- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02461732
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
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Texas
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Houston, Texas, Forenede Stater, 77054
- University of Texas Health Science Center at Houston - Center for Neurobehavioral Research on Addiction
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Aktiv komparator: 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 |
Eksperimentel: 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 |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
PTSD Symptoms
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- HSC-MS-14-0486
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