- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT01267032
Helping Veterans Quit Smoking by Improving Their Sleep (ISCWCBTI)
Improving Smoking Cessation Outcomes in PTSD With CBT for Insomnia
Přehled studie
Postavení
Podmínky
Detailní popis
In summary, participation will involve a screening period of approximately one week, six weeks of temporally aligned IC ("Integrated Care" - manualized smoking cessation treatment integrating components of behavioral treatment for PTSD) and behavioral sleep treatments (Cognitive-Behavioral Treatment for Insomnia or CBTI), and follow-up telephone interviews at two months and six months.
Screening: Patients in the VA Palo Alto inpatient psychiatry and domiciliary programs indicating interest in quitting cigarette smoking will be pre-screened by the Medical Director to determine whether an individual's psychiatric conditions contraindicates use of bupropion or NRT (Nicoderm). Patients interested in quitting will be referred to the study coordinator. Coordinator will be notified whether medication or NRT is contraindicated for participant and/or of a diagnosed sleep disorder (treated or untreated) other than insomnia.
Continuing participants will be consented and then complete 24 hours of cued symptom reporting using a personal digital assistant (PDA) to verify their capacity to adhere to this component of the study protocol. Continuing participants will undergo a research psychodiagnostic assessment followed by an ambulatory screening polysomnogram (PSG) to exclude undiagnosed sleep disorders. (Participants exhibiting evidence of sleep disorder will be referred for a clinical sleep study.) Screening assessments and psychodiagnostics have been sequenced with the aim of minimizing burden for those excluded.
Participants meeting all inclusion and exclusion criteria will be randomized to IC+CBTI or IC+Desensitization Treatment for Insomnia (DTI: a manualized placebo control intervention). They will meet twice with the IC therapist to complete IC sessions 1 and 2. Over the course of these sessions, they will negotiate a quit date at least three weeks from that time and at least four weeks prior to their projected discharge from inpatient treatment. (Inpatient stays in both of these programs average thirteen weeks.) IC sessions 3 and 4 will be evenly spaced between IC session 2 and the planned quit date. Three weeks prior to their quit date, they will initiate sleep treatment (sessions 1 and 2) and nightly mattress actigraphy. Two weeks prior to their quit date they will begin PDA-based EMA. One to two weeks prior to their quit date, they will commence bupropion and receive sleep treatment session 3. One week prior to their quit date they will receive sleep treatment session 4. On their quit date they will begin NRT. Thereafter, for weeks four through six, they will receive IC sessions five through eight and sleep treatment session five through seven, respectively. At the end of week six, they will receive IC session eight which will also serve as the 3 week assessment of smoking status (the primary outcome assessment of the study). (Note that the first planned assessment of cessation status will occur prior to the expected discharge date for all participants.) The final research interventions will be telephone interviews at two months and six months. Salivary cotinine samples will be obtained at the end of each post-quit week (only if the participant is not using NRT) the last corresponding to the primary outcome assessment, at both telephone follow-up smoking status assessments (by mail).
Typ studie
Zápis (Aktuální)
Fáze
- Fáze 2
Kontakty a umístění
Studijní místa
-
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California
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Palo Alto, California, Spojené státy, 94304-1290
- VA Palo Alto Health Care System, Palo Alto, CA
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- Potential participants will be smokers who have smoked at least 10 cigarettes per day for the past year,
- are motivated to make a smoking cessation attempt,
- are na ve to behavioral sleep treatment and are willing to be randomly assigned to either one of the sleep treatment arms.
- Participants must meet the criteria for PTSD and or partial PTSD.
- They will indicate a willingness to forgo the use of all alternative tobacco products during their attempt to quit cigarettes.
- They will be fluent in English.
Exclusion Criteria:
- Candidates who meet DSM-IV criteria for schizophrenia,
- current manic syndrome,
- lifetime but not current PTSD or partial PTSD,
- or current substance abuse/dependence will be excluded.
- positive Brain Injury Screen will not result in exclusion from the study.
- subjects reporting a prior diagnosis of severe obstructive sleep apnea will be excluded unless they have been successfully treated via weight loss, surgery, or continuous positive airway pressure to which they are reliably adherent.
- We expect these criteria to exclude 15 to 20% of potential participants.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: Arm 1
Integrated Care + Cognitive-Behavioral Treatment for Insomnia
|
A PTSD-aware smoking cessation intervention developed by Miles McFall, PhD.
A behavioral treatment aimed at improving sleep continuity and subjective sleep through stimulus control, sleep restriction, and attenuation of maladaptive sleep-related cognitions.
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Falešný srovnávač: Arm 2
Integrated Care + Desensitization Treatment for Insomnia
|
A PTSD-aware smoking cessation intervention developed by Miles McFall, PhD.
A credible sham treatment for insomnia matching CBTI in treatment time, patient expectations, therapist expectations, etc.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Časové okno |
|---|---|
|
seven-day point prevalence abstinence
Časové okno: 21 days post-quit-day
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21 days post-quit-day
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Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Vrchní vyšetřovatel: Steven H. Woodward, PhD, VA Palo Alto Health Care System, Palo Alto, CA
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další identifikační čísla studie
- SPLA-09-S09
- 1I01CX000301-01 (Jiné číslo grantu/financování: DVA)
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
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