Trial Outcomes & Findings for Acceptance and Commitment Therapy for Tobacco Cessation Among Psychiatric Partial Hospital Patients (NCT NCT03911960)

NCT ID: NCT03911960

Last Updated: 2020-09-25

Results Overview

proportion of smokers seen during the partial hospital visit who enroll in the study

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 17 participants
• Primary outcome timeframe: Through study completion, approximately 5 months.
• Results posted on: 2020-09-25

Participant Flow

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).

Participant milestones

Measure	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	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.
Overall Study STARTED	9	5
Overall Study COMPLETED	4	2
Overall Study NOT COMPLETED	5	3

Reasons for withdrawal

Measure	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	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.
Overall Study Lost to Follow-up	5	3

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Acceptance and Commitment Therapy n=9 Participants 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	Enhanced Usual Care n=5 Participants 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 n=14 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants	5 Participants n=7 Participants	13 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Age, Continuous	41.33 years STANDARD_DEVIATION 17.30 • n=5 Participants	34.00 years STANDARD_DEVIATION 12.39 • n=7 Participants	38.71 years STANDARD_DEVIATION 15.64 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants	5 Participants n=7 Participants	12 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	9 Participants n=5 Participants	5 Participants n=7 Participants	14 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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

proportion of smokers seen during the partial hospital visit who enroll in the study

Outcome measures

Measure	All Participants n=66 Participants This outcome assesses interest in the trial prior to randomization.	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.
Feasibility of Recruitment: Proportion of Smokers Seen During the Partial Hospital Visit Who Enroll in the Study	17 Participants	—

PRIMARY outcome

Timeframe: through study completion, an average of 7 weeks.

number of scheduled counseling sessions completed

Outcome measures

Measure	All Participants n=9 Participants This outcome assesses interest in the trial prior to randomization.	Enhanced Usual Care n=5 Participants 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.
Percentage of Counseling Sessions Completed	48 percentage of sessions completed	80 percentage of sessions completed

PRIMARY outcome

Timeframe: at study completion, an average of 7 weeks post-enrollment

Population: participants who completed the follow-up 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)

Outcome measures

Measure	All Participants n=4 Participants This outcome assesses interest in the trial prior to randomization.	Enhanced Usual Care n=2 Participants 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.
Client Satisfaction Questionnaire	27.00 units on a scale Standard Deviation 6.63	27.5 units on a scale Standard Deviation 0.71

PRIMARY outcome

Timeframe: At study completion, an average of 7 weeks post enrollment

Population: participants who completed the follow-up survey

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.

Outcome measures

Measure	All Participants n=4 Participants This outcome assesses interest in the trial prior to randomization.	Enhanced Usual Care n=2 Participants 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.
Number of Participants Who Are Rehospitalized for Psychiatric Reasons	0 Participants	0 Participants

SECONDARY outcome

Timeframe: at study completion, an average of 7 weeks post enrollment

Population: all participants who started the intervention

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.

Outcome measures

Measure	All Participants n=9 Participants This outcome assesses interest in the trial prior to randomization.	Enhanced Usual Care n=5 Participants 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.
Number of Participants Who Are Abstinent From Tobacco	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Change between baseline and study completion, 7 weeks post-enrollment

Population: participants who completed follow-up assessment

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)

Outcome measures

Measure	All Participants n=4 Participants This outcome assesses interest in the trial prior to randomization.	Enhanced Usual Care n=2 Participants 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.
Kessler 6	-4.25 units on a scale Standard Deviation 7.59	-5.0 units on a scale Standard Deviation 7.07

OTHER_PRE_SPECIFIED outcome

Timeframe: Change between baseline and study completion, 7 weeks post-enrollment

Population: people who completed follow-up

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.

Outcome measures

Measure	All Participants n=4 Participants This outcome assesses interest in the trial prior to randomization.	Enhanced Usual Care n=2 Participants 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.
Avoidance Inflexibility Scale	-9.25 units on a scale Standard Deviation 15.69	6.5 units on a scale Standard Deviation 6.36

OTHER_PRE_SPECIFIED outcome

Timeframe: Change between baseline and study completion, 7 weeks post-enrollment

Population: participants who completed the follow-up survey

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.

Outcome measures

Measure	All Participants n=4 Participants This outcome assesses interest in the trial prior to randomization.	Enhanced Usual Care n=2 Participants 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.
Commitment to Quitting Scale	4.25 units on a scale Standard Deviation 7.63	4.5 units on a scale Standard Deviation 4.95

Adverse Events

Acceptance and Commitment Therapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Enhanced Usual Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Sandra Japuntich

Hennepin Healthcare

Phone: 6128736856

Email: sandra.japuntich@hcmed.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place