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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acceptance and Commitment Therapy | Experimental | 2 in person and 5 telephone sessions of Acceptance and Commitment Therapy for tobacco cessation plus up to 8 weeks of nicotine patch. |
|
| Enhanced Usual Care | Active Comparator | 2 in-person sessions of tobacco cessation counseling, electronic referral to state quitline, up to 8 weeks of nicotine patch |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acceptance and Commitment Therapy | Behavioral | 2 in person and 5 telephone sessions of acceptance and commitment therapy for tobacco cessation plus up to 8 weeks of nicotine patch |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Through study completion, approximately 5 months. |
| Percentage of Counseling Sessions Completed | number of scheduled counseling sessions completed | through study completion, an average of 7 weeks. |
| 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) | at study completion, an average of 7 weeks post-enrollment |
| 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. | At study completion, an average of 7 weeks post enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | at study completion, an average of 7 weeks post enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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)
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| Name | Affiliation | Role |
|---|---|---|
| Sandra Japuntich, Ph.D. | Hennepin Healthcare Research Institute | Principal Investigator |
| Ernestine Jennings, Ph.D. | The Miriam Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Miriam Hospital | Providence | Rhode Island | 02906 | United States |
Only the Principal Investigator will give permission for the release of aggregated study data. No identifiable data will be released. Participants in the proposed research will be informed, during consent, that completely de-identified data (i.e., data that has been cleaned of all 18 types of HIPAA identifiers) will be available to other qualified researchers. Within 18 months of study completion, we will make datasets available to interested investigators who submit a written request to the PI. The only contingency on the use of the data will be that ethical guidelines be followed (e.g., only individuals who have completed a research ethics training course will have access to the data, the data will be stored securely). The NIH will be notified of transmissions of the data to interested investigators.
within 18 months of study completion
ethical guidelines for The Miriam Hospital will be followed (the investigator will have completed a research ethics training course and the data will be stored securely)
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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).
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | This analysis calculates the number of smokers screened in the partial hospitalization program who participated in the trial | Posted | Count of Participants | Participants | Through study completion, approximately 5 months. |
|
|
5 weeks (from enrollment to follow-up)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sandra Japuntich | Hennepin Healthcare | 6128736856 | sandra.japuntich@hcmed.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jun 11, 2019 | Jun 25, 2019 | ICF_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 1, 2020 | Sep 23, 2020 | SAP_002.pdf |
| Prot | Yes | No | No | Study Protocol | Sep 4, 2019 | Sep 23, 2020 | Prot_003.pdf |
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| ID | Term |
|---|---|
| D000073869 | Tobacco Smoking |
| D001523 | Mental Disorders |
| ID | Term |
|---|---|
| D012907 | Smoking |
| D001519 | Behavior |
| D064424 | Tobacco Use |
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| ID | Term |
|---|---|
| D064869 | Acceptance and Commitment Therapy |
| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| Enhanced Usual Care | Behavioral | 2 in person sessions of tobacco cessation counseling, up to 8 weeks of nicotine patch, referral to state quitline. |
|
| 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) |
| Change between baseline and study completion, 7 weeks post-enrollment |
| Change between baseline and study completion, 7 weeks post-enrollment |
| 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. | Change between baseline and study completion, 7 weeks post-enrollment |
| BG001 |
| 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
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| Primary | Percentage of Counseling Sessions Completed | number of scheduled counseling sessions completed | Posted | Number | percentage of sessions completed | through study completion, an average of 7 weeks. |
|
|
|
| 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) | participants who completed the follow-up questionnaire | Posted | Mean | Standard Deviation | units on a scale | at study completion, an average of 7 weeks post-enrollment |
|
|
|
| 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. | participants who completed the follow-up survey | Posted | Count of Participants | Participants | At study completion, an average of 7 weeks post enrollment |
|
|
|
| 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. | all participants who started the intervention | Posted | Count of Participants | Participants | at study completion, an average of 7 weeks post enrollment |
|
|
|
| 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) | participants who completed follow-up assessment | Posted | Mean | Standard Deviation | units on a scale | Change between baseline and study completion, 7 weeks post-enrollment |
|
|
|
| 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. | people who completed follow-up | Posted | Mean | Standard Deviation | units on a scale | Change between baseline and study completion, 7 weeks post-enrollment |
|
|
|
| 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. | participants who completed the follow-up survey | Posted | Mean | Standard Deviation | units on a scale | Change between baseline and study completion, 7 weeks post-enrollment |
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| 0 |
| 9 |
| 0 |
| 9 |
| 0 |
| 9 |
| EG001 | 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. | 0 | 5 | 0 | 5 | 0 | 5 |
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