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Completed

NCT Number: NCT03911960

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

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.

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Key information

Conditions

Tobacco Smoking Behavior Mental Disorders Psychiatric Disorder Psychiatric Hospitalization Smoking Tobacco Use

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Miriam Hospital

Providence, Rhode Island, 02906, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

Enhanced Usual Care

Behavioral

2 in person sessions of tobacco cessation counseling, up to 8 weeks of nicotine patch, referral to state quitline.

Primary outcomes

  1. Feasibility of Recruitment: Proportion of Smokers Seen During the Partial Hospital Visit Who Enroll in the Study

    Time frame: 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

    Time frame: through study completion, an average of 7 weeks.

    number of scheduled counseling sessions completed

  3. Client Satisfaction Questionnaire

    Time frame: 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

    Time frame: 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 outcomes

  1. Number of Participants Who Are Abstinent From Tobacco

    Time frame: 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

    Time frame: 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 outcomes

  1. Avoidance Inflexibility Scale

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

The Miriam Hospital

Other

Registry information

Official study title

Acceptance and Commitment Therapy for Tobacco Cessation Initiated in a Psychiatric Partial Hospital

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Apr 11, 2019
Registry last updated
Sep 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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