Trial of a Novel Cognitive-Behavioral Treatment for Posttraumatic Stress and Substance Dependence
Randomized Controlled Trial of a Novel Cognitive-Behavioral Treatment for Posttraumatic Stress and Substance Dependence
Tutkimuksen yleiskatsaus
Tila
Yksityiskohtainen kuvaus
The proposed study is a randomized controlled clinical trial, comparing the efficacy of two cognitive-behavioral therapy (CBT) interventions: standard CBT for substance dependence and a novel integrated CBT program for PTSD and substance dependence. The study will run for approximately 3 years. A total of 100 participants will be enrolled at a rate of 4 participants per month over 25 months to ensure that 80 participants complete the protocol (presuming 20% attrition). Each participant will attend 12 treatment sessions, meeting twice per week for 6 weeks. Treatment sessions will last 1-hour each.
Primary study outcomes will include frequency and quantity of substance use and PTSD symptom severity. Substance use-related outcomes will include: rates of substance abstinence, as measured by (1) urine toxicology testing, (2) alcohol breath level analyses, and (3) participants' self-report of substance use. PTSD symptom outcomes will include symptom severity ratings as measured by clinical interview (i.e., Clinician-Administered PTSD Scale-5; CAPS-5) and self-report (Posttraumatic Checklist; PCL-5).
Secondary study outcomes will include examination of mediational effects. Specifically, changes in distress tolerance, as indexed via self-report (Distress Tolerance Scale) and computer/behavioral tasks (i.e., Mirror-Tracing Task, Paced Auditory Serial Addition Task-Computerized Version, Breath-Holding Task), are expected during the course of the treatment. Changes in cue reactivity are also expected over the course of treatment, as indexed by decreased psychophysiological reactivity (heart rate, respiration rate) during script-driven imagery tasks (listening to trauma/drug related scripts vs. netural). A total of four sessions (baseline/screening and sessions 4, 8, 12) will be preceded by the laboratory sessions.
Opintotyyppi
Ilmoittautuminen (Todellinen)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskelupaikat
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Texas
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Houston, Texas, Yhdysvallat, 77054
- University of Texas Health Science Center at Houston - Center for Neurobehavioral Research on Addiction
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Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
Inclusion Criteria:
- Age 18-65
- English language proficiency
- Current (past month) substance dependence, noting exclusions as delineated below
- History of trauma exposure, as per DSM-5 Criterion A1 definition
- Current (past month) PTSD symptoms: score of at least 25 on PCL-5 and/or at least 4 symptoms of moderate severity (scored 2 or higher) endorsed on CAPS-5
- Seeking treatment for trauma-related symptoms and substance dependence
Exclusion Criteria:
- Exclusive [only] nicotine dependence
- Alcohol dependence requiring detoxification
- Opiate dependence requiring detoxification
- Current or past bipolar I disorder
- Current or past major psychotic disorder
- Active (past 6 months) psychotic spectrum symptoms
- Major unstable medical conditions
- Current (past month) suicidal ideation with intent and/or plan
- Current (past month) homicidal ideation with intent and/or plan
- Inability to provide verbal/written consent
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
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Active Comparator: CBT for Substance Dependence
Standard CBT for substance use disorders
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Topics covered include: drug triggers; antecedents/consequences of drug use; relapse prevention; coping skills; problem thinking; changing problem thinking; lifestyle balance; values; increasing non-drug activities |
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Kokeellinen: Integrated CBT for PTSD and Substance Dependence
Integrated CBT for PTSD and substance use disorders, combining elements of cognitive processing therapy for PTSD with coping skills and relapse prevention for substance use disorders
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Topics covered include: drug triggers; antecedents/consequences of drug use; relapse prevention; coping skills; problem thinking; changing problem thinking; lifestyle balance; values; increasing non-drug activities; education on PTSD and trauma/PTSD/substance use associations; discussion and written statement of impact of trauma on beliefs about self, others, world; written account of trauma memory and in-session review and discussion; cognitive exercises and cognitive restructuring regarding trauma-related thoughts; review of any between-session trauma-relevant substance use and cravings |
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
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PTSD Symptoms
Aikaikkuna: for the duration of the study / through the conclusion of treatment, up to 8 weeks
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PCL-5 self-report measure: severity of symptoms
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for the duration of the study / through the conclusion of treatment, up to 8 weeks
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Substance Use
Aikaikkuna: for the duration of the study / through the conclusion of treatment, up to 8 weeks
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(1) rates of substance abstinence, as measured via urine toxicology testing, alcohol breath level analyses, and participants' self-reports of substance use; (2) longest sustained abstinence, defined as the maximum number of self-reported days of abstinence for each participant.
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for the duration of the study / through the conclusion of treatment, up to 8 weeks
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PTSD Diagnosis
Aikaikkuna: for the duration of the study / through the conclusion of treatment, up to 8 weeks
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CAPS interview measure: severity of symptoms
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for the duration of the study / through the conclusion of treatment, up to 8 weeks
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Yhteistyökumppanit ja tutkijat
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus
Ensisijainen valmistuminen (Todellinen)
Opintojen valmistuminen (Todellinen)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Arvio)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- HSC-MS-14-0486
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