Tobacco Dependence
Conditions
Keywords
Smoking Cessation, Inpatient Psychiatry, Stages of Change
Brief summary
This study aims to evaluate, in a randomized controlled trial, tobacco treatments of varying intensities for smokers hospitalized on acute psychiatric inpatient units.
Detailed description
Using a three group additive design, this randomized clinical trial (N=956) aims to evaluate tobacco cessation treatments of varying intensities initiated in the acute psychiatric inpatient setting. The three groups are: 1. Usual Care (N=132) consisting of brief cessation advice, a quit smoking guide, and nicotine replacement provided during hospitalization; 2. Brief Treatment (N=416) adds a stage-based manual, computer-delivered stage-tailored individualized feedback and brief cessation counseling sessions during hospitalization and repeated at months 3 and 6, and access to 12 weeks of nicotine replacement following hospitalization; 3. Extended Treatment (N=408) builds upon our current brief treatment and provides 12 additional weeks of nicotine replacement (24 weeks total) with individualized, counselor-delivered motivational and manualized cognitive behavioral cessation treatment. This study seeks to determine: (i) whether the initial successes seen in an academic-based psychiatric hospital can be replicated in a larger and more diverse patient population; and (ii) if more extended and intensive treatment combining nicotine replacement therapy (NRT) with individualized, counselor-delivered motivational and manualized cessation-focused cognitive behavioral counseling (CBT) can outperform our current best practices. Ultimately, this research could lead to a model smoking cessation intervention for smokers with severe mental illness and, more generally, may provide a useful model for understanding the nature and complexity of intervening on comorbidities. We hypothesize that the extended treatment will outperform the brief treatment, and that both treatment groups will be more effective than usual care in producing quit attempts and ultimately abstinence from cigarettes. Secondary specific aims will model the cost-effectiveness and budgetary impacts of the treatment conditions; examine moderators and mediators of treatment outcomes; and prospectively examine the relation between changes in smoking, mental health functioning, and use of other substances over time.
Interventions
BEHAVIORALBrief Intervention
(N=416) adds a stage-based manual, computer-delivered stage-tailored individualized feedback and brief cessation counseling sessions during hospitalization and repeated at months 3 and 6, and access to 12 weeks of nicotine replacement following hospitalization
BEHAVIORALExtended Treatment
(N=408) builds upon our current brief treatment and provides 12 additional weeks of nicotine replacement (24 weeks total) with individualized, counselor-delivered motivational and manualized cognitive behavioral cessation treatment.
BEHAVIORALUsual Care
(N=132) brief cessation advice, a quit smoking guide, and nicotine replacement provided during hospitalization
Sponsors
National Institute of Mental Health (NIMH)
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
NRT
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants will be men and women 18 years of age and older, recruited from four acute inpatient psychiatry units at the Alta Bates Summit Medical Center - Herrick Campus, located in Berkeley, CA, one acute inpatient psychiatry unit at Langley Porter Psychiatric Institute, located in San Francisco, CA, and two acute inpatient psychiatry units at Stanford Hospital, located in Stanford, CA. Inclusion criteria are: smoking 5 or more cigarettes per day and at least 100 cigarettes in one's lifetime, no plan to relocate outside of the greater Bay Area in the next 18 months, and telephone access for scheduling follow-up assessments.
Exclusion criteria
* Study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Quit Smoking at 3, 6, 12, and 18 Months | 3, 6, 12, and 18 Month Follow-up | Number of Participants who Quit Smoking at 3, 6, 12, and 18 Months |
| Commitment to Abstinence | baseline, 3, 6, 12, and 18 months | Changes from one assessment point to the next in a Likert scale (1 to 10) measure of desire to quit smoking. 10 = strongest desire to quit. |
| Number of Participants With Quit Attempts Lasting 24 Hours or More | 3, 6, 12, and 18 months follow-up | Number of participants with quit attempts lasting 24 hours or more at each follow up timepoint. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Usual Care Usual Care: brief cessation advice, a quit smoking guide, and nicotine replacement provided during hospitalization | 132 |
| Brief Treatment Brief Intervention: adds a stage-based manual, computer-delivered stage-tailored individualized feedback and brief cessation counseling sessions during hospitalization and repeated at months 3 and 6, and access to 12 weeks of nicotine replacement following hospitalization | 416 |
| Extended Treatment Extended Treatment: builds upon our current brief treatment and provides 12 additional weeks of nicotine replacement (24 weeks total) with individualized, counselor-delivered motivational and manualized cognitive behavioral cessation treatment. | 408 |
| Total | 956 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Death | 4 | 10 | 15 |
Baseline characteristics
| Characteristic | Usual Care | Brief Treatment | Extended Treatment | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 12 Participants | 11 Participants | 25 Participants |
| Age, Categorical Between 18 and 65 years | 130 Participants | 404 Participants | 397 Participants | 931 Participants |
| Age, Continuous | 38 years | 39 years | 38 years | 39 years |
| Region of Enrollment United States | 132 participants | 416 participants | 408 participants | 956 participants |
| Sex/Gender, Customized Female | 63 Participants | 202 Participants | 194 Participants | 459 Participants |
| Sex/Gender, Customized Male | 67 Participants | 209 Participants | 211 Participants | 487 Participants |
| Sex/Gender, Customized Transgender | 2 Participants | 5 Participants | 3 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 17 / 132 | 120 / 416 | 126 / 408 |
| serious Total, serious adverse events | 105 / 132 | 308 / 416 | 310 / 408 |
Outcome results
Primary
Commitment to Abstinence
Changes from one assessment point to the next in a Likert scale (1 to 10) measure of desire to quit smoking. 10 = strongest desire to quit.
Time frame: baseline, 3, 6, 12, and 18 months
Population: Missing values at each timepoint per group were excluded from analyses.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Usual Care | Commitment to Abstinence | Baseline | 5.83 score on a scale |
| Usual Care | Commitment to Abstinence | 12 month | 7.06 score on a scale |
| Usual Care | Commitment to Abstinence | 6 month | 6.65 score on a scale |
| Usual Care | Commitment to Abstinence | 18 month | 7.05 score on a scale |
| Usual Care | Commitment to Abstinence | 3 month | 6.27 score on a scale |
| Brief Treatment | Commitment to Abstinence | 18 month | 7.47 score on a scale |
| Brief Treatment | Commitment to Abstinence | Baseline | 6.20 score on a scale |
| Brief Treatment | Commitment to Abstinence | 3 month | 7.44 score on a scale |
| Brief Treatment | Commitment to Abstinence | 6 month | 7.22 score on a scale |
| Brief Treatment | Commitment to Abstinence | 12 month | 7.44 score on a scale |
| Extended Treatment | Commitment to Abstinence | 3 month | 7.09 score on a scale |
| Extended Treatment | Commitment to Abstinence | 18 month | 7.37 score on a scale |
| Extended Treatment | Commitment to Abstinence | 12 month | 7.33 score on a scale |
| Extended Treatment | Commitment to Abstinence | Baseline | 5.85 score on a scale |
| Extended Treatment | Commitment to Abstinence | 6 month | 7.21 score on a scale |
Primary
Number of Participants Who Quit Smoking at 3, 6, 12, and 18 Months
Number of Participants who Quit Smoking at 3, 6, 12, and 18 Months
Time frame: 3, 6, 12, and 18 Month Follow-up
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Usual Care | Number of Participants Who Quit Smoking at 3, 6, 12, and 18 Months | 3 month | 13 Participants |
| Usual Care | Number of Participants Who Quit Smoking at 3, 6, 12, and 18 Months | 6 month | 15 Participants |
| Usual Care | Number of Participants Who Quit Smoking at 3, 6, 12, and 18 Months | 12 month | 21 Participants |
| Usual Care | Number of Participants Who Quit Smoking at 3, 6, 12, and 18 Months | 18 month | 17 Participants |
| Brief Treatment | Number of Participants Who Quit Smoking at 3, 6, 12, and 18 Months | 18 month | 80 Participants |
| Brief Treatment | Number of Participants Who Quit Smoking at 3, 6, 12, and 18 Months | 3 month | 70 Participants |
| Brief Treatment | Number of Participants Who Quit Smoking at 3, 6, 12, and 18 Months | 12 month | 78 Participants |
| Brief Treatment | Number of Participants Who Quit Smoking at 3, 6, 12, and 18 Months | 6 month | 75 Participants |
| Extended Treatment | Number of Participants Who Quit Smoking at 3, 6, 12, and 18 Months | 18 month | 82 Participants |
| Extended Treatment | Number of Participants Who Quit Smoking at 3, 6, 12, and 18 Months | 6 month | 78 Participants |
| Extended Treatment | Number of Participants Who Quit Smoking at 3, 6, 12, and 18 Months | 12 month | 74 Participants |
| Extended Treatment | Number of Participants Who Quit Smoking at 3, 6, 12, and 18 Months | 3 month | 63 Participants |
Primary
Number of Participants With Quit Attempts Lasting 24 Hours or More
Number of participants with quit attempts lasting 24 hours or more at each follow up timepoint.
Time frame: 3, 6, 12, and 18 months follow-up
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Usual Care | Number of Participants With Quit Attempts Lasting 24 Hours or More | 3 month | 42 participants |
| Usual Care | Number of Participants With Quit Attempts Lasting 24 Hours or More | 6 month | 40 participants |
| Usual Care | Number of Participants With Quit Attempts Lasting 24 Hours or More | 12 month | 47 participants |
| Usual Care | Number of Participants With Quit Attempts Lasting 24 Hours or More | 18 month | 47 participants |
| Brief Treatment | Number of Participants With Quit Attempts Lasting 24 Hours or More | 18 month | 183 participants |
| Brief Treatment | Number of Participants With Quit Attempts Lasting 24 Hours or More | 3 month | 181 participants |
| Brief Treatment | Number of Participants With Quit Attempts Lasting 24 Hours or More | 12 month | 156 participants |
| Brief Treatment | Number of Participants With Quit Attempts Lasting 24 Hours or More | 6 month | 169 participants |
| Extended Treatment | Number of Participants With Quit Attempts Lasting 24 Hours or More | 18 month | 165 participants |
| Extended Treatment | Number of Participants With Quit Attempts Lasting 24 Hours or More | 6 month | 149 participants |
| Extended Treatment | Number of Participants With Quit Attempts Lasting 24 Hours or More | 12 month | 170 participants |
| Extended Treatment | Number of Participants With Quit Attempts Lasting 24 Hours or More | 3 month | 162 participants |