Psychiatric Disorder, Psychiatric Hospitalization, Tobacco Smoking
Conditions
Keywords
tobacco smoking, psychiatric disorder, psychiatric hospitalization, acceptance and commitment therapy
Brief summary
People with serious mental illness are three times more likely to smoke cigarettes than people without mental illness. People with mental illness are less likely to be successful in quitting smoking than those without mental illness. Therefore, the healthcare community needs to find ways to get people with mental illness treatment to help them stop smoking. This study explores whether a treatment, called acceptance and commitment therapy, which is an affective therapy for serious mental illness, can help patients with serious mental illness stop smoking. In particular, the investigators test whether patients will be interested in receiving acceptance and commitment therapy for smoking cessation in a psychiatric partial hospital (also known as a day treatment program), whether they are able to complete the treatment, and whether it will help them stop smoking compared to usual care. To test these research questions, 40 patients in the Rhode Island Hospital's psychiatric partial hospital will be recruited. Half of the patients will receive acceptance and commitment therapy to help them stop smoking (2 in person sessions, 5 telephone sessions) and half will receive usual care (2 in person sessions, electronic referral to the Rhode Island tobacco quit line). All participants will be offered the nicotine patch. All participants will complete a baseline survey and a follow-up visit at the end of treatment to measure whether they stopped smoking and whether they liked the treatment. The study will also measure how many participants completed the treatment sessions. If successful, this treatment model could be a way to get more patients with mental illness into treatment.
Detailed description
BACKGROUND: There is a significant disparity in tobacco use in that smokers with mental illness smoke at twice the rate of the general population, use more tobacco per day and are disproportionately affected by smoking-related disease. Few models exist for treating tobacco use in individuals with mental illness. Acceptance and Commitment Therapy (ACT) is a treatment strategy that helps individuals accept discomfort while making value-guided change. It has been used successfully to treat psychiatric symptoms in people with serious mental illness (SMI) and is well-suited to treat smoking in people with SMI. Psychiatric partial hospitalization programs provide an opportunity to intervene on tobacco use in people with SMI. OBJECTIVE: This study tests the feasibility of offering an ACT-based smoking cessation treatment initiated in a psychiatric partial hospital program and continuing post-discharge. AIMS: The study has 3 aims: (1) To assess the feasibility, acceptability, and safety of an ACT-based, partial hospital initiated, counseling intervention for smoking cessation. (2) To collect preliminary evidence of the efficacy (i.e., effect size estimates) of ACT-based counseling initiated in the partial hospital compared to usual care. (3) To explore of the effect of treatment condition (ACT vs. Usual Care) on ACT treatment targets. DESIGN: This study is a randomized design (n=40), where patients in an ACT-based psychiatric partial hospital will be offered up to 8 weeks of the nicotine patch and randomly assigned to either ACT care (n=20; two in-person ACT-based counseling sessions + 5 ACT-based telephone counseling sessions) or to Enhanced Usual Care (n=20; two in person medication management counseling sessions + referral to the state quit line). Outcomes assessed at end of treatment include: feasibility (percent of eligible patients who enroll, percent of patients completing treatment), acceptability (patient satisfaction ratings), safety (hospital readmissions, symptom exacerbation), efficacy (CO confirmed 7 day point prevalence abstinence at end of treatment) and ACT treatment targets (tolerance of discomfort, mindfulness and acceptance). SIGNIFICANCE: This study tests a treatment model for smokers with SMI, a group with particularly refractory smoking behavior. If successful, this model could be implemented broadly in psychiatric day treatment programs.
Interventions
BEHAVIORALAcceptance and Commitment Therapy
2 in person and 5 telephone sessions of acceptance and commitment therapy for tobacco cessation plus up to 8 weeks of nicotine patch
BEHAVIORALEnhanced Usual Care
2 in person sessions of tobacco cessation counseling, up to 8 weeks of nicotine patch, referral to state quitline.
Sponsors
The Miriam Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants will be male and female * psychiatry partial hospital patients * current daily smokers -≥ age 18 * have regular telephone access * able to read and write English
Exclusion criteria
-current use of tobacco cessation treatment (bupropion prescribed for a psychiatric indication will be permitted)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Are Rehospitalized for Psychiatric Reasons | At study completion, an average of 7 weeks post enrollment | This is a simple count based on follow-up survey data of the number of participants who reported being hospitalized for a psychiatric reason following enrollment in the study. |
| Feasibility of Recruitment: Proportion of Smokers Seen During the Partial Hospital Visit Who Enroll in the Study | Through study completion, approximately 5 months. | proportion of smokers seen during the partial hospital visit who enroll in the study |
| Percentage of Counseling Sessions Completed | through study completion, an average of 7 weeks. | number of scheduled counseling sessions completed |
| Client Satisfaction Questionnaire | at study completion, an average of 7 weeks post-enrollment | The Client satisfaction Questionnaire, measures acceptability of the intervention to patients, minimum value=8, maximum value=32, higher scores indicate higher satisfaction (higher scores mean better outcome) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Are Abstinent From Tobacco | at study completion, an average of 7 weeks post enrollment | a simple count of those who have both a carbon monoxide value consistent with abstinence and self-reported abstinence. Expired carbon monoxide value of less than 6 parts per million was considered abstinent. |
| Kessler 6 | Change between baseline and study completion, 7 weeks post-enrollment | Kessler 6, global distress measure, minimum value=0, maximum value=24, higher scores = greater distress (worse outcome), this study measures the change in global distress between enrollment and study completion. The change in global distress score minimum value=-24, maximum value=24 (lower scores indicate a better outcome: a reduction in distress) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Avoidance Inflexibility Scale | Change between baseline and study completion, 7 weeks post-enrollment | The avoidance inflexibility scale is a 13-item self-report assessment in which respondents to consider how they respond to difficult thoughts that encourage smoking (e.g., I need a cigarette, I wish I could have a cigarette now!), different feelings that encourage smoking (e.g., stress, fatigue, boredom, enjoyment, satisfaction, etc.), and bodily sensations that encourage smoking (e.g., physical cravings or withdrawal symptoms).The Avoidance Inflexibility Scale measures smoking-related experiential avoidance, minimum score= 13, maximum score=65, higher score indicate more avoidance (worse outcome), the study outcome is the change between avoidance measured at baseline, and at study completion, 7 weeks post-enrollment. Minimum score=-52, maximum score=52 lower scores = better outcome. |
| Commitment to Quitting Scale | Change between baseline and study completion, 7 weeks post-enrollment | Commitment to Quitting Scale, range 8-40, higher scores indicate greater commitment, commitment will be measured as the change between baseline and study completion, 7 weeks post enrollment. |
Countries
United States
Participant flow
Recruitment details
3 participants consented to the study and were randomized but completed none of the study procedures (did not complete the baseline questionnaire, any of the counseling sessions, or the follow-up visit).
Participants by arm
| Arm | Count |
|---|---|
| Acceptance and Commitment Therapy 2 in person and 5 telephone sessions of Acceptance and Commitment Therapy for tobacco cessation plus up to 8 weeks of nicotine patch.
Acceptance and Commitment Therapy: 2 in person and 5 telephone sessions of acceptance and commitment therapy for tobacco cessation plus up to 8 weeks of nicotine patch | 9 |
| Enhanced Usual Care 2 in-person sessions of tobacco cessation counseling, electronic referral to state quitline, up to 8 weeks of nicotine patch
Enhanced Usual Care: 2 in person sessions of tobacco cessation counseling, up to 8 weeks of nicotine patch, referral to state quitline. | 5 |
| Total | 14 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 5 | 3 |
Baseline characteristics
| Characteristic | Enhanced Usual Care | Total | Acceptance and Commitment Therapy |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 1 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants | 13 Participants | 8 Participants |
| Age, Continuous | 34.00 years STANDARD_DEVIATION 12.39 | 38.71 years STANDARD_DEVIATION 15.64 | 41.33 years STANDARD_DEVIATION 17.3 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 5 Participants | 12 Participants | 7 Participants |
| Region of Enrollment United States | 5 Participants | 14 Participants | 9 Participants |
| Sex: Female, Male Female | 3 Participants | 8 Participants | 5 Participants |
| Sex: Female, Male Male | 2 Participants | 6 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 9 | 0 / 5 |
| other Total, other adverse events | 0 / 9 | 0 / 5 |
| serious Total, serious adverse events | 0 / 9 | 0 / 5 |
Outcome results
Primary
Client Satisfaction Questionnaire
The Client satisfaction Questionnaire, measures acceptability of the intervention to patients, minimum value=8, maximum value=32, higher scores indicate higher satisfaction (higher scores mean better outcome)
Time frame: at study completion, an average of 7 weeks post-enrollment
Population: participants who completed the follow-up questionnaire
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Participants | Client Satisfaction Questionnaire | 27.00 units on a scale | Standard Deviation 6.63 |
| Enhanced Usual Care | Client Satisfaction Questionnaire | 27.5 units on a scale | Standard Deviation 0.71 |
Primary
Feasibility of Recruitment: Proportion of Smokers Seen During the Partial Hospital Visit Who Enroll in the Study
proportion of smokers seen during the partial hospital visit who enroll in the study
Time frame: Through study completion, approximately 5 months.
Population: This analysis calculates the number of smokers screened in the partial hospitalization program who participated in the trial
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Participants | Feasibility of Recruitment: Proportion of Smokers Seen During the Partial Hospital Visit Who Enroll in the Study | 17 Participants |
Primary
Number of Participants Who Are Rehospitalized for Psychiatric Reasons
This is a simple count based on follow-up survey data of the number of participants who reported being hospitalized for a psychiatric reason following enrollment in the study.
Time frame: At study completion, an average of 7 weeks post enrollment
Population: participants who completed the follow-up survey
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Participants | Number of Participants Who Are Rehospitalized for Psychiatric Reasons | 0 Participants |
| Enhanced Usual Care | Number of Participants Who Are Rehospitalized for Psychiatric Reasons | 0 Participants |
Primary
Percentage of Counseling Sessions Completed
number of scheduled counseling sessions completed
Time frame: through study completion, an average of 7 weeks.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Participants | Percentage of Counseling Sessions Completed | 48 percentage of sessions completed |
| Enhanced Usual Care | Percentage of Counseling Sessions Completed | 80 percentage of sessions completed |
Secondary
Kessler 6
Kessler 6, global distress measure, minimum value=0, maximum value=24, higher scores = greater distress (worse outcome), this study measures the change in global distress between enrollment and study completion. The change in global distress score minimum value=-24, maximum value=24 (lower scores indicate a better outcome: a reduction in distress)
Time frame: Change between baseline and study completion, 7 weeks post-enrollment
Population: participants who completed follow-up assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Participants | Kessler 6 | -4.25 units on a scale | Standard Deviation 7.59 |
| Enhanced Usual Care | Kessler 6 | -5.0 units on a scale | Standard Deviation 7.07 |
Secondary
Number of Participants Who Are Abstinent From Tobacco
a simple count of those who have both a carbon monoxide value consistent with abstinence and self-reported abstinence. Expired carbon monoxide value of less than 6 parts per million was considered abstinent.
Time frame: at study completion, an average of 7 weeks post enrollment
Population: all participants who started the intervention
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Participants | Number of Participants Who Are Abstinent From Tobacco | 1 Participants |
| Enhanced Usual Care | Number of Participants Who Are Abstinent From Tobacco | 0 Participants |
Other Pre-specified
Avoidance Inflexibility Scale
The avoidance inflexibility scale is a 13-item self-report assessment in which respondents to consider how they respond to difficult thoughts that encourage smoking (e.g., I need a cigarette, I wish I could have a cigarette now!), different feelings that encourage smoking (e.g., stress, fatigue, boredom, enjoyment, satisfaction, etc.), and bodily sensations that encourage smoking (e.g., physical cravings or withdrawal symptoms).The Avoidance Inflexibility Scale measures smoking-related experiential avoidance, minimum score= 13, maximum score=65, higher score indicate more avoidance (worse outcome), the study outcome is the change between avoidance measured at baseline, and at study completion, 7 weeks post-enrollment. Minimum score=-52, maximum score=52 lower scores = better outcome.
Time frame: Change between baseline and study completion, 7 weeks post-enrollment
Population: people who completed follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Participants | Avoidance Inflexibility Scale | -9.25 units on a scale | Standard Deviation 15.69 |
| Enhanced Usual Care | Avoidance Inflexibility Scale | 6.5 units on a scale | Standard Deviation 6.36 |
Other Pre-specified
Commitment to Quitting Scale
Commitment to Quitting Scale, range 8-40, higher scores indicate greater commitment, commitment will be measured as the change between baseline and study completion, 7 weeks post enrollment.
Time frame: Change between baseline and study completion, 7 weeks post-enrollment
Population: participants who completed the follow-up survey
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Participants | Commitment to Quitting Scale | 4.25 units on a scale | Standard Deviation 7.63 |
| Enhanced Usual Care | Commitment to Quitting Scale | 4.5 units on a scale | Standard Deviation 4.95 |