Acceptance and Commitment Therapy for Tobacco Cessation Among Psychiatric Partial Hospital Patients

• Sponsor: The Miriam Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT03911960
• Collaborator: (none)
• Enrollment: 17
• Location: 1
• Arms: 2
• Actual Duration (Months): 7
• Patients Per Site Per Month: 2.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Tobacco Smoking; Psychiatric Disorder; Psychiatric Hospitalization	Behavioral: Acceptance and Commitment Therapy; Behavioral: Enhanced Usual Care	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 17 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Acceptance and Commitment Therapy for Tobacco Cessation Initiated in a Psychiatric Partial Hospital
• Actual Study Start Date: Apr 16, 2019
• Actual Primary Completion Date: Nov 15, 2019
• Actual Study Completion Date: Nov 15, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Behavioral: 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
Active Comparator: Enhanced Usual Care 2 in-person sessions of tobacco cessation counseling, electronic referral to state quitline, up to 8 weeks of nicotine patch	Behavioral: Enhanced Usual Care; 2 in person sessions of tobacco cessation counseling, up to 8 weeks of nicotine patch, referral to state quitline.

Outcome Measures

Primary Outcome Measures

1. 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

2. Percentage of Counseling Sessions Completed [through study completion, an average of 7 weeks.]

   number of scheduled counseling sessions completed

3. 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)

4. 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.

Secondary Outcome Measures

1. 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.

2. 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 Outcome Measures

1. 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.

2. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Miriam Hospital	Providence	Rhode Island	United States	02906

Sponsors and Collaborators

• The Miriam Hospital

Investigators

• Principal Investigator: Sandra Japuntich, Ph.D., Hennepin Healthcare Research Institute
• Principal Investigator: Ernestine Jennings, Ph.D., The Miriam Hospital

Study Documents (Full-Text)

• Informed Consent Form - Jun 11, 2019
• Statistical Analysis Plan - Jul 1, 2020
• Study Protocol - Sep 4, 2019

More Information

Publications

None provided.

• Responsible Party: The Miriam Hospital
• ClinicalTrials.gov Identifier: NCT03911960
• Other Study ID Numbers: 1R03DA043596-01A1
• First Posted: Apr 11, 2019
• Last Update Posted: Sep 25, 2020
• Last Verified: Jan 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by The Miriam Hospital: tobacco smoking; psychiatric disorder; psychiatric hospitalization; acceptance and commitment therapy
• Additional relevant MeSH terms: Mental Disorders; Problem Behavior

Study Results

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).

Arm/Group Title	Acceptance and Commitment Therapy	Enhanced Usual Care
Arm/Group Description	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	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.
Period Title: Overall Study
STARTED	9	5
COMPLETED	4	2
NOT COMPLETED	5	3

Baseline Characteristics

Arm/Group Title	Acceptance and Commitment Therapy	Enhanced Usual Care	Total
Arm/Group Description	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	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.	Total of all reporting groups
Overall Participants	9	5	14
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	8 88.9%	5 100%	13 92.9%
>=65 years	1 11.1%	0 0%	1 7.1%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	41.33 (17.30)	34.00 (12.39)	38.71 (15.64)
Sex: Female, Male (Count of Participants)
Female	5 55.6%	3 60%	8 57.1%
Male	4 44.4%	2 40%	6 42.9%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	2 22.2%	0 0%	2 14.3%
White	7 77.8%	5 100%	12 85.7%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (Count of Participants)
United States	9 100%	5 100%	14 100%

Outcome Measures

1. Primary Outcome

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.

Outcome Measure Data

Analysis Population Description

This analysis calculates the number of smokers screened in the partial hospitalization program who participated in the trial

Arm/Group Title	All Participants
Arm/Group Description	This outcome assesses interest in the trial prior to randomization.
Measure Participants	66
Count of Participants [Participants]	17 188.9%

2. Primary Outcome

Title	Percentage of Counseling Sessions Completed
Description	number of scheduled counseling sessions completed
Time Frame	through study completion, an average of 7 weeks.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Acceptance and Commitment Therapy	Enhanced Usual Care
Arm/Group Description	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	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.
Measure Participants	9	5
Number [percentage of sessions completed]	48	80

3. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

participants who completed the follow-up questionnaire

Arm/Group Title	Acceptance and Commitment Therapy	Enhanced Usual Care
Arm/Group Description	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	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.
Measure Participants	4	2
Mean (Standard Deviation) [units on a scale]	27.00 (6.63)	27.5 (0.71)

4. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

participants who completed the follow-up survey

Arm/Group Title	Acceptance and Commitment Therapy	Enhanced Usual Care
Arm/Group Description	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	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.
Measure Participants	4	2
Count of Participants [Participants]	0 0%	0 0%

5. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

all participants who started the intervention

Arm/Group Title	Acceptance and Commitment Therapy	Enhanced Usual Care
Arm/Group Description	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	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.
Measure Participants	9	5
Count of Participants [Participants]	1 11.1%	0 0%

6. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

participants who completed follow-up assessment

Arm/Group Title	Acceptance and Commitment Therapy	Enhanced Usual Care
Arm/Group Description	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	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.
Measure Participants	4	2
Mean (Standard Deviation) [units on a scale]	-4.25 (7.59)	-5.0 (7.07)

7. Other Pre-specified Outcome

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

Outcome Measure Data

Analysis Population Description

people who completed follow-up

Arm/Group Title	Acceptance and Commitment Therapy	Enhanced Usual Care
Arm/Group Description	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	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.
Measure Participants	4	2
Mean (Standard Deviation) [units on a scale]	-9.25 (15.69)	6.5 (6.36)

8. Other Pre-specified Outcome

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

Outcome Measure Data

Analysis Population Description

participants who completed the follow-up survey

Arm/Group Title	Acceptance and Commitment Therapy	Enhanced Usual Care
Arm/Group Description	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	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.
Measure Participants	4	2
Mean (Standard Deviation) [units on a scale]	4.25 (7.63)	4.5 (4.95)

Adverse Events

Time Frame	5 weeks (from enrollment to follow-up)
Arm/Group Title	Acceptance and Commitment Therapy		Enhanced Usual Care
Arm/Group Description	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		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.
All Cause Mortality
	Acceptance and Commitment Therapy		Enhanced Usual Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/9 (0%)		0/5 (0%)
Serious Adverse Events
	Acceptance and Commitment Therapy		Enhanced Usual Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/9 (0%)		0/5 (0%)
Other (Not Including Serious) Adverse Events
	Acceptance and Commitment Therapy		Enhanced Usual Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/9 (0%)		0/5 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.