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RISE for PTSD and Substance Use Disorder in Veterans

A legfontosabb adatok

Ki végzi
VA Office of Research and Development
Hol
Durham (Egyesült Államok)A helyszín megnézése
Azonosító
Állapot
Toborzás még nem indult
Résztvevők
30 fő, tervezett
Kezdés
2028. aug. 1.
Várható befejezés
2030. júl. 31.
A vizsgálat típusa
Beavatkozással járó, 2 csoportAz egyik csoport egy már használt kezelést kap, összehasonlításként.
A vizsgált kezelések
  • Written Exposure Therapy
  • Cognitive Behavioral Therapy for Substance Use Disorders (skill components)
  • Cognitive Behavioral Therapy for Substance Use Disorders
A regiszteradat frissítve
2026. október 29.

Ki vehet részt

Életkor
18 év felett
Nem
Nők és férfiak
Egészséges önkéntesek
Nem vehetnek részt

A regiszter feltételei, szó szerint

Mind a 8 feltétel megnézéseKevesebb

Ki vehet részt

  • Is a U.S. military Veteran enrolled at Durham VA Health Care System (DVAHCS)
  • Meets DSM-5 criteria for posttraumatic stress disorder (PTSD) and a substance use disorder (other than tobacco use disorder)
  • If taking psychotropic medication, has been on a stable dose for at least four weeks at time of baseline assessment
  • Speaks and writes English

Ki nem vehet részt

  • Has an unstable psychotic or bipolar disorder
  • Has significant cognitive impairment
  • Is currently engaged in psychotherapy for posttraumatic stress disorder (PTSD) or a substance use disorder (SUD); Exception: Veterans who complete RISE and elect to begin additional psychotherapy before the 3-month follow-up will not be withdrawn; type and duration of additional treatment will be covaried in follow-up analyses
  • Is at imminent risk for suicide, homicide, or severe withdrawal symptoms

Helyszínek itt: Egyesült Államok

  • Durham VA Medical Center, Durham, NCDurham, Egyesült ÁllamokContact: Samantha J Meckes, PhDToborzás még nem indult

A vizsgálatról

Mit akar kideríteni a vizsgálat

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.

A teljes eredeti leírásKevesebb

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.

A vizsgálat 2 csoportja

  • RISEA vizsgált kezelés

    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.

    Kezelés: Written Exposure Therapy és Cognitive Behavioral Therapy for Substance Use Disorders (skill components)

  • CBT-SUDMár használt kezelés, összehasonlításként

    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.

    Kezelés: Cognitive Behavioral Therapy for Substance Use Disorders

Kérdések a vizsgálat csapatának

  1. Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
  2. Megtérítik az utazási költséget?
  3. Megtarthatom a saját orvosomat?
  4. Mi történik, ha ki akarok lépni?

Contact the study team: see the registry record → Contacts and Locations

Oldal nyomtatása az orvosomnak

Adatok és források

Regiszteradat
Szerepel a ClinicalTrials.gov-on.
Hivatalos cím
RISE: Rapid Recovery Through Integrated Substance Use Treatment and Written Exposure for PTSD
A regiszteradat frissítve
2026. október 29.