to individual treatment goals.
Also known as: CBT-SUD
Feasibility: Participant Recruitment
Rate of eligible screened Veterans and enrollment rate, used as an indicator of the reach and accessibility of RISE.
Time frame: Baseline
Feasibility: Study Retention
Proportion of enrolled participants retained through study completion.
Time frame: post-treatment (6 weeks), 3-month follow-up
Feasibility: Number of Sessions Attended
Average number of treatment sessions attended by participants in each arm, used as a behavioral indicator of treatment engagement.
Time frame: 6 weeks
Feasibility: Treatment Completion
Proportion of participants who complete all six treatment sessions, used as a behavioral indicator of feasibility.
Time frame: 6 weeks
Feasibility: Study Withdrawals
Number and proportion of participants who withdraw from the study prior to treatment completion.
Time frame: post-treatment (6 weeks), 3-month follow-up
Acceptability: Client Satisfaction Questionnaire-8 (CSQ-8) Score
The CSQ-8 is an 8-item measure of participant satisfaction with treatment. A mean score of 24 or higher corresponds to sufficient overall treatment satisfaction.
Time frame: 6 weeks
Treatment Acceptability and Adherence Scale (TAAS)
A self-report measure of participants' expectations regarding the acceptability and credibility of their assigned treatment.
Time frame: Baseline
Revised Vanderbilt Therapeutic Alliance Scale, Short Form (VTAS-R)
A brief self-report measure of the quality of the therapeutic relationship between participant and therapist.
Time frame: 6 weeks
Demographic Questionnaire
Standard sociodemographic data including age, sex, race, ethnicity, and education.
Time frame: Baseline
Treatment History Form
Self-report measure assessing prior and concurrent utilization of mental health and substance use treatment services.
Time frame: Baseline, post-treatment (6 weeks), 3-month follow-up
Combat Exposure Scale (CES)
A brief self-report measure of combat-related exposure during military service.
Time frame: Baseline
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
A structured clinical interview for diagnosing PTSD and assessing symptom severity according to DSM-5 criteria.
Time frame: Baseline, post-treatment (6 weeks), 3-month follow-up
Quick Structured Clinical Interview for DSM-5 Disorders (QuickSCID-5)
A structured diagnostic interview used to confirm presence of a substance use disorder and screen for other DSM-5 psychiatric disorders.
Time frame: Baseline, post-treatment (6 weeks), 3-month follow-up
Clinical Opiate Withdrawal Scale (COWS)
A clinician-administered scale used to assess signs and symptoms of opioid withdrawal and screen for withdrawal risk.
Time frame: Baseline
Clinical Institute Withdrawal Assessment (CIWA)
A clinician-administered scale used to assess signs and symptoms of alcohol withdrawal and screen for withdrawal risk.
Time frame: Baseline
PTSD Checklist for DSM-5 (PCL-5)
A 20-item self-report measure assessing the 20 DSM-5 symptoms of PTSD, used to track change in PTSD symptom severity.
Time frame: Baseline, post-treatment (6 weeks), 3-month follow-up
PTSD Checklist for DSM-5, Weekly
An adapted version of DSM-5 adjusted to assess PTSD symptom severity on a weekly basis.
Time frame: Week 1, 2, 3, 4, 5, 6
Brief Addiction Monitor-Revised (BAM-R)
A self-report measure assessing substance use frequency, risk factors, and protective factors over the past 30 days.
Time frame: Baseline, post-treatment (6 weeks), 3-month follow-up
Brief Addiction Monitor for IOP (BAM-IOP)
An abbreviated version of the BAM-R administered at each therapy session to monitor within-treatment substance use.
Time frame: Week 1, 2, 3, 4, 5, 6
Patient Health Questionnaire-9 (PHQ-9)
A 9-item self-report measure of depressive symptom severity.
Time frame: Baseline, post-treatment (6 weeks), 3-month follow-up
Brief Inventory of Psychosocial Functioning (B-IPF)
A self-report measure of psychosocial functioning across domains including interpersonal relationships, work, and self-care.
Time frame: Baseline, post-treatment (6 weeks), 3-month follow-up
Semi-Structured Interview
A CFIR-informed qualitative interview eliciting participant feedback on the RISE treatment protocol, feasibility of study participation, and recommendations for improvement.
Time frame: 6 weeks
Plan to share: No — The investigators do not plan to share individual participant data.
No publications or documents are linked to this record.
Start is estimated for Aug 2028; primary completion for Apr 2030, 20 months later.
Of 1,064 non-industry interventional studies with no phase under Stress Disorders, Post-Traumatic, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 53. This study's planned 20 months is below that.
Counting every sponsor, half of 1,092 studies reached it within 34 months; a quarter within 17 and three quarters within 53.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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