Acceptance and Commitment Therapy for Tobacco Cessation Among Psychiatric Partial Hospital Patients
Primary Purpose
Tobacco Smoking, Psychiatric Disorder, Psychiatric Hospitalization
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Acceptance and Commitment Therapy
Enhanced Usual Care
Sponsored by
About this trial
This is an interventional treatment trial for Tobacco Smoking focused on measuring tobacco smoking, psychiatric disorder, psychiatric hospitalization, acceptance and commitment therapy
Eligibility Criteria
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)
Sites / Locations
- The Miriam Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Acceptance and Commitment Therapy
Enhanced Usual Care
Arm Description
2 in person and 5 telephone sessions of Acceptance and Commitment Therapy for tobacco cessation plus up to 8 weeks of nicotine patch.
2 in-person sessions of tobacco cessation counseling, electronic referral to state quitline, up to 8 weeks of nicotine patch
Outcomes
Primary Outcome Measures
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
Percentage of Counseling Sessions Completed
number of scheduled counseling sessions completed
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)
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.
Secondary Outcome Measures
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.
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03911960
Brief Title
Acceptance and Commitment Therapy for Tobacco Cessation Among Psychiatric Partial Hospital Patients
Official Title
Acceptance and Commitment Therapy for Tobacco Cessation Initiated in a Psychiatric Partial Hospital
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
April 16, 2019 (Actual)
Primary Completion Date
November 15, 2019 (Actual)
Study Completion Date
November 15, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Miriam Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Smoking, Psychiatric Disorder, Psychiatric Hospitalization
Keywords
tobacco smoking, psychiatric disorder, psychiatric hospitalization, acceptance and commitment therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Acceptance and Commitment Therapy
Arm Type
Experimental
Arm Description
2 in person and 5 telephone sessions of Acceptance and Commitment Therapy for tobacco cessation plus up to 8 weeks of nicotine patch.
Arm Title
Enhanced Usual Care
Arm Type
Active Comparator
Arm Description
2 in-person sessions of tobacco cessation counseling, electronic referral to state quitline, up to 8 weeks of nicotine patch
Intervention Type
Behavioral
Intervention Name(s)
Acceptance and Commitment Therapy
Intervention Description
2 in person and 5 telephone sessions of acceptance and commitment therapy for tobacco cessation plus up to 8 weeks of nicotine patch
Intervention Type
Behavioral
Intervention Name(s)
Enhanced Usual Care
Intervention Description
2 in person sessions of tobacco cessation counseling, up to 8 weeks of nicotine patch, referral to state quitline.
Primary Outcome Measure Information:
Title
Feasibility of Recruitment: Proportion of Smokers Seen During the Partial Hospital Visit Who Enroll in the Study
Description
proportion of smokers seen during the partial hospital visit who enroll in the study
Time Frame
Through study completion, approximately 5 months.
Title
Percentage of Counseling Sessions Completed
Description
number of scheduled counseling sessions completed
Time Frame
through study completion, an average of 7 weeks.
Title
Client Satisfaction Questionnaire
Description
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
Title
Number of Participants Who Are Rehospitalized for Psychiatric Reasons
Description
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
Secondary Outcome Measure Information:
Title
Number of Participants Who Are Abstinent From Tobacco
Description
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
Title
Kessler 6
Description
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
Other Pre-specified Outcome Measures:
Title
Avoidance Inflexibility Scale
Description
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
Title
Commitment to Quitting Scale
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sandra Japuntich, Ph.D.
Organizational Affiliation
Hennepin Healthcare Research Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ernestine Jennings, Ph.D.
Organizational Affiliation
The Miriam Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Miriam Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
within 18 months of study completion
IPD Sharing Access Criteria
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)
Learn more about this trial
Acceptance and Commitment Therapy for Tobacco Cessation Among Psychiatric Partial Hospital Patients
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