Study Stopped
Terminated after two years by CSRD
Helping Veterans Quit Smoking by Improving Their Sleep
ISCWCBTI
Improving Smoking Cessation Outcomes in PTSD With CBT for Insomnia
2 other identifiers
interventional
142
1 country
1
Brief Summary
This project is designed to determine whether an efficacious behavioral intervention for insomnia can improve the quit rates achieved by an efficacious smoking cessation program aimed at PTSD patients ("Integrated Care"). A second aim is to deepen our understanding of the mechanisms relating sleep and smoking in PTSD.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 23, 2010
CompletedFirst Posted
Study publicly available on registry
December 24, 2010
CompletedStudy Start
First participant enrolled
October 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedDecember 2, 2014
December 1, 2014
1.7 years
December 23, 2010
December 1, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
seven-day point prevalence abstinence
21 days post-quit-day
Study Arms (2)
Arm 1
EXPERIMENTALIntegrated Care + Cognitive-Behavioral Treatment for Insomnia
Arm 2
SHAM COMPARATORIntegrated Care + Desensitization Treatment for Insomnia
Interventions
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.
A credible sham treatment for insomnia matching CBTI in treatment time, patient expectations, therapist expectations, etc.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California, 94304-1290, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Steven H. Woodward, PhD
VA Palo Alto Health Care System, Palo Alto, CA
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 23, 2010
First Posted
December 24, 2010
Study Start
October 1, 2011
Primary Completion
June 1, 2013
Study Completion
June 1, 2013
Last Updated
December 2, 2014
Record last verified: 2014-12