- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01267032
Helping Veterans Quit Smoking by Improving Their Sleep (ISCWCBTI)
Improving Smoking Cessation Outcomes in PTSD With CBT for Insomnia
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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).
Type d'étude
Inscription (Réel)
Phase
- Phase 2
Contacts et emplacements
Lieux d'étude
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California
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Palo Alto, California, États-Unis, 94304-1290
- VA Palo Alto Health Care System, Palo Alto, CA
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: Arm 1
Integrated Care + Cognitive-Behavioral Treatment for Insomnia
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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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Comparateur factice: Arm 2
Integrated Care + Desensitization Treatment for Insomnia
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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.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
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seven-day point prevalence abstinence
Délai: 21 days post-quit-day
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21 days post-quit-day
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Steven H. Woodward, PhD, VA Palo Alto Health Care System, Palo Alto, CA
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- SPLA-09-S09
- 1I01CX000301-01 (Autre subvention/numéro de financement: DVA)
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