Tech and Telephone Smoking Cessation Treatment for Young Veterans With PTSD
| Status: | Recruiting |
|---|---|
| Conditions: | Smoking Cessation |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - 39 |
| Updated: | 2/20/2019 |
| Start Date: | February 13, 2019 |
| End Date: | May 2020 |
| Contact: | Ellen Herbst, MD |
| Email: | Ellen.Herbst@va.gov |
| Phone: | (415) 221-4810 |
This project aims to enhance the scalability of an office-based smoking cessation treatment
protocol for veterans with PTSD, integrated care (IC), by adapting it to be delivered over
the telephone and to incorporate mobile technology components. Mobile technology components
include: (1) the Stay Quit Coach (SQC) mobile application (app), and (2) the iCO mobile
Smokerlyzer, a smartphone-compatible carbon monoxide monitor. Eighty U.S. military veteran
smokers with PTSD, ages 18-39, will be randomized to receive either: (1) the telephone-and
technology-facilitated intervention (n=40), or (2) the current standard of care (referral to
the VA telephone Quitline) (n=40) as a control. All participants will receive a baseline
(Week 0) office visit and will optionally be prescribed nicotine replacement therapy (NRT).
Participants in the intervention condition will receive eight 20- to 30-minute video or
telephone counseling sessions and be asked to use the SQC app and iCO Mobile Smokerlyzer.
Control participants will receive up to eight weekly proactive telephone sessions through the
VA telephone Quitline. Assessments will occur at baseline (Week 0), treatment end (Week 8),
and at three months (Week 12) and six months (Week 24) post-randomization. The primary aims
of this pilot randomized controlled trial are: (1) to assess the feasibility and
acceptability of the intervention; and (2) to assess the impact of the adapted IC
intervention on treatment retention compared to treatment as usual (i.e., VA Quitline).
protocol for veterans with PTSD, integrated care (IC), by adapting it to be delivered over
the telephone and to incorporate mobile technology components. Mobile technology components
include: (1) the Stay Quit Coach (SQC) mobile application (app), and (2) the iCO mobile
Smokerlyzer, a smartphone-compatible carbon monoxide monitor. Eighty U.S. military veteran
smokers with PTSD, ages 18-39, will be randomized to receive either: (1) the telephone-and
technology-facilitated intervention (n=40), or (2) the current standard of care (referral to
the VA telephone Quitline) (n=40) as a control. All participants will receive a baseline
(Week 0) office visit and will optionally be prescribed nicotine replacement therapy (NRT).
Participants in the intervention condition will receive eight 20- to 30-minute video or
telephone counseling sessions and be asked to use the SQC app and iCO Mobile Smokerlyzer.
Control participants will receive up to eight weekly proactive telephone sessions through the
VA telephone Quitline. Assessments will occur at baseline (Week 0), treatment end (Week 8),
and at three months (Week 12) and six months (Week 24) post-randomization. The primary aims
of this pilot randomized controlled trial are: (1) to assess the feasibility and
acceptability of the intervention; and (2) to assess the impact of the adapted IC
intervention on treatment retention compared to treatment as usual (i.e., VA Quitline).
Inclusion Criteria:
- Male and female veterans eligible for VA services.
- Ages 18 to 39 (inclusive).
- Meets lifetime criteria for PTSD using the DSM-V.
- Smoked at least 5 cigarettes per day for 15 of the past 30 days.
- Interested in smoking cessation and willing to receive interventions.
- A smartphone (iOS or Android) user and comfortable using a smartphone.
- Females must have a negative urine pregnancy test and must be practicing an effective
method of birth control (e.g., surgically sterile, spermicide with barrier, male
partner sterilization; or abstinent and agrees to continue abstinence or to use an
acceptable method of contraception, as listed above, should sexual activity commence).
- Ability to attend screening appointment in-person or via V-tel at SFVAMC or an
associated clinic and participate in 8 weekly sessions, follow-up sessions at Weeks 12
and 24, and monthly nicotine replacement check-ins.
Exclusion Criteria:
- Current, unstable psychotic or bipolar disorders; dementia; current, severe substance
use disorder deemed to be unstable by the study physician; or other psychiatric
disorders judged to be unstable in the clinical judgment of the PI or study physician.
- Montreal Cognitive Assessment (MoCA) score below 23, reflective of substantial
cognitive impairment.
- Clinically significant unstable medical conditions, in the clinical judgment of the PI
or study physician.
- Female participants who are pregnant, intend to become pregnant during the study
period, and/or are not using an effective method of birth control.
- Concurrent participation in another smoking cessation study.
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